`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. IPR2015-00632
`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
`
`

`

`TABLE OF CONTENTS
`
`
`Page
`
`
`
` 
`I. 
`
`V. 
`
`Mandatory Notices (37 C.F.R. § 42.8) ....................................................................... 1 
`A. 
`Real Party-in-Interest ........................................................................................ 1 
`B. 
`Related Matters .................................................................................................. 1 
`C. 
`Counsel and Service Information ................................................................... 1 
`D. 
`Power of Attorney ............................................................................................ 2 
`Payment of Fees (37 C.F.R. § 42.103) ....................................................................... 2 
`II. 
`III.  Background and Summary of the ’773 Patent ......................................................... 2 
`IV.  Requirements for Inter Partes Review (37 C.F.R. § 42.104) ..................................... 5 
`A.  Grounds for Standing (37 C.F.R. § 42.104(b)(1)) ........................................ 5 
`B. 
`Identification of Challenged Claims and Specific Statutory
`Grounds (37 C.F.R. § 42.104(b)(1)-(2)) ......................................................... 5 
`Claim Construction (37 C.F.R. § 42.104(b)(3)) ............................................ 6 
`1. 
`“heat-treating the entire shank”/ “entire instrument shank” ........ 6 
`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” ................................................................................... 7 
`“permanent deformation” .................................................................14 
`3. 
`“diameter of 0.5 to 1.6 millimeters” .................................................14 
`4. 
`Effective Filing Date of the Challenged Claims ....................................................15 
`A. 
`Prior Applications in the ’773 Patent Family Do Not Support
`Heat Treatment in a Reactive Atmosphere ................................................16 
`Additional Reasons That the Challenged Claims Cannot Claim
`Priority to Earlier Applications .....................................................................19 
`VI.  How the Claims Are Unpatentable Under 37 C.F.R. § 42.104(b)(4) ..................20 
`A. 
`Level of Skill in the Art ..................................................................................20 
`B. 
`Ground 1: Anticipation of Claims 1-17 by Luebke 2008 .........................21 
`
`C. 
`
`B. 
`
`
`
`
`
`-i-
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`

`

`TABLE OF CONTENTS
`(continued)
`
`Page
`
`C. 
`
`F. 
`
`Ground 2: Anticipation of Claims 1-7 and 9-12 by Gao; Ground
`3: Obviousness of Claims 8 and 13-17 in View of Gao and ISO
`3630-1 ...............................................................................................................23 
`1. 
`Overview of Gao .................................................................................24 
`2. 
`Overview of ISO 3630-1 ....................................................................24 
`3. 
`Anticipation of Claims 1-7 and 9-12; Obviousness of
`Claims 8 and 13-17 ..............................................................................24 
`D.  Ground 4: Obviousness of Claims 1-17 in Further View of Khier ........28 
`E.  Ground 5: Anticipation of Claims 1, 2 and 9-12 by Kuhn; Ground
`6: Obviousness of Claims 8, 13, 15 and 17 in View of Kuhn and
`ISO 3630-1 .......................................................................................................28 
`1. 
`Overview of Kuhn ..............................................................................29 
`2. 
`Anticipation of Claims 1, 2, and 9-12; Obviousness of
`Claims 8, 13, 15 and 17 ......................................................................29 
`Ground 7: Obviousness of Claims 1-17 in View of Kuhn, ISO
`3630-1, Pelton and McSpadden ....................................................................34 
`1. 
`Overview of McSpadden ...................................................................34 
`2. 
`Overview of Pelton .............................................................................34 
`3. 
`Obviousness of Claims 1-17 ..............................................................35 
`G.  Grounds 8 and 9: Obviousness of Claims 1-17 in Further View of
`Khier .................................................................................................................43 
`H.  Ground 10: Obviousness of Claims 1-17 in View of McSpadden,
`Miyazaki, and ISO 3630-1 .............................................................................43 
`1. 
`Overview of Miyazaki .........................................................................43 
`2. 
`Obviousness of Claims 1-17 ..............................................................45 
`Ground 11: Obviousness of Claims 1-17 in View of Matsutani,
`Pelton, and ISO 3630-1 .................................................................................49 
`1. 
`Overview of Matsutani .......................................................................49 
`2. 
`Obviousness of claims 1-17 ...............................................................51 
`Ground 12: Obviousness of Claims 1-17 in Further View of Khier ......58 
`-ii-
`
`
`I. 
`
`J. 
`
`
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`
`

