US Endodontics, LLC’s
`Hearing Presentation
`
`US Endodontics, LLC
`
`Petitioner,
`
`v.
`
`Gold Standard Instruments, LLC,
`
`Patent Owner.
`
`
`Case IPR2015-00632
`
`Patent 8,727,773 B2
`
`April 5, 2016
`
`IPR2015-00632 – Ex. 1042
`US Endodontics, LLC, Petitioner
`
`1
`
`
`Hearing Presentation
`
`US Endodontics, LLC
`
`Petitioner,
`
`v.
`
`Gold Standard Instruments, LLC,
`
`Patent Owner.
`
`
`Case IPR2015-00632
`
`Patent 8,727,773 B2
`
`April 5, 2016
`
`IPR2015-00632 – Ex. 1042
`US Endodontics, LLC, Petitioner
`
`1
`
`
`
`Exemplary Endodontic File
`
`
`
`
`
`2
`
`
`
`US Pat. No. 8,727,773
`US Pat. No. 8,727,773
`
`
`
`
`
`It A method for manufacturing or modifying an endo dontie
`instrument for use in performing root eana] therapy on a
`tooth, the method oomprising:
`(a) providing an elongate shank having a eutting edge
`extending from a distal end of the shank along an axial
`length of the shank, the shank oomprising a superelastie
`nickel titanium alloy, and
`(b) after step (a), heat-treating the entire shank at a tern-
`perature from 400“ C. up to but not equal to the melting
`point of the superelastie 1liCkE‘:l titanium alloy,
`wherein the heat treated shank has an angle greater than 10
`degrees of permanent deformation after torque at -45
`degrees of flE'}4.'.iDI1 when tested in aeeordanee with ISO
`Standard 3630-].
`
`Ex. 1001 (’773 Patent), Claim 1.
`Ex. 1001 (’773 Patent), Claim 1.
`
`3
`
`
`
`US Pat. No. 8,727,773
`US Pat. No. 8,727,773
`
`
`
`
`
`13. A method for manufacturing or modifying an endodon-
`tie instrument for use in performing root eanal therapy on a
`tooth, the method eomprising:
`(a) providing an elongate shank having helieal flutes defin-
`ing a eutting edge extending fi‘om a distal end of the
`shank along an axial length of the shank, the instrtunent
`being in aeeordanee with ISO Standard 3630-], the
`shank eonsisting essentially of a superelastie niekel tita-
`nium alloy; and
`(I9) after step (a), heat-treating the entire instrument shank
`at a temperature from 475” C. to 525” C11
`wherein the heat-treated shank has an angle greater than 10
`degrees of permanent deformation after torque at 45° of
`fleaion tested in aeeordanee with ISO Standard 3630-].
`
`Ex. 1001 (’773 Patent), Claim 13.
`Ex. 1001 (’773 Patent), Claim 13.
`
`4
`
`
`
`US Pat. No. 8,727,773
`US Pat. No. 8,727,773
`
`
`
`
`
`Q Well, you do not claim to he the inventor
`
`of a superelaatic nickel—titanium alloy that comprioea
`
`54 to 5? weight percent nickel and 43 to 45 weight
`
`percent titanium. Correct?
`
`A
`
`I'm not the inventor of the material?
`
`Q Correct.
`
`A
`
`Q
`
`No,
`
`I'm not the inventor of the material.
`
`Endodontic filea comprising thia
`
`composition were known in the art prior to the time
`
`that you firat filed your application for a patent
`
`in
`
`Eflfld. Correct?
`
`A
`
`That'o correct.
`
`They were known.
`
`Ex. 1038 (Luebke’s Cross-Examination), 66:6-17.
`Ex. 1038 (Luebke’s Cross-Examination), 66:6-17.
`
`5
`
`
`
`The Board’s Claim Construction Ruling
`
`
`
`
`
`“For purposes of this Decision we have
`given all claim terms their ordinary and
`customary meaning as would be
`understood by a skilled artisan in light of
`the Specification of the ’773 patent.”
