UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`

`

`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION .......................................................................................... 1
`
`THE 044 PATENT .......................................................................................... 2
`
`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 8
`
`IV. CLAIM CONSTRUCTION ............................................................................ 9
`
`A.
`
`“tubular clutch” (claim 11) .................................................................. 10
`
`1.
`
`2.
`
`“tubular clutch” is not a means-plus-function term. ................. 10
`
`The plain and ordinary meaning of “tubular clutch” is “a
`tubular component that can operate to reversibly lock two
`components in rotation.” ........................................................... 11
`
`B.
`
`“clicker” (claim 14) ............................................................................. 13
`
`V.
`
`THE PRIOR ART .......................................................................................... 14
`
`A.
`
`Burroughs ............................................................................................ 14
`
`VI. THE CHALLENGED CLAIMS ARE PATENTABLE ............................... 21
`
`A.
`
`Burroughs Does Not Disclose Or Render Obvious A Helical
`Groove Provided Along An Outer Surface Of Said Dose Dial
`Sleeve .................................................................................................. 21
`
`1.
`
`Petitioner and Mr. Leinsing Propose Two Different,
`Conflicting Modifications to Burroughs ................................... 21
`
`a)
`
`Petitioner’s Proposed Modification ................................ 21
`
`b) Mr. Leinsing’s Proposed Modification ........................... 25
`
`2.
`
`Burroughs Does Not Disclose A Helical Groove Provided
`Along An Outer Surface Of Said Dose Dial Sleeve ................. 27
`
`i
`
`

`

`3.
`
`4.
`
`5.
`
`Petitioner Fails To Meet Its Burden Of Showing That
`Burroughs In View Of The Knowledge of a POSA
`Renders Obvious A Helical Groove Provided Along An
`Outer Surface Of The Dose Dial Sleeve ................................... 27
`
`Petitioner Does Not Establish A Reason To Modify
`Burroughs’ Threads To Include A Groove, As Suggested
`In The Petition ........................................................................... 29
`
`Petitioner Does Not Establish A Reason For A POSA To
`Attempt Mr. Leinsing’s Proposed Modification ....................... 34
`
`a)
`
`b)
`
`Petitioner Offers No Rationale For The Proposed
`Modification ................................................................... 34
`
`A POSA Would Have Been Deterred From Making
`Mr. Leinsing’s Proposed Modification ........................... 35
`
`B.
`
`Burroughs Does Not Disclose Or Render Obvious That The
`Helical Groove Of The Dose Dial Sleeve Has A Different Lead
`Than The Internal Threading Of The Drive Sleeve ............................ 38
`
`1.
`
`2.
`
`3.
`
`Burroughs Does Not Disclose Or Render Obvious A
`Helical Groove Of The Dose Dial Sleeve ................................. 39
`
`Burroughs Does Not Disclose That The First Lead And
`Second Lead Are Different ....................................................... 39
`
`Burroughs Does Not Render Obvious That The First Lead
`And Second Lead Are Different ............................................... 40
`
`C.
`
`Burroughs Does Not Disclose Or Render Obvious “A Tubular
`Clutch Located Adjacent A Distal End of Said Dose Dial Grip,
`Said Tubular Clutch Operatively Coupled to Said Dose Dial
`Grip” .................................................................................................... 43
`
`1.
`
`Burroughs’ Button 32 Is Not “A Tubular Component That
`Can Operate To Reversibly Lock Two Components In
`Rotation.” .................................................................................. 44
`
`ii
`
`

`

`2.
`
`Burroughs Expressly Discloses A Clutch That Is Not
`Button 32, Is Not Tubular, And Is Not Located Adjacent
`To A Distal End Of A Dose Dial Grip ...................................... 47
`
`VII. CONCLUSION .............................................................................................. 48
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .................................................................... 32, 34
`Cutsforth, Inc. v. MotivePower, Inc.,
`636 F. App’x 575 (Fed. Cir. 2016) ..................................................................... 32
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 31
`In re GPAC,
`57 F.3d 1573 (Fed. Cir. 1995) .............................................................................. 8
`Icon Health & Fitness, Inc. v. Strava, Inc.,
`849 F.3d 1034 (Fed. Cir. 2017) .......................................................................... 28
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 28
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 29
`Plas-Pak Indus. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 30
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .................................................................... 32, 43
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) .................................................................... 11, 13
`Other Authorities
`37 C.F.R. § 42.6(a)(3) .............................................................................................. 29
`37 CFR § 42.6(a)(2)(ii) ............................................................................................ 51
`37 CFR § 42.6(a)(2)(iii) ........................................................................................... 51
`37 CFR § 42.8 .......................................................................................................... 51
`iv
`
`

