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 IPR2015-00632
`Patent 8,727,773 B2
`
`PETITIONER’S REPLY IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC
`Patent Owner
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
`PETITIONER’S REPLY IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`Introduction......................................................................................................1
`
`Claims 1-17 are Obvious Over the Teachings of Matsutani Taken with
`Pelton and ISO 3630-1.....................................................................................2
`
`III. Claims 1, 9, 10 and 12 are Anticipated by Kuhn, and Claim 8 is
`Obvious Over Kuhn and ISO 3630-1 ............................................................11
`
`A.
`
`B.
`
`Kuhn Discloses Heat Treating the “Entire Shank” .............................12
`
`Kuhn Discloses a Heat Treated Shank that Exhibits “greater
`than 10 degrees of permanent deformation” .......................................13
`
`IV. Claims 1-17 are Obvious Over Kuhn, ISO 3630-1, McSpadden and
`Pelton .............................................................................................................16
`
`V.
`
`Patent Owner’s “Evidence” Of Secondary Considerations is
`Unavailing......................................................................................................18
`
`VI. Conclusion .....................................................................................................25
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Atlas Powder Co. v. Ireco Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) ..........................................................................13
`
`In re Best,
`562 F.2d 1252 (C.C.P.A. 1977)..........................................................................13
`
`Covidien LP v. Ethicon Endo Surgery, Inc.,
`Case IPR2013-00209 (P.T.A.B. June 9, 2014).....................................................5
`
`In re DBC,
`545 F.3d 1373 (Fed. Cir. 2008) ..........................................................................23
`
`Gator Tail, LLC v. Mud Buddy, LLC,
`618 Fed. App’x 992 (Fed. Cir. 2015) ...................................................................4
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) ................................................................................4
`
`K-Swiss Inc. v. Glide ’n Lock GmbH,
`567 F. App’x 906 (Fed. Cir. 2014) .......................................................................8
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007)...................................................................................... 4-5, 9
`
`Merck & Cie v. Gnosis S.p.A.,
`808 F.3d 829 (Fed. Cir. 2015) ............................................................................18
`
`Ortho-McNeill Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ............................................................................5
`
`ii
`
`
`
`UPDATED EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 8,727,773 B2 (the “’773 patent”)
`
`Declaration of A. Jon Goldberg
`
`Harmeet Walia et al., An Initial Investigation of the Bending
`and Torsional Properties of Nitinol Root Canal Files, 14 J.
`ENDODONTICS 346 (1988) (“Walia”)
`
`Fujio Miura et al., The super-elastic property of the Japanese
`NiTi alloy wire for use in orthodontics, 90 AM. J.
`ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 1 (1986)
`(“Miura”)
`
`Satish B. Alapati, “An investigation of phase transformation
`mechanisms for nickel-titanium rotary endodontic
`instruments,” Ph.D. thesis, 2006. (“Alapati”)
`
`Alan R. Pelton et al., Optimisation of Processing and
`Properties of Medical-Grade Nitinol Wire, 9 Minimally
`Invasive Therapies & Allied Techs. 107 (2000) (“Pelton”)
`
`U.S. Patent No. 5,697,906 to Ariola et al.
`
`Prosecution History of the ’773 patent
`
`Prosecution History of U.S. Patent No. 8,062,033
`
`Prosecution History of U.S. Patent No. 8,562,341
`
`U.S. Provisional Patent Application No. 60/578,091
`
`U.S. Patent Application Publication No. 2008/0032260
`A1, Luebke (“Luebke 2008”)
`
`Prosecution History of U.S. Patent No. 8,083,873
`
`iii
`
`
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`U.S. Patent Application Publication No. 2011/0271529 A1,
`Gao et al. (“Gao”)
`
`U.S. Provisional Patent Application No. 61/332,954
`
`International Standard ISO 3630-1, 1st ed. (1992)
`
`International Standard ISO 3630-1, 2nd ed. (2008)
`
`Salwa E. Khier et al., Bending properties of superelastic and
`nonsuperelastic nickel-titanium orthodontic wires, 99 AM. J.
`ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 310 (1991)
`(“Khier”)
`
`Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties of Nickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002) (“Kuhn”)
`
`U.S. Patent No. 5,628,674 to Heath et al.
