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 PGR2015-00019
`Patent 8,876,991 B2
`
`
`
`PETITIONER’S REPLY IN SUPPORT OF
`PETITION FOR POST-GRANT REVIEW
`
`
`
`
`
`

`
`
`
`TABLE OF CONTENTS
`
` Page
`
`I.
`
`Introduction ...................................................................................................... 1
`
`II.
`
`The Challenged Claims are Not Enabled Under 35 U.S.C. § 112(a) .............. 2
`
`A. A Significant Portion of the Claimed Temperature Ranges Do
`Not Achieve the Claimed Permanent Deformation .............................. 2
`
`B.
`
`C.
`
`D.
`
`E.
`
`Luebke Admitted that a Significant Portion of the Claimed
`Temperature Ranges are Unlikely to Achieve the Claimed
`Permanent Deformation ........................................................................ 4
`
`Petitioner’s Testing Confirms that a Significant Portion of the
`Claimed Temperature Ranges Fail to Achieve the Claimed
`Deformation ........................................................................................... 5
`
`Patent Owner’s Alleged “Testing” Should Not Be Given Any
`Weight ................................................................................................... 8
`
`Undue Experimentation Would Be Required to Practice the Full
`Scope of the Claimed Invention .......................................................... 10
`
`III. The Specification Lacks Adequate Written Description Support for
`the Challenged Claims ................................................................................... 15
`
`A.
`
`The Board Has Not Previously Rejected Petitioner’s Arguments ...... 15
`
`B.
`
`Luebke Did Not Have Possession of the Claimed Invention
`with Respect to a Significant Portion of the Claimed
`Temperature Ranges—A Fact that He Admitted ................................ 16
`
`IV. Petitioner Has Demonstrated that the Challenged Claims are Not
`Entitled to an Effective Filing Date Earlier than January 29, 2014 .............. 17
`
`V.
`
`Patent Owner Concedes that Claims 12-16 are Unpatentable Over
`Luebke 2008 Alone and that Claim 15 is Additionally Unpatentable
`Over Luebke 2008 in View of Heath or ISO Standard 3630-1 ..................... 18
`
`VI. Kuhn Anticipates Claims 12-14 and 16, and Renders Obvious Claim
`15 Either Alone or in View of Heath or the 1992 ISO Standard 3630-1 ...... 18
`
`i
`
`

`
`
`
`A. Kuhn Does Not State the Heat Treated Files Recovered Their
`Original State After Bending ............................................................... 19
`
`B.
`
`Patent Owner’s Experimental Results are Unavailing ........................ 20
`
`C. Kuhn Describes in Detail the Bend Test Employed ........................... 22
`
`D.
`
`E.
`
`The 2001 Publication Does Not “Confirm that the Heat-Treated
`Specimens Discussed in Kuhn are Superelastic” ................................ 23
`
`The Board’s Final Written Decision in IPR2015-00632 is
`Consistent with Petitioner’s Position that Kuhn’s Disclosure of
`Heat-Treating Would Meet the ’991 Patent’s Claimed
`Deformation Limitation ....................................................................... 24
`
`VII. Conclusion ..................................................................................................... 25
`
`ii
`
`

`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1234 (Fed. Cir. 2003) ............................................................................ 3
`
`Page
`
`Impax Labs. Inc. v. Aventis Pharm. Inc.,
`468 F.3d 1366 (Fed. Cir. 2006) .......................................................................... 21
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.
` 424 F.3d 1336 (Fed. Cir. 2005) ......................................................................... 16
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008) ............................................................................ 9
`
`Sitrick v. Dreamworks, LLC,
`516 F.3d 993 (Fed. Cir. 2008) .............................................................................. 2
`
`
`
`iii
`
`