`

`37 CFR § 42.24(a)(1)(i) ........................................................................................... 51
`37 CFR § 42.24(a)(1)(i) ........................................................................................... 51
`M.P.E.P. 2141.03 ....................................................................................................... 8
`
`
`M.P.E.P. 2141.03 ....................................................................................................... 8
`
`v
`
`

`

`
`
`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
`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.)
`vi
`
`

`

`
`
`Exhibit #
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Description
`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
`Excerpts from McGraw Hill Dictionary of Scientific and
`Technical Terms (Sixth edition, McGraw-Hill 2003), p. 972 and
`1873
`Excerpts from Merriam-Webster’s Collegiate Dictionary (10th
`edition, Merriam-Webster, Inc. 2001), p. 538
`The New Oxford American Dictionary (Oxford University Press
`2001), p. 789-90
`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. 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-SRC-CLW (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. 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. Va.), Dkt. No. 61
`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. Va.), Dkt. No. 64
`Excerpts from Transcript, Conference Call dated Aug. 2, 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.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes
`for 2016 Amendments
`
`vii
`
`

`

`
`
`Exhibit #
`2024
`
`2025
`
`Description
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`Redline of Amended Patent Owner Preliminary Response (filed
`February 20, 2019)
`2026-2099 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.
`Reserved
`Reserved
`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)
`
`2104
`2105
`2106
`2107
`2108
`2109
`2110
`2111
`2112
`
`2100
`
`2101
`
`2102
`2103
`
`2113
`
`2114
`
`viii
`
`

`

`
`
`Exhibit #
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`2121
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`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, Participant 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
`
`ix
`
`

`

`
`
`Exhibit #
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`2138
`
`2139
`
`2140
`
`2141
`
`Description
`Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens
`for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-
`123 (2008)
`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)
`
`x
`
`

`

`
`
`Exhibit #
`
`2142
`
`2143
`
`2144
`
`2145
`
`2146
`2147
`2148
`2149
`2150
`2151
`
`2152
`2153
`2154
`2155
`2156
`2157
`
`2158
`
`2159
`
`Description
`Prix Galien USA Announces 2009 Final Candidates (Prix Galien
`USA, August 7, 2009)
`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
`Reserved
`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)
`xi
`
`

`

`
`
`Exhibit #
`
`2160
`
`2161
`2162
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`2168
`2169
`2170
`2171
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`Description
`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
`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)
`
`xii
`
`

`

`
`
`Exhibit #
`
`2177
`
`2178
`
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`2187
`2188
`2189
`2190
`2191
`
`Description
`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)
`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
`
`xiii
`
`

`

`
`
`Exhibit #
`
`2192
`
`2193
`
`2194
`2195
`2196
`2197
`2198
`2199
`
`2200
`
`2201
`2202
`2203
`2204
`2205
`2206
`2207
`
`2208
`
`2209
`
`2210
`
`2211
`
`Description
`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
`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
`
`xiv
`
`

`

`
`
`Exhibit #
`
`2212
`2213
`2214
`2215
`2216
`2217
`2218
`
`Description
`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
`Collar Friction Model Demonstration 3
`SoloSTAR Dial Inject Video
`
`xv
`
`

