Case IPR2015-006321 Patent 8,727,773 82
`
`GOLD STANDARD EXHIBIT 2053
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`1
`
`
`
`GOLD STANDARD EXHIBIT 2053
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`1
`
`
`
`Patent Owner’s Demonstratives
`
`US Endodontics, LLC, v. Gold Standard Instruments, LLC
`
`Case IPR2015-00632 | Patent 8,727,773 B2
`
`1
`
`
`
`Burden of Proof
`
`● Petitioner must prove unpatentability by a
`preponderance of the evidence
`– 35 U.S.C. § 316(e)
`● Petitioner argues—incorrectly—that Patent Owner has
`the burden to demonstrate patentability
`
`– Petitioner’s Reply (Paper 57, 1)
`
`● Petitioner has not carried its burden
`
`2
`
`
`
`Conventional Wisdom
`
`At the time of invention, superelasticity was considered
`a highly desirable property for endodontic instruments
`
`3
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`Goldberg Declaration
`
`Ex. 1002, ¶ 25
`
`4
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`Q. Looking at the McSpadden reference that you talked a little bit about this
`morning, you will agree that there are many places in the McSpadden
`reference that tout the desirability of a stiffer superelastic nickel-titanium
`endodontic file; correct?
`A. Correct.
`Q. And you agree that that is the opposite of Dr. Luebke’s invention; correct?
`A. Correct.
`Q. And you’ve seen in many of the prior art references upon which the
`defendants have relied that there’s the specific praise for and touting of the
`desirability of superelasticity; correct?
`A. Correct.
`Q. And that is the opposite of Dr. Luebke’s invention, which is to decrease
`superelasticity in endodontic files to fix a particular problem; correct?
`A. Correct.
`
`Ex. 2002 (Second substitute), 104-105 (Dr. Goldberg’s testimony)
`
`5
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`Lemon Declaration
`
`Ex. 2028, ¶¶ 22, 32
`
`6
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`Luebke Declaration
`
`Ex. 2027, ¶¶ 17, 18
`
`7
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`McSpadden (2001)
`
`Ex. 1022, ¶ 44
`
`8
`
`
`
`Conventional Wisdom Regarding Superelastic Endodontic Files
`
`McSpadden (2001)
`
`Ex. 1022, ¶ 48
`
`9
`
`
`
`Kuhn Does Not Anticipate or Render Obvious
`the Challenged Claims of the ’773 Patent
`
`● Kuhn does not teach or suggest making a permanently
`deformable file
`
`● Kuhn does not heat treat the entire shank
`
`● Kuhn teaches away
`
`10
`
`
`
`Kuhn Does Not Teach or Suggest Making a
`Permanently Deformable File
`
`● Kuhn investigated fatigue properties of files (Ex. 1019, 716)
`
`● Kuhn annealed files at various temperatures for only
`10-15 minutes (Ex. 1019, 717)
`
`● Petitioner concedes that file heated at 510°C does not
`show permanent deformation (Paper 2, 32)
`
`● Petitioner relies solely on file heated at 400°C (10 min)
`(Paper 2, 30-31)
`
`11
`
`
`
`Kuhn Figure 4A A
`
`!\ . ;
`
`.:.,.:····· .. -· .• ~ ......... .
`
`,1'"'
`··'
`.,., ... r-- ,.,
`.:·
`~ - .J'·
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`
`-Profile 0.04/20
`-
`- -Profile 400°C 1 0'
`· · ··· · ·· · Profile 51 0°C 1 o•
`
`M~R\
`
`-120
`
`-100
`
`-80
`
`-60
`
`-40
`
`-20
`
`0
`
`20
`
`Temp .°C
`60
`40
`
`Ex. 2026, ¶ 75 (citing Ex. 1019, 718 (Fig. 4A))
`
`12
`
`
`
`Kuhn Figure 2
`
`Profile 0.04/20 active part
`-
`· · • · · Profile 0.04/20 inactive pa11
`
`.. ~ .. •.-
`.. - . ., ...
`·•···.·.