`

`TABLE OF CONTENTS
`(continued)
`
`Page
`
`
`
`The Grounds in This Petition Are Not Redundant ..................................58 
`K. 
`VII.  Conclusion ...................................................................................................................60 
`
`
`
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`-iii-
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`

`

`
`
`Exhibit #
`
`LISTING OF EXHIBITS
`
`
`Exhibit Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`U.S. Patent No. 8,727,773 B2 (the “’773 patent”)
`
`Declaration of A. Jon Goldberg
`Harmeet Walia et al., An Initial Investigation of the Bending and Tor-
`sional Properties of Nitinol Root Canal Files, 14 J. ENDODONTICS
`346 (1988) (“Walia”)
`Fujio Miura et al., The super-elastic property of the Japanese NiTi alloy
`wire for use in orthodontics, 90 AM. J. ORTHODONTICS & DENTOFA-
`CIAL ORTHOPEDICS 1 (1986) (“Miura”)
`
`Satish B. Alapati, “An investigation of phase transformation
`mechanisms for nickel-titanium rotary endodontic instruments,”
`PhD thesis, 2006. (“Alapati”)
`
`Alan R. Pelton et al., Optimisation of Processing and Properties
`of Medical-Grade Nitinol Wire, 9 Minimally Invasive Therapies
`& Allied Techs. 107 (2000) (“Pelton”);
`
`U.S. Patent No. 5,697,906 to Ariola et al.
`
`Prosecution history of the ’773 patent
`
`Prosecution history of U.S. Patent No. 8,062,033
`
`Prosecution history of U.S. Patent No. 8,562,341
`
`US. Provisional Patent Application No. 60/578,091
`
`U.S. Patent Application Publication No. 2008/0032260 A1,
`Luebke (“Luebke 2008”)
`
`Prosecution history of U.S. Patent No. 8,083,873
`
`U.S. Patent Application Publication No. 2011/0271529 A1, Gao
`et al. (“Gao”)
`
`U.S. Provisional Patent Application No. 61/332,954
`
`
`
`
`
`-iv-
`
`
`
`

`

`LISTING OF EXHIBITS
`(continued)
`
`International Standard ISO 3630-1, 1st ed. (1992)
`
`International Standard ISO 3630-1, 2nd ed. (2008)
`Salwa E. Khier et al., Bending properties of superelastic and nonsupere-
`lastic nickel-titanium orthodontic wires, 99 AM. J. ORTHODONTICS &
`DENTOFACIAL ORTHOPEDICS 310 (1991) (“Khier”)
`Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical Proper-
`ties of Nickel-Titanium Endodontic Instruments, 28 J. ENDODONTICS
`716 (2002) (“Kuhn”)
`
`U.S. Patent No. 5,628,674 to Heath et al.
`Edgar Schäfer et al., Bending properties of rotary nickel-titanium in-
`struments, 96 ORAL SURGERY ORAL MEDICINE ORAL PATHOLO-
`GY 757 (2003)
`
`U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et al.
`(“McSpadden”)
`
`U.S. Patent No. 7,713,815 B2 to Matsutani et al. (“Matsutani”)
`S. Miyazaki et al., Characteristics of Deformation and Transformation
`Pseudoelasticity in Ti-Ti Alloys, 43 J. PHYSIQUE COLLOQUES C4-
`255 (1982) (“Miyazaki”)
`
`Franklin S. Weine, ENDODONTIC THERAPY, 6th Ed., 2004,
`Chapter 5 (“Weine”)
`
`Japanese Unexamined Patent Application Publication No. 2006-
`149675, Matsutani et al.
`
`English translation of Japanese Unexamined Patent Application
`Publication No. 2006-149675, Matsutani et al.
`
`
`
`-v-
`
`
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`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 1-17 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. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Party-in-Interest
`
`Petitioner US Endodontics, LLC is the real party-in-interest.
`
`B. Related Matters
`
`The ’773 patent is currently being asserted against Petitioner by licensee
`
`Dentsply International, Inc. (“Dentsply”) and its wholly owned subsidiary Tulsa Den-
`
`tal 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). Petitioner is not aware of any pending administrative matter that 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
`
`
`
`- 1 -
`
`

