US Endodontics, LLC’s
`Hearing Presentation
`
`US Endodontics, LLC
`
`Petitioner,
`
`v.
`
`Gold Standard Instruments, LLC,
`
`Patent Owner.
`
`
`
`Case PGR2015-00019
`
`Patent 8,876,991 B2
`
`October 19, 2016
`
`US Endodontics, LLC – Ex. 1046
`US Endodontics, LLC v. Gold Standard Instruments, LLC
`PGR2015-00019
`
`1
`
`
`Hearing Presentation
`
`US Endodontics, LLC
`
`Petitioner,
`
`v.
`
`Gold Standard Instruments, LLC,
`
`Patent Owner.
`
`
`
`Case PGR2015-00019
`
`Patent 8,876,991 B2
`
`October 19, 2016
`
`US Endodontics, LLC – Ex. 1046
`US Endodontics, LLC v. Gold Standard Instruments, LLC
`PGR2015-00019
`
`1
`
`
`
`Endodontic File
`Endodontic File
`
`
`
`
`
`HIIBII----~'
`
`2
`
`
`
`Grounds Upon Which Trial Was Instituted
`
`
`
`
`
`Paper 17 (Board’s Decision on Institution), p. 37.
`
`3
`
`
`
`US Pat. No. 8,876,991 – Claim 12
`
`
`
`
`
`Ex. 1001 (’991 Patent), Claim 12.
`
`4
`
`
`
`US Pat. No. 8,876,991 – Claims 13 and 14
`
`
`
`
`
`Ex. 1001 (’991 Patent), Claims 13 and 14.
`
`5
`
`
`
`US Pat. No. 8,876,991 – Claims 15 and 16
`
`
`
`
`
`Ex. 1001 (’991 Patent), Claims 15 and 16.
`
`6
`
`
`
`Patent Owner Did Not Submit Expert Testimony
`
`
`
`
`Patent Owner did not submit any declaration testimony
`from an expert in this proceeding to rebut the
`testimony of Petitioner’s expert, Dr. Goldberg.
`
`
`Paper 31 (Petitioner’s Reply), p. 1.
`
`7
`
`
`
`Claims 12-16 are Eligible for Post-Grant Review
`
`• Petitioner has demonstrated that the applications to
`
`which the ’991 patent claims priority do not:
`
`
`– provide an enabling disclosure for the methods recited in
`claims 12-16
`– provide written description for the subject matter of
`claims 12-16
`
`• Thus, the effective filing date for claims is January 29,
`2014, the actual filing date of the ’311 application.
`
`Paper 17 (Board’s Institution Decision), p. 21.
`
`
`8
`
`
`
`Lack of Enablement
`
`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)
`
`
`“[W]hen a range is claimed, there must be reasonable
`enablement of the scope of the range.”
`
`AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1234, 1244 (Fed. Cir. 2003)
`
`
`“Claims which include a substantial measure of inoperatives . . .
`are fairly rejected under 35 U.S.C. § 112.”
`
`In re Corkill,
`771 F.2d 1496, 1501 (Fed. Cir. 1985)
`9
`
`
`
`
`Lack of Enablement – Undue Experimentation Would be
`Required to Practice the Full Scope of the Invention
`
`Factors relevant to “undue experimentation” include:
`
`
`(1) the quantity of experimentation necessary,
`(2) the amount of direction or guidance presented,
`(3) the presence or absence of working examples,
`(4) the nature of the invention,
`(5) the state of the prior art,
`(6) the relative skill of those in the art,
`(7) the predictability or unpredictability of the art, and
`(8) the breadth of the claims.
`
`In re Wands,
`858 F.2d 731, 737 (Fed. Cir. 1988)
`
`10
`
`
`
`Lack of Enablement – Undue Experimentation Would be
`Required to Practice the Full Scope of the Invention
`
`
`
`Practicing the full scope of the claimed invention
`
`would require undue experimentation as the results
`of heat treatment depend on several variables,
`including temperature, time, alloy composition and
`alloy treatment history.
`
`
`Paper 1 (Petition), p. 41 (citing Ex. 1002 (Decl. of A. Jon Goldberg, Ph.D.), ¶ 111).
`
`11
`
`
`
`Lack of Enablement – Undue Experimentation Would be
`Required to Practice the Full Scope of the Invention
`
`Ex. 1002 (Decl. of A. Jon Goldberg, Ph.D.), ¶ 113.
`
`12
`
`
`
`Lack of Enablement – Undue Experimentation Would be
`Required to Practice the Full Scope of the Invention
`
`Ex. 2039 (Cross-Examination of A. Jon Goldberg, Ph.D.), 179:13-25.
`
`13
`
`
`
`Lack of Enablement
`
`
`
`
`
`Ex. 1002 (Decl. of A. Jon Goldberg, Ph.D.), ¶ 102.
`
`14
`
`
`
`Lack of Enablement
`
`During prosecution of a related application, U.S. Pat. Appl. No. 12/977,625, the
`
`applicant sought to traverse a prior art rejection based on the “criticality” of the
`temperature being over 400°C:
`
`
`Paper 1 (Petition), pp. 7-8 (quoting Ex. 1003, p. 83), pp. 25-26.
`
`15
`
`
`
`Lack of Enablement
`
`
`
`
`
`Ex. 1003 (Prosecution history of ’991 patent), p. 153.
`
`16
`
`
`
`Lack of Enablement – A Significant Portion of the Claimed
`Temperature Ranges Do Not Achieve the Claimed Deformation
`
`
`
`
`
`Ex. 1018 (Decl. of Adam Kozak), pp. 4, 10 of 40.