`
`Edgar Schäfer et al., Bending properties of rotary nickel-
`titanium instruments, 96 ORAL SURGERY ORAL MEDICINE
`ORAL PATHOLOGY 757 (2003)
`
`U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et
`al. (“McSpadden”)
`
`U.S. Patent No. 7,713,815 B2 to Matsutani et al. (“Matsutani”)
`
`S. Miyazaki et al., Characteristics of Deformation and
`Transformation Pseudoelasticity in Ti-Ti Alloys, 43 J.
`PHYSIQUE COLLOQUES C4255 (1982) (“Miyazaki”)
`
`Franklin S. Weine, ENDODONTIC THERAPY, 6th Ed.,
`2004, Chapter 5 (“Weine”)
`
`Japanese Unexamined Patent Application Publication No.
`2006-149675, Matsutani et al.
`
`English Translation of Japanese Unexamined Patent
`Application Publication No. 2006-149675, Matsutani et al.
`
`iv
`
`
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`Transcript of May 20, 2015 Teleconference
`
`Gold Standard Instruments LLC’s Website
`
`Prosecution History of U.S. Patent No. 8,876,991
`
`Petitioner’s Notice of Cross-Examination of Neill H.
`Luebke, D.D.S., M.S.
`
`Order Denying Motion for Preliminary Injunction
`
`Acknowledgment of Deponent and Errata Sheet from Nov.
`12, 2014 Deposition of Neill H. Luebke
`
`Petitioner’s Notice of Cross-Examination of Ronald R.
`Lemon, D.M.D.
`
`U.S. Patent No. 6,431,863 to Sachdeva et al.
`
`Petitioner’s Notice of Cross-Examination of Robert Sinclair,
`Ph.D.
`
`U.S. Patent No. 6,149,501 to Farzin-Nia et al.
`
`(Redacted) Transcript of Dec. 9, 2015 Cross-Examination of
`Neill H. Luebke, D.D.S., M.S.
`
`Transcript of Jan. 8, 2016 Cross-Examination of Ronald R.
`Lemon, D.M.D.
`
`Transcript of Jan. 18, 2016 Cross-Examination of Robert
`Sinclair, Ph.D.
`
`Dentsply Int’l and Tulsa Dental Prods. LLC d/b/a Tulsa
`Dental Specialties v. US Endodontics, LLC, No. 2:14-cv-196,
`Deposition Transcript of Neill H. Luebke, dated Oct. 8, 2014
`(E.D. Tenn.), pp. 1 and 199.
`
`v
`
`
`
`I.
`
`Introduction
`
`Patent Owner’s Response fails to demonstrate that claims 1-17 of the ’773
`
`patent are patentable over the prior art.
`
`Matsutani discloses heat-treating a superelastic, nickel titanium (“Ni-Ti”)
`
`shank of an endodontic instrument such that it would achieve the claimed
`
`permanent deformation of the ’773 patent. A skilled artisan would have been
`
`motivated to combine Matsutani with Pelton, which teaches the specifically
`
`claimed heat treatment temperatures and duration. Indeed, during the prosecution
`
`of the ’773 patent, the named inventor, Dr. Luebke, identified the treatment
`
`temperatures and duration disclosed in Pelton as achieving “what the application
`
`accomplishes.”1 Although he believed incorrectly that that information first
`
`appeared in a 2012 publication, it was in fact first published in Pelton in 2000.
`
`Kuhn also discloses heat-treating a superelastic, Ni-Ti shank of an
`
`endodontic instrument to improve its physical characteristics, and discloses the
`
`heat treatment temperatures and the other claimed limitations, either alone or in
`
`1 Dr. Luebke is Patent Owner’s financially-interested President. Ex. 1038, 10:12-
`
`22, 14:2-15, 19:12-16. He serves as a validity expert in the related district court
`
`action for Patent Owner’s exclusive licensees and real parties-in-interest—
`
`Dentsply and Tulsa Dental Specialties. Ex. 1038, 13:1-8; Paper No. 21, p. 2.
`
`1
`
`
`
`combination with the other prior art. In the district court action, Dr. Luebke
`
`testified that Kuhn discloses heat-treating the entire shank of a Ni-Ti endodontic
`
`instrument in the claimed temperature range.2 Such testimony is in accord with the
`
`opinion of Petitioner’s expert, but is contrary to the position Patent Owner has
`
`advanced in this proceeding, albeit with a replacement expert on the prior art.
`
`Finally, Patent Owner’s attempt to rebut the Board’s findings of prima facie
`
`obviousness with alleged evidence of secondary considerations is unavailing.
`
`Patent Owner relies on improper hearsay and fails to provide any nexus between
`
`the claimed invention and the identified considerations.
