LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG LUYE
`PHARMACEUTICAL CO., LTD., and NANJING LUYE PHARMACEUTICAL CO., LTD.
`
`Petitioners
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`
`THERAPEUTICS, INC.,
`
`Patent Owners
`
`IPR2016-01096
`U.S. Patent 6,667,061
`
`Petitioners’ Oral Argument
`August 28, 2017
`
`1
`
`
`PHARMACEUTICAL CO., LTD., and NANJING LUYE PHARMACEUTICAL CO., LTD.
`
`Petitioners
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`
`THERAPEUTICS, INC.,
`
`Patent Owners
`
`IPR2016-01096
`U.S. Patent 6,667,061
`
`Petitioners’ Oral Argument
`August 28, 2017
`
`1
`
`
`
`
`
`Institution of Trial for the ’061 PatentInstitution of Trial for the ’061 Patent
`
`
`
`Ground 1Ground 1
`
`
`
`Ground 2Ground 2
`
`Paper 13 (Institution Decision) at 20, 31
`
`22
`
`
`
`
`
`’061 Patent Claim 1’061 Patent Claim 1
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claim 1Ex.1001, Claim 1
`
`Paper 5, (Pet.) at 32-33, 49-50
`
`33
`
`
`
`
`
`’061 Patent Claims 2-3’061 Patent Claims 2-3
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 2-3Ex.1001, Claims 2-3
`
`Paper 5 (Pet.) at 33-34, 50-51
`
`44
`
`
`
`
`
`’061 Patent Claims 4-5, 10-11’061 Patent Claims 4-5, 10-11
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 4-5Ex.1001, Claims 4-5
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 10-11Ex.1001, Claims 10-11
`
`Paper 5 (Pet.) at 34-35
`
`55
`
`
`
`
`
`’061 Patent Claims 6-7, 12-13’061 Patent Claims 6-7, 12-13
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 6-7Ex.1001, Claims 6-7
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 12-13Ex.1001, Claims 12-13
`
`Paper 5 (Pet.) at 34-35, 51-52
`
`66
`
`
`
`
`
`’061 Patent Claims 8-9’061 Patent Claims 8-9
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 8-9Ex.1001, Claims 8-9
`
`Paper 5 (Pet.) at 34-35, 52
`
`77
`
`
`
`
`
`’061 Patent Claims 17, 18, and 19’061 Patent Claims 17, 18, and 19
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 17-19Ex.1001, Claims 17-19
`
`Paper 5 (Pet.) at 53
`
`88
`
`
`
`
`
`’061 Patent Claims 20-21’061 Patent Claims 20-21
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 20-21Ex.1001, Claims 20-21
`
`Paper 5 (Pet.) at 53-54
`
`99
`
`
`
`
`
`’061 Patent Claims 22-23’061 Patent Claims 22-23
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claims 22-23Ex.1001, Claims 22-23
`
`Paper 5 (Pet.) at 37-38, 54-56
`
`1010
`
`
`
`
`
`The Overriding Issue of ViscosityThe Overriding Issue of Viscosity
`
`Petitioners have demonstrated that
`the injection vehicles in the Johnson
`and Gustafsson references have an
`inherent viscosity within the
`claimed range
`
`Paper 5, (Pet.) at 33, 50
`
`1111
`
`
`
`
`The ‘061 Patent Admits That a Vehicle With a Viscosity The ‘061 Patent Admits That a Vehicle With a Viscosity
`
`of About 20 cp Was Knownof About 20 cp Was Known
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col. 2, ll.34-37Ex.1001, col. 2, ll.34-37
`
`Paper 5 (Pet.) at 15
`
`1212
`
`
`
`
`The ‘061 Patent Disclaims An Injection Vehicle The ‘061 Patent Disclaims An Injection Vehicle
`
`With 3% CMCWith 3% CMC
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col. 3, ll.3-8Ex.1001, col. 3, ll.3-8