`
`17
`
`
`
`Lack of Enablement – A Significant Portion of the Claimed
`Temperature Ranges Do Not Achieve the Claimed Deformation
`
`
`
`
`
`Ex. 1041 (Decl. of Lou Fiorini), p. 13 of 46.
`
`18
`
`
`
`Lack of Enablement – Patent Owner's Alleged
`“Testing” Should Not Be Given Any Weight
`
`
`Patent Owner’s “testing” has major flaws:
`
`– It does not provide an identification of the manufacturer
`and the brand of the files.
`– No way to confirm whether the shanks of such files were
`superelastic prior to heat treatment.
`– Luebke’s “declaration” provides no explanation as to the
`amount of experimentation that went into settling on 24
`hours of heat treatment.
`– Patent Owner failed to identify the condition of the files
`received by the company that heat treated the same.
`
`Paper 31 (Petitioner’s Reply), p. 9.
`
`19
`
`
`
`Lack of Written Description
`
`In order to satisfy the written description requirement,
`
`the specification 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)
`
`20
`
`
`
`Lack of Written Description
`
`In order to satisfy the written description requirement,
`
`the specification “must describe the invention
`
`sufficiently to convey to a person of skill in the art that
`the patentee had possession of the claimed invention
`at the time of the application, i.e., that the patentee
`invented what is claimed.”
`
`
`Lizardtech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336, 1345 (Fed. Cir. 2005)
`
`21
`
`
`
`Lack of Written Description
`
`
`“As Petitioner notes, the only description in the
`
`’991 patent of how to achieve the claimed
`permanent deformation result is Example 4 of
`the Specification, which describes heat-
`treatment at 500°C for 75 minutes, and the
`Specification lacks guidance on how to modify
`Example 4 and still produce the claimed result.”
`
`Paper 17 (Board’s Decision on Institution), p. 26.
`
`22
`
`
`
`Lack of Written Description
`
`During prosecution of a related application, U.S. Pat. Appl. No. 12/977,625, the
`
`applicant sought to traverse a prior art rejection based on the “criticality” of the
`temperature being over 400°C:
`
`
`Paper 1 (Petition), pp. 7-8 (quoting Ex. 1003, p. 83), 25-26.
`
`23
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1003 (Prosecution history of ’991 patent), p. 153.
`
`24
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 192:2-6.
`
`25
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 193:12-18.
`26
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 193:19-194:1.
`27
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 194:2-4.
`
`28
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 194:5-9.
`
`29
`
`
`
`Lack of Written Description
`
`
`
`
`
`Ex. 1040 (Neill Luebke’s Cross-examination in IPR2015-00632), 194:10-12.
`30
`
`
`
`Luebke 2008 Anticipates Claims 12-16
`
`• Patent Owner’s only argument regarding instituted
`
`Grounds 3 and 4 is that since claims 12-16 are
`
`entitled to a priority date of at least June 7, 2005,
`Luebke 2008 does not constitute prior art.
`
`• Patent Owner does not, and cannot, otherwise
`dispute that claims 12-16 are unpatentable as
`anticipated by Luebke 2008 and claim 15 is
`additionally unpatentable over Luebke 2008 in view
`of Heath or ISO Standard 3630-1.
`
`Paper 31 (Petitioner’s Reply), p. 18.
`
`31
`
`
`
`Kuhn Anticipates Claims 12-14 and 15,
`and Renders Claim 15 Obvious
`
`
`
`
`
`Ex. 1030 (Kuhn), Abstract.
`
`32
`
`
`
`Kuhn Heat-treats the “entire shank”
`
`
`
`
`
`Ex. 1030 (Kuhn), p. 718.
`
`33
`
`
`
`Kuhn Heat-treats the “entire shank”
`
`
`
`
`
`Ex. 2001 (testimony from N. Luebke in related district court action), 81:8-15.
`
`34
`
`
`
`Kuhn’s Heat Treatment Achieves the
`Claimed Permanent Deformation
`
`
`
`
`
`Ex. 1030 (Kuhn), Fig. 6A.
`
`35
`
`
`
`Kuhn Does Not State That the Heat-Treated Files
`Recovered Their Original State After Bending
`
`Patent Owner misreads Kuhn’s statement that
`
`non-heat-treated files “recover[ed] their
`
`original” state after bending as applying to the
`heat-treated files.
`
`
`
`Ex. 1002 (Decl. of A. Jon Goldberg, Ph.D.), ¶ 168.
`
`36
`
`
`
`
`
`
`
`Kuhn Does Not State That the Heat-Treated Files
`Recovered Their Original State After Bending
`
`
`
`
`
`Ex. 2039 (Cross-examination of A. Jon Goldberg, Ph.D.), 148:9-150:8.
`
`37
`
`
`
`Kuhn Does Not State That the Heat-Treated Files
`Recovered Their Original State After Bending
`
`
`
`
`
`Ex. 2039 (Cross-examination of A. Jon Goldberg, Ph.D.), 157:3-16.
`
`38
`
`
`
`Patent Owner’s Kuhn “Experiment” is Unavailing
`
`“[P]roof of efficacy is not required for a prior art
`
`reference to be enabling for purposes of anticipation.”
`
`
`
`Impax Labs., Inc. v. Aventis Pharm., Inc.,
`468 F.3d 1366, 1383 (Fed. Cir. 2006)
`
`39
`
`
`
`Patent Owner’s Kuhn “Experiment” is Unavailing
`
`Ex. 1002 (Decl. of A. Jon Goldberg, Ph.D.), ¶ 113.
`
`40
`
`
`
`Patent Owner’s Kuhn “Experiment” is Unavailing
`
`Ex. 2039 (Cross-Examination of A. Jon Goldberg, Ph.D.), 179:13-25.
`
`41
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