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. IPR2018-01676
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
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`
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`
`

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`TABLE OF CONTENTS
`
`Pages
`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND OF THE TECHNOLOGY .................................................. 4
`II.
`III. THE 044 PATENT .......................................................................................... 6
`IV. CLAIM CONSTRUCTION ..........................................................................12
`V.
`LEVEL OF ORDINARY SKILL IN THE ART ...........................................12
`VI. THE PRIOR ART ..........................................................................................14
`A. U.S. Patent No. 6,235,004 (“Steenfeldt-Jensen”) (Ex. 1014) .............14
`1.
`Steenfeldt-Jensen’s Fifth Embodiment .....................................16
`2.
`Steenfeldt-Jensen’s First Embodiment .....................................20
`3.
`Steenfeldt-Jensen’s First Embodiment Operates
`Differently From the Fifth Embodiment ...................................22
`B. U.S. Patent Application Publication No. 2002/0052578
`(“Møller”) ............................................................................................25
`VII. THE CITED PRIOR ART DOES NOT TEACH OR RENDER
`OBVIOUS THE CHALLENGED CLAIMS.................................................29
`A.
`The Challenged Claims Are Patentable in View of Ground 1 ............29
`1.
`Steenfeldt-Jensen Does Not Teach or Render Obvious a
`“drive sleeve comprising an internal threading … adapted
`to engage an external thread of said piston rod” (all
`challenged claims).....................................................................29
`The Challenged Claims Are Patentable in View of Ground 2 ............47
`1.
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “a drive sleeve extending
`along a portion of said piston rod” (all challenged claims) ......47
`
`B.
`
`
`
`i
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`

`

`2.
`
`3.
`
`A POSA Would Not Have Been Motivated to Modify
`Møller to Include Steenfeldt-Jensen’s Externally-
`Threaded Dose Scale Drum and Internally-Threaded
`Housing (all challenged claims)................................................56
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “said dose dial sleeve
`comprising a helical groove configured to engage a
`threading provided by said main housing, said helical
`groove provided along an outer surface of said dose dial
`sleeve” (all challenged claims) .................................................61
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “a least one flexible arm
`… and at least one spline … to provide said audible
`feedback” (claim 15) .................................................................64
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “wherein said main
`housing further comprises a helical rib … adapted to be
`seated in said helical groove provided along said outer
`surface of said dose dial sleeve” (claim 19) .............................65
`VIII. CONCLUSION ..............................................................................................65
`
`
`4.
`
`5.
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`
`ii
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`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Eurand, Inc. v. Mylan Pharms., Inc. (In re Cyclobenzaprine
`Hydrochloride Extended-Release Capsule Patent Litig.),
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 31
`General Elec. Co. v. United Techs. Corp.,
`IPR2017-00428, Paper No. 38 (P.T.A.B. June 22, 2018) .................................. 58
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 47
`In re GPAC,
`57 F.3d 1573 (Fed. Cir. 1995) ............................................................................ 13
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) .............................................................................. 59
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 56, 61
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .......................................................................... 59
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ...................................................................... 49, 64
`Plas-Pak Indus. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 46
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .................................................................... 58, 59
`Procter & Gamble Co. v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 31
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 55
`
`
`
`
`iii
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`

`

`Other Authorities
`37 CFR § 42.6(a)(2)(ii) ............................................................................................ 68
`37 CFR § 42.6(a)(2)(iii) ........................................................................................... 68
`37 CFR § 42.8 .......................................................................................................... 68
`37 CFR § 42.24(a)(1)(i) ........................................................................................... 68
`M.P.E.P. 2141.03 ..................................................................................................... 13
`M.P.E.P. 2143 .......................................................................................................... 49
`
`
`
`
`
`
`
`
`iv
`
`

`

`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.)
`
`
`
`
`v
`
`

`

`Exhibit #
`
`2011
`
`2012
`
`2013
`
`2014
`2015
`
`2016
`
`2017
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`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
`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. 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-
`
`
`
`
`vi
`
`

`

`Exhibit #
`
`2026
`
`2100
`
`Description
`cv-09105-SRC-CLW (D.N.J.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes for
`2016 Amendments
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`2027
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`2028-2099 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)
`
`2101
`
`2102
`2103
`
`2104
`2105
`2106
`2107
`2108
`2109
`2110
`2111
`2112
`
`2113
`
`2114
`
`
`
`
`vii
`
`

`

`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)
`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)
`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
`
`
`
`
`viii
`
`