`
`In sum, Patent Owner fails to demonstrate that claims 1-17 are novel and/or
`
`nonobvious over the prior art. The Board should thus finally determine that the
`
`claims are unpatentable.
`
`II.
`
`Claims 1-17 are Obvious Over the Teachings of Matsutani Taken with
`Pelton and ISO 3630-1
`
`Patent Owner asserts that the alleged invention “exhibits two major
`
`improvements over prior art files: (1) it fractures less often during use; and (2)
`
`better negotiates the root canal without damaging the tooth.” Paper No. 44, p. 2.
`
`2 The district court denied plaintiffs’ motion for preliminary injunction finding that
`
`they would not likely prevail on the merits of demonstrating that claims of the ’773
`
`patent are valid over prior art at issue in this proceeding. Ex. 1032, pp. 17-18, 20.
`
`2
`
`
`
`Both of these “improvements” are disclosed in Matsutani by the precise
`
`mechanism disclosed in the ’773 patent: heat-treating a superelastic, Ni-Ti shank
`
`of an endodontic file so that it will remain deformed when bent. Ex. 1002, ¶¶ 84-85
`
`(citing Ex. 1023, 4:31-44, 5:42-60, 2:35-37, 8:40-47). See also Ex. 1038, 154:12-
`
`155:2 and Ex. 1040, 186:10-188:21. Matsutani teaches that the heat treatment
`
`results in a file with a portion that can follow the root canal with high fidelity, and
`
`that has increased flexibility and high fatigue resistance. Ex. 1023, 4:45-64; Ex.
`
`1002, ¶¶ 84-85.
`
`Despite this disclosure, Patent Owner argues that a single sentence in
`
`Matsutani reciting that a problem may occur in the position of a rotational axis of
`
`the file if more than 3/4 of the work portion is heat treated, is consistent with the
`
`alleged conventional wisdom at the time that a softer, deformable file was
`
`unsuitable and would not work. Paper No. 44, pp. 48-49. This is nonsensical.
`
`Matsutani specifically discloses heat-treating a portion of the file—the portion that
`
`is inserted into the root canal—to make a softer, deformable file. Ex. 1023, 4:31-
`
`52, 8:40-47; Ex. 1002, ¶ 84; Ex. 1038, 157:20-158:15; Ex. 1040, 196:11-197:10.
`
`Patent Owner also relies on that same single sentence to argue that
`
`Matsutani teaches away from heat-treating the entire shank. Paper No. 44, p. 48.
`
`Again, Matsutani merely states that a problem may occur if the entire shank is heat
`
`3
`
`
`
`treated, not that a problem would occur.3 This is not a teaching away. Gator Tail,
`
`LLC v. Mud Buddy, LLC, 618 Fed. App’x 992, 999 (Fed. Cir. 2015).4 If anything,
`
`the cited sentence confirms that it is, in fact, possible to heat treat the entire shank
`
`to obtain the claimed permanent deformation. While Matsutani discloses a
`
`preference for one approach, i.e., partial heat treatment, it does not mean that such
`
`approach was the only one available to arrive at the desired result, namely, a shank
`
`that fractures less, and better negotiates the root canal without damaging the tooth.
`
`Indeed, there are only two options: heat-treating a portion of the shank or
`
`heat-treating the entire shank, which further confirms that it would have been
`
`obvious to heat treat the entire shank based on the teachings of Matsutani. KSR
`
`Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007) (“obvious to try” applicable
`
`3 Patent Owner’s expert, Dr. Sinclair, initially testified that Matsutani states that a
`
`problem would occur if the entire shank was heat treated. Ex. 2026, ¶ 167. On
`
`cross-examination, he conceded that Matsutani states “may,” not “would.” Ex.
`
`1040, 199:1-201:2, 212:4-14.
`
`4 In In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), cited by Patent Owner, Paper
`
`No. 44, p. 48, the Federal Circuit upheld the BPAI’s decision to reject, on
`
`obviousness grounds, claims directed to one of two alternative resins disclosed in a
`
`prior art reference, even though such reference described the claimed resin as
`
`“inferior.”
`
`4
`
`
`
`where “there are a finite number of identified, predictable solutions” to a known
`
`problem”); Ortho-McNeill Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364
`
`(Fed. Cir. 2008); Covidien LP v. Ethicon Endo Surgery, Inc., Case IPR2013-
`
`00209, Paper No. 29 (P.T.A.B. June 9, 2014).