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col. 3, ll.18-34Ex.1001, col. 3, ll.18-34
`
`Paper 5 (Pet.) at 15; Paper 40 (Reply) at 3, Ex.1024 paragraph 70
`
`1313
`
`
`
`
`
`Exemplary Viscosity Values Set Forth In the ‘061 PatentExemplary Viscosity Values Set Forth In the ‘061 Patent
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col.6, ll.9-20Ex.1001, col.6, ll.9-20
`
`Paper 5 (Pet.) at 17-18
`
`1414
`
`
`
`
`
`Exemplary Viscosity Values Set Forth In the ‘061 PatentExemplary Viscosity Values Set Forth In the ‘061 Patent
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col.9, ll.43-47Ex.1001, col.9, ll.43-47
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col.10, ll.17-27Ex.1001, col.10, ll.17-27
`
`Paper 5 (Pet.) at 24
`
`1515
`
`
`
`
`Patent Office Requires Applicants To Show Patent Office Requires Applicants To Show
`
`Unexpected ResultsUnexpected Results
`
`
`4/9/03 Office Action, 4/9/03 Office Action,
`
`Ex.1016, p.4Ex.1016, p.4
`
`* * *
`
`Paper 5 (Pet.) at 16-18
`
`1616
`
`
`
`
`
`Tracy DeclarationTracy Declaration
`
`
`
`Tracy Decl., Ex.1018, p.1-2Tracy Decl., Ex.1018, p.1-2
`
`Paper 5 (Pet.) at 17-18; Paper 40 (Reply) at 9-10
`
`1717
`
`
`
`
`Tracy States “CMC is the viscosity-controlling Tracy States “CMC is the viscosity-controlling
`
`component”component”
`
`
`
`Tracy Decl., Ex.1018, p.2Tracy Decl., Ex.1018, p.2
`
`Paper 5 (Pet.) at 17-18; Paper 40 (Reply) at 14
`
`1818
`
`
`
`
`Patent Owners Used Tracy to “Evidence” Viscosity To Patent Owners Used Tracy to “Evidence” Viscosity To
`
`Overcome Prior ArtOvercome Prior Art
`
`
`05/14/03 Applicants’ Response,05/14/03 Applicants’ Response,
`
`Ex.1017, p.3Ex.1017, p.3
`
`Paper 5 (Pet.) at 17-18
`
`1919
`
`
`
`
`
`Tracy Sufficient To Overcome the Cited Prior ArtTracy Sufficient To Overcome the Cited Prior Art
`
`
`07/24/03 Notice of Allowance, 07/24/03 Notice of Allowance,
`
`Ex.1019, p.2Ex.1019, p.2
`
`Paper 5 (Pet.) at 18
`
`2020
`
`
`
`
`The Board Rejected Patent Owners’ Inherency The Board Rejected Patent Owners’ Inherency
`
`ArgumentsArguments
`
`
`
`Institution Decision, Paper 13, p.12Institution Decision, Paper 13, p.12
`
`Paper 13 (Institution Decision) at 12
`
`2121
`
`
`
`
`Based On Tracy, the Board Finds That Johnson Meets Based On Tracy, the Board Finds That Johnson Meets
`
`the Viscosity Limitationthe Viscosity Limitation
`
`
`
`Institution Decision, Paper 13, p.14Institution Decision, Paper 13, p.14
`
`Paper 13 (Institution Decision) at 14
`
`2222
`
`
`
`
`Based On Tracy, the Board Finds That Gustafsson Meets Based On Tracy, the Board Finds That Gustafsson Meets
`
`the Viscosity Limitationthe Viscosity Limitation
`
`
`Institution Decision, Institution Decision,
`
`Paper 13, p.24-25Paper 13, p.24-25
`
`Paper 13 (Institution Decision) at 24-25
`
`2323
`
`
`
`
`Johnson And Gustafsson Meet The Claimed Johnson And Gustafsson Meet The Claimed
`
`Viscosity LimitationViscosity Limitation
`
`
`
`Institution Decision, Paper 13, p.32Institution Decision, Paper 13, p.32
`
`Paper 13 (Institution Decision) at 32
`
`2424
`
`
`
`
`
`The Other Limitations Are Known In The Prior ArtThe Other Limitations Are Known In The Prior Art
`
`2525
`
`
`
