UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER INC.,
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case IPR2018-016761
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S SUR-REPLY
`
`
`
`
`
`
`
`
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00978, has been joined as petitioner in
`
`this proceeding.
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER INC.,
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case IPR2018-016761
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S SUR-REPLY
`
`
`
`
`
`
`
`
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00978, has been joined as petitioner in
`
`this proceeding.
`
`
`
`
`
`
`I.
`
`TABLE OF CONTENTS
`
`Page
`
`GROUND 1 DOES NOT RENDER THE CHALLENGED CLAIMS
`OBVIOUS ........................................................................................................ 1
`
`A.
`
`B.
`
`C.
`
`Steenfeldt-Jensen Does Not Suggest a Threaded Driver Tube ............. 1
`
`Even If Steenfeldt-Jensen Did Suggest a Threaded Driver Tube
`With Respect to Its First Embodiment, It Would Not Apply to
`the Fifth Embodiment ............................................................................ 1
`
`Even If Steenfeldt-Jensen Suggested a Threaded Driver Tube
`With Respect to Its First Embodiment, A POSA Would Not Be
`Motivated to Make Petitioners’ Modification to the Fifth
`Embodiment .......................................................................................... 3
`
`1.
`
`2.
`
`3.
`
`A High Injection Force Would Dissuade a POSA From
`Petitioners’ Modification ............................................................ 4
`
`Petitioners Argue that Their Modification is Obvious
`Solely On the Basis of Reasonable Expectation of Success
` ..................................................................................................... 4
`
`Sanofi Presented Non-Obviousness Arguments Beyond
`the Friction Collar Model ............................................................ 5
`
`D. Dr. Slocum’s Models Are Not Flawed .................................................. 5
`
`1.
`
`2.
`
`3.
`
`There is no Bias ........................................................................... 6
`
`The Analytical Model Tests Total Change in Friction ............... 7
`
`The Models Are Not Designed to Fail ........................................ 8
`
`E.
`
`Steenfeldt-Jensen Does Not Teach or Suggest an Internally
`Threaded Driver Tube in the Form of an Integrated Nut Member
`at Column 3, Lines 41-47 ...................................................................... 9
`
`1.
`
`Steenfeldt-Jensen Does Not Teach a Nut Member
`Integrally With a Driver Tube ................................................... 10
`i
`
`
`
`2.
`
`Steenfeldt-Jensen Does Not Suggest an Nut Member
`Integrally Formed With a Driver Tube ..................................... 11
`
`F.
`
`The Board Should Reject Petitioners’ New Argument that
`Steenfeldt-Jensen Suggests a Threaded Driver Tube Because of
`Disclosures in Giambattista ................................................................. 12
`
`II.
`
`GROUND 2 DOES NOT RENDER THE CHALLENGED CLAIMS
`OBVIOUS ...................................................................................................... 13
`
`A. A POSA Would Not Be Motivated To Combine Møller’s First
`and Second Embodiments ................................................................... 14
`
`B. Møller’s First and Second Embodiments Are Not Structurally or
`Functionally Equivalent ...................................................................... 16
`
`C. Møller And Steenfeldt-Jensen Do Not Render Obvious A Dose
`Dial Sleeve With Grooves On Its Outer Surface ................................ 17
`
`D. Møller and Steenfeldt-Jensen Do Not Render Obvious A Clicker
`With A Flexible Arm And Splines ...................................................... 18
`
`III. CONCLUSION .............................................................................................. 20
`
`
`
`
`ii
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`In re Gordon, 733 F.2d 900 ....................................................................................... 5
`Integra Lifesciences I, Ltd. v. Merck KGaA,
`496 F.3d 1334 (Fed. Cir. 2007) .............................................................................. 6
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ................................................................. 5, 14, 19
`KSR Intern. Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................. 19
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) .............................................................................. 14
`
`Plas-Pak Indus. v. Sulzer Mixpac AG
`600 F. App’x 755 (Fed. Cir. 2015) ........................................................................ 5
`Statutes and Regulations
`35 U.S.C. § 24 ............................................................................................................ 7
`35 U.S.C. §316(e) .................................................................................................... 17
`37 CFR § 42.24(a)(1)(i) ........................................................................................... 23