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

`
`
`
`1016
`
`1017
`
`Edgar Schäfer et al., Bending Properties of Rotary Nickel-
`Titanium Instruments, 96 ORAL SURGERY ORAL MEDICINE ORAL
`PATHOLOGY 757 (2003)
`
`Luca Testarelli et al., Bending Properties of a New Nickel-
`Titanium Alloy with a Lower Percent by Weight of Nickel, 37 J.
`ENDODONTICS 1293 (2011)
`
`1018
`
`Declaration of Adam Kozak
`
`1019
`
`1020
`
`1021
`
`Excerpts of Expert Report of Robert Sinclair, Ph.D., Dentsply
`International, Inc. v. US Endodontics, LLC, Docket No. CV-2-14-
`196 (E.D. Tenn.)
`
`Alan R. Pelton et al., The Physical Metallurgy of Nitinol for
`Medical Applications, 55 J. METALS 33-37 (May 2003)
`
`S. Miyazaki et al., Characteristics of Deformation and
`Transformation Pseudoelasticity in Ti-Ti Alloys, 43 J. PHYSIQUE
`COLLOQUES C4-255 (1982)
`
`1022
`
`U.S. Patent Appl. Pub. No. 2008/0032260 A1 to Luebke
`
`1023
`
`International Standard ISO 3630-1, 1st ed. (1992)
`
`1024
`
`U.S. Patent No. 5,628,674 to Heath et al.
`
`1025
`
`1026
`
`1027
`
`1028
`
`U.S. Patent Appl. Pub. No. US 2006/0115786 A1 to
`Matsutani et al.
`
`Japanese Unexamined Patent Appl. Pub. No. 2006-149675
`to Matsutani et al.
`
`English translation of Japanese Unexamined Patent Appl.
`Pub. No. 2006-149675 to Matsutani et al.
`
`Transmittal from prosecution history of U.S. Patent Appl. Serial
`No. 11/287,771, enclosing Japanese Patent Appl. No. 2004344717
`to Matsutani et al.
`
`v
`
`

`
`
`
`1029
`
`1030
`
`Transmittal from prosecution history of U.S. Patent Appl. Serial
`No. 11/287,771, with English translation of enclosed Japanese
`Patent Appl. No. 2004-344717 to Matsutani et al.
`
`Grégoire Kuhn & Laurence Jordan, Fatigue and
`Mechanical Properties of Nickel-Titanium Endodontic
`Instruments, 28 J. ENDODONTICS 716 (2002)
`
`1031
`
`U.S. Patent Appl. Pub. No. 2002/0137008 A1, McSpadden et al.
`
`1032
`
`1033
`
`1034
`
`Teresa Roberta Tripi et al., “Fabrication of Hard Coatings on NiTi
`Instruments,” 29 J. ENDODONTICS 132 (2003)
`
`Harmeet Walia et al., An Initial Investigation of the Bending and
`Torsional Properties of Nitinol Root Canal Files, 14 J.
`ENDODONTICS 346 (1988)
`
`M. G. A. Bahia, Fatigue Behaviour of Nickel–Titanium
`Superelastic Wires and Endodontic Instruments, FATIGUE &
`FRACTURE OF ENG’G MATS. & STRUCTURES 29, 518–523 (2006)
`
`1035
`
`Printout of the webpage:
`
`http://www.tulsadentalspecialties.com/default/endodontics/RotaryFil
`es /ProFileISO.aspx, accessed on July 22, 2015, and Safety Data
`Sheet for Nickel Titanium Wire: NITINOL 55, linked on that
`webpage.
`
`1036
`
`Masao J. Drexel et al., The Effects of Cold Work and Heat
`Treatment on the Properties of Nitinol Wire, Proc. Int’l
`Conference on Shape Memory & Superelastic Techs., SMST-
`2006, pp. 447-454 (2008)
`
`1037
`
`Prosecution history of U.S. Patent No. 8,562,341
`
`1038
`
`W.A. Brantley et al., Differential Scanning Calorimetric Studies of
`Nickel Titanium Rotary Endodontic Instruments, 28 J.
`ENDODONTICS 567 (2002)
`
`1039
`
`Transcript of December 3, 2015 Teleconference
`
`vi
`
`