`

`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)
`
`
`
`
`ix
`
`

`

`Exhibit #
`
`2142
`
`2143
`
`2144
`
`2145
`
`2146
`2147
`2148
`2149
`2150
`2151
`
`2152
`2153
`2154
`2155
`2156
`2157
`2158
`
`2159
`
`2160
`
`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)
`Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices,
`4 J. Diabetes Sci. and Tech. 505-513 (2010)
`
`
`
`
`x
`
`

`

`Exhibit #
`
`2161
`2162
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`2168
`2169
`2170
`2171
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`Description
`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)
`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)
`
`
`
`
`xi
`
`

`

`Exhibit #
`
`2178
`
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`2187
`2188
`2189
`2190
`2191
`
`2192
`
`2193
`
`Description
`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
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicare Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicaid Plans
`
`
`
`
`xii
`
`

`

`Exhibit #
`
`2194
`2195
`2196
`2197
`2198
`2199
`
`2200
`
`2201
`2202
`2203
`2204
`2205
`2206
`2207
`
`2208
`
`2209
`
`2210
`
`2211
`2212
`2213
`
`Description
`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
`Excerpts from Ernest Rabinowicz, Friction And Wear of Materials,
`2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995)
`Reserved
`
`
`
`
`xiii
`
`

`

`Exhibit #
`
`2214
`2215
`2216
`2217
`2218
`
`Description
`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
`
`
`
`
`
`xiv
`
`
`
`
`
`
`
`
`

`

`I.
`
`INTRODUCTION
`The 044 Patent concerns a novel and non-obvious pen injector that permits a
`
`user to set the appropriate dosage from a multi-dose cartridge and self-administer
`
`the injection. The unique combination of mechanisms and functionality described
`
`and claimed in the 044 Patent was the result of a successful effort by the inventors
`
`to improve upon existing, but flawed, insulin pen injectors on the market in the
`
`2003 timeframe.
`
`Patent Owner respectfully submits that challenged claims 11, 14-15, and 18-
`
`19 of the 044 Patent are patentable over Grounds 1-2 presented in the Petition.
`
`Petitioner concedes that Steenfeldt-Jensen does not disclose each of the limitations
`
`of the challenged claims. Thus, Ground 1 alleges that the challenged claims are
`
`obvious over Steenfeldt-Jensen alone, and Ground 2 alleges that the challenged
`
`claims are obvious over Møller and Steenfeldt-Jensen. The challenged claims are
`
`patentable for at least the following reasons.
`
`
`
`First, to satisfy the claim limitation requiring a “drive sleeve comprising an
`
`internal
`
`threading” Petitioner
`
`argues
`
`that Steenfeldt-Jensen
`
`“expressly
`
`contemplates a modification” where the driver tube of Steenfeldt-Jensen has
`
`internal threading. Petition at 40-41. This is incorrect as Steenfeldt-Jensen
`
`contains no such disclosure. Instead, Steenfeldt-Jensen refers to a “nut member”
`
`
`
`1
`
`

`

`or “nut element” having internal threads – not the driver tube. There is no
`
`suggestion that the driver tube itself can be modified to have internal threading.
`
`
`
`Second, even assuming Petitioner’s argument were true—that Steenfeldt-
`
`Jensen has a disclosure that suggests modifying its driver tube to have internal
`
`threads—this disclosure is only applicable to Steenfeldt-Jensen’s first embodiment,
`
`not its fifth embodiment as Petitioner argues. The disclosure is recited in the
`
`description of the first embodiment, refers to components in the first embodiment,
`
`and is not repeated in, or applicable to, any other embodiments.
`
`Third, a POSITA would not have been motivated to apply Petitioner’s
`
`proposed modification to Steenfeldt-Jensen’s fifth embodiment because doing so
`
`would result in an inferior device with significantly higher injection force. Patent
`
`Owner’s expert, Prof. Alexander Slocum, has created analytical and physical
`
`models demonstrating that Petitioner’s modifications result in a rotating thrust
`
`surface interface that acts like a disc brake (i.e., where friction is generated as one
`
`component rotates on top of another component) and requires significantly greater
`
`injection force (~50% increase) from the user. Prof. Slocum’s calculations prove
`
`that Petitioner’s proposed modification to Steenfeldt-Jensen’s fifth embodiment
`
`severely degrades its performance and that a POSA would not have been motivated
`
`to modify Steenfeldt-Jensen in the way proposed by Petitioner.
`
`
`
`
`2
`
`