`

`
`
`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. § 42.103)
`
`The required fee of $23,800 is being paid through the Patent Review Processing
`
`System. The USPTO is authorized to charge any fee deficiency, or credit any over-
`
`payment, to Deposit Account 11-0600 (Kenyon & Kenyon LLP).
`
`III. BACKGROUND AND SUMMARY OF THE ’773 PATENT
`
`The ’773 patent describes a method of modifying a nickel titanium endodontic
`
`instrument for use in root canal therapy. A root canal involves drilling through the
`
`hard outer portion of a tooth and removing diseased tissue (pulp) from the inside. A
`
`thin 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. 1002 at ¶ 23.
`
`As claimed, the file (or other endodontic instrument) includes a component
`
`made from a superelastic, nickel titanium (“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 nickel
`
`titanium alloy. As a result of the heat treatment, the instruments allegedly “exhibit
`
`higher resistance to torsion breakage, can withstand increased strain, have higher flex-
`
`ibility, have increased fatigue life and maintain any acquired shape upon fracture bet-
`
`
`
`- 2 -
`
`

`

`
`
`ter.” Ex. 1001 at 9:19-23.
`
`The nickel titanium 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. Ex. 1003. When appropriately processed, Ni-Ti can exhib-
`
`it both superelasticity (also known as pseudoelasticity) and shape memory. Superelas-
`
`ticity 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 one that is flexible and does not revert to its original shape immediately after it is
`
`deformed. However, when the material is heated past a transformation temperature
`
`(austenite finish temperature), it reverts to its pre-deformation shape. In other words,
`
`it “remembers” its original shape. Ex. 1002 at ¶ 27.
`
`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: aus-
`
`tenite and martensite. In the austenite phase, the individual atoms in the crystal are
`
`arranged rigidly, whereas in the martensite phase, the atoms can shift within the lat-
`
`tice, making the material more flexible. The transformation between austenite and
`
`martensite depends principally on temperature, with martensite occurring at lower
`
`temperatures. Ex. 1002 at ¶ 28-29; see Ex. 1004 at 5-6; Ex. 1005 at 25.
`
`When Ni-Ti is in the martensite phase at ambient temperatures, it exhibits
`
`shape memory; when subjected to a bending force it will stay deformed, returning to
`- 3 -
`
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`
`

`

`
`
`its original shape when heated above a transformation temperature to form austenite.
`
`When ambient temperatures are higher than the transformation temperature, Ni-Ti is
`
`stable as austenite rather than martensite. However, a sufficient applied stress may
`
`transform the austenite phase into a more flexible but meta-stable martensite phase
`
`despite being above its transformation temperature, allowing considerably more de-
`
`formation. When the stress is released, Ni-Ti reverts quickly to the austenite phase,
`
`returning the object to its previous shape. This is superelasticity. Ex. 1002 at ¶¶ 30-31;
`
`Ex. 1004 at 5-6; Ex. 1005 at 25.
`
`As noted above, the transformation between stable austenite and martensite
`
`phases occurs as a result of temperature changes. Above a transformation tempera-
`
`ture, the Ni-Ti is austenite; below, it is martensite. By 2004, it was well known in the
`
`art that heat treatment of Ni-Ti could change the transformation temperature ranges.
`
`Ex. 1002 at ¶ 32; see, e.g., Ex. 1006 at 367-69; Ex. 1007 at 3:12-30. The invention of the
`
`’773 patent, as described by the applicant, is the use of heat treatment to increase the
`
`transformation temperature (austenite finish temperature) so that a Ni-Ti endodontic
`
`file, under conditions of use (i.e., at body temperature), is in the martensite phase ra-
`
`ther than the austenite phase such that it will exhibit non-superelastic properties. See
`
`Ex. 1008 at 144-60; 1 Ex. 1002 at ¶¶ 33-34. This enables the Ni-Ti file to maintain a
`
`
`1
`Cites to prosecution history exhibits are to the page numbers added by Peti-
`
`tioner. In other instances, page cites are to the original document numbering.
`
`
`
`- 4 -
`
`