`
`’061 Patent Acknowledges That Syringeabilty, Injectability, and ’061 Patent Acknowledges That Syringeabilty, Injectability, and
`
`Suspendability Are Well-Known Issues Considered By A POSASuspendability Are Well-Known Issues Considered By A POSA
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, 1:17-22Ex.1001, 1:17-22
`
`Paper 5, (Pet.) at 7
`
`2626
`
`
`
`
`The ‘061 Patent Admits Any Active or Microparticle The ‘061 Patent Admits Any Active or Microparticle
`
`WorksWorks
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col. 4, ll.25-30Ex.1001, col. 4, ll.25-30
`
`Paper 40 (Reply) at 6, 24-25
`
`2727
`
`
`
`
`
`The ‘061 Patent Defines MicroparticlesThe ‘061 Patent Defines Microparticles
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col. 5, ll.14-18Ex.1001, col. 5, ll.14-18
`
`Paper 5 (Pet.) at 20; Paper 40 (Reply) at 6
`
`2828
`
`
`
`
`
`Polymeric BinderPolymeric Binder
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, col.14, ll.10-18Ex.1001, col.14, ll.10-18
`
`*
`
`*
`
`*
`
`Paper 40 (Reply) at 7
`
`2929
`
`
`
`
`
`Prior Art For Instituted GroundsPrior Art For Instituted Grounds
`
`Ground 1
`
`Ground 2
`
`Claims 1-13, 22, 23
`
`Claims 1-3, 6-9, 12, 13, 17-23
`
`Johnson
`
`(Ex.1009)
`
`Gustafsson
`
`(Ex. 1011)
`
`U.S. Patent No. 5,654,010
`
`International Publication
`No. WO 1997/014408
`
`Kino
`
`(Ex. 1010)
`
`Ramstack
`
`(Ex. 1005)
`
`U.S. Patent No. 5,656,299
`
`International Publication
`No. WO 1995/013799
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 20, 31
`
`3030
`
`
`
`
`
`Prior Art For Instituted Ground 1Prior Art For Instituted Ground 1
`
`Ground 1
`
`Ground 2
`
`Claims 1-13, 22, 23
`
`Claims 1-3, 6-9, 12, 13, 17-23
`
`Johnson
`
`(Ex.1009)
`
`Gustafsson
`
`(Ex. 1011)
`
`U.S. Patent No. 5,654,010
`
`International Publication
`No. WO 1997/014408
`
`Kino
`
`(Ex. 1010)
`
`Ramstack
`
`(Ex. 1005)
`
`U.S. Patent No. 5,656,299
`
`International Publication
`No. WO 1995/013799
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 20
`
`3131
`
`
`
`
`
`’061 Independent Claim’061 Independent Claim
`
`
`The ’061 Patent, The ’061 Patent,
`
`Ex.1001, Claim 1Ex.1001, Claim 1
`
`Paper 5 (Pet.) at 32-33, 49-50
`
`3232
`
`
`
`
`
`Claim 1 Reads on Johnson’s VehicleClaim 1 Reads on Johnson’s Vehicle
`
`
`
`Johnson, Ex.1009, col.10, ll.17-21Johnson, Ex.1009, col.10, ll.17-21
`
`
`
`Johnson, Ex.1009, col.11, l.65-col.12, l.5Johnson, Ex.1009, col.11, l.65-col.12, l.5
`
`Paper 5 (Pet.) at 24-26
`
`3333
`
`
`
`
`
`Claim 1 Reads on Johnson’s VehicleClaim 1 Reads on Johnson’s Vehicle
`
`
`
`Johnson, Ex.1009, col.12, ll. 40-45Johnson, Ex.1009, col.12, ll. 40-45
`
`Paper 5 (Pet.) at 24-26
`
`3434
`
`
`
`
`The Johnson Reference and The ‘061 Patent Have A The Johnson Reference and The ‘061 Patent Have A
`
`Common InventorCommon Inventor
`
`Paper 5, (Pet.) at 9
`
`3535
`
`
`
`
`Patent Owner Admits That 0.75% CMC Has A Viscosity Patent Owner Admits That 0.75% CMC Has A Viscosity
`
`Of Approximately 7 cpOf Approximately 7 cp
`
`Kino
`Vehicle
`
`Tracy Declaration
`
`Kino
`Vehicle
`
`0.5% CMC
`
`
`
`Viscosity < 7cpViscosity < 7cp
`
`• CMC is viscosity
`controlling agent
`
`• 0.75% CMC has a
`viscosity of approx.