`
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`
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`
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`
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`
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`
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`
`-120
`
`-100
`
`-60
`
`-40
`
`-20
`
`0
`
`20
`
`40
`
`60
`
`Ex. 2026, ¶ 79 (citing Ex. 1019, 718 (Fig. 2))
`
`13
`
`
`
`020614010 Sample 3
`
`Peak= 25 31 •c
`
`30.91 •c
`222220mW
`
`220
`
`2 1 5
`
`21.0
`
`I
`~ ! 20.5
`~
`I
`
`20.0
`
`19 5
`
`19 0
`
`Heat
`
`Asea = 136 842 mJ
`Delta H = 14 3291 J/g
`
`Onset = 17 30 'C
`
`Cool
`
`Peak = -43 64 ' C
`
`Asea = -42 326 mJ
`Deha H = -4 4321 Jig
`
`Peak = 23 82 •c
`
`1847+-~~----------~------------~------------~----------~------------~------------~----------~------------~
`-65.4
`-60
`80
`20
`-20
`80
`100
`40
`TemperalUre rc)
`
`Ex. 2026, ¶ 83 (discussing Ex. 2031, Ex. A (EdgeFile X3))
`
`14
`
`
`
`Dr. Sinclair’s Declaration (Ex. 2026)
`Shows Kuhn’s Files Remained Superelastic
`
`Kuhn Figure 6A
`
`A
`
`-Profile 0.04/20
`-
`· ·Profile 400°C J 0'
`······· · Profile 5 I oo-c 1 0'
`
`3
`
`2
`
`z
`i,S
`
`I
`
`0,5
`
`mm
`
`Ex. 2026, ¶ 89 (citing Ex. 1019, 720 (Fig. 6A))
`
`15
`
`
`
`Dr. Sinclair’s Declaration (Ex. 2026)
`Shows Kuhn’s Files Remained Superelastic
`
`.. _ _ ... . . . . . Yo
`
`0
`
`1
`
`2
`
`Ex. 2026, ¶ 93 (discussing Ex. 1019, 720 (Fig. 6A))
`
`16
`
`
`
`Miura Figure 5
`
`(g)
`1000
`Load
`
`500
`
`- - untreated control
`- - - 5 min. heat application
`---10min.
`-
`• · - 60m 11.
`__ ........... l20min.
`
`II
`
`II
`
`H
`
`0
`
`0.5
`
`1 . 0
`1 . 5
`Deflection
`
`2. 0 (mm)
`
`Fig. 5. Results of the heat application on 0.016 inch Japanese
`NiTi alloy wire at 400c C.
`
`Ex. 2026, ¶ 97 (citing Ex. 1004, 4 (Fig. 5))
`
`17
`
`
`
`Ex. 1004 Figure 3
`
`-·-- Co·Cr-Hi
`stamfess 'te•l
`- - -
`.. --·--- WOfk·hardened NiTi
`- - - Japanese Nili
`
`(g)
`1500
`
`Load 1000
`
`500
`
`0
`
`0.5
`
`1 . 0
`1.5
`Deflection
`
`2.0 (mm)
`
`Fig. 3. Load deflection curves produced by the three-point bending test.
`
`Ex. 2026, ¶ 98 (citing Ex. 1004, 4 (Fig. 3))
`
`18
`
`
`
`Pelton Figure 5 (in part)
`
`1600
`
`1400
`
`1200
`
`,...._
`~ 1000
`~ ........
