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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
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I. 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
II. Payment of Fees (37 C.F.R. § 42.103) ....................................................................... 2
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
C. 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
3. “permanent deformation” .................................................................14
4. “diameter of 0.5 to 1.6 millimeters” .................................................14
V. 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
B. 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
TABLE OF CONTENTS (continued)
Page
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C. 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
F. 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
I. 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
J. Ground 12: Obviousness of Claims 1-17 in Further View of Khier ......58
TABLE OF CONTENTS (continued)
Page
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K. The Grounds in This Petition Are Not Redundant ..................................58
VII. Conclusion ...................................................................................................................60
LISTING OF EXHIBITS
-iv-
Exhibit # Exhibit Description
1001 U.S. Patent No. 8,727,773 B2 (the “’773 patent”)
1002 Declaration of A. Jon Goldberg
1003 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”)
1004 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”)
1005 Satish B. Alapati, “An investigation of phase transformation mechanisms for nickel-titanium rotary endodontic instruments,” PhD thesis, 2006. (“Alapati”)
1006 Alan R. Pelton et al., Optimisation of Processing and Properties of Medical-Grade Nitinol Wire, 9 Minimally Invasive Therapies & Allied Techs. 107 (2000) (“Pelton”);
1007 U.S. Patent No. 5,697,906 to Ariola et al.
1008 Prosecution history of the ’773 patent
1009 Prosecution history of U.S. Patent No. 8,062,033
1010 Prosecution history of U.S. Patent No. 8,562,341
1011 US. Provisional Patent Application No. 60/578,091
1012 U.S. Patent Application Publication No. 2008/0032260 A1, Luebke (“Luebke 2008”)
1013 Prosecution history of U.S. Patent No. 8,083,873
1014 U.S. Patent Application Publication No. 2011/0271529 A1, Gao et al. (“Gao”)
1015 U.S. Provisional Patent Application No. 61/332,954
LISTING OF EXHIBITS (continued)
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1016 International Standard ISO 3630-1, 1st ed. (1992)
1017 International Standard ISO 3630-1, 2nd ed. (2008)
1018 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”)
1019 Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical Proper-ties of Nickel-Titanium Endodontic Instruments, 28 J. ENDODONTICS 716 (2002) (“Kuhn”)
1020 U.S. Patent No. 5,628,674 to Heath et al.
1021 Edgar Schäfer et al., Bending properties of rotary nickel-titanium in-struments, 96 ORAL SURGERY ORAL MEDICINE ORAL PATHOLO-
GY 757 (2003)
1022 U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et al. (“McSpadden”)
1023 U.S. Patent No. 7,713,815 B2 to Matsutani et al. (“Matsutani”)
1024 S. Miyazaki et al., Characteristics of Deformation and Transformation Pseudoelasticity in Ti-Ti Alloys, 43 J. PHYSIQUE COLLOQUES C4-255 (1982) (“Miyazaki”)
1025 Franklin S. Weine, ENDODONTIC THERAPY, 6th Ed., 2004, Chapter 5 (“Weine”)
1026 Japanese Unexamined Patent Application Publication No. 2006-149675, Matsutani et al.
1027 English translation of Japanese Unexamined Patent Application Publication No. 2006-149675, Matsutani et al.
- 1 -
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: [email protected]; [email protected]; and
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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-
- 3 -
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
- 4 -
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.
- 5 -
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-
- 7 -
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.
- 8 -
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,
- 9 -
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,
- 10 -
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
need not show the flexion test, the examiner concluded that because the prior art
showed the “same material/manufacture steps” as the claimed invention, it also
“would have the same properties.” Id. Following this rejection, the applicant requested
an interview with the examiner, agreeing with the examiner’s reasoning that the flex-
ion test “is only referred to inferentially” but disagreeing with his conclusion that Pa-
- 11 -
tel’s heat-treated wire would have the same properties. See id. at 145. The applicant
submitted sixteen pages of notes distinguishing Patel (U.S. Pat. App. Pub. No.
2005/0090844) as “evidence that the Patel device is superelastic and that the subject
matter of claim 1 does not have this property.” See id. at 145-60. The applicant, Neill
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-
perature (37°C), the instrument would be in the martensitic phase. See id.
Following the interview, the examiner expressed his understanding of the ap-
plicant’s invention to be heat treatment of a superelastic instrument that results in
“non-superelastic properties that allows for some degree of permanent deformation,”
in contrast to the prior art in which heat treatment was used “to arrive at a superelas-
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
the applicant amend the claim to distinguish the prior art. Id. In other words, the ex-
aminer declined to give any weight to the “wherein” clause; if he had considered the
“wherein” clause to be a limitation, then the applicant’s argument that Patel did not
disclose a permanently deformable device (which the Examiner accepted) would have
itself been enough. Instead, and in response to the examiner’s suggestion, the appli-
cant amended the claim to add the requirement that the starting material, prior to the
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
- 12 -
method itself in any way. It therefore does not confer patentable weight and is not
limiting for the purpose of determining patentability over the prior art.4
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
that “allows for some degree of permanent deformation” (to quote the examiner’s
understanding of the invention). See Ex. 1008 at 227-28. During prosecution, neither
the examiner nor the applicant thought it necessary to show that a heat-treated in-
strument actually would (or would not), if tested, meet the precise condition that the
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
4 Petitioner notes that in Griffin v. Bertina, 285 F.3d 1029, 1032-34 (Fed. Cir.
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-
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.
- 13 -
claimed “deformation percentage”). Here, the 10-degree threshold is not even de-
scribed as an optimum or working range, but merely as an arbitrary limit.
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
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
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
- 14 -
heat-treated in air, the files heat-treated according to the Luebke application “dis-
played Af temperatures of 37.5 +/- 0.9°C, which is more consistent with a shape-
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-
cluded the same “wherein” language as the Challenged Claims. Although Prof. Ber-
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-
tinguish the claimed files from the prior art Id. at 406.
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-
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.
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-
ters.” The diameters of tapered endodontic files are usually measured at the tip, but
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
- 15 -
that this term means “diameter of 0.5 to 1.6 millimeters at the proximate end.”
V. EFFECTIVE FILING DATE OF THE CHALLENGED CLAIMS
GSI bears the ultimate burden of demonstrating entitlement to an earlier appli-
cation’s filing date. See In re NTP, Inc., 654 F.3d 1268, 1276-77 (Fed. Cir. 2011). This
burden is not satisfied merely because the later application is a “continuation” of the
earlier one and shares the same specification. See Research Corp. Techs. v. Microsoft Corp.,
627 F.3d 859, 865, 869-70 (Fed. Cir. 2010). To meet its burden, GSI must show that
the claimed invention was “disclosed in the manner provided by the first paragraph of
[35 U.S.C.] section 112” in the earlier application. 35 U.S.C. § 120 (2006); see Anascape,
Ltd. v. Nintendo of Am., Inc., 601 F.3d 1333, 1334-35 (Fed. Cir. 2010). If the earlier ap-
plication is not an immediate parent, every intervening application must comply with
section 112. Lockwood v. Am. Airlines, 107 F.3d 1565, 1571 (Fed. Cir. 1997). The earlier
application(s) must “reasonably convey[ ] to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc.
v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The claimed combi-
nation, not just its individual elements, must be described. See Hyatt v. Dudas, 492 F.3d
1365, 1369-71 (Fed. Cir. 2007).
Petitioner identifies the following non-exhaustive set of reasons that demon-
strate that GSI will not be able to meet its burden of proving that the claims at issue
are entitled to a filing date earlier than April 25, 2012, the actual filing date of the ap-
plication (“the ’841 app.”) that directly led to the ’773 patent.
- 16 -
A. Prior Applications in the ’773 Patent Family Do Not Support Heat Treatment in a Reactive Atmosphere
If the Board concludes that the “heat-treating” step of claims 1 and 13 includes
treatment in any environment, including environments reactive with nickel titanium,
then claims 1-17 are not entitled to an effective filing date earlier than April 25, 2012.
The first disclosure, in any application related to the ’773 patent, of heat-
treating in an atmosphere other than one in which nickel titanium is unreactive ap-
peared in the original claims of the’841 app., which was filed on April 25, 2012. The
disclosure of every earlier continuation application is limited to conducting the “heat-
treating” step in an atmosphere consisting essentially of a gas unreactive with nickel
titanium, and no other atmosphere. Every discussion of heat treatment in the earlier
applications, except in the context of optionally heat treating coated instruments (Ex.
1009 at 32), specifies that an unreactive atmosphere is used, such that one of ordinary
skill would understand the unreactive atmosphere to be a requirement, not an option.
Ex. 1002 at ¶¶ 47-58. And earlier applications distinguish coated instruments (includ-
ing ones with an “inherent heat treatment”) from the claimed, heat-treated instru-
ments. Id. at ¶ 52; See, e.g., Ex. 1009 at 33-36. Thus, one of ordinary skill would have
understood the heat-treating step disclosed by every priority application to the ’773
patent to require heat-treating in an unreactive atmosphere. Ex. 1002 at ¶¶ 57-58.5
5 GSI’s licensee argued in the pending district court litigation that a passing ref-
erence to chemical vapor deposition (CVD) in earlier-filed applications supports
- 17 -
This is confirmed by the prosecution history of an earlier application in the
same family as the ’773 patent, namely the ’933 app. As noted above, during the pros-
ecution of that application, the applicant submitted a declaration of Prof. Berzins.
Berzins 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 proper-
ties and transformations.” Ex. 1009 at 411. Berzins stated that he performed the same
heat treatment described in the examples of the ’773 patent (and earlier applica-
tions)—500°C for 75 minutes—except that the atmosphere was air rather than argon.