`
`Paper 29 (Institution Decision), p. 9.
`
`6
`
`
`
`Grounds Upon Which Trial Was Instituted
`
`
`
`
`
`Paper 29 (Institution Decision), p. 32.
`
`7
`
`
`
`Matsutani, Pelton and ISO 3630-1 Render All Claims
` of the ’773 Patent Unpatentable
`
`
`
`
`Claims 1-17 are unpatentable under 35 U.S.C. 103(a) over
`Matsutani, Pelton and ISO 3630-1.
`
`
`
`
`Exs. 1023 (Matsutani), 1006 (Pelton) and 1016/1017 (ISO 3630-1).
`
`8
`
`
`
`Goals of the Alleged Invention of the ’773 Patent
`
`
`
`
`
`Ex. 1001 (’773 Patent), 9:19-30.
`
`9
`
`
`
`Goals of the Alleged Invention of the ’773 Patent
`
`
`
`
`
`Paper 44 (Patent Owner’s Response), p. 2.
`
`10
`
`
`
`Matsutani Achieves the Same
`Goals of the Alleged Invention
`
`
`
`
`
`Ex. 1023 (Matsutani), 4:45-52.
`
`11
`
`
`
`Matsutani Achieves the Same
`Goals of the Alleged Invention
`
`
`
`
`
`Ex. 1023 (Matsutani), 4:58-64.
`
`12
`
`
`
`Matsutani Achieves the Same
`Goals of the Alleged Invention
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 188:16-21.
`
`13
`
`
`
`Matsutani Achieves the Same Goals
`By the Same Method
`
`
`Ex. 1023 (Matsutani), 4:31-35.
`
`
`Ex. 1023 (Matsutani), 4:42-44.
`
`14
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Matsutani Achieves the Same Goals
`By the Same Method
`
`
`
`
`
`
`
`
`
`Ex. 1023 (Matsutani), Fig. 2.
`
`15
`
`
`
`Matsutani Achieves the Same Goals
`By the Same Method
`
`
`
`
`
`
`
`
`
`Ex. 1023 (Matsutani), 5:46-57.
`
`16
`
`
`
`Matsutani Achieves the Same Goals
`By the Same Method
`
`
`
`
`
`
`Ex. 1023 (Matsutani), 8:30-39.
`
`17
`
`
`
`
`
`
`
`
`
`Matsutani Achieves the Same Goals
`By the Same Method
`
`
`
`
`
`
`Ex. 1023 (Matsutani), 8:40-47.
`
`18
`
`
`
`
`
`
`
`
`
`Matsutani Discloses Heat-Treating up to About 3/4
`of the Working Portion of the Shank
`
`
`
`
`
`Ex. 1023 (Matsutani), 5:20-29.
`
`19
`
`
`
`Matsutani Discloses Heat-Treating up to About 3/4
`of the Working Portion of the Shank
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 197:1-10.
`
`20
`
`
`
`Matsutani Does Not Teach Away from
`the Alleged Invention of the ’773 Patent
`
`
`
`
`
`Ex. 1023 (Matsutani), 5:37-42.
`
`21
`
`
`
`Matsutani Does Not Teach Away from
`the Alleged Invention of the ’773 Patent
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 200:21-201:2.
`
`22
`
`
`
`Matsutani Does Not Teach Away from
`the Alleged Invention of the ’773 Patent
`
`
`“[I]f a reference describes a modification as ‘somewhat inferior,’
`then the reference does not teach away.”
`
`
`
`Gator Tail, LLC v. Mud Buddy, LLC,
`618 Fed. App’x 992, 999 (Fed. Cir. 2015) (citation omitted)
`
`
`
`23
`
`
`
`Motivation to Heat Treat “Entire Shank”
`
`
`“[O]ne of ordinary skill in the art would have had a reasonable
`expectation of success in treating the entire shank. And, as
`
`explained above (¶ 201), the artisan would have been motivated
`to do so because treating the entire shank would have been
`easier and less expensive.”