`37 CFR § 42.6(a)(2)(ii) ............................................................................................ 23
`37 CFR § 42.8 .......................................................................................................... 23
`
`
`
`
`iii
`
`
`
`
`
`
`
`Exhibit #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`EXHIBIT LIST
`
`Description
`Press Release, “Mylan Enhances Partnership with Biocon through
`Strategic Collaboration for Insulin Products”, Feb. 13, 2013 (PR
`Newswire), available at http://newsroom.mylan.com/press-
`releases?item=122834
`Press Release, “Mylan Commences Phase III Clinical Trials for
`its Generic Version of Advair Diskus® and Insulin Analog to
`Lantus®”, Sept. 16, 2014 (PR Newswire), available at
`http://newsroom.mylan.com/press-releases?item=123251
`Press Release, “Mylan and Biocon Present Clinical Data on
`Insulin Glargine at the American Diabetes Association’s 77th
`Scientific Sessions”, June 10, 2017 (PR Newswire), available at
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-
`Present-Clinical-Data-on-Insulin-Glargine-at-the-American-
`Diabetes-Associations-77th-Scientific-Sessions
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH v. Eli Lilly and Company,
`C.A. No. 1-14-cv-00113-RGA (D. Del), Dkt. No. 1
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop
`Industrie v. Merck Sharp & Dohme Corp., C.A. No. 1-16-cv-
`00812-RGA (D. Del), Dkt. No. 1
`Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v.
`Mylan, N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5,
`2018), Dkt. No. 45
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al.
`v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.
`Oct. 24, 2017), Dkt. No. 1
`Excerpts from Defendants’ Invalidity Contentions, dated Jan. 25,
`2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case
`No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Amended Invalidity Contentions,
`dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan
`N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Exhibit C to Amended Invalidity
`
`iv
`
`
`
`
`
`Exhibit #
`
`2011
`
`2012
`
`2013
`
`2014
`2015
`
`2016
`
`2017
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Description
`Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al.
`v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Aug. 13, 2018 Service of Sanofi’s Responses to Mylan’s
`Amended Contentions, Sanofi-Aventis U.S. LLC et al. v. Mylan
`N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`MP4 file of Sanofi’s Patented Pen animation
`Excerpt from Defendants’ opening claim construction brief, dated
`October 12, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp
`& Corp., Case No. 16-cv-812-RGA (D. Del.), Dkt. No. 192
`International Patent WO 99/3855
`Excerpt from Joint claim construction statement, Ex. A, dated
`October 8, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Animation depicting Møller’s first embodiment
`Animation depicting Møller’s second embodiment
`Defendants Opposition to Plaintiffs Motion to Stay dated Nov.
`22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 44
`Joint Proposed Discovery Plan dated Dec. 14, 2017, Sanofi-
`Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-
`09105-SRCCLW (D.N.J.)
`Letter from A. Calmann to Judge Waldor dated Apr. 24, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No.
`2:17-cv-09105-SRC-CLW (D.N.J.), Dkt. No. 90
`Motion to Expedite Defendants Motion Requesting an Expedited
`Scheduling Conference dated Nov. 22, 2017 , Sanofi-Aventis
`U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-
`IMK (N.D. W. Va.), Dkt. No. 46
`Initial Planning Meeting Report and Discovery Proposals dated
`Dec. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 61
`
`v
`
`
`
`
`
`Exhibit #
`
`2024
`
`2025
`
`2026
`
`2027
`2028-2099
`2100
`
`2101
`
`2102
`2103
`
`2104
`
`2105
`2106
`
`2107
`2108
`2109
`2110
`2111
`2112
`2113
`
`2114
`
`Description
`Transcript of Motion / Scheduling Conference dated Jan. 3,
`2018,Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case
`No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 64
`Redline of Amended Patent Owner Preliminary Response (filed
`February 20, 2019)
`Report of the Local Patent Rules Committee, Explanatory Notes
`for 2016 Amendments
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`Reserved
`Leinsing Deposition Exhibit 2100: Thomas van der Burg,
`Injection Force of SoloSTAR® Compared with Other Disposable
`Insulin Pen Devices at Constant Volume Flow Rates, J. of
`Diabetes Sci. and Tech., Vol. 5, Issue 1, 150-155 (Jan. 2001)
`Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An
`evaluation of prefilled insulin pens: a focuse on the Next
`Generation FlexPen®, Med. Devices: Evidence & Research, 41-
`50 (2010:3)
`Leinsing Deposition Exhibit 2102: Hand drawings
`Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of
`Burroughs
`Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of
`the 486 Patent
`Leinsing Deposition Exhibit 2105: Hand drawings
`Leinsing Deposition exhibit 2106: Annotations of Figures 11 and
`12 of Giambattista
`Declaration of Alexander Slocum, Ph.D.