See id. at 409. He informed the PTO that such treatment produced shanks that re-
mained superelastic at both room temperature and mouth temperature, id. at 409-10,
contrary to the goals of the applicant’s invention. Prof. Berzins did not identify any
portion of the shank that was not, in his view, superelastic following heat-treatment in
air.6 Citing this declaration, and distinguishing the prior art (Matsutani, Ex. 1023), the
claims to heat treatment in reactive atmospheres. See, e.g., Ex. 1009 at 32-33. This is
wrong because (i) there is no disclosure that CVD would occur at the claimed heat-
treatment times and temperatures or would result in permanent deformation, and
(ii) the atmosphere in which CVD takes place (in contrast to the reactants) is typically
inert, as is the case with the only chemical vapor deposition reference cited in the ’773
patent. Ex. 1002 at ¶ 55.
6 GSI’s licensee has asserted that Prof. Berzins only subjected part of the instru-
- 18 -
applicant argued that “heat-treating the instrument in an atmosphere consisting essen-
tially 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 re-
moved. Id. at 405-06. Although Prof. Berzins did not perform the claimed flexion
test—an exercise the applicant evidently thought unnecessary—the declaration indi-
cated that the air-heat-treated shank would not pass such test. The applicant endorsed
that belief in response to an outstanding rejection. Id. at 406. It is also apparent that
the examiner accepted the applicant’s representations, remarking that the temperature
range and treatment environment had “been shown critical in providing distinguishing
shape memory qualities along the entire length of the shank from the prior art, which
teaches heat treatment at temperatures outside this range … and without the de-
scribed atmosphere.” Id. at 494. See also Ex. 1002 at ¶ 57.
Given the applicant’s representations that replacing the only heat treatment
conditions actually disclosed in the application (that is, heat-treating in an atmosphere
unreactive with Ni-Ti) with an air atmosphere (an atmosphere reactive with Ni-Ti)
fails to produce the desired results, and the PTO’s reliance on such representations, it
cannot be said that applicant possessed an invention comprising conducting the heat-
treatment step in atmospheres that are both reactive and unreactive with Ni-Ti prior
ment to heat treatment. Even if true, the declaration indicates that the entire file re-
mained superelastic after heat treatment in air. Ex. 1002 at ¶ 57.
- 19 -
to the April 25, 2012 filing date of the ’841 app.
For the reasons discussed above, the applicant considered the unreactive at-
mosphere to be an essential part of his invention when he filed his earlier applications,
which do not describe heat treatment in any other atmosphere. Therefore, if the
claims of the ’773 patent are not limited to treatment in an unreactive atmosphere,
then they are not entitled to a priority date earlier than April 25, 2012.
B. Additional Reasons That the Challenged Claims Cannot Claim Priority to Earlier Applications
An adequate written description must describe the claimed combination, not
just the individual elements thereof. Hyatt, 492 F.3d at 1369-71. Therefore, if the
“wherein” clause is determined to be limiting, GSI must show that the earlier applica-
tion(s) described the achievement of the claimed result using the claimed heat treat-
ments, including the claimed time and temperature ranges, rather than merely the spe-
cific treatment conditions described in Example 4, i.e., heat treating at 500°C, for 75
minutes in an argon atmosphere. See Ex. 1009 at 35-36. The earlier filed applications
do not. Example 4 is the only section in any of the priority applications, other than
certain of the claims (which differ in the various applications), that discusses perma-
nent deformation. Heat treatments using times and temperatures other than 500°C,
for 75 minutes, and atmospheres other than argon, mentioned elsewhere in the speci-
fications are not described as imparting any degree of permanent deformation.
Additionally, the Patent Owner must show continuity of disclosure to support
- 20 -
a priority claim. See Liberty Mutual Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00003,
Institution Decision (Paper 15), at 18. Therefore, at least to the extent that GSI relies
on the claims of earlier applications, it must specifically point to equivalent disclosures
in all intervening applications. See id. As an example, while claim 11 of the ’933 app.
includes a “wherein” clause similar to the “wherein” clauses in the Challenged Claims,
Ex. 1009 at 10, intervening application number 13/336,579 has no such clause in any
original claim. Ex. 1010 at 29-31. Petitioner submits that Example 4 alone is not
enough to establish support for the “wherein” clause, and even if claim 11 of the ’933
application cures that deficiency, the priority date of the ’773 patent should be its
April 25, 2012 filing date because continuity is lacking.
Finally, Provisional App. No. 60/578,091 lacks any of the examples in the ’773
patent. Ex. 1011. It makes no mention of the claimed bend-testing or permanent de-
formation.
VI. 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 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 Ph.D. or equivalent degree in materials
science, metallurgy, or a related field and at least one year of experience so as to un-
- 21 -
derstand the structural, chemical, and mechanical properties that can be manipulated
in nickel titanium alloy materials used in dental applications. Ex. 1002 at ¶ 62. This
level of education and experience applies whether the invention is deemed to have
been made in 2004, 2012, or any time in between. Id.
B. Ground 1: Anticipation of Claims 1-17 by Luebke 2008
Luebke 2008 published February 7, 2008 and is one of the underlying applica-
tions that is part of the priority chain for the ’773 patent. Because the ’773 patent is
not entitled to a priority date earlier than its own filing date of April 25, 2012 (see supra
section V), Luebke 2008 is prior art patent under § 102(b). Petitioner’s arguments re-
garding the claims’ lack of entitlement to an earlier filing date are based on the failure
of earlier applications to describe the claims in their full scope. As such, Petitioner’s
argument that Luebke 2008 anticipates the Challenged Claims is consistent with its
argument that the Challenged Claims are not entitled to the filing date of Luebke
2008. See, e.g., Chester v. Miller, 906 F.2d 1574, 1577 (Fed. Cir. 1990).
Claims 1-17 are anticipated by Example 4 and Figure 6 of Luebke 2008. Exam-
ple 4 discloses files with “an elongate shank having a cutting edge extending from a
distal end of the shank along an axial length of the shank.” Ex. 1012 at ¶ 41. This is
the first part of step (a) from claim 1, almost verbatim. Luebke 2008 also notes that the
cutting edge is defined by helical flutes as required by claim 13. E.g., id. at ¶ 10. Fur-
ther, the disclosed file is made of a superelastic, nickel titanium alloy: The application
states that the composition of the alloy “avoid[s] the inclusion of elements that affect
- 22 -
the superelastic properties of the alloy.” Id. at ¶¶ 28, 41; Ex. 1002 at ¶ 90; see also Ex.
1008 at 8, 172.
Luebke 2008 discloses heat treating files at 500°C for 75 minutes in an argon
atmosphere. Id. This satisfies step (b) in claim 1 and is within the 475-525°C range of
claim 13. Further, it would be understood that the “entire shank” was being treated,
Ex. 1002 at ¶ 91, as confirmed by applicant’s successful arguments during prosecution
of the application that published as Luebke 2008. See Ex. 1013 at 85-86. Regarding the
“wherein” clause, Luebke 2008 discusses testing the treated shanks under ISO 3630-1
to determine their angle of permanent deformation. Ex. 1012 at ¶ 41. Example 4 does
not mention 45° of flexion being used, but (i) claim 11 of the application does specify
that parameter, and (ii) the ISO standard itself specifies 45° of flexion for the bend
test, Ex. 1017 at 13. The results show angles of permanent deformation exceeding 10
degrees for the treated shanks. Ex. 1012 at Fig. 6; see also id. at claim 11 (specifying the
10-degree threshold). Regarding claim 13, Luebke 2008 discloses that the shanks are
“in accordance with ISO Standard 3630-1” by noting that they are “ISO size[s].” Ex.
1012 at ¶ 41.
Luebke 2008 also discloses the dependent claim limitations. Claim 2 requires
treatment at 475-525°C. Claims 9 and 15 require treatment at a “single temperature.”
Claims 10 and 11 narrow that temperature to 400-525°C and 475-525°C, respectively.
Luebke 2008 discloses that treatment occurs at a single temperature of 500°C. Ex.
1002 at ¶ 100. Claims 3 and 14 limit treatment time to 1-2 hours; Luebke 2008 dis-
- 23 -
closes heat treatment for 75 minutes. Ex. 1012 at ¶ 41. Claims 4, 5, and, 16 are each
met by an unreactive atmosphere. Luebke 2008 discloses treatment in argon. Id. Claim
8 limits the diameter of the shank to 0.5 to 1.6 millimeters at the proximal end (see su-
pra section IV-C-4). Luebke 2008 discloses this. Id. at ¶ 26. Claims 12 and 17 limit the
alloy composition to 54-57% nickel and 43-46% titanium, by weight. Example 4 in
Luebke 2008 discloses this. Id. at ¶ 41.
Claim 6 requires treatment in an atmosphere that is “unreactive,” “ambient,” or
otherwise “acceptable,” at a temperature of 475-525°C, for 1-2 hours. Claim 7 re-
quires that the shank’s alloy comprise 54-57% nickel and 43-46% titanium by weight,
and that treatment occur at exactly 500°C for 1-2 hours. Example 4 in Luebke 2008
describes treating a shank with exactly that nickel titanium composition for 75
minutes at 500°C in an argon atmosphere. This satisfies both claims 6 and 7.
Based on the foregoing, Luebke 2008 anticipates claims 1-17 of the ’773 patent.
C. 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
Gao was filed May 6, 2011 and published November 10, 2011. Ex. 1014. It
claims priority to provisional application, No. 61/332,954, filed May 10, 2010. Ex.
1015.7 Gao is prior art under § 102(a) and (e) to the relevant priority date of the ’773
patent (i.e., April 25, 2012). Section V, supra. The second edition of ISO 3630-1 pub-
7 Petitioner has provided parallel cites to the provisional application.
- 24 -
lished in 2008 and so is prior art under § 102(b). Ex. 1017. Claims 1-7 and 9-12 are
anticipated by Gao. Claims 8 and 13-17 are obvious in view of Gao and ISO 3630-1.