`
`
`Ex. 1002 (Goldberg’s Decl.), ¶ 206.
`
`24
`
`
`
`Matsutani’s Heat Treatment Methods
`
`
`
`
`
`Ex. 1023 (Matsutani), Figs. 4(a)-(c).
`
`25
`
`
`
`Matsutani’s Heat Treatment Methods
`
`
`
`
`
`Ex. 1023 (Matsutani), Figs. 4(d), (e).
`
`26
`
`
`
`Obvious to Try Heat-Treating “Entire Shank”
`
`“When there is a design need or market pressure to solve a
`
`problem and there are a finite number of identified,
`
`predictable solutions, a person of ordinary skill has good reason
`to pursue the known options within his or her technical grasp . . .
`. In that instance the fact that a combination was obvious to try
`might show that it was obvious under 103.”
`
`
` KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398, 421 (2007)
`
`27
`
`
`
`Obvious to Try Heat-Treating “Entire Shank”
`
`“In KSR, 550 U.S. at 421, the Supreme Court explained that
`
`‘obvious to try’ may apply when ‘there are a finite number of
`
`identified, predictable solutions’ to a known problem. . . . The
`Federal Circuit elaborated that the identified path must ‘present
`a finite (and small in the context of the art) number of options
`easily traversed to show obviousness.’”
`
`
`
`
`Covidien LP v. Ethicon Endo Surgery, Inc.,
`Case IPR2013-00209, Paper 29, *14
`(P.T.A.B. June 9, 2014) (citation omitted)
`
`
`28
`
`
`
`No Issues with Heat-Treating “Entire Shank”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 164:18-165:2.
`
`29
`
`
`
`No Issues with Heat-Treating “Entire Shank”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 167:8-15.
`
`30
`
`
`
`Heat-treating “Entire Shank” is
`Easier than Partially Heat-Treating
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 177:21-178:6.
`
`31
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1023 (Matsutani), 8:15-21.
`
`32
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1016 (ISO 3630-1, first edition), p. 19 of 28.
`
`33
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1017 (ISO 3630-1, second edition), p. 19 of 26.
`
`34
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 161:21-162:8.
`
`35
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 162:22-163:6.
`
`36
`
`
`
`Matsutani Discloses the Claimed Bend Testing
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 190:11-14.
`
`37
`
`
`
`Matter of Routine Experimentation to
` Heat Treat at Claimed Temp./Time
`
`“‘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 routine
`experimentation.”
`
`
`In re Applied Materials, Inc.,
`692 F.3d 1289, 1295 (Fed. Cir. 2012).
`
`38
`
`
`
`Matter of Routine Experimentation to
` Heat Treat at Claimed Temp./Time
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 182:9-16.
`
`39
`
`
`
`Matter of Routine Experimentation to
` Heat Treat at Claimed Temp./Time
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 170:8-22.
`
`40
`
`
`
`Matter of Routine Experimentation to
` Heat Treat at Claimed Temp./Time
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 194:10-195:1.
`
`41
`
`
`
`Motivation to Combine – Pelton Discloses
`Claimed Heat Treatment Temp./Time
`
`
`
`
`
`Ex. 1006 (Pelton), p. 114.
`
`42
`
`
`
`Motivation to Combine – Pelton Discloses
`Claimed Heat Treatment Temp./Time
`
`
`
`
`
`Ex. 1006 (Pelton), p. 114.
`
`43
`
`
`
`Motivation to Combine – Applicant Cited Pelton
`During Prosecution of the ’773 Patent
`
`
`
`
`
`Ex. 1008 (Prosecution History of ’773 Patent), p. 159.
`
`44
`
`
`
`Motivation to Combine – Applicant Cited Pelton
`During Prosecution of the ’773 Patent
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 192:11-21.