`

`
`
`curved shape when subjected to a bending force. In other words, when subjected to a
`
`bending force, the Ni-Ti file will remain bent (deformed) until heated to a tempera-
`
`ture above the austenite transformation temperature.
`
`IV. 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 less than one year after the date on which Petitioner, the real party-in-
`
`interest, was served with a complaint alleging infringement of the ’773 patent. Peti-
`
`tioner is not barred or estopped from requesting IPR.
`
`B. Identification of Challenged Claims and Specific Statutory Grounds (37
`C.F.R. § 42.104(b)(1)-(2))
`
`Petitioner challenges claims 1-17 of the ’773 patent (“the Challenged Claims”)
`
`under 35 U.S.C. §§ 102 and 103, as set forth below. Cancellation of these claims is re-
`
`quested. Petitioner requests that claims 1-17 be cancelled on the following grounds:2
`
`Ground 1: Claims 1-17 under § 102(b) by Luebke 2008
`
`Ground 2: Claims 1-7 and 9-12 under § 102(a) and (e) by Gao
`
`Ground 3: Claims 8 and 13-17 under § 103(a) over Gao and ISO 3630-1
`
`Ground 4: Claims 1-17 under § 103(a) over Gao, ISO 3630-1, and Khier
`
`Ground 5: Claims 1, 2, and 9-12 under § 102(b) by Kuhn
`
`2
`With respect to § 103 Grounds, Petitioner also relies on the knowledge of one
`
`of ordinary skill, as explained in further detail in Section VI.
`
`
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`

`
`
`Ground 6: Claims 8, 13, 15 and 17 under § 103(a) over Kuhn and ISO 3630-1
`
`Ground 7: Claims 1-17 under § 103(a) over Kuhn, ISO 3630-1, McSpadden, and
`
`Pelton
`
`Ground 8: Claims 1-17 under § 103(a) over Kuhn, ISO 3630-1, and Khier
`
`Ground 9: Claims 1-17 under § 103(a) over Kuhn, ISO 3630-1, McSpadden, Pelton,
`
`and Khier
`
`Ground 10: Claims 1-17 under § 103(a) over McSpadden, Miyazaki, and ISO 3630-1
`
`Ground 11: Claims 1-17 under § 103(a) over Matsutani, Pelton, and ISO 3630-1
`
`Ground 12: Claims 1-17 under § 103(a) over Matsutani, Pelton, ISO 3630-1, and
`
`Khier
`
`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 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 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. 1001 at Ab-
`
`
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`- 6 -
`
`

`

`
`
`stract, 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. Additional-
`
`ly, 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 V,
`
`regarding priority date).
`
`The contrary position is that (i) the claim language does not expressly limit heat
`
`treatment to an unreactive atmosphere, and (ii) dependent claims 4-6 and 16 purport
`
`to cover treatment in “any atmosphere,” which includes “unreactive, ambient or any
`
`other acceptable heat treatment process.”3 For the purposes of this proceeding, the
`
`Board must apply the “broadest reasonable construction.” Under this standard, and
`
`for purposes of this proceeding only, Petitioner submits that the claims should be
`
`construed to include heat treatment in any environment.
`
`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. Petitioner sub-
`
`mits that, for the purpose of patentability under 35 U.S.C. §§ 102-103, this clause
`
`should not be considered a limitation because it only states the intended result of per-
`
`forming the claimed heat treatment process. However, if the “wherein” clause is de-
`
`
`3
`These claims represent the first disclosure, in any of the applications to which
`
`the ’773 claims priority, of heat treatment in anything other than “an atmosphere con-
`
`sisting essentially of a gas unreactive with the shank.” See Section V.A., infra.
`
`
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`- 7 -
`
`

`

`
`
`termined to be a limitation, then, based on the applicant’s representations and argu-
`
`ments during prosecution, it is met by a prior art reference disclosing “some degree of
`
`permanent deformation” and/or by a heat-treated file with an austenite finish temper-
`
`ature above mouth temperature. These points are explained further below.
`
`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 8-9 (PTAB Mar. 21, 2014) (finding “where-
`
`in” clause not limiting insofar as it described intended result); M.P.E.P. § 2111.04.
`
`The “wherein” clause at issue here 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 re-
`
`quire the performance of any additional step(s). It is just the intended result.
`
`As shown below, step (a) involves the provision of a known instrument, and
`
`step (b) involves the application of a ubiquitous metallurgical technique to that in-
`
`strument. The “wherein” clause merely recites the result of a known or obvious pro-
`
`cess—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,
`- 8 -
`
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`