1. Overview of Gao
Gao describes a method of heat treating a superelastic endodontic rotary in-
strument in order to raise the austenite finish temperature to above 25°C. See Ex. 1014
at Abstract. The result is a non-superelastic file in the martensite phase that is suscep-
tible to permanent deformation. Such file shows increased flexibility and resistance to
fatigue in bending and in twisting. See id. at Figs. 4-10. Gao discloses treatment tem-
peratures of 300-510°C for 5-120 minutes. Id. at ¶¶ 31-32. See also Ex. 1002 at ¶ 110.
2. Overview of ISO 3630-1
ISO 3630-1 is a standard governing several aspects of the construction, label-
ing, and testing of endodontic instruments. The first edition was published in 1992
and includes, in relevant part, information about the structural features of endodontic
files, including their sizes, as well as methods of testing, for example, the stiffness of
the files. See generally Ex. 1016. The second edition, which includes a similar disclosure,
published in 2008. See Ex. 1017.
3. Anticipation of Claims 1-7 and 9-12; Obviousness of Claims 8 and 13-17
Gao anticipates claim 1. Claim 1 requires “providing an elongate shank having
a cutting edge . . .” Gao discloses an “endodontic instrument” having an “elongate
shank” with the claimed “cutting edge.” Ex. 1002 at ¶ 108; see, e.g., Ex. 1014 at ¶¶ 8,
30-31, Fig. 1; Ex. 1015 at 8-9, 11. Claim 1 requires that the shank “compris[e] a super-
- 25 -
elastic nickel titanium alloy.” Gao discloses a “method for manufacturing a non-
superelastic rotary file” that comprises “providing a superelastic rotary file” that “in-
cludes a shape memory alloy,” which in turn “includes nickel and titanium.” Ex. 1014
at ¶¶ 62, 72-73; claims 1, 6, 7; Ex. 1015 at 20-21, 26-27; see also Ex. 1014 at ¶¶ 31-32;
Ex. 1015 at 8-9; Ex. 1002 at ¶ 109.
Claim 1 further requires “heat-treating the entire shank at a temperature from
400° C. up to but not equal to the melting point of the superelastic nickel titanium al-
loy.” Gao discloses a “post heat treatment” that occurs (i) “after the traditional NiTi
rotary file manufacturing process (e.g., grinding of the flutes) using regular superelastic
NiTi wires,” and (ii) at a preferred temperature of 370-510°C. Ex. 1014 at ¶¶ 31-32;
Ex. 1015 at 8-9; Ex. 1002 at ¶ 110. One of ordinary skill would have understood that
the “entire shank” was to be treated because Gao (i) discloses “heating the superelas-
tic rotary file” (rather than a part of it), and (ii) teaches that the handle (which is not
part of the shank) can be installed after heat treatment. Ex. 1014 at ¶¶ 32, 62; Ex.
1015 at 9, 20; Ex. 1002 at ¶ 110.
As stated previously, the “wherein” clause of claim 1 is not limiting. Neverthe-
less, Gao discloses that after heat treatment, the resulting endodontic instruments are
“in their martensitic state” and “non-superelastic.” E.g., Ex. 1014 at ¶¶ 4, 29, 62, claim
1; Ex. 1015 at 8, 20. Preferably, the treatment achieves an austenite finish temperature
above 37°C, Ex. 1014 at ¶¶ 6, 67; Ex. 1015 at 21, which is how the inventor of the
’773 patent defined his invention during prosecution. See Ex. 1008 at 144-60; Ex. 1002
- 26 -
at ¶ 112; Section IV-C-2, supra. Gao also notes that “the present invention instrument
would not return to the original complete straight state after being bent or deflected,”
i.e., it would be permanently deformed. Ex. 1014 at ¶ 25; Ex. 1015 at 8; Ex. 1002 at
¶ 112. Therefore, claim 1 is unpatentable as anticipated by Gao. While claim 1 does
not require that the bending test of ISO 3630-1 be performed, Gao does disclose do-
ing so, to measure the instrument’s stiffness—the actual purpose of the test. See Ex.
1014 at ¶¶ 43-46; Ex. 1015 at 14-16.
Regarding claim 13, Gao specifically discloses “helical flutes.” Ex. 1014 at ¶ 30;
Ex. 1015 at 8, which one of ordinary skill would have understood to define the “cut-
ting edge(s),” Ex. 1002 at ¶ 115. It also would have been obvious to make the instru-
ment “in accordance with ISO Standard 3630-1,” which Gao itself references. Ex.
1002 at ¶ 116; Ex. 1014 at ¶¶ 11, 15; Ex. 1015 at 15, 18. And, Gao discloses treatment
to a preferred upper bound of 510°C, which is “at a temperature from 475 °C. to
525°C.” Ex. 1002 at ¶ 117. Therefore, claim 13 is unpatentable as obvious over Gao
in view of ISO Standard 3630-1.
Gao also renders obvious the dependent claims. Claim 2 limits the temperature
to 475-525°C; claims 9 and 15 require a “single temperature,” while claims 10 and 11
narrow that temperature to 400-525°C and 475-525°C. Gao discloses treatment at “a
temperature ranging from about 300° C. to about 600° C., and more preferably from
about 370° C. to about 510° C.” Ex. 1014 at ¶¶ 30-32; Ex. 1015 at 8-9. Gao’s method
does not discuss varying the temperature, so one of ordinary skill would have under-
- 27 -
stood that a “single temperature” would be used in a treatment. Ex. 1002 at ¶ 119.
Gao’s preferred upper limit of 510°C is within the claimed ranges.
Claims 3 and 14 limit the treatment time to 1-2 hours. Gao’s treatments range
from 5-120 minutes, or preferably 10-60 minutes. Ex. 1014 at ¶ 31; Ex. 1015 at 8-9;
thus, both claimed limits are disclosed. Ex. 1002 at ¶ 121.
Claim 4 recites “step (b) is performed in any atmosphere.” Gao discloses a
“controlled atmosphere.” Ex. 1014 at ¶ 31; Ex. 1015 at 8-9. Claims 5 and 16 require
that “the atmosphere” be “unreactive, ambient or any other acceptable heat treatment
process.” Gao’s process is “acceptable” because it, for example, increases flexibility.
Ex. 1002 at ¶ 122. Regarding claim 8, it would have been obvious to construct the
shank with a diameter of 0.5 to 1.6 mm (at the handle end, see supra section IV-C-4),
since the ISO standard discloses a multitude of sizes within that range. See Ex. 1017 at
5; Ex. 1002 at ¶ 123; see, also, Ex. 1020 at 3:49-53 (disclosing the exact range of 0.5 to
1.6 mm). Claims 12 and 17 require an alloy composition of 54-57% nickel and 43-
46% titanium, by weight. Gao discloses a preferred content of 54.5-57% nickel and
43-45.5% titanium by weight. Ex. 1014 at ¶ 85; Ex. 1015 at 22-23; Ex. 1002 at ¶ 124.
Claims 6 and 7 combine already-discussed limitations on alloy composition,
atmosphere, temperature, and time, with claim 7 further limiting temperature to
500°C. That temperature is within Gao’s preferred 370-510°C range, near its upper
bound. See K-Swiss Inc., 567 F. App’x at 913 (“‘where the general conditions of a claim
are disclosed in the prior art,’ as here, ‘it is not inventive to discover the optimum or
- 28 -
workable ranges by routine experimentation.’”) (citation omitted). The ’773 patent
does not state or suggest that the 500°C treatment temperature is so precise a re-
quirement that treating at 510°C would produce considerably different results. Since
the other limitations of claims 6 and 7 are satisfied for the reasons discussed above,
those claims also are unpatentable. Ex. 1002 at ¶ 125.
D. Ground 4: Obviousness of Claims 1-17 in Further View of Khier
If the claims are limited to heat treatment in an unreactive atmosphere (see Sec-
tion IV-C-1), Khier cures any deficiency in Gao. Khier, which published in 1991 and
is prior art under § 102(b), teaches that, in heat treating Ni-Ti alloys, “vacuum or inert
atmosphere conditions are required because the nickel-titanium alloys react quickly
with air at elevated temperatures.” Ex. 1018 at 311. Gao discloses treatment “under a
controlled atmosphere,” Ex. 1014 at ¶ 31; Ex. 1015 at 9; based on Khier, one of ordi-
nary skill would have used an inert atmosphere to heat-treat the Ni-Ti files of Gao.
Ex. 1002 at ¶ 127. For the above reasons, claims 1-17 are unpatentable even under a
narrower construction of “heat-treating.”
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
Kuhn published in 2002, and the first edition of ISO 3630 published in 1992.
Both are prior art to the ’773 patent under § 102(b), even if the patent is entitled to
the earliest claimed priority date. Kuhn anticipates claims 1, 2 and 9-12. In combina-
tion with ISO 3630-1, it renders obvious claims 8, 13, 15 and 17.
- 29 -
1. Overview of Kuhn
Kuhn explores the effects of mechanical fatigue and, in relevant part, heat
treatment on superelastic endodontic files. Files made from Ni-Ti are treated at vari-
ous temperatures between 350°C and 700°C, and their bending properties were test-
ed. Ex. 1019 at 717. It was found that treatment at 400°C for 10 minutes produced
“good results,” including an increase in the transformation temperature and an in-
crease in flexibility. Id. at 716, 719-20. Treatment at 510°C for 10 minutes also in-
creased flexibility. Id. at 719-20. See also Ex. 1002 at ¶ 71.
2. Anticipation of Claims 1, 2, and 9-12; Obviousness of Claims 8, 13, 15 and 17
Claim 1 requires “providing an elongate shank having a cutting edge extending
from a distal end of the shank along an axial length of the shank.” Kuhn discloses
ProFile and Hero endodontic files that “have a 25-mm length, a taper ranging be-
tween 0.04 and 0.06 mm per mm length, and sizes 20 to 40, representing the diameter
of the tip base of the file, given in hundredth of millimeter.” Ex. 1019 at 716-17. One
of ordinary skill would have understood Kuhn’s reference to “engine-driven rotary
files,” id. at 716, to refer to instruments having the claimed “cutting edge.” Ex. 1002 at
¶ 130. Claim 1 further requires that “the shank compris[e] a superelastic nickel titani-
um alloy.” Kuhn specifies that the identified shanks are made from superelastic
“Nickel Titanium,” or “NiTi”; and, one of Kuhn’s aims was “to show fatigue charac-
teristics of superelastic NiTi” because “[s]hape memory alloys are increasingly used in
- 30 -
superelastic conditions under complex cyclic deformation situations.” Ex. 1019 at 716.