`
`1040
`
`Excerpts of Deposition Transcript of Neill H. Luebke, D.D.S.,
`M.S., Dec. 9, 2015, US Endodontics, LLC v. Gold Standard
`Instruments, LLC, IPR2015-00632, Ex. 1038 (P.T.A.B.)
`
`1041
`
`Declaration of Lou Fiorini
`
`1042
`
`Supplemental Declaration of A. Jon Goldberg, Ph.D.
`
`1043
`
`1044
`
`1045
`
`Excerpts of Claim Construction Hearing Transcript, June 14,
`2016, Dentsply International, Inc. v. US Endodontics, LLC, Case
`No. 2:14-CV-196 (E.D. Tenn.)
`
`Excerpts of Deposition Transcript of Neill H. Luebke, D.D.S.,
`M.S., June 2, 2016, Dentsply International, Inc. v. US
`Endodontics, LLC, Case No. 2:14-CV-196 (E.D. Tenn.)
`
`Excerpts of Deposition Transcript of Robert Sinclair, Ph.D., Jan.
`18, 2016, US Endodontics, LLC v. Gold Standard Instruments,
`LLC, IPR2015-00632, Ex. 1040 (P.T.A.B.)
`
`
`
`
`
`
`
`vii
`
`

`
`
`
`I.
`
`Introduction
`
`Patent Owner’s Response fails to demonstrate that claims 12-16 of the ’991
`
`patent are patentable under either 35 U.S.C. § 112(a) and/or over the prior art.
`
`Notably, Patent Owner did not provide any declaration testimony from an expert in
`
`this proceeding to rebut the testimony of Petitioner’s expert, Dr. Goldberg. Instead
`
`Patent Owner relies on unsupported attorney argument and mischaracterizations of
`
`Dr. Goldberg’s testimony.
`
`With respect to lack of enablement, Patent Owner fails to cite any evidence
`
`to rebut Petitioner’s experimental results, discussed and included in the Petition,
`
`which demonstrate that a significant portion of the claimed heat treatment
`
`temperature ranges do not achieve the claimed permanent deformation.
`
`Regarding lack of written description, which entails a “possession” test, the
`
`inventor, Neill Luebke, admitted that heat treatment temperatures between 50°C
`
`and 250°C would not achieve greater than the claimed 10 degrees of permanent
`
`deformation, and that he did not know whether heat-treating at 300°C would
`
`achieve the same.
`
`Turning to the prior art, Patent Owner’s only argument with respect to the
`
`Luebke 2008 reference is that it is not prior art. If the Board maintains its
`
`preliminary determination that claims 12-16 of the ’991 patent are not entitled to
`
`an effective filing date earlier than the actual filing date of the patent application
`
`1
`
`

`
`
`
`that directly resulted in the issuance of the ’991 patent, which Petitioner submits it
`
`should, then Luebke 2008 undisputedly anticipates claims 12-16, and additionally
`
`renders claim 15 unpatentable in view of Heath and/or ISO Standard 3630-1.
`
`Lastly, Patent Owner did not submit any expert testimony to rebut the
`
`opinions of Petitioner’s expert, Dr. Goldberg, regarding Kuhn. Since Patent
`
`Owner’s unsupported attorney arguments cannot prevail over Dr. Goldberg’s
`
`opinions, the Board should determine that Kuhn anticipates claims 12-14 and 16,
`
`and renders obvious claim 15 alone, or in view of Heath or ISO Standard 3630-1.
`
`II. The Challenged Claims are Not Enabled Under 35 U.S.C. § 112(a)
`
`A. A Significant Portion of the Claimed Temperature Ranges Do Not
`Achieve the Claimed Permanent Deformation
`
`Patent Owner asserts that (i) “the ‘wherein’ clause limits the heat treatments
`
`encompassed by claims 12-16 to only those that result in a NiTi file that is capable
`
`of exhibiting the claimed degree of permanent deformation.,” and, therefore,
`
`“claims 12-16 are limited to operative embodiments.” See Paper 27, pp. 17 and 19.
`
`Such argument is nonsensical. Indeed, Patent Owner cites no legal authority to
`
`support its position that the enablement requirement of 35 U.S.C. § 112 does not
`
`apply in the same manner to claims that contain such “wherein” clauses. A
`
`“patentee who chooses broad claim language must make sure the broad claims are
`
`fully enabled.” Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008).
`
`2
`
`