`
`Matsutani’s mention that there “may” be an issue if the entire shank is
`
`heated would not have led a skilled artisan to conclude that the alternative choice
`
`was inoperable or unsuitable for the intended use, especially in view of the added
`
`expense and effort required to partially heat treat the shank. Ex. 1002, ¶¶ 201-206.
`
`Indeed, Dr. Luebke testified that when he heat treated the entire shank, he
`
`encountered no problem with the rotational axis of the shank, and it worked
`
`“perfectly.” Ex. 1038, 164:3-165:2, 167:8-15; Ex. 1040, 303:8-304:4.
`
`Tellingly, Patent Owner did not ask Petitioner’s expert, Dr. Goldberg, a
`
`single question during cross-examination regarding the teachings of Matsutani, and
`
`the added difficulty and expense associated with heat-treating just a portion of a
`
`Ni-Ti shank. Instead, Patent Owner asserts incorrectly that Dr. Goldberg
`
`acknowledged that Matsutani teaches away from heat-treating the entire shank.
`
`Paper No. 44, p. 49. To the contrary, Dr. Goldberg testified that a person of
`
`ordinary skill in the art would have been motivated to heat treat the entire shank
`
`based on Matsutani’s disclosure, because it would have been easier and less
`
`expensive than heat-treating a portion of the same. Ex. 1002, ¶¶ 201–206.
`
`5
`
`
`
`Patent Owner also asserts incorrectly that Petitioner and Dr. Goldberg failed
`
`“to address the several methods Matsutani offered for selective heat treatment.”
`
`Paper No. 44, p. 50. Dr. Goldberg specifically addressed these methods, opining
`
`that one of ordinary skill in the art would have recognized that heat-treating only a
`
`part of a solid shank would be more difficult and expensive than heat-treating the
`
`entire shank. Ex. 1002, ¶ 201. See also Paper No. 2, p. 53.
`
`Instead of directly challenging Dr. Goldberg on these points, Patent Owner
`
`cites to Dr. Sinclair’s declaration to allege that “the five methods taught by
`
`Matsutani for partially heat-treating files are not difficult or expensive.” Paper No.
`
`44, pp. 50-51. Patent Owner, quoting Dr. Sinclair’s declaration, asserts that “These
`
`methods require basic heating and cooling equipment and techniques.” Paper No.
`
`44, p. 51. Patent Owner’s citations miss the point, and its position lacks credibility.
`
`It is beyond legitimate dispute that it would be more difficult to partially
`
`heat treat a Ni-Ti shank. See Ex. 1002, ¶¶ 201-206. Ni-Ti conducts heat, and if one
`
`subjects only a portion of a Ni-Ti component to heat treatment, one must
`
`necessarily apply insulating and/or cooling means to the portion not to be heat
`
`treated. Ex. 1023, Figs. 4(a)-(e), 6:54-7:28; Ex. 1040, 176:15-177:13, 217:11-13;
`
`Ex. 2037, 178:14-24. Whether the methods of partial heat-treating “require basic
`
`heating and cooling techniques,” as Dr. Sinclair asserts, does not address the fact
`
`that they would require additional steps and would be more difficult to implement.
`
`6
`
`
`
`In an attempt to discredit Dr. Goldberg’s testimony, Patent Owner asserts
`
`that Dr. Goldberg “has no experience heat-treating endodontic files.” Paper No. 44,
`
`p. 51. Dr. Goldberg, a Ph.D. in Dental Materials-Metallurgical Engineering,
`
`indisputably has the requisite experience to support his opinions. See, e.g., Ex.
`
`1002, ¶¶ 1-7. Notably, Patent Owner relies on Dr. Sinclair despite the fact that he
`
`has never heat treated an endodontic file. Ex. 1040, 44:9-18, 45:4-16, 50:18-51:4.
`
`In any event, when Dr. Sinclair was questioned whether it would be easier to
`
`heat treat an entire shank as opposed to partially heat-treating the same, he
`
`grudgingly testified that it would not be “much easier” to heat treat an entire shank,
`
`thereby conceding that it would be easier. Ex. 1040, 177:21-178:6, 207:18-208:8.
`
`He further testified that he did not think anyone had yet invented a device to allow
`
`one to partially heat treat multiple shanks at the same time. Ex. 1040, 183:20-
`
`184:11, 209:9-210:3, 218:22-220:2.