`

`
`
`I.
`
`INTRODUCTION
`Petitioner’s single obviousness ground fails to render the challenged claims
`
`obvious because the sole prior art reference fails to disclose or render obvious
`
`multiple limitations of the challenged claims.
`
`First, Petitioner admits that its prior art reference, U.S. Patent No. 6,221,046
`
`(“Burroughs”), does not disclose the required “helical groove” on an outer surface
`
`of a dose dial sleeve in a pen-type injector and does not disclose that this helical
`
`groove has a different lead than the internal threading found in a drive sleeve of such
`
`an injector. Petition at 39, 40. Despite acknowledging these shortcomings in
`
`Burroughs, Petitioner proposes a modification to the reference that Petitioner’s own
`
`expert rejected at his deposition. Indeed, Petitioner’s expert proposes a different
`
`modification to Burroughs in his declaration that Petitioner did not raise in the
`
`Petition. Moreover, Petitioner fails to offer any reason to modify the Burroughs’
`
`disclosure (whether according to Petitioner’s unsupported modification, or
`
`according to Mr. Leinsing’s modification) to include either a helical groove or an
`
`internal threading that has a different lead from the helical groove. As Professor
`
`Slocum explains, although Petitioner and Mr. Leinsing claim that providing an
`
`internal threading with a different lead improves a user’s ability to sense movements
`
`of the dose dial during dose setting, the purported evidence cited by Petitioner for
`
`this rationale actually relates to problems associated with sensing small movements
`1
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`
`
`

`

`
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`of the injection button during injection, not movements of the dose dial during dose
`
`setting. Further, Burroughs in any case already provides a different and superior
`
`solution to the purported problem of sensing movements of the dose dial.
`
`Second, Burroughs does not disclose a tubular clutch, as required by the
`
`challenged claims. Petitioner relies on Burroughs’ injection button 32 for the tubular
`
`clutch limitation, but Burroughs’ button does not meet the proper construction of
`
`“tubular clutch” -- a component that can operate to reversibly lock two components
`
`in rotation -- because it does not reversibly lock Burroughs’ dial and Burroughs’
`
`housing in rotation, and also does not reversibly lock Burroughs’ dial to Burroughs’
`
`nut.
`
`For these reasons, as detailed further below, Patent Owner respectfully
`
`requests that the Board find all challenged claims of the 044 Patent to be patentable
`
`over the asserted grounds of invalidity.
`
`II. THE 044 PATENT
`The 044 Patent is directed to a pen-type injector for medications such as
`
`insulin and insulin glargine. Ex. 1002, 1:20-24. Such injectors are regularly used
`
`by patients without formal medical training, such as diabetic patients who manage
`
`their condition through self-treatment. Id., 1:25-29. The 044 Patent teaches that pen
`
`injectors should meet several criteria, including being robust in construction while
`
`2
`
`

`

`
`
`being easy to manipulate and understand by the user, who in many cases may be
`
`physically infirm and have impaired vision. Id., 1:30-35.
`
`The figures below, from the 044 Patent, depict an embodiment of an improved
`
`injection pen that meets these requirements. An animation of the embodiment’s
`
`operation has been submitted as Ex. 2012.
`
`3
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`

`

`
`
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`
`
`
`FIG. ‘1
`
`FIG. 2
`
`
`
`EX.
`
`Ex. 1002, Figs. 1 and 2 (highlighted)
`1002, Figs. 1 and 2 (highlighted)
`4
`
`
`

`

`
`
`The injection pen of the shown embodiment comprises a cartridge retaining
`
`part 2 (light blue), an internally threaded main housing 4 (grey), a medicament
`
`cartridge 8, a cartridge piston 10 (dark green), an insert 16 (orange), a piston rod 20
`
`(yellow), a drive sleeve 30 (red), a clicker 50 (purple), and clutch 60 (dark blue), an
`
`externally-grooved dose dial sleeve 70 (light green), a dose dial grip 76 (brown), and
`
`a button 82 (pink). The injection pen includes a window 44 in the main housing 4
`
`that indicates the selected dosage to the user.
`
`As seen below, in this embodiment, the dose value is selected by rotating the
`
`dial grip portion 76 (brown) of a dose dial sleeve 70 (light green), which winds out
`
`of the main housing 4 (grey) on a helical path defined by a threaded engagement
`
`between a helical groove on the surface of the dose dial sleeve and a helical rib 46
`
`inside the housing. Id., 5:50-6:3; Figs. 9-10.
`
`5
`
`