`800
`V'J en
`..... 600
`
`-(/)
`
`(J)
`
`400
`
`200
`
`0
`
`Ex. 2026, ¶ 99 (citing Ex. 1006, 111 (Fig. 5))
`
`19
`
`
`
`
`
`fIr_1u r '. Pu-um: -411;-5: "U :13
`
`Fl::LIIr 2 PM-Iml -=:uII|I1r NI
`
`‘\l
`
`Ex. 2026, ¶¶ 102-103 (citing Ex. 2030, Ex. A (EdgeFiles X3 and X1))
`
`20
`
`
`
`The Kuhn 2002 Article Itself Confirms That the
`Tested Files Recover Their Original State
`
`Kuhn (2002)
`
`Ex. 1019, 716
`
`21
`
`
`
`The Kuhn 2002 Article is a Continuation of the Kuhn 2001 Article
`
`Kuhn (2002)
`
`Ex. 1019, 716 and 720
`
`22
`
`
`
`Kuhn 2001 (Ex. 2024) Corroborates the Superelastic Nature of
`the Heat Treated Files in Kuhn 2002 (Ex. 1019)
`
`Kuhn (2001)
`
`* * *
`
`* * *
`
`Ex. 2024, 516; Paper 44, 27; Ex. 2026, ¶ 81
`
`23
`
`
`
`The Superelastic Files in Kuhn 2001 (Ex. 2024)
`Had to Be Clamped Down for SEM Testing
`
`Kuhn (2001)
`
`Ex. 2024, 516; Paper 44, 27-28; Ex. 2026, ¶ 81
`
`24
`
`
`
`Kuhn Does Not Heat Treat the Entire Shank
`
`Kuhn states that the
`files are cut with a
`diamond saw
`
`Table 1 states that
`the heat treatment
`was on the “active
`part” of file
`
`Ex. 1019, 717
`
`25
`
`
`
`Kuhn Teaches Away From the Claimed Invention
`
`Kuhn concludes that
`stiffness is very important
`and heat treatments are
`not required
`
`Kuhn suggests “recovery”
`heat treatments prior to
`file machining
`
`Ex. 1019, 720
`
`26
`
`
`
`Kuhn and 1992 ISO Do Not Render Challenged Claims Obvious
`
`● 1992 ISO requires the working part of an endodontic file to be
`a stainless or carbon steel alloy (Ex. 1016 at 8, § 4.1.1)
`— It does not relate to Nickel-Titanium endodontic files
`
`● 1992 ISO does not fill in the gaps in Petitioner’s proof:
`— The claims are directed to a process, not files
`— 1992 ISO does not mention heating entire shank
`— 1992 ISO does not suggest permanent deformation
`
`● Petitioner does not assert that ISO cures deficiencies in Kuhn
`
`Paper 44 at 34-36
`
`27
`
`
`
`Pelton Does Not Fill In the Gaps of the Cited References
`
`● Pelton (Ex. 1006) does not meet any claim limitation
`
`● Pelton relied on solely for the temperature and times used
`for heat-treating NiTi wire
`
`● Pelton is focused on optimizing superelasticity of wire for
`superelastic products
`
`● Pelton does not suggest heat treatments after machining
`
`● Pelton does not suggest a preference for heat treatments
`within the claimed range
`
`● Pelton contradicts Dr. Goldberg’s theory of superelasticity
`
`Paper 44 at 36, 37, 42, 52, 53
`
`28
`
`
`
`Kuhn, 1992 ISO, McSpadden and Pelton
`Do Not Render Challenged Claims Obvious
`
`● McSpadden teaches that a stiffer superelastic file is preferable
`(i.e., a file having higher loading plateau in a stress-strain test
`than conventional superelastic files) Ex. 1022, ¶48
`
`● Dr. Goldberg admitted in court that McSpadden teaches the
`opposite of the claimed invention Ex. 2002 (Second substitute), 104-105
`
`Paper 44 at 37, 41
`
`29
`
`
`
`McSpadden Teaches Stiffer Files
`Are Better For Root Canal Therapy
`
`[0048] The increased loading plateau 175 is desirable fo r
`several reasons. For a given file design and diameter, a
`higher loading plateau increases the apparent stiffness of the
`file (in both bending and torsion) and therefore its respon(cid:173)
`siveness and ease of manipulation by endodontists. Files
`formed from conventional
`iTi alloys can often feel overly
`flexible and non-responsive and, thus, exhibit reduced tactile
`feedback and difficult mani ulation control-partic.ularly in
`the smaller diameter files~ Endodontic. files fabricated from
`improved superelastic alloys ha,ring increased stiffness in
`accordance \Vith one preferred embodiment of the invention
`provide improved responsiveness and manipulation control
`without significantly adversel
`incre.asin
`the risk of file
`breakage or canal Vlall transportation.