`
`Patent Owner also attempts to distinguish Matsutani from the claimed
`
`invention by arguing that while Matsutani discloses performing “a bend test on his
`
`heat-treated files,” it “does not identify the test as the ISO Standard 3630-1 bend
`
`test.” Paper No. 44, pp. 53-54. However, both Drs. Sinclair and Luebke admitted
`
`that the 45º bend test disclosed in Matsutani is essentially the same as the ISO
`
`Standard 3630-1 test; neither one could identify a single difference between the
`
`7
`
`
`
`two. Ex. 1038, 161:21-163:5; Ex. 1040, 189:22-190:14. Compare Ex. 1023, 8:15-
`
`21 with Ex. 1016, pp. 19-20 of 28. See also Ex. 1002, ¶ 212.
`
`Patent Owner does not dispute Matsutani’s disclosure of the claimed file
`
`sizes and compositions recited in claims 8, 12, 13 and 17 of the ’773 patent.
`
`Regarding the claimed temperatures and times to heat-treat a Ni-shank so that it
`
`would demonstrate permanent deformation, Drs. Luebke and Sinclair agreed that it
`
`would have been a matter of routine experimentation for a skilled artisan, prior to
`
`the alleged invention, to have determined the same. Ex. 1038, 181:21-182:16; Ex.
`
`1040, 59:15-21, 169:22-171:2. See K-Swiss Inc. v. Glide ’n Lock GmbH, 567 F.
`
`App’x 906, 913 (Fed. Cir. 2014). The prior art conveys readily that there were a
`
`variety of known, viable options in terms of heat treatment temperature and
`
`duration to obtain the desired result, including the claimed temperatures and times
`
`claimed in the ’773 patent. Id.
`
`Pelton discloses the specifically claimed heat treatment temperatures and
`
`times that would raise the shape recovery temperature of a Ni-Ti shank such that it
`
`would be permanently deformed when bent. See Ex. 1002, ¶¶ 211-220 (citing Ex.
`
`1006, pp. 111, 114); Ex. 1040, 192:11-21. Pelton teaches that thermal treatments
`
`can be used to modify the austenite finish (Af) temperature (i.e., shape recovery
`
`temperature) of a superelastic, Ni-Ti alloy, which will affect other mechanical
`
`properties, especially plateau stresses. Ex. 1006, p. 117.
`
`8
`
`
`
`In fact, Dr. Luebke cited to one of Pelton’s figures as disclosing the heat
`
`treatment temperatures and times that would result in his claimed invention during
`
`the prosecution of ’773 patent. Ex. 1008, p. 159; Ex. 1040, 111:13-112:3, 113:10-
`
`14, 192:22-193:11.5 Such figure provides the temperatures and times to raise the Af
`
`temperature of a Ni-Ti alloy to above body temperature so that it will exhibit
`
`permanent deformation when bent. Ex. 1002, ¶ 213. Dr. Luebke cited the same
`
`figure during the prosecution of a later application to represent that the disclosed
`
`heat treatment temperatures and times will result in a Ni-Ti instrument that meets
`
`the permanent deformation limitation. Ex. 1030, pp. 127-128, ¶ 6; Ex. 1040,
`
`145:20-150:9.
`
`As the Board noted correctly, that Pelton is not concerned specifically with
`
`endodontic instruments would not mean that a person of skill in the art would not
`
`have been motivated to consider the same. Paper No. 29, pp. 24-25 (citing KSR
`
`Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007)). Further, in light of Luebke’s
`
`reliance on Pelton, Patent Owner cannot credibly deny a skilled artisan’s
`
`motivation to apply the heat treatment temperatures and times disclosed therein to
`
`5 While Luebke cited a 2012 publication as the source of the figure, such figure is
`
`identical to the one in the Pelton article from 2000. Compare Ex. 1008, p. 159 with
`
`Ex. 1006, Fig. 10. See also Ex. 1038, 119:20-120:13.
`
`9
`
`
`
`the superelastic, Ni-Ti shank of Matsutani to cause the heat treated portion to be
`
`permanently deformed when bent.
`
`Numerous other references equate raising the Af (i.e., shape recovery)
`
`temperature with decreasing superelasticity such that a Ni-Ti alloy would
`
`demonstrate permanent deformation. See, e.g., Ex. 1005, p. 59 of 76; Ex. 1014, ¶¶
`
`24, 25, 62; Ex. 1037, 4:12-15. In fact, real party-in-interest Dentsply filed a patent
`
`application that specifically claims a method of heat-treating a superelastic, Ni-Ti
`
`endodontic file to raise its Af to above body temperature so that it will demonstrate
`
`permanent deformation in use. Ex. 1014, ¶¶ 24, 25, 62.