`
`
`
`See also AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003)
`
`(“[W]hen a range is claimed, there must be reasonable enablement of the scope of
`
`the range.”). Since heat treatments at from 25°C to at least 300°C will not result in
`
`a nickel titanium (“NiTi”) shank exhibiting the claimed permanent deformation,
`
`and the ’991 patent specification provides no mention of any heat treatment
`
`temperatures and times, other than 500° C for 75 minutes, that would result in a
`
`shank achieving the claimed permanent deformation, claims 12 through 16 of the
`
`’991 patent are not enabled. See Paper 1, pp. 35-40.
`
`Patent Owner also argues that “it is undisputed that the testing Petitioner
`
`conducted at 25°C is outside the scope of the claims” because Dr. Goldberg
`
`“admitted” that heating something at 25°C is not a heat treatment process, but “a
`
`form of conditioning.” Paper 27, p. 18. Patent Owner appears to imply that heat-
`
`treating exactly at 25°C is not a heat treatment process and thus, outside the scope
`
`of the claims, whereas heat-treating at slightly above 25°C—for example, at
`
`25.5°C or 26°C—is a heat treatment process, and thus, may be within the scope of
`
`the claims. Dr. Goldberg’s testimony does not support such an assertion.
`
`Rather than an admission, the cited testimony from Dr. Goldberg is
`
`consistent with his direct testimony, namely, that “subjecting a Ni-Ti instrument to
`
`25-37°C will not alter its transformation temperatures. Effective heat-treatment
`
`requires enough thermal energy for the individual atoms to move to different
`
`3
`
`

`
`
`
`positions within the solid material. Heat-treatment at 25-37°C does not provide this
`
`energy.” Ex. 1002, ¶¶ 101, 102. Dr. Goldberg’s testimony fully supports
`
`Petitioner’s position that heating at such temperatures will not result in the NiTi
`
`shank of an instrument achieving the claimed permanent deformation.
`
`B.
`
`Luebke Admitted that a Significant Portion of the Claimed
`Temperature Ranges are Unlikely to Achieve the Claimed
`Permanent Deformation
`
`Even Luebke does not believe it is possible to achieve the claimed
`
`permanent deformation for a significant portion of the claimed temperature ranges.
`
`During a deposition in IPR2015-00632, Luebke was asked whether a NiTi shank
`
`can be heated within a wide range of temperatures claimed in the ’991 patent in
`
`order to achieve the required degree of deformation and he provided the following
`
`testimony:
`
`Q Do you believe you could heat-treat at 300 degrees and get the
`
`claimed amount of permanent deformation?
`
`A I guess you have to try.
`
`Q You don’t know?
`
`A I don’t know.
`
`Q Could you heat-treat at 50 degrees and get the claimed amount of
`
`permanent deformation?
`
`A I would guess not.
`
`Q How about 100 degrees?
`
`A I would guess not.
`
`4
`
`

`
`
`
`Q How about 150 degrees?
`
`A How many temperatures are we going to do?
`
`Q A few more.
`
`A I -- I would guess not.
`
`Q How about 250 degrees?
`
`A I would guess not.
`
`Ex. 1040, 193:12-194:12 (objections omitted).
`
`C.
`
`Petitioner’s Testing Confirms that a Significant Portion of the
`Claimed Temperature Ranges Fail to Achieve the Claimed
`Deformation
`
`Patent Owner argues that Petitioner’s testing is deficient because “testing at
`
`only two temperatures is insufficient to show a lack of enablement.” Paper 27, p.
`
`20. Patent Owner cites no authority for such argument. To the contrary, Dr.
`
`Goldberg reasonably concluded that Petitioner’s test results demonstrate an
`
`“absence of an enabling disclosure to satisfy the ‘wherein’ clause at heat treatment
`
`temperatures of greater than 25°C up to 300°C.” Ex. 1002, ¶ 103. Further, as the
`
`Board correctly noted, the similarity of the bend-test results of samples heated at
`
`25°C and at 300°C suggests that “shanks heat-treated at temperatures within the
`
`range from 25°C to 300°C for durations from 75 minutes to twelve hours would
`
`likewise fail to satisfy the ‘wherein’ clause of claim 12.” Paper 17, pp. 17-18.
`
`Patent Owner suggests, without any support, that Petitioner may have
`
`“test[ed] longer periods of time at 300°C” and “not provide[d] the results of that
`
`5
`
`