Further, Kuhn notes that superelasticity and shape memory are properties that may be
exhibited by Ni-Ti, but specifies that superelastic alloys “have a transition temperature
range (TTR) lower than mouth temperature.” Id. at 716. The transition temperature
listed by Kuhn is 35°C, which is below mouth temperature (37°C), indicating the non-
heat-treated files were superelastic per the definition provided in Kuhn. Id. at 719; Ex.
1002 at ¶ 131. Further, when the non-heat-treated ProFile instruments were bent, they
returned to their original shape. Ex. 1019 at 720. Claim 1 further requires “heat-
treating the entire shank at a temperature from 400 °C up to but not equal to the
melting point of the superelastic nickel titanium alloy.” Kuhn discloses treatments at
various temperatures, including 400°C, 510°C, 600°C, and 700°C. Ex. 1019 at 717.
Kuhn does not mention treating only a portion of the instruments, so one of ordinary
skill would have understood that the “entire shank” was to be treated. Ex. 1002 at
¶ 132. Additionally, Kuhn performed bend-testing on the entire shank, confirming
that the entire shank was treated. Id.; Ex. 1019 at 718.
Since the “wherein” clause is not a limitation for the reasons discussed above
(section IV-C-2), Kuhn therefore discloses all of the limitations of claim 1.
Even if the “wherein” clause is deemed a limitation, Kuhn meets it when the
treatment temperature was 400°C. The results of bend testing—Figure 6A in Kuhn—
show that the 400°C-treated file, after being deformed by 8 mm, remained deformed
by approximately 1.8 mm. Ex. 1019 at 720; Ex. 1002 at ¶¶ 135-136. This is considera-
- 31 -
bly greater than the untreated file, id., and shows that the shank took on the general
condition claimed by the ’773 patent. See K-Swiss, 567 Fed. App’x at 913. The results
are consistent with the identified ISO 3630-1 test; permanent deformability undoubt-
edly increased with the heat treatment. Ex. 1002 at ¶ 136. Furthermore, Kuhn disclos-
es that the treatment increased the transformation temperature from 35°C to 40°C,
above oral temperature. Ex. 1019 at 719; Ex. 1002 at ¶ 137. Under these conditions,
the claimed test would be satisfied. Ex. 1002 at ¶ 136; Section IV-C-2.
The link between permanent deformation and transition temperature is con-
sistent with the applicant’s arguments during prosecution. Distinguishing Patel (US
Pat. App. Pub. No. 2005/0090844), the applicant discussed “critical differences” with
the claimed invention: Patel, he noted, preferably had an austenite finish temperature
“between 26 °C and 36 °C,” which was below body temperature, while his own inven-
tion involved an austenite finish temperature of 39°C, above body temperature. Ex.
1008 at 147. In other words, Kuhn’s heat-treated instrument possesses the very prop-
erty (an austenite finish temperature above body temperature) the applicant used to
distinguish his invention from the prior art. See Ex. 1002 at ¶¶ 33-34, 137. It is also
consistent with Prof. Berzins’ declaration, which states that Luebke’s files had an aus-
tenite finish temperature of 37.5°C, which was “more consistent with a shape-
memory file” than lower values. See Ex. 1009 at 410; Section V-A. Therefore, claim 1
is anticipated by Kuhn even if the “wherein” clause is treated as limiting.
Independent claim 13 is substantially similar to claim 1 except that (i) the cut-
- 32 -
ting edge is defined by “helical flutes,” (ii) the shank is “in accordance with ISO
Standard 3630-1,” and (iii) the temperature of treatment is 475-525°C. Regarding (ii),
it would have been obvious to construct the shanks in accordance with ISO Standard
3630-1, whose goal—like that of any standard—was standardization.8 Ex. 1002 at
¶ 140. Regarding (i), files in accordance with the standard would have helical cutting
flutes, and would otherwise satisfy the structural limitations of the shank provided in
step (a). Id.; see Ex. 1016 at 4-5; Ex. 1017 at 4. Regarding (iii), Kuhn discloses heat
treatment at 510°C, among other temperatures. Ex. 1019 at 717. The 510°C treatment
did not produce a transformation temperature above 37°C, nor did the resulting in-
strument show significant permanent deformation—most likely as a result of the
short treatment time. See Ex. 1006 at 113, Fig. 9 (“At the highest ageing temperature,
550°C, there is an initial decrease in Af and then a rapid increase.”). But, because the
“wherein” clause is not limiting (see supra section IV-C-2), claim 13 is also unpatenta-
ble as obvious over Kuhn in view of ISO Standard 3630-1.
8 If the Board determines that claim 13 requires compliance with the 2008 edi-
tion of ISO 3630-1, then claims 13-17 cannot have been described or enabled by the
priority applications filed before 2008. In that case, the priority date of claims 13-17
could be no earlier than December 23, 2010, the filing date of the first application in
the ’773 patent family dated after 2008, and the 2008 edition of ISO 3630-1 would be
prior art. It would have been equally obvious to comply with that edition.
- 33 -
Dependent claim 2 limits treatment temperature to 475-525°C. For the same
reason, if the “wherein” clause is not limiting, then claim 2 is anticipated.
The combination of Kuhn and the ISO-3630 standard would also render obvi-
ous claim 8, which requires that the shank have a diameter, at the handle end (see supra
section IV-C-4), between 0.5 and 1.6 millimeters. Kuhn specifies the heat-treated in-
struments’ size at the tip (0.2 mm), length (25 mm), and taper (0.04). Ex. 1019 at 717.
If the instrument is tapered over the ISO standard working length (16 mm), or the en-
tire length, the proximal-end diameter is 0.84 or 1.2 mm, respectively. Ex. 1016 at 5;
Ex. 1017 at 5; Ex. 1002 at ¶ 141. Both are within the claimed range. Further, the ex-
act range of 0.5 and 1.6 millimeters was known in the prior art. See, e.g., Ex. 1020 at
3:49-53.
Claims 9 and 15 require that the heat treatment occur at a “single temperature.”
Kuhn discloses shanks were treated at 400°C and no other temperature. Ex. 1002 at
¶ 143. Claims 10 and 11 limit the “single temperature” to 400-525°C and 475-525°C,
respectively. Kuhn discloses treatment at 400°C, which meets claim 10. Because the
“wherein” clause is not limiting and Kuhn discloses treatment at 510°C, claim 11 is
anticipated, and claim 15 (which requires a temperature of 475-525°C) is obvious. Id.
Claims 12 and 17 require that the composition of the shank be 54-57% nickel
and 43-46% titanium by weight. The “Profile” endodontic instruments tested in
Kuhn, see Ex. 1019 at 720, had a composition of 54.26% nickel and 45.42% titanium.
Ex. 1021 at 759; Ex. 1002 at ¶ 144. Thus, Kuhn also anticipates claim 12 and renders
- 34 -
claim 17 obvious.
F. Ground 7: Obviousness of Claims 1-17 in View of Kuhn, ISO 3630-1, Pelton and McSpadden
McSpadden published in 2002, and Pelton published in 2000. Therefore, both
are prior art under § 102(b). In combination with Kuhn and ISO 3630-1, McSpadden
and Pelton render obvious claims 1-17.
1. Overview of McSpadden
McSpadden discloses an endodontic instrument and a method of manufactur-
ing the same. The instrument may be made of nickel titanium alloys exhibiting supere-
lastic properties. Ex. 1022 at ¶ 8. McSpadden teaches that heat treatment should not
be applied prior to machining because the residual stresses in the material result in
improved machinability. Id. at ¶ 52. Instead, McSpadden teaches that heat treatment
should be applied after machining, “in order to achieve the desired degree of supere-
lasticity or other material properties and/or to set a desired file shape (straight, pre-
curved or pre-twisted).” Id. at ¶ 52. See also Ex. 1002 at ¶ 72.
2. Overview of Pelton
Pelton describes optimization in the manufacturing and treatment of nickel ti-
tanium alloys. In relevant part, Pelton discusses the effects of heat treatment (ageing)
on a particular Ni-Ti alloy, having 50.8% nickel (by the number of atoms, not by
weight), under a variety of conditions, including temperatures between 300°C and
600°C and times between 2 and 180 minutes. Ex. 1006 at 112-14. From these experi-
- 35 -
ments, Pelton derived relationships among temperature, time, and austenite finish
temperature, where the starting austenite finish temperature is 11 °C:
Ex. 1006 at 114. The results show that heat-treating at 450°C for 100 min, or at
550°C for 60 min, raised the Af temperature to 40°C, which is above “mouth temper-
ature.”
3. Obviousness of Claims 1-17
The Ni-Ti alloy discussed in Pelton was 50.8% nickel, by atomic percentage.
- 36 -
One of ordinary skill would have been motivated to use such an alloy in making an
endodontic file because it exhibits the same relevant properties as Kuhn’s alloy: (i) it is
made from nickel and titanium, (ii) it is superelastic, and (iii) it has a transformation
temperature below oral temperature. Ex. 1002 at ¶ 146. Furthermore, McSpadden
suggests using this alloy (which it calls SE508) in endodontic files. See, e.g., Ex. 1022 at
¶¶ 40, 50, Table 1; Ex. 1002 at ¶ 146. A person of ordinary skill would have con-
structed such a file to have the ubiquitous structural properties described by claims 1
and 13, i.e., an “elongate shank” with “helical flutes” that define a “cutting edge ex-
tending from the distal end,” “along an axial length of the shank.” Ex. 1002 at ¶ 147.