`Curriculum Vitae of Alexander Slocum, Ph.D.
`Expert Report of Henry R. Grabowski, Ph.D.
`Curriculum Vitae of Henry R. Grabowski, Ph.D.
`Declaration of Dr. Robin S. Goland
`Curriculum Vitae of Dr. Robin S. Goland
`Bradley M. Wright et al., A Review Of Insulin Pen Devices And
`Use In The Elderly Diabetic Population, 3 Clinical Medicine
`Insights: Endocrinology & Diabetes 54-63 (2010)
`Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices,
`EMJ Diabet., 58-64 (2014:2)
`vi
`
`
`
`
`
`Exhibit #
`2115
`
`2116
`
`2117
`2118
`
`2119
`
`2120
`2121
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`2128
`
`Description
`Arthritis & Diabetes, What do diabetes and arthritis have in
`common? Plenty., https://www.arthritis.org/living-with-
`arthritis/comorbidities/diabetes-and-arthritis/
`Andreas Bode, Development of the SoloSTAR insulin pen device
`design verification and validation, 6 Expert Opinion on Drug
`Delivery 103-112 (2008)
`Sanofi’s Patented Pen animation
`John Carter, Usability, Paticipant Acceptance, and Safety of a
`Prefilled Insulin Injection Device in a 3-Month Observational
`Survey in Everyday Clinical Practice in Australia, J. Diabetes Sci
`& Tech., Vol. 3, Issue 6, 1425-1438 (Nov. 2009)
`Sherwyn Schwartz, Correct Use of a New Reusable Insulin
`Injection Pen by Patients with Diabetes: A Design Validation
`Study, 4 J. Diabetes Sci. and Tech. 1229-1235 (2010)
`Reserved
`DBA Design Effectiveness Awards 2009
`SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22,
`2009)
`Arnd Friedrichs et al., Dose Accuracy and Injection Force of
`Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech.
`1346-1353 (2013)
`Stacey A. Seggelke et al., Effect of Glargine Insulin Delivery
`Method (Pen Device Versus Vial/Syringe) on Glycemic Control
`and Patient Preferences in Patients with Type 1 and Type 2
`Diabetes, 20 ENDOCRINE PRACTICE, 536, 536, 538–539
`(2014)
`Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated
`Patients with Type 1 and Type 2 Diabetes Mellitus, 5 J. Diabetes
`Sci. and Tech. 158-165 (2011)
`Jerome S. Fischer et al., United States Patient Preference and
`Usability for the New Disposable Insulin Device Solostar® versus
`Other Disposable Pens, 2 JOURNAL OF DIABETES SCIENCE
`AND TECHNOLOGY 1157-1160 (2008)
`U.S. Provisional Patent Application 60/073820
`Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens
`for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-
`123 (2008)
`
`vii
`
`
`
`
`
`Exhibit #
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`2138
`
`2139
`
`2140
`
`2141
`
`2142
`
`Description
`Nicolae Hancu et al., A Pan-European and Canadian Prospective
`Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin
`Injection Device in Type 1 and Type 2 Diabetes, 5 J. Diabetes Sci.