`

`
`
` I's.
`
`a .- 5
`\
`
`‘._-
`
`‘i-IT-:af”(XXIII/{If},
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`46%?
`
`E(60) C(70) 0(30)
`
`N32)
`
`
`
`FIG. 11
`
`
`
`Ex. 1002, Figs. 9 – 11 (highlighted and annotated)
`Ex. 1002, Figs. 9 — 11 (highlighted and annotated)
`6
`
`6
`
`

`

`
`
`
`
`Dose markings (numbers) printed on an external surface of the dose dial
`
`sleeve 70 indicate the dosage. Id., 5:17-21. In this embodiment, a clicker 50 detents
`
`the dose dial sleeve relative to the housing at each fixed dosage unit and provides
`
`audible feedback (e.g., one click for every unit dialed) to assist in dose selection. Id.,
`
`4:33-44, 5:54-60.
`
`Once the correct dose is selected, the user delivers the dose by pressing the
`
`dose button 82 (pink) with his or her finger or thumb, as shown in Figure 11. Id.,
`
`6:27-28. This user action returns the dose dial sleeve into the housing and delivers
`
`the dose by causing the drive sleeve 30 (red) to move toward the distal end of the
`
`pen, as indicated by the arrow D in Figure 11. This in turn causes a piston rod 20
`
`(yellow) to advance a piston 10 (dark green) into the cartridge to dispense the stored
`
`medication. Id., 6:44-46. During this does injection process the dose button and
`
`drive sleeve are not rotationally coupled to the dose dial sleeve, allowing the dose
`
`dial sleeve to rotate back into the housing along the path defined by the helical
`
`groove (arrow C in Figure 11), while the dose button and drive sleeve travel on an
`
`axial path without rotating (arrows A and D in Figure 11). Id., 6:27-34; Fig. 11.
`
`Once the dose is administered, the dose dial sleeve returns to the starting or
`
`“zero dose” position and is prevented from rotating further into the device. Id., 6:47-
`
`7
`
`

`

`
`
`51. The user then releases the dose button, which returns the internal mechanism of
`
`the device into the dose dialing state. Id., 6:39-43.
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`The correct level of ordinary skill is defined by a person who understands the
`
`mechanical elements (e.g., lead screws, clutches, gears) used in drug injection
`
`delivery devices as well as the principles governing the interactions of such
`
`mechanical elements, and further understands the basics of device design and
`
`manufacturing. That person will have a bachelor’s degree in mechanical engineering
`
`or an equivalent degree. Ex. 2107, ¶ 102. Patent Owner’s proposed level of ordinary
`
`skill reflects the educational level of workers in the field and the sophistication of
`
`the technology. Id.; In re GPAC, 57 F.3d 1573, 1579 (Fed. Cir. 1995); see M.P.E.P.
`
`2141.03.
`
`
`
`Patent Owner does not believe Petitioner’s proposed level of ordinary skill
`
`should be adopted because the level of ordinary skill proposed by the Petitioner is
`
`inconsistent across IPR Nos. 2018-01670, -01675, -01676, -01678, -01679, -01680,
`
`-01682, -01684, and 2019-00122. For example, in IPRs 2018-01684, -01682, -
`
`01680, and -01670 Petitioner’s proposed level of ordinary skill does not require any
`
`years of experience, whereas in other petitions, Petitioner states that a POSA would
`
`have had “design experience,” “approximately three years of experience in medical-
`
`device design,” or “three-year's experience” depending on the petition. See
`
`8
`
`

`

`
`
`IPR2018-01675, Paper 2 at 14; IPR2018-01676, Paper 2 at 14. Petitioner provides
`
`no reasoning for the inconsistency. Moreover, Mr. Leinsing testified that three years
`
`of experience is not required. Therefore, Patent Owner’s proposed level of ordinary
`
`skill should be accepted. Regardless, the slight differences between Patent Owner
`
`and Petitioner’s level of ordinary skill do not affect the arguments made below.
`
`
`IV. CLAIM CONSTRUCTION
`Petitioner alleges that the ground presented in the Petition “