`7cp
`
`Paper 5 (Pet.) at 17-18; Ex.1002 paragraph 44
`
`3636
`
`
`
`
`Patent Owner Admits That 1.5% CMC Has A Patent Owner Admits That 1.5% CMC Has A
`
`Viscosity of 27 cpViscosity of 27 cp
`
`Johnson
`Vehicle
`
`Tracy Declaration
`
`Johnson
`Vehicle
`
`3% CMC
`
`
`
`Viscosity > 27cpViscosity > 27cp
`
`• CMC is viscosity
`controlling agent
`
`• 1.5% CMC has a
`viscosity of 27cp
`
`Paper 5 (Pet.) at 17-18, 33; Ex.1002 paragraph 44
`
`3737
`
`
`
`
`
`‘061 Patent vs. Johnson Prior Art‘061 Patent vs. Johnson Prior Art
`
`
`
`The ‘061 Patent, Ex.1001, col.9, ll.43-47The ‘061 Patent, Ex.1001, col.9, ll.43-47
`
`
`
`The ‘061 Patent, Ex.1001, col. 3, ll.3-8The ‘061 Patent, Ex.1001, col. 3, ll.3-8
`
`
`
`Johnson, Ex.1009, col.12, ll.39-45Johnson, Ex.1009, col.12, ll.39-45
`
`Paper 5 (Pet.) at 24-26; Paper 40 (Reply) at 16-17
`
`3838
`
`
`
`
`The ‘061 Patent And The Tracy Declaration Do Not The ‘061 Patent And The Tracy Declaration Do Not
`
`Describe CMC Used Or Other Viscosity FactorsDescribe CMC Used Or Other Viscosity Factors
`
`
`
`Reply, Paper 40, p.13Reply, Paper 40, p.13
`
`
`
`Reply, Paper 40, p.15Reply, Paper 40, p.15
`
`Paper 40 (Reply) 13, 15
`
`3939
`
`
`
`
`Kino Teaches Wetting Agents And Density Kino Teaches Wetting Agents And Density
`
`Enhancing AgentsEnhancing Agents
`
`
`
`Kino, Ex.1010, col. 4, ll.38-60Kino, Ex.1010, col. 4, ll.38-60
`
`*
`
`*
`
`*
`
`Paper 5 (Pet.) at 26-27
`
`4040
`
`
`
`
`Motivation To Combine Johnson’s Formulation With Motivation To Combine Johnson’s Formulation With
`
`Kino’s Filler To Arrive At Claims 4, 5, 10, 11Kino’s Filler To Arrive At Claims 4, 5, 10, 11
`
`
`DeLuca Supp. Decl., DeLuca Supp. Decl.,
`
`Ex.1024, paragraph 76Ex.1024, paragraph 76
`
`Paper 40 (Reply) at 17
`
`4141
`
`
`
`
`Prior Art Motivates A POSA To Increase the Viscosity To Prior Art Motivates A POSA To Increase the Viscosity To
`
`Prevent SedementationPrevent Sedementation
`
`
`
`USP23, Ex.1034, p. 1949USP23, Ex.1034, p. 1949
`
`Paper 40 (Reply) at 5
`
`4242
`
`
`
`
`Motivation To Combine Johnson’s Formulation With Motivation To Combine Johnson’s Formulation With
`
`Kino’s Wetting Agent To Arrive At Claims 4,5, 10, 11Kino’s Wetting Agent To Arrive At Claims 4,5, 10, 11
`
`
`DeLuca Supp. Decl., DeLuca Supp. Decl.,
`
`Ex.1024, paragraph 76Ex.1024, paragraph 76
`
`Paper 40 (Reply) at 17
`
`4343
`
`
`
`
`
`Prior Art For Instituted Ground 2Prior Art For Instituted Ground 2
`
`Ground 1
`
`Ground 2
`
`Claims 1-13, 22, 23
`
`Claims 1-3, 6-9, 12, 13, 17-23
`
`Johnson
`
`(Ex.1009)
`
`Gustafsson
`
`(Ex. 1011)
`
`U.S. Patent No. 5,654,010
`
`International Publication
`No. WO 1997/014408
`
`Kino
`
`(Ex. 1010)
`
`Ramstack
`
`(Ex. 1005)
`
`U.S. Patent No. 5,656,299
`
`International Publication
`No. WO 1995/013799
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 31
`
`4444
`
`
`
`
`Patent Owner Admits That 1.5% CMC Has A Patent Owner Admits That 1.5% CMC Has A
`
`Viscosity of 27 cpViscosity of 27 cp
`
`Gustafsson
`Vehicle
`
`Tracy Declaration
`
`Gustafsson
`Vehicle
`
`3% CMC
`
`
`
`Viscosity > 27cpViscosity > 27cp
`
`• CMC is viscosity