`and Tech. 1224-1234 (2011)
`Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing
`Accuracy with a Novel Pen Device (SoloSTAR) as Performed by
`Patients with Diabetes in a Clinical Setting, 10 Diabetes Tech. &
`Threapeutics 322-327 (2008)
`ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15,
`2000)
`Meike Krzywon et al., Study on the Dosing Accuracy of
`Commonly Used Disposable Insulin Pens, 14 Diabetes Tech. &
`Therapeutics 804-809 (2012)
`Lantus SoloSTAR Pen Guide
`Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in
`Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989)
`Douglas Merritt et al., Dose Accuracy and Injection Force of
`Disposable Pens Delivering Pramlintide for the Treatment of
`Diabetes, 4 J. Diabetes Sci. and Tech. 1438-1446 (2010)
`
`Novo Nordisk Form 6-K (Feb. 9, 2009)
`Novo Nordisk History
`W. Schady et al, Observations on Severe Ulnar Neuropathy in
`Diabetes, 12 J Diabetes and Its Complications 128-132 (1998)
`
`Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn
`Between SoloSTAR and FlexPen at Three Different Dose Levels,
`10 Diabetes Tech. & Therapeutics 359-362 (2008)
`
`Riccardo Perfetti, Reusable and Disposable Insulin Pens for the
`Treatment of Diabetes: Understanding the Global Differences in
`User Preference and an Evaluation of Inpatient Insulin Pen Use,
`12 Diabetes Tech. & Therapeutics 79-85 (2010)
`John Shelmet et al., Preference and resource utilization in elderly
`patients: InnoLet versus vial/syringe, 63 Diabetes Res. and
`Clinical Prac. 27-35 (2004)
`Prix Galien USA Announces 2009 Final Candidates (Prix Galien
`USA, August 7, 2009)
`
`viii
`
`
`
`
`
`Exhibit #
`2143
`
`2144
`
`2145
`
`2146
`
`2147
`2148
`2149
`2150
`2151
`
`2152
`
`2153
`2154
`2155
`2156
`2157
`2158
`
`2159
`
`2160
`
`2161
`
`2162
`
`Description
`Thomas Haak et al., Comparison of Usability and Patient
`Preference for the New Disposable Insulin Device SoloStar
`Versus FlexPen, Lilly Disposable Pen, and a Prototype Pen: An
`Open-Label Study, 29 CLINICAL THERAPEUTICS, 650-660
`(2007)
`Alastair Clarke & Geralyn Spollett, Dose accuracy and injection
`force dynamics of a novel disposable insulin pen, 4 EXPERT
`OPINION ON DRUG DELIVERY 165-174 (2007)
`US Lantus SoloSTAR Launch Book, 2007, PTX-0705, Document
`bates stamped SANOFI_00232909-45
`Lantus COMPASS Study Report (Nov. 29, 2007), PTX-0739,
`Document bates stamped SANOFI3_90330807-1025
`Steenfeldt-Jensen 5th Embodiment Animation
`Steenfeldt-Jensen 1st Embodiment Animation
`Steenfeldt-Jensen 2nd Embodiment Animation
`Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation
`Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
`Animation
`Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
`Collar Friction Animation
`International Patent Application WO999038554A1
`Reserved
`Reserved
`Reserved
`Declaration of Chris Langley
`Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin
`Therapy With the Ideal Pen, 957-967 (The Diabetes
`EDUCATOR)
`Serpil Savas et al., The effects of the diabetes related soft tissue
`hand lesions and the reduced hand strength on functional
`disability of hand in type 2 diabetic patients, 77 Diabetes Res. and
`Clinical Prac. 77-83 (2007)
`Jean-Louis Selam, Evolution of Diabetes Insulin Delivery
`Devices, 4 J. Diabetes Sci. and Tech. 505-513 (2010)