`
`
`
`data.” Paper 27, p. 22. Notably, Patent Owner does not even attempt to argue that
`
`testing for longer periods of time at temperatures between 25°C and 300°C could
`
`achieve the claimed permanent deformation. In any event, in response to this and
`
`other unfounded criticisms concerning Petitioner’s testing, see id. at 22-23,
`
`Petitioner engaged a second independent laboratory to test additional samples of
`
`the same model and size of files previously tested in order to confirm the original
`
`test results. This supplemental testing comprised the following heat treatment
`
`cycles: 40°C for each of 75 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours,
`
`and 28 hours; and 300°C for 24 and 28 hours.
`
`The samples heat treated at 40°C showed between 0.56 and 1.50 degrees of
`
`deformation, averaging 1.00 degrees, far below the 10 degrees required by the
`
`claims of the ’991 patent. Ex. 1041, p. 13. The samples heat treated at 300°C
`
`showed between 1.36 and 2.59 degrees of deformation, averaging 1.81 degrees,
`
`also far below the claimed 10 degrees. Id. at 13.
`
`This testing also addressed Patent Owner’s criticism that “bending in the
`
`same direction as the initial bend” “results in less deformation.” Paper 27, pp. 22-
`
`23. As an initial matter, nothing in the ’991 patent specification or ISO Standard
`
`3630-1 provides any guidance to bend in the opposite direction as any initial bend.
`
`Further, although neither Petitioner nor its expert, Dr. Goldberg, agrees with such
`
`criticism, see Ex. 1042, ¶ 9, Petitioner’s supplemental testing called for bending in
`
`6
`
`

`
`
`
`the opposite direction as any initial bend, id. (citing Ex. 1041, p. 10). The testing
`
`confirmed that heat treatment of a NiTi shank at temperatures between 25°C and
`
`up to and including 300°C does not cause the shank to achieve the claimed
`
`deformation, and demonstrated the invalidity of Patent Owner’s criticisms. Ex.
`
`1042, ¶¶ 7-10.
`
`Patent Owner argues that “Petitioner has not established that a person of
`
`ordinary skill in the art selected the heat treatment times and temperatures for the
`
`heat treatment experiments performed by Petitioner.” Paper 27, p. 20. Such
`
`criticism of Petitioner’s testing is misplaced. Petitioner relies on its test results to
`
`show that a significant portion of the broad range of claimed temperatures do not
`
`achieve the claimed permanent deformation. See Paper 1, pp. 40-45.
`
`Further, it is irrelevant whether Petitioner’s expert, Dr. Goldberg, selected
`
`the times and temperatures for the testing. The temperatures of 25°C and 300°C
`
`were dictated by temperature ranges recited in claims 12-16. With respect to the
`
`duration of the heat treatments, despite the fact that the ’991 patent specification
`
`discloses only one time—75 minutes—Petitioner’s testing included heat treatment
`
`cycles of not only 75 minutes, but also 2 hours, 4 hours, 8 hours, and 12 hours.
`
`Patent Owner provides no support for its argument that the specification’s
`
`disclosure of a single heat treatment time of 75 minutes would have provided “a
`
`reasonable amount of guidance” for a person of skill in the art to test for times that
`
`7
`
`