`
`Ignoring Dr. Luebke’s and Dentsply’s representations to the Patent Office as
`
`well as the state of the art, Patent Owner asserts that the combination of Matsutani
`
`and Pelton would not meet the claimed permanent deformation limitation because
`
`one allegedly cannot predict “NiTi’s mechanical behavior by looking only at its
`
`crystal structure.” Paper No. 44, p. 53 (emphasis added). Patent Owner’s argument
`
`is unavailing. As Dr. Sinclair and Patent Owner admit, increasing the shape
`
`recovery temperature is directly correlated to increasing the Af temperature. Ex.
`
`1040, 103:16-104:4; Paper No. 44, p. 53, line 7. Matsutani specifically teaches
`
`raising the shape recovery temperature of a Ni-Ti shank to above body temperature
`
`so that the heat treated portion will keep its deformed shape when bent, and Pelton
`
`discloses the specifically claimed temperatures and times to accomplish the same.
`
`10
`
`
`
`Finally, Patent Owner, relying on Dr. Sinclair’s citation to Exhibit 2033 at
`
`2:24-29, asserts that “NiTi can exhibit superelastic behavior” below its Af. Paper
`
`No. 44, p. 53 (citing Ex. 2026, ¶¶ 49, 78). However, the cited passage does not
`
`detract from the numerous references and party admissions that equate permanent
`
`deformation with an Af above body temperature. Further, Both Patent Owner and
`
`Dr. Sinclair ignore the following sentence from Exhibit 2033 that recites, “Thus, a
`
`second requirement for this recovery heat treatment is that the Af not be increased
`
`above the temperature at which the alloy is to be use.” Ex. 2033, 2:29-31. When
`
`cross-examined on this point, Dr. Sinclair conceded that this reference indicates
`
`that the optimum condition to maintain superelasticity of a Ni-Ti alloy would be an
`
`Af temperature below the temperature at which the alloy is to be used. Ex. 1040,
`
`157:6-158:21.
`
`III. Claims 1, 9, 10 and 12 are Anticipated by Kuhn, and Claim 8 is Obvious
`Over Kuhn and ISO 3630-16
`
`6 In light of the Board’s finding that the “wherein” clause is a limitation, and for
`
`the purposes of this Reply only, Petitioner acknowledges that the reasons provided
`
`in Ground 5 of the Petition do not support a finding that claims 2 and 11 are
`
`anticipated by Kuhn, and that the reasons provided in Ground 6 do not support a
`
`finding that claims 13, 15, and 17 are obvious over Kuhn and ISO 3630-1.
`
`11
`
`
`
`Patent Owner asserts that Kuhn does not disclose two limitations required by
`
`claims 1, 9, 10, and 12: heat treating the “entire shank” and the “greater than 10
`
`degrees of permanent deformation.” Paper No. 44, pp. 15-34. This is incorrect.
`
`A.
`
`Kuhn Discloses Heat Treating the “Entire Shank”
`
`Kuhn specifically notes that, during bend testing, the entire shank became
`
`deformed, up to the part near the handle, when bending exceeded 6 millimeters.
`
`Ex. 1002, ¶ 132 (citing Ex. 1019, p. 718); Ex. 2034, 60:12-19. In the district court
`
`litigation, Dr. Luebke admitted that Kuhn discloses heat treating the entire shank of
`
`an endodontic file. Ex. 2001 (Second Substitute), 79:11-81:15; Ex. 1041, 199:5-12.
`
`Despite Dr. Luebke’s prior admissions, Patent Owner now relies on the
`
`opinions of Dr. Sinclair to argue that Kuhn does not disclose heat treating the
`
`entire shank. Patent Owner cites to Dr. Sinclair’s opinion that “Kuhn expressly
`
`states that the files were cut before heat treatment.” Paper No. 44, p. 17; Ex. 2026,
`
`¶ 71. However, Dr. Sinclair admitted that Kuhn does not expressly state this, and
`
`that he is relying on his interpretation of Kuhn, which is at odds with both Dr.
`
`Goldberg’s and Dr. Luebke’s testimony. Ex. 1040, 231:18-232:14.
`
`Further, Kuhn’s Table 1, on which Dr. Sinclair relies, does not state that
`
`only the “active part” of the file was heat treated, and such interpretation is
`
`contradicted by Kuhn’s disclosure of bend test results indicating that “the part that
`
`12
`
`
`
`has the maximum cross-sectional area near the handle becomes deformed in turn.”