`SoloSTAR Principles of Operation, PTX-0553, Document bates
`stamped SANOFI_00406383-94
`Sanofi Patent Drive Sleeve and Piston Rod Animation
`ix
`
`
`
`
`
`Exhibit #
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`2168
`2169
`2170
`2171
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`2178
`
`Description
`Deposition of Karl R. Leinsing, dated June 3, 2019 for IPR2018-
`01675, -01676, -01678, -01680
`Deposition of Karl R. Leinsing, dated June 4, 2019 for IPR2018-
`01675, -01676, -01678, -01680
`Opinion and Order regarding Claim Construction, Sanofi-Aventis
`U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-SLW
`(D.N.J. May 9, 2019), Dkt. No. 319
`
`Memorandum and Order regarding Claim Construction, Sanofi-
`Aventis U.S. LLC v. Merck, No. 16-812-RGA (D. Del. Jan. 12,
`2018), Dkt. No. 192
`Giambattista Animation (1)
`Giambattista Animation (2)
`U.S. Patent No. 4,648,872
`U.S. Patent No. 4,747,824
`U.S. Patent No. 6,248,093
`Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva
`Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309
`Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel
`Syndrome in Patients With Diabetic Polyneuropathy, 25 Diabetes
`Care 565-569 (2002)
`Jefferson Becker et al., An evaluation of gender, obesity, age and
`diabetes mellitus as risk factors for carpal tunnel syndrome, 113
`Clinical Neurophysiology 1429-1434 (2002)
`A. Pfutzner et al., Prefilled insulin device with reduced injection
`force: patient perception and accuracy, 24 Current Med. Res. and
`Opinion 2545-2549 (2008)
`Ercan Cetinus et al., Hand grip strength in patients with type 2
`diabetes mellitus, Diabetes Res. and Clinical Prac. 1-9 (2005)
`Ragnhild I. Cederlund et al., Hand disorders, hand function, and
`activities of daily living in elderly men with type 2 diabetes, 23 J.
`Diabetes and Its Complications 32-99 (2009)
`Shubha Gundmi et al., Hand dysfunction in type 2 diabetes
`mellitus: Systematic review with meta-analysis, 61 Annals of
`Physical and Rehabilitation Med. 99-104 (2018)
`
`x
`
`
`
`
`
`Exhibit #
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`2187
`2188
`2189
`2190
`2191
`
`2192
`
`2193
`
`2194
`
`2195
`
`Description
`Joule J. Li et al., Muscle grip strength predicts incident type 2
`diabetes: Population-based cohort study, 65 Metabolism Clinical
`and Experimental 883-892 (2016)
`Considering Insulin Pens for Routine Hospital Use - Consider
`This... (ISMP article),
`https://www.ismp.org/resources/considering-insulin-pens-routine-
`hospital-use-consider
`Trigger Finger Overview (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/trigger-
`finger/symptoms-causes/syc-20365100
`Bone and joint problems associated with diabetes (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/diabetes/in-
`depth/diabetes/art-20049314
`Peripheral Neuropathy (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/peripheral-
`neuropathy/symptoms-causes/syc-20352061
`Charles E. Buban, A pen that seeks to improve diabetes care,
`INQUIRER.NET (2008), Document Bates stamped
`SANOFI_00006282-84
`"Sanofi-aventis’ SoloSTAR(R) Insulin Pen for Lantus and Apidra
`Receives the Prestigious GOOD DESIGN Award", (PR Newswire
`Feb. 14), Document Bates stamped SANOFI_00006299-301
`
`Select Injectable Insulin Drugs Approved by the FDA in the U.S.