`

`
`
`1274-76 (Fed. Cir. 2010). In fact (as shown below in Section VI), 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.
`
`The foregoing is consistent with the examiner’s apparent understanding of this
`
`clause. 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 defor-
`
`mation after torque at 45 degrees of flexion.” Ex. 1008 at 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 73 (emphasis supplied). In response, the ap-
`
`plicant amended the claim to recite a nickel and titanium alloy in a particular ratio, id.
`
`at 100, without asserting any error in the examiner’s reasoning. See id. at 103. Thereaf-
`
`ter, the examiner withdrew the enablement rejection. See id. at 125-31. When he even-
`
`tually 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 227-28 (emphasis supplied). In other
`
`words, the examiner did not treat the “wherein” clause as a limitation on the method,
`- 9 -
`
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`

`
`
`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 su-
`
`perelasticity, 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 prop-
`erties as the claimed invention (same material/manufacture steps). It is
`only after Patel’s wire is cold 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.
`
`Id. at 129 (underline emphasis supplied). Thus, in addition to noting that the prior art
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`need not show the flexion test, the examiner concluded that because the prior art
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`showed the “same material/manufacture steps” as the claimed invention, it also
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`“would have the same properties.” Id. Following this rejection, the applicant requested
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`an interview with the examiner, agreeing with the examiner’s reasoning that the flex-
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`ion test “is only referred to inferentially” but disagreeing with his conclusion that Pa-
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`tel’s heat-treated wire would have the same properties. See id. at 145. The applicant
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`submitted sixteen pages of notes distinguishing Patel (U.S. Pat. App. Pub. No.
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`2005/0090844) as “evidence that the Patel device is superelastic and that the subject
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`matter of claim 1 does not have this property.” See id. at 145-60. The applicant, Neill
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`Luebke, argued that, unlike the prior art, the instrument resulting from his method
`
`had a high enough transformation temperature that, during clinical use at body tem-
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`perature (37°C), the instrument would be in the martensitic phase. See id.
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`Following the interview, the examiner expressed his understanding of the ap-
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`plicant’s invention to be heat treatment of a superelastic instrument that results in
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`“non-superelastic properties that allows for some degree of permanent deformation,”
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`in contrast to the prior art in which heat treatment was used “to arrive at a superelas-
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`tic device.” Id. at 163. Despite the fact that the pending claim included a “wherein”
`
`clause requiring post-treatment permanent deformation, the examiner suggested that
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`the applicant amend the claim to distinguish the prior art. Id. In other words, the ex-
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`aminer declined to give any weight to the “wherein” clause; if he had considered the
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`“wherein” clause to be a limitation, then the applicant’s argument that Patel did not
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`disclose a permanently deformable device (which the Examiner accepted) would have
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`itself been enough. Instead, and in response to the examiner’s suggestion, the appli-
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`cant amended the claim to add the requirement that the starting material, prior to the
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`heat-treatment step, be a “superelastic nickel titanium alloy.” Id. at 168-70.
`
`In sum, the “wherein” clause describes the intended result; it does not alter the
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`method itself in any way. It therefore does not confer patentable weight and is not
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`limiting for the purpose of determining patentability over the prior art.4
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`If the Board disagrees with Petitioner’s position that the “wherein” clauses at
`
`issue are not limiting, the Board should nevertheless find that the prior art sufficiently
`
`satisfies those limitations if it discloses a method of making a heat-treated instrument
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`that “allows for some degree of permanent deformation” (to quote the examiner’s
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`understanding of the invention). See Ex. 1008 at 227-28. During prosecution, neither