Similarly, it would have been obvious to construct the file in accordance with the well-
known ISO 3630-1 standard as required by claim 13. Id.
Kuhn teaches that Ni-Ti endodontic instruments having a transformation tem-
perature of 40°C have beneficial properties. Ex. 1002 at ¶ 151. This is in agreement
with other art; for example, Matsutani teaches that it is desirable to heat treat a nickel
titanium endodontic instrument, that is initially superelastic, such “that the shape re-
covery temperature” at the tip of a Ni-Ti endodontic instrument “is sufficiently higher
than room temperature and body temperature” so that the instrument does not
straighten within the root canal. Ex. 1023 at 5:43-60; Ex. 1002 at ¶ 151. Kuhn also
teaches that fatigue crack propagation rate and fatigue life strongly depend on test
temperature. Ex. 1019 at 720. Pelton goes further, teaching that fatigue-crack propa-
gation is reduced if the Ni-Ti alloy is fully martensitic, and provides the specific time
- 37 -
and temperature combinations to increase the Af temperature above mouth tempera-
ture (such that a file heat-treated according to the conditions in Pelton would remain
martensitic during conditions of use). Ex. 1006 at 116. Matsutani confirms that heat-
treating a Ni-Ti instrument in order to raise the transition temperature above mouth
temperature results in increased durability and reduced the likelihood of breaking. Ex.
1022 at 2:13-17 (an object of the invention is a tool “that is enhanced in durability by
weakening the action of returning to an original shape of the tip portion of the work
portion.”); id. at 5:46-49 (“it is preferable that the shape recovery temperature of the
shape memory portion is sufficiently higher than room temperature and body temper-
ature.”)
These teachings would have motivated one of ordinary skill to heat-treat a Ni-
Ti instrument to achieve a transformation temperature of 40°C, or above body tem-
perature. Ex. 1002 at ¶¶ 151-52. As described above, such a transformation tempera-
ture imparts permanent deformability and falls within the invention of the ’773 patent.
See supra sections III, IV-C-2.
Pelton describes ways of achieving that end through heat treatment of a supere-
lastic Ni-Ti alloy. As can be seen from the figures shown above, an austenite finish
temperature of 40°C may be achieved by heat treating anywhere between 300°C and
600°C, for an appropriate amount of time. See Ex. 1002 at ¶ 153. It would have been
obvious to follow Pelton’s teachings to produce an instrument having an austenite
finish temperature of 40°C, above the 37°C threshold identified by the inventor. Id.
- 38 -
As shown by Pelton, this could be done using a variety of heat-treatment methods. See
Ex. 1006 at 112-15. One of ordinary skill therefore would have found it obvious to
select an appropriate combination of time and temperature to reach the 40°C trans-
formation temperature taught by Kuhn. Ex. 1019 at ¶¶ 718; Ex. 1002 at ¶¶ 151-53.
Meanwhile, McSpadden teaches that any such heat treatment should occur after the
Ni-Ti is machined into an endodontic file. Ex. 1002 at ¶ 149; Ex. 1022 at ¶¶ 51-52.
Pelton and Matsutani each observed that increased flexibility improved cyclic fatigue
durability. McSpadden also explained that heat-treating after machining instead of be-
forehand resulted in cutting edges that are “sharper and cleaner,” see id. at ¶¶ 16, 52,
providing motivation for one of ordinary skill in the art to have applied McSpadden’s
teachings to the identified prior art combination. Ex. 1002 at ¶ 149.
In sum, in view of Kuhn, ISO 3630-1, McSpadden, and Pelton, it would have
been obvious to (i) manufacture an endodontic file of the kind described in step (a) of
claims 1 and 13 of the ’773 patent using the using the superelastic nickel titanium alloy
disclosed by Pelton, and (ii) apply a heat treatment to the file (step (b)) after the file
has been manufactured. Ex. 1002 at ¶¶ 150, 155. The artisan would have been moti-
vated to select a treatment that results in an Af temperature of about 40°C, and Pelton
includes such treatments at temperatures over 400°C. Id. at ¶ 151-55; Ex. 1006 at 114.
The “wherein” clause would be satisfied by virtue of the 40°C Af temperature. Ex.
1002 at ¶ 156. Therefore, claim 1 is unpatentable.
Claims 4 and 5 are unpatentable because it would have been obvious to use an
- 39 -
acceptable atmosphere. Ex. 1002 at ¶ 157; Ex. 1022 at ¶ 64. Claims 8-10 also are un-
patentable for substantially the same reasons discussed in Grounds 5 and 6. Kuhn also
discloses the size limitation required by claim 8, for the reasons set forth above with
respect to Grounds 5 and 6. Claims 9 and 10 limit treatment to a “single tempera-
ture;” one of ordinary skill would have understood Pelton to teach treatment at any
one single temperature for a length of time up to 3 hours. Ex. 1002 at ¶ 158.
Furthermore, even if the Board determines that the “wherein” clauses are limit-
ing, claims 2, 11, 13, 15 and 169 are unpatentable in view of Pelton because treatments
at temperatures between 475°C and 525°C (for example, 475°C for about 2.5 hours)
are within the range of options disclosed by Pelton for reaching Kuhn’s 40°C austen-
ite finish temperature, all of which would have been obvious. Ex. 1002 at ¶¶ 153, 160.
Because Pelton describes the effects of treatment time and temperature on Af temper-
ature (and with it, permanent deformability), as well as flexibility and tensile strength,
the treatment parameters are result-effective variables, and optimizing them would
have been within the skill of the ordinary artisan. See In re Applied Materials, Inc., 692
F.3d 1289-1295-99 (Fed. Cir. 2012). Claim 16 would have been obvious for the same
reasons as claims 4 and 5.
9 The “single temperature” limitation of claims 11 and 15 are met for the same
reason as claim 9. The limitations of claim 13 are discussed above with claim 1. Claim
16 is met for the same reason as claims 4 and 5.
- 40 -
Furthermore, in view of Pelton, claim 3, which limits treatment time to 1-2
hours, would have been obvious. Pelton discloses that, for example, one hour of
treatment at 550°C or two hours’ treatment at 525°C will produce an austenite finish
temperature of about 40°C. Ex. 1006 at 114; Ex. 1002 at ¶ 162. This is within the time
and temperature requirements of claim 3.
Claims 12 and 17, which limit the composition of the alloy to 43-46% titanium
and 54-57% nickel, by weight, would have been obvious in view of Pelton. The alloy
chosen by Pelton—which it would have been obvious to use—contains 50.8% nickel
by atomic percentage (i.e., 50.8% of the atoms are nickel atoms). This translates into a
by-weight percentage of nickel of about 55.9%, within the claimed range. Ex. 1002 at
¶ 163. The balance is titanium, about 44.1%, also within the claimed range. Id.
Claims 6 and 14 require treatment for 1-2 hours at 475-525°C. A review of
Figure 10 of Pelton shows that one of the options laid out for the artisan to achieve a
40°C austenite finish temperature is treatment at 525°C for two hours. See Ex. 1006 at
114; Ex. 1002 at ¶ 164. Pelton also shows that higher temperatures of 500-550°C re-
sulted in a considerably lower “loading plateau,” Ex. 1006 at 114-15, and one of ordi-
nary skill would have understood a lower loading plateau to mean greater flexibility.
Ex. 1002 at ¶ 164. It was well known that flexibility is an advantage for Ni-Ti endo-
dontic instruments, id., and Kuhn even placed an “emphasis on flexibility,” Ex. 1019
at 716. Therefore 525°C would have been viewed as an appropriate choice for achiev-
ing the goals of Kuhn. Claim 6 also includes the same limitation as claim 5, which
- 41 -
would have been obvious for the same reason. Accordingly, claims 6 and 14 would
have been obvious. Ex. 1002 at ¶¶ 164-65.
Claim 7 requires treatment at exactly 500°C for 1-2 hours. While Pelton does
not discuss achieving a 40°C austenite finish temperature using this combination, the
named inventor of the ’773 patent submitted notes to the PTO during prosecution
that included the following graph:
Ex. 1008 at 159. In his notes, the applicant stated, “As seen by the graph above, “ob-
taining an Af temperature of 39°C is accomplished with 500°C temperature and ap-
proximately two hours of heating. This is what this application accomplishes.” Id.
While the graph cited by the applicant refers to a 2012 publication, this is the same
graph included in the prior-art Pelton publication (reproduced above)—the 2012 pub-
lication includes the logo of the journal in which Pelton published.
The graph seems to show that heat treatment at 500°C for two hours will pro-
- 42 -
duce an Af temperature of about 35°C, not 39°C. However, because the inventor told
the PTO that this treatment accomplishes 39°C in order to obtain allowance of the
’773 patent, the Board should determine that the patent owner is bound by this repre-
sentation. Cf. Yeda Research & Dev. Co. v. ImClone Sys., 443 F. Supp. 2d 570, 623-24
(S.D.N.Y. 2006) (applying judicial estoppel to preclude argument that figure in patent
did not disclose claim element, where applicant had argued during prosecution that
the same figure did describe the same claim element); see also, e.g., Tyler Refrigeration v.
Kysor Indus. Corp., 777 F.2d 687, 690 (Fed. Cir. 1985) (holding that admission during
prosecution that patent was “prior art” was binding in subsequent litigation).10 There-
fore, for the purposes of this inter partes review, Pelton teaches that treatment at 500°C
for two hours will result in an Af temperature of 39°C. See also Ex. 1024 at 258-59
(showing permanent deformation after heat-treatment at 500°C for one-hour); Ex.
1002 at ¶¶ 79-82, 185; Section VI-H-2, infra. One of ordinary skill would have under-
stood that an Af temperature of 39°C would have substantially the same effect as Af
temperature of 40°C, and so would have been motivated to follow Pelton’s teaching.