`
`Ex. 1022, ¶ 48
`
`30
`
`
`
`Dr. Goldberg Admitted That McSpadden
`Teaches the Opposite of the ’773 Patent
`
`Q. Looking at the McSpadden reference that you talked a little bit about this
`morning, you will agree that there are many places in the McSpadden
`reference that tout the desirability of a stiffer superelastic nickel-titanium
`endodontic file; correct?
`A. Correct.
`Q. And you agree that that is the opposite of Dr. Luebke’s invention; correct?
`A. Correct.
`Q. And you’ve seen in many of the prior art references upon which the
`defendants have relied that there’s the specific praise for and touting of the
`desirability of superelasticity; correct?
`A. Correct.
`Q. And that is the opposite of Dr. Luebke’s invention, which is to decrease
`superelasticity in endodontic files to fix a particular problem; correct?
`A. Correct.
`
`Ex. 2002 (Second substitute), 104-105 (E.D. TN)
`
`31
`
`
`
`Matsutani, Pelton, and 1992 ISO
`Do Not Render Challenged Claims Obvious
`
`● Matsutani does not heat treat the entire shank
`— Matsutani selectively heat treats only the tip
`
`● Matsutani wants a significant portion of the shank to
`be superelastic
`— The remaining work portion and the entire non-work
`portion of the shank are superelastic
`
`Ex. 1023, Fig. 1 and 5:20-42
`
`32
`
`
`
`Matsutani Does Not Heat the Entire Shank
`
`Matsutani – Figure 1
`
`file shank
`(5)
`
`For a file with a 16 mm work portion,
`the heated portion is preferably “3 mm
`to 6 mm from the tip” and “more
`preferably about 3 mm or 4 mm”
`
`Ex. 1023, 5:29-33
`
`superelastic portion
`NOT HEATED
`(7)
`
`shape
`memory
`portion
`HEATED
`(6)
`
`33
`
`
`
`Matsutani’s Invention
`
`Matsutani
`
`1
`
`2
`
`3
`
`* * *
`
`Ex. 1023, 2:25-28; 32-34; Ex. 1023, 2:58-67
`
`34
`
`
`
`Matsutani’s Invention
`
`Matsutani
`
`* * *
`
`4
`
`5
`
`Ex. 1023, 3:6-10; Ex. 1023, 4:25-30
`
`35
`
`
`
`Matsutani Expressly Discourages Heating
`the Entire Work Portion
`
`● Matsutani explains exactly why he thinks it would be bad to heat
`treat the entire work portion of the file
`
`Ex. 1023, 5:37-42
`
`36
`
`
`
`Petitioner Fails to Adequately Explain Why One Would Modify
`Matsutani–Dr. Goldberg’s Opinion is Conclusory
`
`Goldberg Declaration
`
`Ex. 1002, ¶ 201
`
`37
`
`
`
`Dr. Goldberg’s Conclusory Opinion is Entitled to No Weight
`
`● The evidentiary record regarding Dr. Goldberg’s conclusory
`assertion–that a person of ordinary skill in the art would
`have inferred that heating the entire shank with Matsutani’s
`heat-treating procedures would “avoid the difficulties and
`added expense associated with partial heat-treatment.”
`Institution Decision (Paper 29 at 28)
`
`38
`
`
`
`Dr. Goldberg Admitted to Having No Knowledge of the Common
`Methods of Heat Treating NiTi
`
`Q. And you would agree that you don’t know what the common methods of
`heating nickel-titanium are, correct?
`* * *
`
`A. 145 of the transcript. Okay.
`Q. And you were asked, “And the heat treatment was performed by immersion of the
`wire in a nitrate salt bath? And you said, “Yes.” Did I read that correctly?
`A. Yes.
`Q. Then the follow-up question, “Is that a common way of heat treatment?” And
`you replied, “I don’t even know in general and I don’t know specifically for
`nickel-titanium if that’s a common method.” Did I read that correctly?
`A. Yes.
`Q. And the next question was, “You don’t know what the common methods for
`heat treatment of nickel titanium are,” to which you responded, “No,
`because those – no.” Did I read that correctly?
`Mr. Ginsberg: Without the objections to form that were in the record.
`A. Yes.