`U.S. Dollar Sales of Lantus SoloSTAR
`U.S. New Prescriptions of Lantus SoloSTAR
`U.S. Total Prescriptions of Lantus SoloSTAR
`U.S. Share of Sales by Drugs in the Lantus Franchise
`Formulary Placement of Long-Acting Insulin Pen Products:
`Commercial Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicare Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicaid Plans
`Formulary Placement of Long-Acting Insulin Pen Products in
`Healthcare Exchanges
`U.S. Share of Long-Acting Pens Among All Pens
`
`xi
`
`
`
`
`
`Exhibit #
`2196
`2197
`2198
`2199
`2200
`
`2201
`
`2202
`
`2203
`
`2204
`
`2205
`
`2206
`2207
`2208
`
`2209
`
`2210
`
`2211
`
`2212
`
`2213
`
`2214
`
`2215
`2216
`
`Description
`U.S. Dollar Sales of Long-Acting Pens
`U.S. New Prescriptions of Long-Acting Pens
`U.S. Total Prescriptions of Long-Acting Pens
`U.S. Share of Long-Acting Pen Products
`Yuzu Sato et al., Clinical Aspects of physical exercise for
`diabetes/metabolic syndrome, 77S Diabetes Research and Clinical
`Practice S87 (2007)
`2007 Good Design Award from The Chicago Athenaeum:
`Museum of Architecture and Design
`Reserved
`
`U.S. Total Marketing Expenditure of Long Acting Insulin
`Franchises
`U.S. Total Marketing Expenditures of Long-Acting Insulin Pens
`
`U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs
`
`Møller First Embodiment Animation
`Møller Second Embodiment Animation
`Press Release, Lantus / Apdira SoloSTAR help to improve patient
`satisfaction (June 27, 2011), Document bates stamped
`SANOFI_00179886-88
`Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on
`Research and Development for 1990s New Drug Introductions,
`20 Pharmacoeconomics 15 (2002)
`Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A
`Decade of Direct-to-Consumer Advertising of Prescription
`Drugs, 357 N. Engl. J. Med. 673 (2007)
`Collar Friction Model Demonstrator Animation
`
`Excerpts from Ernest Rabinowicz, Friction And Wear of
`Materials, 2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995)
`Reserved
`
`Excerpts from Alexander H. Slocum, Precision Machine Design,
`706-709 (Prentice-Hall, Inc. 1992)
`Collar Friction Model Demonstration 1
`Collar Friction Model Demonstration 2
`xii
`
`
`
`
`
`
`
`
`Exhibit #
`2217
`2218
`2219
`2220
`2221
`2222
`2223
`2224
`2225
`
`2226-2315
`2316
`
`2317
`2318
`2319
`
`Description
`Collar Friction Model Demonstration 3
`SoloSTAR Dial Inject Video
`Declaration of Robert Vlasis
`Biography of Robert Vlasis
`Declaration of Anna E. Dwyer
`Biography of Anna E. Dwyer
`SoloSTAR wins the 2008 Good Design award (February 8, 2008)
`Expert Opinion on Drug Delivery
`Excerpt from the Trial Transcript for Sanofi v. Merck, 16cv812
`(RGA) (District of Delaware) (May 29, 2018)
`Reserved
`Deposition of Karl Robert Leinsing, MSME, P.E. (October 10,
`2019)
`Deposition of William C. Biggs, MD (October 15, 2019)
`Deposition of DeForest McDuff, Ph. D. (October 9, 2019)
`Declaration of Robert Veasey (July 15, 2019)
`
`xiii
`
`
`
`
`
`For the reasons discussed in the Patent Owner Response (“Response”) and
`
`below, the Board should affirm the patentability of claims 11, 14, 15, 18, and 19
`
`over Petitioners’ challenge.
`
`I.
`
`GROUND 1 DOES NOT RENDER THE CHALLENGED CLAIMS
`OBVIOUS
`A.
`Steenfeldt-Jensen Does Not Suggest a Threaded Driver Tube
`As a threshold matter, Steenfeldt-Jensen nowhere discloses a threaded driver
`
`tube. See Response, 29-31. Accordingly, the parties’ arguments about whether
`
`Steenfeldt-Jensen at 7:41-47 can be applied to the fifth embodiment are beside the
`
`point. In Reply, Petitioners argue that Sanofi unduly focuses on whether 7:41-47
`
`disclosed a threaded driver tube and does not consider three other passages that
`
`purportedly support a threaded driver tube. Reply, 4 (citing EX1014, 2:40-53, 3:10-
`
`20, 3:41-47). Sanofi, however, discussed these passages in its Response, 29-31 and
`
`Petitioners do not rebut Sanofi’s arguments (Reply, 4).
`
`B.
`
`Even If Steenfeldt-Jensen Did Suggest a Threaded Driver Tube
`With Respect to Its First Embodiment, It Would Not Apply to the
`Fifth Embodiment
`Even if Steenfeldt-Jensen discloses a threaded driver tube, a POSA would not
`
`have applied it to the fifth embodiment (the basis of Petitioners’ challenge). Notably,
`
`Petitioners concede that the passage at 7:41-47 (the passage that purports to disclose
`
`a threaded driver tube) is not a blanket statement covering every embodiment in
`
`Steenfeldt-Jensen. Reply, 4. Petitioners now argue that despite no express recitation
`
`1
`
`
`
`
`
`that the passage applies to the fifth embodiment, a POSA would have recognized
`
`that it applies to the fifth embodiment due to the “analogous structures and functions
`
`for driving the piston rod” in the fifth embodiment. Reply, 5-7. Petitioners explain
`
`away the lack of an express statement linking the passage to the fifth embodiment
`
`by arguing that, “Steenfeldt-Jensen frequently avoids redundant disclosures, relying
`
`on POSAs to recognize earlier discussions apply to analogous aspects of later
`
`embodiments.” Reply, 5.