Ex. 1002 at ¶ 166. The time and temperature limitations of claims 6, 7, and 14 are thus
satisfied by a treatment that produces the claimed effect. The treatment-environment
limitation of claim 6 and the alloy-composition limitation of claim 7 are satisfied for
10 Alternatively, the Board should determine that the applicant admitted that the
results of heat treatment at 500°C for 2 hours were within the scope of the claim.
- 43 -
the same reasons discussed above regarding claims 5 and 12.
For the above reasons, claims 1-17 would have been obvious in view of Kuhn,
ISO 3630-1, Pelton, and McSpadden.
G. Grounds 8 and 9: Obviousness of Claims 1-17 in Further View of Khier
If the claims are construed to require heat treatment in an unreactive atmos-
phere, Khier cures any deficiency with respect to Ground 6 or 7 because it teaches
that, in heat treating Ni-Ti alloys, “vacuum or inert atmosphere conditions are re-
quired because the nickel-titanium alloys react quickly with air at elevated tempera-
tures.” Ex. 1018 at 311. Kuhn used a nitrate salt bath, Ex. 1019 at 717, Pelton does
not specify an environment for heat treatment, and McSpadden lists “inert gas” as
one possible environment, Ex. 1022 at ¶ 64. One of ordinary skill would have known
from Khier that an inert atmosphere would be appropriate in the heat treatment of
Ni-Ti, to avoid a reaction with the Ni-Ti, and would have been motivated to use it.
Ex. 1002 at ¶¶ 168-69.
H. Ground 10: Obviousness of Claims 1-17 in View of McSpadden, Miyazaki, and ISO 3630-1
McSpadden published September 26, 2002. Miyazaki published in 1982. Both
are prior art to the ’773 patent under § 102(b).
1. Overview of Miyazaki
Miyazaki explores the deformation behavior, including superelasticity of nickel
titanium alloys. Ex. 1024 at 255. The alloys studied ranged from 49.8% to 51.6% nick-
- 44 -
el, by atomic percentage. Id. Temperatures ranged from 200°C to 1000°C, and all
treatment times were 1 hour. Id.; see Ex. 1002 at ¶ 79.
One of Miyazaki’s experiments involved measuring forward and reverse critical
stresses (forces) of a Ni-Ti alloy with 49.8 at% nickel, heat treated at 1000°C (1273K),
500°C (773K), or 400°C (673K). The stresses were measured at various temperatures
between about -73°C and 100°C. Figure 6 illustrates the results of this experiment:
Ex. 1024 at 258. Generally, σM refers to the stress required to induce a transformation
to martensite, whereas σR is the stress within the material as it reverts to austenite
when loading is removed. Ex. 1002 at ¶ 80. If no value for σR is present at a particular
testing temperature, then the material is not superelastic at that temperature, and there
has been permanent deformation. Id.; see Ex. 1024 at 258. Meanwhile, σM is associated
with flexibility; higher values mean that more force is required to deform (e.g., bend)
the material. Ex. 1002 at ¶¶ 81-82.
- 45 -
2. Obviousness of Claims 1-17
It would have been obvious to combine McSpadden and Miyazaki. McSpadden
suggests heat treatment after manufacturing “in order to achieve the desired degree of
superelasticity or other material properties and/or to set a desired file shape (straight,
pre-curved or pre-twisted).” Ex. 1022 at ¶ 51 (emphasis supplied). McSpadden notes
that shape may be important to the user, including “pre-curved.”
It was known in the endodontic field that, in a curved root canal, the tendency
of an instrument to straighten out (including a superelastic Ni-Ti instrument) could
result in too much material being removed from one side of the canal, a phenomenon
called “zipping.” Ex. 1002 at ¶¶ 75, 172; Ex. 1025 at 209. This is a problem that could
be reduced if the practitioner bent the instrument before inserting it into the canal, a
technique called “pre-curving.” Ex. 1002 at ¶ 172. “Pre-curving” was known to be
beneficial. Id.; Ex. 1025 at 183-84; see also Ex. 1003 at 351 (noting possible benefit in
Ni-Ti files); Ex. 1023 at 2:35-38, 4:45-58. However, superelastic instruments are not
amenable to pre-curving because they return to their original shape after being bent.
Ex. 1002 at ¶ 172.
It was known that heat treatment of superelastic, Ni-Ti instruments can solve
this problem. Similar to Weine, Matsutani describes the tendency of a superelastic Ni-
Ti instrument to straighten within the canal creates forces against the canal wall, re-
sulting in over-cutting of certain portions of the canal. Ex. 1023 at 1:52-64. Matsu-
tani’s solution is to apply heat treatment to a portion of the instrument in order to
- 46 -
remove its superelasticity and instead confer shape memory properties, so that a den-
tist can pre-curve the instrument. E.g., id. at 4:31-57. This treatment also increases the
instrument’s resistance to cyclic fatigue, so that the instrument is less likely to break.
See id. at 4:58-64. One of ordinary skill would have been motivated to heat-treat a Ni-
Ti endodontic file so as to permit permanent deformation. Ex. 1002 at ¶¶ 173-74.
Miyazaki teaches the properties of various Ni-Ti alloys and how to manipulate
them through heat treatment. See Ex. 1002 at ¶¶ 79-82, 172. Miyazaki discloses heat
treatment of a superelastic Ni-Ti alloy after cold-working. See id. at ¶¶ 80, 171. And, as
discussed below, treating a Ni-Ti endodontic file in accordance with Miyazaki would
result in a permanently deformable instrument. Although Miyazaki is not explicitly re-
lated to endodontic instruments, it was known to look beyond the endodontic field
for useful Ni-Ti art. Ex. 1002 at ¶¶ 66, 172; see Ex. 1003 at 351; Ex. 1005 at 42. There-
fore, it would have been obvious to apply Miyazaki’s heat treatment to McSpadden’s
Ni-Ti endodontic file to obtain a pre-curvable file. Ex. 1002 at ¶¶ 171-74.
Together, McSpadden and Miyazaki render claims 1-17 unpatentable. Claim 1
requires “providing an elongate shank having a cutting edge extending from a distal
end of the shank along an axial length of the shank.” McSpadden teaches a “fluted
endodontic file” having a “working portion” extending from a “proximal end” to a
“distal end,” with “helical flutes” and “helical lands” that define a “cutting edge.” Ex.
1022 at ¶¶ 32-35; Ex. 1002 at ¶ 176. Claim 1 requires that the shank “compris[e] a su-
perelastic nickel titanium alloy.” McSpadden and Miyazaki both teach the use of nickel
- 47 -
titanium alloys having super- (or pseudo-) elastic properties. E.g., Ex. 1022 at ¶ 40; Ex.
1024 at 255; Ex. 1002 at ¶ 177.
Claim 1 further requires “heat-treating the entire shank at a temperature from
400° C. up to but not equal to the melting point of the superelastic nickel titanium al-
loy.” McSpadden teaches heat treatment after machining the file, Ex. 1022 at ¶ 52,
and Miyazaki teaches heat treatments at various temperatures above 400°C, including
500°C, Ex. 1024 at 255; Ex. 1002 at ¶ 178. McSpadden teaches treating “the formed
endodontic file,” which one of ordinary skill would have understood to include the
“entire shank.” Ex. 1002 at ¶ 179.
Last, claim 1 recites the “wherein” clause described above. Because the “where-
in” clause is not a limitation for purposes of patentability (see supra section IV-C-2),
claim 1 is unpatentable as obvious. Nevertheless, Miyazaki shows the results of vari-
ous kinds of heat treatment, including heat treatments that result in permanent de-
formation. As shown in the graph reproduced above, treating a shank with 49.8%
nickel (by atomic percentage) at 500°C for one hour will result in a material that does
not exhibit superelasticity at room temperature (i.e, the temperature at which an ISO
3630-1 test is performed), and will instead permanently deform. See Ex. 1002 at
¶¶ 182-86; Ex. 1024 at 258-59. The same treatment would produce an austenite finish
temperature exceeding body temperature (37°C). Ex. 1002 at ¶¶ 183, 185; see supra sec-
tion III. It would have been obvious to use this treatment because the desirability of
pre-curving an endodontic instrument was well known in the art. Ex. 1022 at ¶ 52;
- 48 -
Ex. 1025 at 183-84; Ex. 1003 at 351; Ex. 1023 at 4:31-64; Ex. 1002 at ¶¶ 172-73, 181.
Furthermore, beyond the ability to permanently deform, the 500°C-treated Ni-Ti
showed more flexibility than, for example, the 400°C-treated Ni-Ti. Ex. 1002 at ¶¶ 82,
181. It therefore would have been obvious to use the 500°C temperature. Id. If the
Board determines that the claims require treatment in an unreactive atmosphere,
Miyazaki discloses a vacuum, Ex. 1024 at 255, and McSpadden discloses “inert gas,”
Ex. 1022 at ¶ 64—neither is reactive with Ni-Ti, and it would have been obvious to
use either, Ex. 1002 at ¶ 187. Therefore, claim 1 is unpatentable.
McSpadden discloses “helical flutes” defining the “cutting edge,” as required by
claim 13. Ex. 1022 at ¶ 189. It also would have been obvious to make the instrument
“in accordance with ISO Standard 3630-1,” since the standard was well-known. Ex.
1002 at ¶ 190; see also supra fn. 8. And, Miyazaki’s treatment at 500°C is “at a tempera-
ture from 475 °C. to 525°C.” Therefore, claim 13 is unpatentable.
The combination of McSpadden, Miyazaki, and the ISO 3630-1 standard also
renders the dependent claims unpatentable. Claim 2 limits the temperature to 475-
525°C; claims 9 and 15 require a “single temperature,” while claims 10 and 11 narrow
that temperature to 400-525°C and 475-525°C. Miyazaki’s treatment at 500°C, as dis-
cussed above, involves treating a single sample at only the one temperature, and it sat-
isfies all of the temperature limitations. Ex. 1002 at ¶ 193.