`controlling agent
`
`• 1.5% CMC has a
`viscosity of 27cp
`
`Paper 5 (Pet.) at 17-18, 50
`
`4545
`
`
`
`
`Gustafsson Teaches An Injection Vehicle Within The Gustafsson Teaches An Injection Vehicle Within The
`
`Claimed Viscosity RangeClaimed Viscosity Range
`
`
`Gustafson, Gustafson,
`
`Ex.1011, p.18, ll.21-24Ex.1011, p.18, ll.21-24
`
`
`Gustafsson,Gustafsson,
`
`Ex.1011, p.19, ll.21-24Ex.1011, p.19, ll.21-24
`
`Paper 5 (Pet.) at 39
`
`4646
`
`
`
`
`Gustafsson Teaches All Of The Components Of The Gustafsson Teaches All Of The Components Of The
`
`Injection Vehicle Must Be Pharmaceutically AcceptableInjection Vehicle Must Be Pharmaceutically Acceptable
`
`
`Gustafsson, Gustafsson,
`
`Ex.1011, p.6, ll.29-33Ex.1011, p.6, ll.29-33
`
`Ex.1024 paragraph 86; Paper 40 (Reply) at 18
`
`4747
`
`
`
`
`
`Gustafsson Teaches Use Of Polymers Including PLGAGustafsson Teaches Use Of Polymers Including PLGA
`
`
`GustafssonGustafsson
`
`Ex.1011, p.6, ll.15-29Ex.1011, p.6, ll.15-29
`
`Paper 40 (Reply) at 24; Ex.1024 paragraph 107
`
`4848
`
`
`
`
`Gustafsson Teaches Microparticles Containing Any Gustafsson Teaches Microparticles Containing Any
`
`Active Can Be Injected Active Can Be Injected
`
`
`GustafssonGustafsson
`
`Ex.1011, p.6, ll.33-35Ex.1011, p.6, ll.33-35
`
`Paper 5 (Pet.) at 39
`
`4949
`
`
`
`
`
`Gustafsson’s Microspheres And Injection VehicleGustafsson’s Microspheres And Injection Vehicle
`
`Gustafsson’s Microspheres
`With PLGA Coating
`
`Gustafsson’s Injection Vehicle
`
`PLGA Coating
`(Polymeric Binder)
`
`Microparticles
`
`Active
`
`Starch
`(Polymer)
`
`Physiological
`sodium chloride
`solution containing
`3%CMC
`
`Paper 5 (Pet.) at 49-52; Paper 40 (Reply) at 19-20
`
`5050
`
`
`
`
`
`Gustafsson Meets the Limitation of MicroparticleGustafsson Meets the Limitation of Microparticle
`
`
`
`Institution Decision, Paper 13, p.25-26Institution Decision, Paper 13, p.25-26
`
`Paper 13 (Institution Decision) at 25-26
`
`5151
`
`
`
`
`Gustafsson Teaches Microparticles Having A Size Gustafsson Teaches Microparticles Having A Size
`
`Within The Claimed RangeWithin The Claimed Range
`
`
`Gustafsson, Gustafsson,
`
`Ex.1011, p.7, ll.28-33Ex.1011, p.7, ll.28-33
`
`Paper 5 (Pet.) at 47
`
`5252
`
`
`
`
`The ‘061 Patent Is Directed To A Composition Suitable The ‘061 Patent Is Directed To A Composition Suitable
`
`For Injection and Not Any Specific MicroparticleFor Injection and Not Any Specific Microparticle
`
`
`The ‘061 Patent, The ‘061 Patent,
`
`Ex.1001, col. 4, ll.25-30Ex.1001, col. 4, ll.25-30
`
`Paper 40 (Reply) at 6, 24-25
`
`5353
`
`
`
`
`Prior Art Teaches Parenterally AdminstratablePrior Art Teaches Parenterally Adminstratable
`
`Microparticles Microparticles
`
`
`Gustafsson, Gustafsson,
`
`Ex.1011, p.6, ll.33-35Ex.1011, p.6, ll.33-35
`
`
`Ramstack,Ramstack,
`
`Ex.1005, p.30, ll.1-4Ex.1005, p.30, ll.1-4
`
`Paper 5 (Pet.) at 39
`
`5454
`
`
`
`
`Ramstack’s Microparticles And Gustafsson’s Injection Ramstack’s Microparticles And Gustafsson’s Injection
`
`Vehicle Are CombinableVehicle Are Combinable
`
`Ramstack’s Microspheres With
`Gustafsson’s PLGA Coating
`