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`the examiner nor the applicant thought it necessary to show that a heat-treated in-
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`strument actually would (or would not), if tested, meet the precise condition that the
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`claims purport to require. “[W]here the general conditions of a claim are disclosed in
`
`the prior art … it is not inventive to discover the optimum or workable ranges by rou-
`
`tine experimentation.” K-Swiss Inc. v. Gilde’n Lock GmbH, 567 F. App’x 906, 913 (Fed.
`
`Cir. 2014) (finding claims obvious even though prior art did not disclose specifically
`
`
`Petitioner notes that in Griffin v. Bertina, 285 F.3d 1029, 1032-34 (Fed. Cir.
`4
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`2002), “wherein” clauses in an interference count were held to be limiting because
`
`they gave “meaning and purpose to the manipulative steps.” There, the issue was
`
`whether a party had shown reduction to practice, which “does not occur until the in-
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`ventor has determined that the invention will work for its intended purpose.” Id. (cita-
`
`tion omitted). By contrast, under Minton, the intended purpose of a claimed method
`
`cannot patentably distinguish it over the prior art, even if stated in the claim itself.
`
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`claimed “deformation percentage”). Here, the 10-degree threshold is not even de-
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`scribed as an optimum or working range, but merely as an arbitrary limit.
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`Additionally, if the Board finds that the “wherein” phrase is limiting, it should
`
`also find that it is met by the prior art disclosure of a heat-treated file with an austenite
`
`finish temperature (or transition temperature) of 37°C or greater. As discussed above,
`
`during prosecution, the applicant argued that the device disclosed by Patel was su-
`
`perelastic (and did not meet the “wherein” clause) because it had an austenite finish
`
`temperature between 26°C and 36°C. The applicant argued that, unlike Patel, the
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`Luebke application results in transition temperatures of 39°C, which is above body
`
`temperature. Ex. 1008 at 147. The applicant further argued that “the temperature of
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`the body is NOT sufficient to transform the Luebke application instrument or device
`
`to austenite,” meaning that it remained martensite and was not superelastic. Id. at 152
`
`(capitalized emphasis in original). The applicant noted that, by heat-treating for two
`
`hours at 500°C, an Af of 39°C is obtained, and stated, “This is what this application
`
`accomplishes.” Id. at 159.
`
`The applicant also linked the recited 10 degrees of permanent deformation to
`
`an austenite finish temperature above body temperature during prosecution of a relat-
`
`ed application. Specifically, during prosecution of U.S. App. No. 11/628,933 (“’933
`
`app.”), the applicant relied upon a declaration from Prof. David Berzins, who com-
`
`pared files heat-treated in air with those heat-treated according to the Luebke applica-
`
`tion, i.e., in argon. Ex. 1009 at 405, 408-14. Dr. Berzins explained that, unlike the files
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`heat-treated in air, the files heat-treated according to the Luebke application “dis-
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`played Af temperatures of 37.5 +/- 0.9°C, which is more consistent with a shape-
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`memory file.” Ex. 1009 at 410, ¶ 8 (internal citations omitted). The claims pending in
`
`the ’933 app. at the time that the applicant submitted the Berzins declaration all in-
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`cluded the same “wherein” language as the Challenged Claims. Although Prof. Ber-
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`zins did not mention subjecting any of the heat-treated files he analyzed to the recited
`
`ISO 3630-1 test, the applicant relied on Berzins’ “Af temperature” explanation to dis-
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`tinguish the claimed files from the prior art Id. at 406.
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`3. “permanent deformation”
`
`Claims 1 and 13 each contains this term within the “wherein” clause discussed
`
`above. If the Board concludes that the “wherein” clause is a limitation, Petitioner
`
`submits that “permanent deformation” means “deformation remaining after force is
`
`removed.” Permanent deformation need not be “permanent” in the sense that the in-
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`strument never returns to its original shape. See, e.g., Ex. 1008 at 110 (applicant ex-
`
`plaining that “martensitic Ni-Ti” exhibited permanent deformation). Martensitic Ni-
`
`Ti will stay deformed when bent. See Ex. 1002 at ¶ 30; Section III, supra.
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`4. “diameter of 0.5 to 1.6 millimeters”
`Claim 8 recites that “the instrument shank has a diameter of 0.5 to 1.6 millime-
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`ters.” The diameters of tapered endodontic files are usually measured at the tip, but
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`the specification makes clear that claim 8 refers to the proximate end, i.e., the end that
`
`is connected to the handle. Ex. 1001 at 4:1-6; Fig. 1a. Therefore, Petitioner submits
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