`
`
`
`exceeded the times utilized by the Petitioner. Tellingly, Patent Owner does not
`
`provide any expert testimony to support such a position. Nevertheless, to address
`
`this additional unfounded criticism, the supplemental testing commissioned by
`
`Petitioner included cycles of 24 and 28 hours at both 40°C and 300°C. See supra,
`
`p. 5. Such heat treatment conditions did not result in shanks achieving the claimed
`
`amount of deformation. Ex. 1042, ¶ 8 (citing Ex. 1041, p. 13).
`
`D.
`
`Patent Owner’s Alleged “Testing” Should Not Be Given Any
`Weight
`
`While Patent Owner strains unsuccessfully to find flaws in Petitioner’s test
`
`results, Patent Owner seeks to rely on a declaration of Luebke and an associated
`
`unsworn test report submitted during the prosecution history of one of Luebke’s
`
`later filed patent applications, U.S. Patent Appl. No. 14/522,013 (“the ’013 appl.”),
`
`with glaring deficiencies. See Paper 27, p. 23.1
`
`As an initial matter, Luebke has a substantial financial stake in the outcome
`
`of this and related proceedings. During a recent hearing in the co-pending district
`
`court litigation, Luebke testified that he had already been paid nearly $1.4 million
`
`
`1 Patent Owner’s appears to have incorrectly cited to Ex. 2035 instead of Exhibit
`
`2034. Petitioner objected to the cited portions of Exhibit 2034 as constituting
`
`inadmissible hearsay and for lack of authentication. See Paper 29, pp. 2-3. In
`
`response, Patent Owner failed to serve any supplemental evidence.
`
`8
`
`

`
`
`
`under the terms of an agreement wherein Luebke, through his company, Patent
`
`Owner Gold Standard Instruments, licensed the family of patents to which the ’991
`
`patent belongs to real-party-in-interest Dentsply. Ex. 1043, 113:23-115-15. Luebke
`
`further testified that he expects to “receive millions of dollars more” in royalties
`
`alone. Id. at 115:16-116:14. Thus, his self-serving statements submitted during the
`
`prosecution of the ’013 appl. should be disregarded. See, e.g., O2 Micro Int’l Ltd.
`
`v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362, n. 3 (Fed. Cir. 2008).
`
`In any event, Luebke’s declaration fails to identify the brand or model of the
`
`files he allegedly had heat treated at 300°C for 24 hours and, thereafter, bend
`
`tested. When questioned about this in the district court case, Luebke testified that
`
`he could not recall the name of the manufacturer or the brand of such files. Ex.
`
`1044, 100:4-103:4. Accordingly, there is no way to confirm whether the shanks of
`
`such files were superelastic prior to the heat treatment, as required by claims 12-16
`
`of the ’991 patent. Luebke’s declaration also provides no explanation as to the
`
`amount of experimentation that went into settling on 24 hours. Patent Owner also
`
`failed to provide any report, let alone declaration, from the company that allegedly
`
`heat treated the files to verify the condition of the same upon receipt.
`
`The fact that the Patent Owner did not provide declaration testimony from
`
`either Luebke let alone an independent expert in this proceeding only highlights
`
`the deficiencies with the declaration associated with the prosecution of Luebke’s
`
`9
`
`