`
`45
`
`
`
`Kuhn Anticipates Claims 1, 9, 10 and 12
`
`
`
`
`
`Ex. 1019 (Kuhn), Abstract.
`
`46
`
`
`
`Kuhn Heat Treats the “Entire Shank”
`
`
`
`
`
`Ex. 1019 (Kuhn), p. 718.
`
`47
`
`
`
`Kuhn Heat Treats the “Entire Shank”
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 231:18-232:3.
`
`48
`
`
`
`Kuhn Heat Treats the “Entire Shank”
`
`
`
`
`
`Ex. 2001 (Second Substitute) (Luebke’s Testimony), 81:8-15.
`
`49
`
`
`
`Kuhn’s Heat Treatment Achieves the
`Claimed Permanent Deformation
`
`
`
`
`
`Ex. 1019 (Kuhn), Fig. 6A.
`
`50
`
`
`
`Use of Unconventional Test
`Does Not Render Claims Patentable
`
`
`
`
`
`Ex. 1040 (Sinclair’s Cross-Examination), 78:21-79:4.
`
`Ex. 1040 (Sinclair’s Cross-Examination), 251:5-8.
`
`51
`
`
`
`Use of Unconventional Test
`Does Not Render Claims Patentable
`
`“[T]he discovery of a previously unappreciated property
`
`of a prior art composition, or of a scientific explanation
`
`for the prior art's functioning, does not render the old
`composition patentably new to the discoverer.”
`
`
`Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999)
`
`52
`
`
`
`Combination of Kuhn, McSpadden and Pelton
`Renders Claims 1-17 Obvious
`
`
`
`
`
`Ex. 1022 (McSpadden), ¶ 52.
`
`53
`
`
`
`No Nexus Between Alleged Secondary
`Considerations and the Claimed Invention
`
`“For objective evidence of secondary considerations to
`
`be accorded substantial weight, its proponents must
`
`establish between the evidence and the merits of the
`claimed invention.”
`
`
`Merck & Cie v. Gnosis S.p.A., 808 F.3d 829, 837 (Fed. Cir. 2015)
`
`54
`
`
`
`No Nexus Between Alleged Secondary
`Considerations and the Claimed Invention
`
`“We have held on a number of occasions that evidence of
`
`commercial success alone is not sufficient to demonstrate
`
`nonobviousness of a claimed invention. Rather, the proponent
`must offer proof ‘that the sales were a direct result of the unique
`characteristics of the claimed invention — as opposed to other
`economic and commercial factors unrelated to the quality of the
`patented subject matter.’”
`
`
`In re DBC, 545 F.3d. 1373, 1384 (Fed. Cir. 2008).
`
`55
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 176:9-16.
`
`56
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 172:14-173:1.
`
`57
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 174:14-175:13.
`
`58
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1038 (Luebke’s Cross-Examination), 177:2-17.
`
`59
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1039 (Lemon’s Cross-
`Examination), 64:9-65:4.
`
`60
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1039 (Lemon’s Cross-Examination), 106:9-19.
`
`61
`
`
`
`No Evidence of Requisite “Nexus”
`
`
`
`
`
`Ex. 1039 (Lemon’s Cross-Examination), 106:21-107:13.
`
`62
`
`
`
`Raising the AF (Shape Recovery)
`Temperature Reduces Superelasticity
`
`
`
`
`
`Ex. 1005 (Alapati), pp. 59-60 of 76.
`
`63
`
`
`
`Raising the AF (Shape Recovery)
`Temperature Reduces Superelasticity
`
`
`
`
`
`Ex. 1014 (Gao), ¶¶ 25, 62.
`
`64
`
`
`
`Raising the AF (Shape Recovery)
`Temperature Reduces Superelasticity
`
`
`
`
`
`Ex. 1037 (Farzin-Nia), 4:12-16.
`
`65
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