`Gustafsson’s Injection Vehicle
`
`PLGA Coating
`(Polymeric Binder)
`
`PLGA
`(Polymer)
`
`Microparticles
`
`Risperidone
`
`Physiological
`sodium chloride
`solution containing
`3%CMC
`
`Paper 5 (Pet.) at 46-47, 54
`
`5555
`
`
`
`
`
`Ramstack Teaches Risperidone As An Active AgentRamstack Teaches Risperidone As An Active Agent
`
`
`RamstackRamstack
`
`Ex.1005, p.30, ll.1-7Ex.1005, p.30, ll.1-7
`
`
`Ramstack,Ramstack,
`
`Ex.1005, p.30, l.20Ex.1005, p.30, l.20
`
`Paper 5 (Pet.) at 46, 54
`
`5656
`
`
`
`
`Ramstack Teaches Macromolecular Bioactive Agents Ramstack Teaches Macromolecular Bioactive Agents
`
`In MicroparticlesIn Microparticles
`
`
`Ramstack,Ramstack,
`
`Ex.1005, p.32 ll.14-17Ex.1005, p.32 ll.14-17
`
`DeLuca Supplemental Decl., Ex.1024 paragraph 107
`
`5757
`
`
`
`
`
`Ramstack Teaches Various Active AgentsRamstack Teaches Various Active Agents
`
`
`
`Institution Decision, Paper 13, p.22Institution Decision, Paper 13, p.22
`
`Paper 13 (Institution Decision) at 22
`
`5858
`
`
`
`
`Patent Owners Did Nothing More Than Combine Well-Patent Owners Did Nothing More Than Combine Well-
`
`Known Elements Known Elements
`
`
`
`Petition, Paper 5, p.23Petition, Paper 5, p.23
`
`Paper 5 (Pet.) at 23
`
`5959
`
`
`
`
`Patent Owners Did Nothing More Than Combine Well-Patent Owners Did Nothing More Than Combine Well-
`
`Known Elements Known Elements
`
`
`
`Petition, Paper 5, p.6Petition, Paper 5, p.6
`
`Paper 5 (Pet.) at 6
`
`6060
`
`
`
`
`
`Secondary Considerations Secondary Considerations
`
`6161
`
`
`
`
`Patent Owners Have Not Demonstrated Patent Owners Have Not Demonstrated
`
`Unexpected ResultsUnexpected Results
`
`
`
`Reply, Paper 40, p.27Reply, Paper 40, p.27
`
`Paper 40 (Reply) at 27
`
`6262
`
`
`
`
`
`Commercial Success Requires NexusCommercial Success Requires Nexus
`
`•
`
`•
`
`“[C]ommercial success alone is not sufficient to demonstrate
`nonobviousness of a claimed invention.” In re DBC, 545 F.3d 1373, 1384
`(Fed. Cir. 2008)
`
`“[T]he proponent must offer proof ‘that 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)
`(citation omitted)
`
`• Patent Owners must establish that any commercial success was based on
`patentable features not found in the prior art. See Asyst Techs., Inc. v.
`Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008); see also J.T. Eaton &
`Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).
`
`Paper 5 (Pet.) at 56; Paper 40 (Reply) at 28, 29
`
`6363
`
`
`
`
`Patent Owner Has Not Shown A Nexus Between the Patent Owner Has Not Shown A Nexus Between the
`
`Alleged Commercial Success And the Patented Invention Alleged Commercial Success And the Patented Invention
`
`
`
`Reply, Paper 40, p.28Reply, Paper 40, p.28
`
`Paper 5 (Pet.) at 57; Paper 40 (Reply) at 28
`
`6464
`
`
`
`
`The Handbook Teaches Low Viscosity Within The The Handbook Teaches Low Viscosity Within The
`
`Claimed RangeClaimed Range
`
`
`
`Handbook, Ex.1008, p.78Handbook, Ex.1008, p.78
`
`
`
`Handbook, Ex.1008, p.79Handbook, Ex.1008, p.79
`
`Paper 5 (Pet.) at 6,9, 25; Paper 40 (Reply) at 4
`
`6565
`
`
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