`
`
`
`later filed ’013 appl., upon which Patent Owner seeks to rely. Petitioner submits
`
`that the testing it performed, which was accompanied by sworn declarations in this
`
`proceeding and which demonstrates that heat-treating shanks at temperatures of
`
`25°C, 40°C, and 300°C did not achieve the claimed deformation, is substantially
`
`more reliable, and the Luebke declaration should be given no weight.
`
`E. Undue Experimentation Would Be Required to Practice the Full
`Scope of the Claimed Invention
`
`1.
`
`Petitioner’s Arguments are Not Premised on an Incorrect
`Claim Interpretation
`
`Patent Owner argues that “[a]ll of the evidence submitted by Petitioner
`
`regarding any alleged undue experimentation is based on Petitioner’s erroneous
`
`claim construction” of the “wherein” clause relating to an austenite finish (Af)
`
`temperature greater than 37°C. Paper 27, p. 24. This argument is incorrect and
`
`ignores the testing Petitioner commissioned, which demonstrates that heat-treating
`
`a superelastic NiTi shank at temperatures between 25°C up to and including 300°C
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`for various durations will not result in a shank that satisfies the claimed
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`deformation limitation. Ex. 1002, ¶¶ 105, 107. It also ignores the fact that
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`numerous references, including Pelton (Ex. 1006, pp. 111, 114) and Alapati (Ex.
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`1005, p. 59), equate raising the Af (i.e., shape recovery) temperature with
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`decreasing superelasticity such that a NiTi alloy would demonstrate permanent
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`deformation. Notably, during the prosecution of the ’991 patent, Luebke himself
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`cited to one of Pelton’s figures depicting Af temperatures as disclosing the heat
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`treatment temperatures and times that would result in his claimed invention. Ex.
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`1003, pp. 127-128.2
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`2. While the Wands Factors Are Illustrative, Not
`Mandatory, the Petition Addresses Each of the Same
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`Patent Owner argues that “Petitioner has not conducted a Wands analysis.”
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`Paper 27, p. 25. As the Board noted, the Wands factors “are illustrative, not
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`mandatory.” Paper 17, p. 19. In any event, the Petition addresses each factor.
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`Regarding the first Wands factor, Patent Owner argues incorrectly that
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`“Petitioner has not addressed the quantity of experimentation that would be needed
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`to practice the claimed invention.” Paper 27, p. 26. Petitioner and Dr. Goldberg
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`both explained that the ability of a file to permanently deform and the amount of
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`such deformation depends on many variables—including, but not limited to, heat
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`treatment time and temperature, NiTi composition, and processing history. Paper 1,
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`pp. 41-45 (citing Ex. 1002, ¶ 111-125). The quantity of experimentation to practice
`
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`2 While Luebke cited a 2012 publication as the source of the figure, such figure is
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`identical to the one in the Pelton article from 2000. Compare Ex. 1003, p. 128 and
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`Ex. 1008, p. 159 with Ex. 1006, Fig. 10.
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`11
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`the invention claimed in the ’991 patent would be undue because the specification
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`provides no guidance with respect to these variables.3
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`Patent Owner’s cites to the testimony of Adam Kozak, a technician who
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`performed the original bend testing on the 25°C and 300°C heat-treated samples, to
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`argue that “ISO bend testing was normal testing in terms of effort and
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`instrumentation.” Paper 27, p. 28 (citing Ex. 2041, 55:8-13). Such testimony is of
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`no moment. Indeed, Mr. Kozak did not testify, nor would he be qualified to testify,
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`that it would be a matter of routine experimentation to arrive at the precise
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`combinations of all of the variables, discussed above, that would result in a heat
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`treated shank achieving the claimed deformation. Such an undertaking is not
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`analogous to simply performing bend-testing of a small number of samples.
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`Regarding the second and third Wands factors, Patent Owner argues that: (1)
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`“Petitioner has not addressed in its petition the guidance provided by Dr. Luebke in
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`the ’991 patent (and earlier related applications) including specific examples for
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`heat-treatment temperatures and durations,” and (2) “Petitioner has not identified
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`
`3 Patent Owner characterizes Dr. Goldberg’s testimony regarding how even a
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`change in a tenth of a percent of the composition can have a material effect on the
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`resulting deformation as an admission that the experimentation needed to practice
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`the invention would not be undue. Paper 27, p. 27. To the contrary, such testimony
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`confirms the exact opposite.
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`12
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`in its petition what a person of skill in the art would glean from the working
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`examples disclosed in the ’991 patent.” Paper 27, pp. 29-30. This is inaccurate. As
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`an initial matter, of the five specific examples provided in the specification, only
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`one—Example 4—involves bend testing, which the Petitioner specifically
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`addressed in its Petition. See Paper 17, p. 20 (citing Paper 1, p. 41 (“An appropriate
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`starting point for [the Wands] analysis is the single example provided by applicant