Claims 3 and 14 limit treatment time to 1-2 hours. Miyazaki’s treatments were
for one hour (3.6 ks). Ex. 1024 at 255; Ex. 1002 at ¶ 194. As for claims 4, 5, and 16,
- 49 -
the vacuum and inert gas discussed above constitute “any atmosphere” and an “unre-
active” atmosphere. Ex. 1002 at ¶ 195. Regarding claim 8, it would have been obvious
to construct the shank with a diameter of 0.5 to 1.6 mm, since the ISO standard dis-
closes a multitude of sizes within that range. See Ex. 1016 at 5; 1017 at 5; Ex. 1002 at
¶ 196. Indeed, this exact range was known in the art. See Ex. 1020 at 3:49-53. Claims
12 and 17 require an alloy composition of 54-57% nickel and 43-46% titanium, by
weight. The 49.8%-nickel alloy discussed by Miyazaki is, by weight, 54.9% nickel and
the balance, 45.1%, titanium. Ex. 1002 at ¶ 197. Claims 6 and 7 combine already-
discussed limitations on alloy composition, atmosphere, temperature, and time, with
claim 7 further limiting temperature to 500°C. All of these are met, as noted above. Id.
at ¶ 198.
I. Ground 11: Obviousness of Claims 1-17 in View of Matsutani, Pelton, and ISO 3630-1
Matsutani was filed May 28, 2004. It is prior art to the ’773 patent under
§ 102(e). Pelton published in 2000, and the first edition of ISO 3630-1 published in
1992. Both are prior art under § 102(b).
1. Overview of Matsutani
Matsutani describes a nickel-titanium endodontic instrument. Matstuani notes
that superelastic nickel titanium instruments were known in the prior art, but suffered
from two problems when used in curved root canals. First, the superelastic instru-
ments’ tendency to straighten out would result in uneven cutting or might penetrate
- 50 -
the side of the root canal. Ex. 1023 at 1:52-64; Ex. 1002 at ¶ 83; cf. Ex. 1025 at 209
(describing “zipping”). Second, rotation of the instrument while inside a curved canal
would cause the tip of the instrument to repeatedly bend back and forth, causing cy-
clic stress and eventual fracture. Ex. 1023 at 1:65-2:7; Ex. 1002 at ¶ 83.11
Matsutani proposed a solution to these problems: apply heat treatment to a
portion of the file in order remove the superelastic characteristic and allow it to exhib-
it shape memory such that it could be permanently deformed. Ex. 1023 at 2:17-40.
Matsutani explains that the shape recovery temperature (i.e., the austenite finish tem-
perature, see Ex. 1002 at ¶ 84) is preferably higher than room and body temperature to
ensure that the superelastic properties do not return during conditions of use. Ex.
1023 at 5:42-60. The shape memory part of the instrument would no longer tend to
return to its original shape within the canal, resulting in more even cutting. Id. at 2:35-
37, 4:42-44, 8:40-47. An endodontist could also pre-curve the instrument to minimize
uneven pressure against the canal wall and route the instrument through the canal as
11 Matsutani was of-record during prosecution of a related application. See Section
V.A. However, this petition presents Matsutani in a new light. During prosecution of
the earlier application, the applicant argued that Matsutani did not heat-treat the entire
shank. But this petition explains why it would have been obvious to do so in view of
additional evidence of the knowledge of one of ordinary skill (which the Examiner did
not have available).
- 51 -
desired. Id. at 4:45-57, 8:30-39. The shape memory portion of the file also has a higher
flexibility and resistance to fatigue, making it less likely to fracture during use. Ex.
1023 at 4:58-64; Ex. 1002 at ¶ 85.
2. Obviousness of claims 1-17
It would have been obvious to combine the teachings of Matsutani with the al-
loy and heat treatment methods of Pelton. Matsutani teaches that a superelastic Ni-Ti
instrument should be heat-treated to remove its superelasticity and convert it to shape
memory Ni-Ti to achieve permanent deformation, just like the ’773 patent. See Ex.
1008 at 227-28. Pelton explains the exact heat-treatment time and temperature com-
binations to impart shape memory. Pelton’s heat-treatments raise the transformation
temperature of a superelastic Ni-Ti alloy from 11°C to about 40°C. Ex. 1006 at Fig.
10; Ex. 1002 at ¶¶ 73-74, 153, 200. It therefore would have been obvious to use Pel-
ton’s teachings to achieve Matsutani’s goal. Ex. 1002 at ¶ 200.
Matsutani teaches that only a portion of the instrument should be treated (and
not the “entire shank”). See Ex. 1023 at 5:20-33. Matsutani’s stated reason for heat-
treating a portion of the file is that if more than 3/4 of the “working portion” (i.e., the
portion with cutting edges) is treated, then the axis of rotation may not be fixed re-
sulting in potential performance issues. Id. at 5:37-42.
Notwithstanding the foregoing, a person of ordinary skill would have had a
reasonable expectation of success when treating the “entire shank.” Matsutani recog-
nizes that endodontic instruments are typically tapered. Id. at 7:58-59 (disclosing in-
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struments with “4/100” taper); see also, e.g., Ex. 1019 at 717 (disclosing instruments
with “a taper ranging between 0.04 and 0.06 mm per mm length”). As the diameter of
the instrument increases along its length, its rigidity increases significantly, reducing
the chance of performance issues. Ex. 1002 at ¶¶ 202-03.
Indeed, on November 29, 2004, just five months after the U.S. application
leading to Matsutani was filed, the same inventors filed another patent application in
Japan explicitly recognizing this fact. See Ex. 1027.12 This new application noted that
with respect to instruments with larger tapers, such as “4/100” and “6/100,” the in-
struments would have a large enough diameter away from the tip so that “even if the
entirety of work portion 4 is subjected to durability heat treatment … operability will
be good.” Ex. 1027 at ¶ 22; Ex. 1002 at ¶¶ 204-05. These larger tapers were in com-
mercial use. See Ex. 1019 at 717; Ex. 1002 at ¶ 204. And, while the Japanese publica-
tion mentions treating the entire “working portion,” the remainder of the shank (what
Matsutani calls the “needle”)13 has the same diameter as the proximal end of the
working portion, but without grooves cut into it. Ex. 1002 at ¶ 205. Its rigidity would
be greater than or equal to that of the “working portion,” such that the entire shank
could be heat-treated with the same effect as treating only the “working portion.” Id..
12 Exhibit 1027 is a certified translation of Exhibit 1026.
13 What the ’773 patent calls a “shank,” Matsutani calls a “needle.” Matsutani uses
“shank” to refer to the portion of the “needle” that does not have a cutting edge.
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This Japanese application, even if not prior art to the ’773 patent under § 102,
is further evidence of the knowledge and skill in the art as of 2004, as well as an arti-
san’s motivation to modify the prior art. See, e.g., Nat’l Steel Car, Ltd. v. Canadian Pac.
Ry., Ltd., 357 F.3d 1319, 1337-39 (Fed. Cir. 2004). An ordinary artisan would have
known how to address the concerns stated in Matsutani without the difficulty and ex-
pense of heat-treating only a portion of the instrument. Ex. 1002 at ¶¶ 203-06.
Matsutani proposed five possible methods of keeping part of the instrument
cool during heat treatment. See Ex. 1023 at 6:42-7:28, Fig. 4. One of ordinary skill
would have recognized that it would have been simpler and cheaper to heat-treat the
entire shank. Ex. 1002 at ¶ 201, 206; compare Ex. 1023, 7:13-18 (describing a method
of inserting a portion of a wire through a small hole to heat-treat it).
Having applied the teachings of Pelton to those of Matsutani, the artisan would
have arrived at the subject matter of claim 1. Claim 1 requires “providing an elongate
shank having a cutting edge extending from a distal end of the shank along an axial
length of the shank.” Figure 1 of Matsutani shows an “elongate shank”, and a cutting
edge is shown extending from the distal end (tip) along the length. Ex. 1023 at Fig. 1,
2:61-3:12; Ex. 1002 at ¶ 208. Claim 1 further requires that the shank “compris[e] a su-
perelastic nickel titanium alloy.” Matsutani teaches that the instrument should be
made of “a Ni-Ti alloy previously provided with a superelastic characteristic.” Ex.
1023 at 6:24-25. Pelton’s alloy is a nickel-titanium alloy having 50.8% nickel by atomic
percentage and is superelastic (before heat treatment) at temperatures between about
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0°C and 60°C. Ex. 1006 at 113-14; Ex. 1002 at ¶ 209. Such an alloy was known to be
appropriate for endodontic files. Ex. 1002 at ¶ 209; see Ex. 1022 at ¶ 40.
Claim 1 further requires “heat-treating the entire shank at a temperature from
400° C. . . .” Matsutani teaches that the shank should be heat-treated to change the
material so that it is no longer superelastic, but rather exhibits shape memory. Ex.
1023 at 2:25-34, 4:31-64; Ex. 1002 at ¶ 210. It also teaches that the heat-treated por-
tion should have a “shape recovery temperature” higher than room temperature and
body temperature. Ex. 1023 at 5:46-57. As explained above, it would have been obvi-
ous to apply this treatment to the “entire shank.” Pelton, meanwhile, teaches the nec-
essary parameters of heat treatment. As described above, Figures 9 and 10 provide
guidance on how to raise the austenite finish temperature, which is also the shape re-
covery temperature, to about 40°C, which is above both room temperature and body
temperature. See Ex. 1006 at 111, 114; Ex. 1002 at ¶¶ 73-74, 153, 200, 212-13. Appli-
cable treatments include temperatures from 400°C to below the melting point of Ni-
Ti. See Ex. 1006 at 114; Ex. 1002 at ¶¶ 153, 211. It would have been obvious to apply
any of these treatments to achieve the goal described by Matsutani. Ex. 1002 at ¶ 211.