`
`Ex. 1002, ¶ 132 (citing Ex. 1019, p. 718). See also Ex. 2034, 60:6-19, 63:6-10.
`
`B.
`
`Kuhn Discloses a Heat Treated Shank that Exhibits “greater than
`10 degrees of permanent deformation”
`
`The Board found correctly that the claims simply recite particular resulting
`
`deformation properties of a heat-treated shank, and that the claims do not require
`
`that the ISO 3630-1 must be employed. Paper No. 29, p. 19.
`
`As an initial matter, ISO 3630-1 does not even mention permanent
`
`deformation. Ex. 1016; Ex. 1040, 76:15-77:10, 80:2-9. Patent Owner’s expert, Dr.
`
`Sinclair, testified that prior to his involvement in this case, he was unfamiliar with
`
`ISO 3630-1, and was not aware of anyone besides Dr. Luebke using this standard
`
`to measure permanent deformation. Ex. 1040, 68:7-9, 78:3-9, 78:21-79:4, 251:5-8.
`
`Patent Owner was unable to cite to a single reference disclosing the use of
`
`ISO 3630-1 for measuring permanent deformation. The best it could do was to cite
`
`a single article from 1995 that mentions measuring permanent deformation after a
`
`stainless steel file was bent 45 degrees. Paper No. 44, p. 12. However, even in this
`
`reference, ISO 3630-1 is not mentioned. Ex. 2029. The ’773 patent claims’ reliance
`
`on this unorthodox way to determine permanent deformation does not render them
`
`patentable. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999);
`
`In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977).
`
`13
`
`
`
`Patent Owner asserts that “Kuhn expressly states that there was no
`
`permanent deformation after heat treatment.” Paper No. 44, pp. 22-23. However,
`
`Patent Owner’s sole “support” for this assertion stems from its improper reliance
`
`on a sentence in Kuhn describing bending curves of the non-heat treated files
`
`depicted in Figure 5, not of the heat treated files depicted in Figure 6A. See Ex.
`
`1019, p. 718; Ex. 1040, 222:1-19.
`
`Patent Owner also relies on Dr. Sinclair’s testimony regarding Figure 6A of
`
`Kuhn to argue that the 400°C heat treated file maintained its superelasticity. Paper
`
`No. 44, pp. 25-27. Such reliance is misplaced. Dr. Sinclair, relying on a greatly
`
`enlarged partial reproduction of Figure 6A, testified, confusingly, that besides “one
`
`stray pixel,” the curve for the 400°C heat-treated file does not “coincide” with the
`
`x-axis at 1.8 mm. Ex. 2026, ¶ 93. Setting aside Dr. Sinclair’s tortured explanation,
`
`a fair evaluation of even the enlarged reproduction confirms that the 400°C heat-
`
`treated file exhibited permanent deformation when the bending force was removed.
`
`Ex. 1002, ¶¶ 133-138; Ex. 2034, 44:1-14. As Dr. Goldberg testified, the bottom
`
`portion of the 400ºC curve intersects the x-axis at about 1.8 mm. Ex. 1002, ¶ 135.
`
`Patent Owner also tries to distinguish the teachings of Kuhn by citing to an
`
`earlier publication from 2001 that lists three authors, two of whom are also listed
`
`on the Kuhn publication at issue here. Paper No. 44, pp. 27-28 (citing Ex. 2024).
`
`Dr. Sinclair relies on this earlier article to suggest that it shows that the ProFile
`
`14
`
`
`
`files heat treated to 400°C in Kuhn were in the austenite phase and that, “regardless
`
`that the 400°C heat treatment increased the Af of the ProFile from 35°C to 40°C,
`
`one of ordinary skill in the art would evaluate the totality of experimental evidence
`
`and conclude that that file would not meet the ‘wherein’ clause of the claims of the
`
`’773 patent.” Ex. 2026, ¶ 81.
`
`Notably, Dr. Sinclair testifies that Kuhn discloses raising the Af to above-
`
`body temperature, which is precisely how Dr. Luebke described his invention to
`
`the Patent Office during the prosecution of the application that led to the ’773
`
`patent. Ex. 1008, pp. 159. Moreover, when Dr. Sinclair was asked whether the
`
`2001 publication actually disclosed data to indicate that the 400°C heat-treated
`
`ProFile files were in the austenite phase, Dr. Sinclair admitted that the cited data
`
`did not, in fact, support the same. Ex. 1040, 234:8-235:1, 239:5-241:3.