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`Luebke for achieving permanent deformation (Example 4).”)). Further, it is of little
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`consequence that Luebke “heated and tested a combined 600 files” considering
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`that, as Patent Owner admits, only 120 of those files were subjected to bend
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`testing, and those 120 files had all been heated at the same temperature and
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`duration (500°C for 75 minutes). Paper 27, p. 30.
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`Regarding the fourth Wands factor, Patent Owner argues that “Petitioner
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`never addresses the nature of the invention.” Paper 27, p. 31. This too is inaccurate.
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`As explained above, Petitioner discussed the “nature of the invention” with
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`reference to all of the variables that can affect whether a heat treated NiTi file will
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`achieve the claimed deformation. See supra, pp. 11-12.
`
`Regarding the fifth Wands factor, Patent Owner argues that “Petitioner never
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`addresses the state of the prior art in its petition as part of a Wands analysis.” Paper
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`27, p. 31. Again, this is inaccurate. Petitioner discussed the Pelton and Miyazaki
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`prior art references in its Wands analysis. Paper 1, pp. 42-45. Further, Petitioner
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`cited to Dr. Goldberg’s testimony on the issue of undue experimentation, which
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`included discussion of numerous prior art references, including Pelton, Kuhn,
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`McSpadden, Miyazaki, and Drexel. Ex. 1002, ¶¶ 113-125 (citing Exs. 1006, 1020,
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`1021, 1031, and 1036).
`
`Regarding the sixth Wands factor, Patent Owner argues incorrectly that
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`“Petitioner never addresses the relative skill of those in the art.” In providing the
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`opinions upon which Petitioner relies, Petitioner’s expert opined specifically on the
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`skill of those in the art. See, e.g., Ex. 1002, ¶¶ 75-77,116, 119, and 125.
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`Regarding the seventh Wands factor, Patent Owner argues that “Petitioner
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`only addresses in passing the predictability or unpredictability of the relied-upon
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`art.” Paper 27, p. 32. This also is inaccurate. Petitioner explained in detail “[t]he
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`complexities inherent in heat-treating Ni-Ti.” Paper 1, pp. 42-45.
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`Regarding the eighth Wands factor, Patent Owner argues that “the petition
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`does not analyze the breadth of the claims as part of a Wands analysis.” Paper 27,
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`p. 33. This too is inaccurate. As the Board noted with respect to this same
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`argument made in Patent Owner’s Preliminary Response, “Petitioner’s undue
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`experimentation analysis argues that the Specification does not provide an enabling
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`disclosure for the broad range of temperatures, heat-treatment durations, and alloy
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`compositions within the scope of claims 12-16.” Paper 17, pp. 19-20. Patent
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`Owner further argues that Petitioner ignored “the actual breadth of the claims when
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`one properly considers the ‘wherein’ clause’s further limitation on the claimed heat
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`treatment process, i.e., it is limited to those heat treatments that result in a file
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`capable of exhibiting the claimed degree of permanent deformation.” Paper 27, p.
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`33. As discussed above, see supra, pp. 2-3, the “wherein” clause does not shield
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`the claims from the enablement requirement.
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`III. The Specification Lacks Adequate Written Description Support for the
`Challenged Claims
`
`A. The Board Has Not Previously Rejected Petitioner’s Arguments
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`Regarding Petitioner’s arguments that the ’991 patent specification lacks
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`written description support for claims 12-16, Patent Owner argues misleadingly
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`that “Petitioner made similar arguments in its ’773 IPR petition, which the Board
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`properly rejected.” Paper 27, p. 34. However, unlike the claims of the ’773 patent,
`
`which require heating at from 400°C and above to achieve the claimed
`
`deformation, the ’991 patent claims recite temperatures from above 25°C and from
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`300°C. In support of its position that the claims of the ’991 patent are not entitled
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`to a filing date earlier than January 29, 2014, Petitioner referred to the fact that
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`during prosecution of the earlier applications, the applicant amended the claims to
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`require heating from 400°C and called that temperature “critical” in distinguishing
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`over the prior art. Paper 1, pp. 24-26. Such argument did not bear significance in
`
`the IPR, because the ’773 patent claims require heating from 400°C and above.
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`15
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`B.
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`Luebke Did Not Have Possession of the Claimed Invention with
`Respect to a Significant Portion of the Claimed Temperature
`Ranges—A Fact that He Admitted
`
`As Patent Owner correctly notes, “the written description requirement of §
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`112 is a ‘possession’ test.” Paper 27, p. 35 (quoting LizardTech, Inc. v. Earth Res.
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`Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (“It requires a patentee to
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`‘describe the invention sufficiently to convey to a person of skill in the art that the
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`patentee had possession of the claimed invention at the time of the applic