Finally, claim 1 recites that “the heat treated shank has an angle greater than 10
degrees of permanent deformation after torque at 45 degrees of flexion when tested in
accordance with ISO Standard 3630-1.” As explained above (section IV-C-1), this is
not a limitation. However, even if it were a limitation, it would be satisfied by the
combination of Matsutani and Pelton. Matsutani teaches that the heat-treated portion
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of the instrument “does not exhibit the characteristic of returning to its original shape,
but can be deformed in a preferable shape.” Ex. 1023 at 4:42-44. Therefore, “the den-
tist can bend (pre-curve)” it. Id. at 4:45. Matsutani also discloses a bending test in
which partially heat-treated instruments were “gripped at a position about 3 mm from
the tip” and “bent about 45 degrees,” and torque was measured Id. at 8:15-21. Matsu-
tani then observes, “even if the shape memory portion 6 is forcibly bent, and then the
bending force is released, the bent shape of the memory portion 6 can be main-
tained.” Id. at 8:30-32. Accordingly, Matsutani teaches that heat treatment would ac-
complish the permanent deformability claimed by the ’773 patent. Ex. 1002 at ¶ 212.
And Pelton teaches how to do so. Id. at ¶ 213.
Additionally, Matsutani teaches that the “shape recovery temperature” should
be above room temperature and body temperature. Ex. 1023 at 5:46-57. The shape
recovery temperature is the austenite finish temperature. Ex. 1002 at ¶ 213; see Ex.
1006 at 111 (“At the lowest test temperatures, the wires are fully martensitic and the
high residual strains are fully recovered by heating above Af (the shape-memory ef-
fect).”). The inventor of the ’773 patent described his invention as one that raises the
austenite finish temperature to above body temperature so that it is martensitic during
use. See supra Section IV-C-2. Pelton teaches what times and temperatures to use for
this purpose; during prosecution of the ’773 patent, the inventor even pointed to a
copy of Pelton’s Figure 10 to show that treatment at 500°C for about 2 hours would
raise Af to 39°C. Compare Ex. 1008 at 159 with Ex. 1006 at 114; see supra Section VI-F-
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3.
For all of the above reasons, the “wherein” clause is satisfied by the combina-
tion of Matsutani and Pelton, and claim 1 is unpatentable as obvious.
Claim 13 differs from claim 1 in that (i) the “cutting edge” is defined by “helical
flutes,” (ii) the instrument is “in accordance with ISO Standard 3630-1,” and (iii) the
heat treatment temperature is 475-525°C. Regarding (i), Figures 1 and 2 of Matsutani
illustrate “helical flutes” (grooves) that define the cutting edge. Ex. 1023 at Figs. 1-2,
3:61-4:7; Ex. 1002 at ¶ 216. Regarding (ii), it would have been obvious to construct
the instrument to comply with a well-known standard. Ex. 1002 at ¶ 217. The 1992
version of the ISO 3630-1 standard calls for 2/100 taper files (Ex. 1016), which
Matsutani’s Japanese application (Ex. 1027) notes may encounter an issue with per-
formance if the entire shank of such a file was heat treated. See Ex. 1027 at ¶ 22.
However, to the extent that claim 13 requires literal compliance with every aspect of
the ISO 3630-1 standard, then it cannot be entitled to a priority date any earlier than
December 23, 2010, which was the date of the applicant’s first application filed after
the 2008 version of the ISO 3630-1 standard was implemented and published. For
example, the 1992 ISO 3630-1 standard calls for files made out of steel, not nickel ti-
tanium. Ex. 1016 at 2. Accordingly, the applicant could not have been in possession,
in 2004, of a nickel-titanium file made in accordance with the ISO 3630-1 standard, as
claim 13 requires, if that ISO 3630-1 standard was referring to the 1992 version. The
2008 ISO 3630-1 standard, which is prior art to the 2010 application is not specifically
- 57 -
limited to tapers of 2/100 (2mm), allowing for tapers greater than 2/100 (2mm),
which, even when fully heat-treated, would not have encountered the potential per-
formance problem noted by Matsutani. Ex. 1002 at ¶¶ 204, 217 & n.9.
Regarding (iii), Pelton shows that treatment between 475 and 525°C will pro-
duce the desired result, provided the appropriate treatment time is chosen. Ex. 1002 at
¶ 218; see Ex. 1006 at 114. Therefore, claim 13 is also unpatentable.
Regarding claim 8, it would have been obvious to construct an instrument so
that the shank’s diameter at the proximal end (see supra section IV-C-4) is 0.5 to 1.6
millimeters. Matsutani discloses the following example: an instrument formed from
raw material with a diameter of 1.0 mm, a working length of 15 mm, a diameter of 0.3
mm at the tip, and a 4/100 taper. Ex. 1023 at 7:55-61. The “4/100” taper means that
for every millimeter of working length, the diameter increases by 0.04 mm. Ex. 1002
at ¶ 222. Therefore, across 15 mm of working length, the diameter increases by 0.6
mm, and the proximal-end diameter is therefore 0.9 mm, within the claimed range. Id.
The additional limitations in dependent claims 2-7, 9-12, and 14-17 all relate to
the alloy or the heat treatment process, which are disclosed in Pelton and are the same
alloy and process described above in Ground 7.14 Therefore, these dependent claims
are unpatentable for the same reasons. Ex. 1002 at ¶¶ 219-21, 223-25.
14 See also Ex. 1024 at 258-59 (showing permanent deformation after heat-
treatment at 500°C for one-hour); Ex. 1002 at ¶ 79-82, 185; Section VI-H-2, infra.
- 58 -
J. Ground 12: Obviousness of Claims 1-17 in Further View of Khier
If the claims are construed to require heat treatment in an unreactive atmos-
phere, Khier cures any deficiency for the same reason as is stated above with respect
to Grounds 8 and 9. See Ex. 1002 at ¶¶ 226-27.
K. The Grounds in This Petition Are Not Redundant
The Board should institute inter partes review on all of the grounds presented in
this petition. Grounds based on Gao and Luebke 2008 (grounds 1-4) depend on the
Board’s determination as to the appropriate priority date of the Challenged Claims (see
supra section V), but are otherwise comprehensive references that anticipate the chal-
lenged claims (except with respect to Gao and claims 8 and 13-17, which are rendered
obvious in combination with the ISO 3630-1 publication). Gao even discloses the
same rationale for the claimed heat treatment that was stated by the applicant of the
’773 patent during prosecution (but which does not appear in the ’773 patent itself),
i.e., raising the austenite finish temperature of a superelastic Ni-Ti endodontic file so
that it is in the martensitic phase during use. Luebke 2008, which is in the same patent
family as the ’773 patent, has substantially the same disclosure of the ’773 patent.
Therefore, these grounds (1-4) are not redundant of each other or of grounds based
on earlier references.
The earlier references are also not redundant of each other. Ground 5 is an an-
ticipation ground, while Ground 6 requires only a determination that it would have
been obvious to apply a well-known ISO standard relating to endodontic files. To-
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gether, these claims cover many (but not all) of the Challenged Claims, but for some
claims they depend on a determination that the “wherein” clause is not limiting.
Regarding the remaining obviousness grounds, Ground 7 relies principally on a
motivation to apply heat treatment to a Ni-Ti endodontic file to achieve a higher
transformation temperature, which Kuhn, Pelton and McSpadden teach to be benefi-
cial because of higher flexibility and greater resistance to fatigue. Ground 10, by con-
trast, relies on a motivation to apply heat treatment so that a practitioner may pre-
curve a Ni-Ti endodontic file, which cannot be done to superelastic files. This helps
prevent unwanted forces against the side of the root canal wall, as noted by Weine
and Matsutani. Ground 11 on the other hand, is based on Matsutani, which itself pro-
vides multiple motivations to heat-treat and permanently deform a file, including elim-
inating the “zipping” problem and also improving cyclic fatigue. Unlike the other
primary references, however, Matsutani suggests only heat-treating 3/4 of the shank.
Therefore, Matustani requires combination with the knowledge of one of ordinary
skill that treating the entire shank would be acceptable and simpler, particularly with
files of greater taper. Because a hypothetical artisan’s motivation to combine the
teachings of various references is a fact-sensitive issue, the Board in its final decision
could accept one motivation and reject the other, based on evidence submitted during
trial and not currently available to Petitioner (e.g., expert testimony). The Board
should therefore institute trial on each of Ground 5-11 (in addition to Ground 1-4).
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VII. CONCLUSION
For the reasons explained above, Petitioner respectfully requests institution of
inter partes review of claims 1-17 of the ’773 patent on each of the grounds presented
herein, and cancellation of those claims in a final written decision.
Dated: Jan. 30, 2015 /Jeffrey S. Ginsberg/ Jeffrey S. Ginsberg (Reg. No. 36,148) Lead counsel for Petitioner US Endodontics, LLC Matthew G. Berkowitz (Reg. No. 57,215) Eric T. Schreiber (Reg. No. 58,771) Back-up counsel for Petitioner US Endodontics, LLC Kenyon & Kenyon LLP One Broadway New York, NY 10004-1007 Tel.: (212) 425-7200
CERTIFICATE OF SERVICE
Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, the undersigned certifies that on Jan-
uary 30, 2015, a complete and entire copy of this Petition for Inter Partes Review along
with complete and entire copies of Petitioner US Endodontics, LLC Exhibits 1001
through 1027 were served via Express Mail on the Patent Owner at the following corre-
spondence address of record for the ʼ773 patent:
Quarles & Brady LLP
Attn: IP Docket
411 E. Wisconsin Avenue
Suite 2350
Milwaukee, WI 53202-4426
A courtesy copy was also provided to litigation counsel for GSI’s licensee:
Steven Lieberman
Rothwell, Figg, Ernst & Manbeck, P.C.
607 14th St. NW, Suite 800
Washington, D.C. 20005
/Matt Berkowitz/___
Kenyon & Kenyon LLP One Broadway New York, NY 10004-1007 Tel.: (212) 425-7200