`
`Patent Owner does not dispute that Kuhn discloses heat treating the shank at
`
`a single temperature as required by claim 9, and a shank within the composition
`
`ranges recited in claim 12, which is the standard composition for Ni-Ti files. See,
`
`e.g., Ex. 1038, 66:6-17. See also Ex. 1002, ¶ 144.
`
`The evidence of record fully supports the finding that claims 1, 9, 10, and 12
`
`of the ’773 patent are anticipated by Kuhn. Claim 8, which adds the requirement
`
`that the shank have a diameter in a known range, is obvious over Kuhn and ISO
`
`15
`
`
`
`3630-1, which discloses file sizes within the claimed range. See Ex. 1016, p. 8; Ex.
`
`1038, 66:18-67:14, 68:3-17; Paper No. 2, p. 33; Ex. 1002, ¶ 141.
`
`IV. Claims 1-17 are Obvious Over Kuhn, ISO 3630-1, McSpadden and
`Pelton
`
`McSpadden discloses subjecting a fully-formed endodontic file to heat
`
`treatment “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, ¶ 52. In order to shift the Board’s attention away from this
`
`clear disclosure, Patent Owner cites to alternative embodiments disclosed in
`
`McSpadden, which are clearly identified as such. For example, Patent Owner relies
`
`on a description in McSpadden of a selective heat treatment to state that
`
`McSpadden teaches way from heat treating the entire shank. Paper No. 44, p. 40.
`
`However, Patent Owner fails to acknowledge that this description pertains to an
`
`“alternative embodiment” to the previously disclosed embodiment describing heat
`
`treating of the entire file. See Ex. 1019, ¶¶ 52, 58.
`
`Patent Owner’s citation to Dr. Goldberg’s alleged “admissions” concerning
`
`McSpadden, Paper No. 44, p. 41, suffers from the same failing. It ignores the
`
`relevant section in McSpadden that discloses heat treating an entire fully-formed,
`
`Ni-Ti file to achieve the “desired degree of superelasticity or other material
`
`properties and/or to set a desired shape. . . .” Ex. 1002, ¶ 72 (citing Ex. 1022, ¶ 52).
`
`16
`
`
`
`Patent Owner does not dispute McSpadden’s disclosure of the claimed file
`
`sizes and compositions recited in claims 8, 12, 13 and 17 of the ’773 patent.
`
`Regarding the specifically claimed heat treatment temperatures and times, Pelton
`
`teaches how to raise the Af temperature of a superelastic, Ni-Ti alloy to achieve the
`
`claimed amount of permanent deformation. Ex. 1002, ¶¶ 73-74, 153, 162-166
`
`(citing Ex. 1006, pp. 114-115); Ex. 1040, 114:4-17. See also supra pp. 8.
`
`Further, a skilled artisan looking to achieve the “good results” disclosed in
`
`Kuhn would have been motivated to look to the teachings of McSpadden, which
`
`discloses heat treating an entire Ni-Ti shank of an endodontic instrument, with the
`
`teachings of Pelton, which the inventor himself admitted describes how to heat
`
`treat a shank such that it would meet the ’773 patent’s claimed permanent
`
`deformation limitation. Paper No. 2, pp. 34-42.
`
`Drs. Luebke and Sinclair admitted that it was known in the art prior to Dr.
`
`Luebke’s alleged invention how to heat treat a superelastic alloy within the
`
`claimed temperatures and times to cause the alloy to demonstrate permanent
`
`deformation. Ex. 1038, 181:21-182:16; Ex. 1040, 29:19-30:19, 34:14-35:11, 59:15-
`
`21, 169:22-171:2. As set forth above, the motivation to combine the teachings of
`
`Pelton with Kuhn and McSpadden is confirmed by Dr. Luebke’s reliance Pelton
`
`during the prosecution of the ’773 patent.
`
`17
`
`
`
`V.
`
`Patent Owner’s “Evidence” Of Secondary Considerations is Unavailing
`
`Patent Owner argues that the patentability of the ’773 patent claims is
`
`confirmed by certain objective evidence of nonobviousness. Paper No. 44, pp. 55-
`
`60. However, Patent Owner does not even attempt to establish the requisite nexus
`
`between the evidence and the merits of the claimed invention. Merck & Cie v.
`
`Gnosis S.p.A., 808 F.3d 829 (Fed. Cir. 2015) (“For objective evidence of secon
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