`
`Mr. Leinsing, however, acknowledges that there are differences between the
`
`embodiments (EX1095, ¶68). Conveniently, he simply states that “while certain
`
`surrounding components may differ between the first and fifth embodiments, [a
`
`POSA] would have understood the driver tubes. . . and nut members . . . were
`
`analogous, both structurally and functionally, for driving the piston.” EX 1106, ¶69.
`
`In contrast, the Response, 22-25 explains that the embodiments are not
`
`analogous and a POSA would not apply a teaching specific to the first embodiment
`
`to the fifth embodiment. The first embodiment, for example, includes a rotatable,
`
`threaded ampoule holder 2, while the fifth embodiment includes a fixed end wall 4
`
`with a threaded bore forming a nut member. These differences mandate completely
`
`different methods for dialing and dose dispensing. Id.
`
`Petitioners further argue that Sanofi’s arguments against combining the
`
`disclosure at 7:41-47 with the fifth embodiment are undercut by Dr. Slocum’s
`
`2
`
`
`
`
`
`testimony. Petitioners argue that Dr. Slocum testified that applying the disclosure
`
`to the first embodiment would impair the first embodiment’s function. Reply, 9-10.
`
`Petitioners contend that Sanofi must be wrong about the first embodiment (i.e., why
`
`would Steenfeldt-Jensen make that disclosure if it would impair the first
`
`embodiment) and therefore wrong about the fifth embodiment. Dr. Slocum opined
`
`about Petitioners’ modification, a threaded driver tube. Dr. Slocum does not agree
`
`with Petitioners regarding what is disclosed at 7:41-47. See Section I.A.
`
`C. Even If Steenfeldt-Jensen Suggested a Threaded Driver Tube With
`Respect to Its First Embodiment, A POSA Would Not Be
`Motivated to Make Petitioners’ Modification to the Fifth
`Embodiment
`
`Even assuming that Steenfeldt-Jensen disclosed a threaded driver tube in the
`
`
`
`
`context of its first embodiment (it does not), Petitioners’ proposed modification to
`
`the fifth embodiment has substantial drawbacks that would counsel a POSA against
`
`the modification.
`
`
`
`Sanofi presented evidence by way of analytical and physical models from Dr.
`
`Slocum demonstrating that a POSA would not modify the fifth embodiment to
`
`include a threaded driver tube because it would result in an inferior pen having a
`
`51% higher injection force. Response, 36-45. In Reply, Petitioners presented no
`
`models or calculations rebutting Sanofi’s evidence. Instead, Petitioners argued that
`
`a higher injection force would not dissuade a POSA from the modification. Reply,
`
`11.
`
`3
`
`
`
`
`
`
`
`1. A High Injection Force Would Dissuade a POSA From
`Petitioners’ Modification
`Dr. Slocum concluded that Petitioners’ proposed modification to the fifth
`
`embodiment would have detrimentally affected the fifth embodiment—for example,
`
`a significantly higher injection force. Response, 36-45. Petitioner, however, argues
`
`that the Board should disregard Dr. Slocum’s findings because they assume “that a
`
`POSA was limited to designing insulin injector pens.” Reply, 10. Petitioners,
`
`however, identify no other application or circumstance where a higher injection
`
`force would be acceptable or even other considerations that would outweigh a higher
`
`injection force. Moreover, Steenfeldt-Jensen is directed to “syringes [that] are
`
`mainly made for users who have to inject themselves frequently, e.g., diabetics.”