`
`Ex. 2034, 84:4–85:13 (IPR deposition)
`
`39
`
`
`
`Evidentiary Record Disproves Dr. Goldberg’s Conclusory
`Statement
`
`Sinclair Declaration
`
`Ex. 2026, ¶ 167 (citing Ex. 1025 (Weine); Ex. 1022 (McSpadden))
`
`40
`
`
`
`Evidentiary Record Disproves Dr. Goldberg’s Conclusory
`Statement
`
`Sinclair Declaration
`
`Ex. 2026, ¶ 170 (citing Ex. 1023 (Matsutani))
`
`41
`
`
`
`Evidentiary Record Disproves Dr. Goldberg’s Conclusory
`Statement
`
`Sinclair Declaration
`
`Ex. 2026, ¶ 174 (citing Ex. 2043 (Dr. Goldberg’s deposition transcript))
`
`42
`
`
`
`Evidentiary Record Disproves Dr. Goldberg’s Conclusory
`Statement
`
`Sinclair Declaration
`
`Ex. 2026, ¶ 177 (citing Ex. 1023)
`
`43
`
`
`
`McSpadden Taught Stiffer NiTi Files As Opposed To More
`Flexible Files
`
`[0012] Another significant drawback is the tendency of tbe
`NiTi material to form latent burrs, rolled metal deposits
`ancVor other imperfections along tbe desired cutting edges
`during the machining process. If these imperfections are not
`cuefully monitored and controlled, they can have deleteri(cid:173)
`ous effects on file performance. Another significant draw(cid:173)
`back i5 that the cutting edges of presently available NiTi
`instruments are not as shar_p as their stainles.s steel counter(cid:173)
`parts and tend to lose their sharpness more rapidly with use.
`Anoth~r signific.:ant drawba<.:k is r~du<.:oo manipulation <.:<.m(cid:173)
`trol due to reduced stiffness and extreme torsional flexibility
`of p resently available NiTi endodontic files as compared
`with stainless s teel files.
`
`[0048] The increased loading plateau 175 is desirable for
`several reasons. For a given file design and diameter, a
`higher loading plateau increases the apparent stiffness of the
`file (in both bending and torsion) and therefore its respon(cid:173)
`siveness and ease of manipulation by endodontists. Files
`formed from conventional NiTi alloys can often feel overly
`flexible and non-responsive and, thus, exhibit reduced tactile
`feedback and difficult mani ulation control- particularly in
`the smaller diameter files. Endodontic files fabricated from
`improved su erelastic alloys having increased stiffness in
`accordance with one preferred embodiment of the invention
`provide improved responsiveness and manipulation control
`without significantly adversely increasing the risk of file
`breakage or canal wall transportation.
`
`Ex. 1022, ¶¶ 12, 48
`
`44
`
`
`
`Kuhn Teaches That Stiffness Is Important and Suggests at
`Most Pre-Machining Recovery Heating
`
`Kuhn concludes that stiffness is very important
`and heat treatments are not required
`
`Ex. 1019, 720
`
`45
`
`
`
`Kuhn Teaches That Stiffness Is Important and Suggests at
`Most Pre-Machining Recovery Heating
`
`Kuhn suggests “recovery” heat treatments prior to file machining
`
`Ex. 1019, 720
`
`46
`
`
`
`Matsutani, Pelton, and 1992 ISO
`Do Not Render Claims Obvious
`
`● Matsutani was distinguished during prosecution
`
`● The “new” information is Dr. Goldberg’s unsupported argument
`that heating the entire shank would be easier and cheaper.
`— Dr. Goldberg previously testified that he is not familiar with
`common methods of heat-treating endodontic files
`— Dr. Goldberg ignores the teaching away in Matsutani
`— Dr. Goldberg’s reliance on Matsutani 2006 (Ex. 1026) is
`misplaced
`
`● Pelton does not mention endodontic files
`
`● 1992 ISO does not mention NiTi or heat treatments
`
`● Combination of references fails to meet limitations
`
`47
`
`
`
`’773 Patent – Figure 6
`
`35~--------------------------------------------------------------~
`
`+780%
`
`+1350%
`
`+1260%
`
`+880%
`
`+1010%
`
`+1041%
`
`Figure 6
`
`( 11) United States Patent
`Luebke
`
`(Sol)
`
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`
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`
`-t....