`
`EX1014, 1:16-18. A POSA, when considering whether to combine the teachings of
`
`one embodiment in Steenfeldt-Jensen with another embodiment in Steenfeldt-
`
`Jensen, would consider the context of Steenfeldt-Jensen – injection pens, e.g.,
`
`diabetic injection pens.
`
`2. Petitioners Argue that Their Modification is Obvious Solely
`On the Basis of Reasonable Expectation of Success
`Petitioners argue that, despite Sanofi’s premise that higher injection force is
`
`
`
`undesirable, “Sanofi never alleges that the petition’s modification is unworkable or
`
`that a POSA would not have reasonably expected success.” Reply, 11. Obviousness
`
`requires “a motivation to combine accompanied by a reasonable expectation of
`
`4
`
`
`
`
`
`achieving what is claimed in the patent-in-suit.” Intelligent Bio-Systems, Inc. v.
`
`Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (emphasis added).
`
`That injection force would increase—a fact that does not appear to be disputed (only
`
`the amount of increase is disputed)—demonstrates that a POSA would not be
`
`motivated to make Petitioners’ modification, even if a POSA could do so. Plas-Pak
`
`Indus. v. Sulzer Mixpac AG, 600 F. App’x 755, 758-60 (Fed. Cir. 2015); In re
`
`Gordon, 733 F.2d 900.
`
`3. Sanofi Presented Non-Obviousness Arguments Beyond the
`Friction Collar Model
`Sanofi’s Response provided additional evidence that there would have been
`
`
`
`additional problems with Petitioners’ modification aside from an increase in
`
`injection force. These problems included that the flexible arms of the driver tube 85
`
`get stuck or get pressed into the ring-shaped wall, ultimately causing the flexible
`
`arms to break and ruin the device. Response, 45-47. In Reply, Petitioners dismiss
`
`this evidence, arguing that fixing these problems would be “straightforward”
`
`because “Mr. Leinsing explains that this would be the type of routine task that a
`
`POSA would have no difficulty addressing.” Reply, 16 citing EX1095, ¶ 76.
`
`Beyond saying so, Mr. Leinsing presents no evidence that doing so would be routine.
`
`D. Dr. Slocum’s Models Are Not Flawed
`
`5
`
`
`
`
`
`
`
`Petitioners further argue that Dr. Slocum’s models are flawed. Neither
`
`Petitioners nor its expert, however, inspected Sanofi’s model and Mr. Leinsing
`
`presented no model of his own.
`
`1. There is no Bias
`Petitioners argue that the models are unreliable due to bias because “they were
`
`
`
`primarily designed” by Mr. Veasey, an inventor of the 044 Patent. Reply, 11-12.
`
`First, Dr. Slocum independently verified the models, conducted his own
`
`experiments, and gathered his own data. EX2107, ¶¶ 242-255, Appendix B, E.
`
`Second, Petitioners fail to show how Mr. Veasey is biased simply because he is an
`
`inventor. Mr. Veasey is not an employee of Sanofi nor does he have a financial stake
`
`in this IPR. Third, even assuming, arguendo, that Mr. Veasey is an interested party,
`
`it is well-established that a party’s interest alone cannot affect the credibility of
`
`scientific evidence when Petitioners have presented no opposing evidence (e.g., no
`
`models). Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1346 (Fed.
`
`Cir. 2007) (rejecting a party’s challenge to witness credibility when the party
`
`presented no opposing evidence as to certain experiments).
`
`
`
`Furthermore, while Petitioners argue that Mr. Veasey selected 11 of 15
`
`variables for the analytical model, the only one they complain about is the coefficient
`
`of friction, arguing that the selected 0.1 should have been lower since “lubricious
`
`plastics can have a coefficient of 0.08 or lower.” Reply, 12-13. Dr. Slocum,
`
`6
`
`
`
`
`
`however, explained that 0.1 was selected to correspond to the parameters of the
`
`FlexPen, the commercial embodiment of Steenfeldt-Jensen’s fifth embodiment.
`
`Response, 37.
`
`
`
`Petitioners also complain that the physical model was “designed by Mr.
`
`Veasey (or others at Mr. Veasey’s company, DCA Design International Ltd.).”
`
`Reply, 13. But aside from a conclusory argument that the collar was too big
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