`c. c
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`
`20
`
`15
`
`10
`
`5
`
`0
`
`larger SD
`
`Iii
`oTT
`oli-N
`
`sx
`
`S1
`
`S2
`
`F1
`
`F2
`
`F3
`
`ISO size
`
`Ex. 1001, Fig. 6
`
`48
`
`
`
`Prior to Heat Treatment, NiTi Files Are Superelastic
`
`Luebke
`
`File Size 25 with 04 taper
`with pressure applied
`
`File Size 25 with 04 taper
`with pressure released,
`file returns to natural
`straight orientation
`
`(Petitioner’s) Ex. 1008, 108-116 (prosecution history of the ’773 patent)
`
`49
`
`
`
`After Heat Treatment, NiTi Files Are Permanently Deformable
`
`Luebke
`
`File Size 25 with 04 taper
`natural straight shape before
`pressure is applied
`
`File Size 25 with 04 taper
`curved state after bending
`pressure applied and after
`pressure released. It does not
`return to original state
`
`(Petitioner’s) Ex. 1008, 108-116 (prosecution history of the ’773 patent)
`
`50
`
`
`
`Claim Construction
`
`● Heat-treating does not require an inert atmosphere
`
`● The “wherein” clause is a limitation
`
`— Sets out required metric for permanent deformation
`
`● Petitioner’s proposed claim interpretations are unreasonable:
`
`— The Af is not claimed or mentioned in the ’773 patent
`— Equating Af with permanent deformation also fails in view
`of Kuhn and Pelton
`
`— Petitioner was unable to overcome this in the Reply
`
`— Petitioner’s attempt to minimize the facts only highlight the
`problems with its proposed claim interpretation
`
`51
`
`
`
`Secondary Indicia of Nonobviousness
`
`● Dr. Luebke fought against conventional wisdom
`● Cited references teach away from permanent deformation
`● Long-felt but unresolved need for endodontic files with improved
`properties: deformable files are now very popular
`● Skepticism: at first, practitioners did not like or prefer the feel of a file made
`according to the claimed process
`● Vortex Blue is commercially successful and the file of choice in several
`dental schools
`● Vortex Blue has received praise in the industry
`● Copying: several companies now market deformable files
`● Licensing: RPI for Petitioner, Bobby Bennett, approached Dr. Luebke to
`license his intellectual property prior to copying Dentsply’s products
`● Dentsply-Tulsa Dental, a leading dental supply company, ultimately licensed
`Dr. Luebke’s intellectual property
`
`Paper 44 at 54-60
`
`52
`
`
`
`Petitioner Admitted the Claimed Heat Treatment Process is
`Essential for a Competitive Product
`
`Q. Do you recall anything that Dr. Goodis communicated
`to you about why he wanted a heat treatment step
`performed?
`
`A. Yes. I think what I recall was his primary purpose was
`to have a product that he could actually compete in
`the marketplace with.
`
`– Deposition of Bobby Bennett (Sept. 19, 2014) (Ex. 2002, 174)
`
`53
`
`
`
`Edge Endo (RPI) Links Improved Properties to the Heat
`Treatment Process
`
`Twice the strength. Half the cost.
`
`Order a FREE Sample Now. Catl8ss.985.3636
`
`s
`
`tronger and lasts longer. A broken file is the one of the worst things that can happen during a procedure. Our revolutionary heat treated Fire(cid:173)
`Wire Tl.l Niti yields performance enhanc1ng durability (PED) that provides not only mcredible flexibility. but far out performs even the most
`expens1ve files on the market in cyclic fat1gue testmg: a key indicator of file strength and durability.
`
`Ex. 2012, 1
`
`54
`
`
`
`Praise for Vortex Blue Endodontic Files
`
`Vortex Blue
`
`Ex. 2043
`
`55
`
`
`
`Zipping
`
`56
`
`
`
`Transportation
`
`57
`
`
`
`Tooth Perforation
`
`58
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