`

`Fourth, the combination of Møller and Steenfeldt-Jensen does not disclose
`
`an internally-threaded drive sleeve. Petitioner points to Møller’s connection bars
`
`12 and nut 13 as the claimed drive sleeve, but this component is not a sleeve.
`
`Tacitly admitting this, Petitioner argues that a POSA would have expected that
`
`connection bars 12 and nut 13 could be formed as a sleeve based on a component
`
`in Møller’s second embodiment. Petitioner fails to explain what would have
`
`motivated a POSA to form connection bars 12 and nut 13 as a sleeve. Petitioner
`
`also fails to explain how to form these elements as a sleeve without impairing
`
`Møller’s pen injector.
`
`Fifth, the combination of Møller and Steenfeldt-Jensen fails to disclose an
`
`externally-threaded dose dial sleeve “configured to engage a threading provided
`
`by [a] main housing.” Instead, Møller discloses an internally-threaded dose
`
`setting drum 17 that engages with a threaded tubular element 5, which is not
`
`Møller’s housing. Petitioner is incorrect that a POSA would have been motivated
`
`to modify Møller’s dose setting drum 17 to have exterior threads, as taught by
`
`Steenfeldt-Jensen’s externally-threaded dose scale drum 80. Rather, Møller
`
`teaches away from Steenfeldt-Jensen’s dose scale drum. Møller expressly
`
`references Steenfeldt-Jensen’s externally-threaded dose scale drum, criticizes it,
`
`and then states that it is an objective of Møller to avoid it. Moreover, it would not
`
`have been obvious to move the dose setting drum 17’s threads from its interior to
`
`
`
`
`3
`
`

`

`its exterior, because (a) there is no reason to do so, (b) the modification would have
`
`resulted in an undesirable increase in the amount of force required by the user to
`
`inject medicine, and (c) external threads would mechanically interfere with helical
`
`reset spring 36.
`
`Finally, the combination of Møller and Steenfeldt-Jensen fails to teach or
`
`render obvious the limitations recited in dependent claims 15 and 17.
`
`
`
`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. BACKGROUND OF THE TECHNOLOGY
`
`At the time of the inventions set forth in the 044 Patent, there were already
`
`several pen-type injectors known in the art. For example, relevant to this
`
`proceeding,
`
`the Steenfeldt-Jensen
`
`reference describes
`
`five pen
`
`injector
`
`embodiments, and its fifth embodiment closely corresponds to the Novo Nordisk
`
`FlexPen device that was commercially available at the time. See Ex. 1014, Figs. 1-
`
`17, Ex. 2107, ¶ 28.
`
`
`
`There were, however, problems and limitations with the prior art injection
`
`pens, including the Novo Nordisk FlexPen (i.e., Steenfeldt-Jensen’s commercial
`
`embodiment), which suffered from relatively high injection force resulting at least
`
`partially from having to overcome the ratchet mechanism between the driver tube
`
`
`
`
`4
`
`

`

`and the housing. See Ex. 2107, ¶ 28. A higher injection force is problematic for
`
`patients lacking dexterity and strength, particularly for certain diabetic patients
`
`suffering from hand and wrist conditions. Id. ¶¶ 47-53 (discussing diabetic
`
`neuropathy and other conditions that limit a diabetic’s hand strength and
`
`flexibility).
`
`
`
`Developing a new pen injector to address prior art limitations is not as
`
`simple as substituting one component or feature for another. See Ex. 2107, ¶ 55.
`
`A substitution or change intended to improve one aspect of a device can negatively
`
`impact some other aspect, and one must consider whether these tradeoffs will
`
`result in an overall poor or flawed design. See id. In the pen injector context,
`
`changes that increase the required injection force would impair the ease of use of
`
`the device; and thus, would not be worth pursuing as it would worsen the patient’s
`
`experience and decrease the likelihood that the patient would remain in strict
`
`compliance with their prescribed medication regime. This in turn accelerates the
`
`progress of their disease. See Ex. 2107, ¶¶ 36, 44.
`
`
`
`The FlexPen, for example, required a high injection force to dispense the
`
`medication. Ex. 2175. It took Novo Nordisk several years to introduce a modified
`
`FlexPen that addressed this particular issue. Indeed, the original Novo Nordisk
`
`FlexPen was introduced in 2001 (see Ex. 2137 at 53, 66, Ex. 2136 at 22), but it was
`
`not until late 2008, five years after the 044 Patent’s priority date and a year after
`
`
`
`
`5
`
`

`

`the launch of the SoloSTAR®, that Novo Nordisk introduced the New Generation
`
`FlexPen (NGFP), which had reduced injection force requirements (see Ex. 2136 at
`
`71).
`
`
`
`The inventors of the 044 Patent successfully balanced these competing
`
`design considerations and produced a novel, non-obvious, mechanical arrangement
`
`that results in an improved pen injector.
`
`III. THE 044 PATENT
`
`Pen injectors are regularly used by patients without formal medical training,
`
`such as diabetic patients who manage their condition through self-treatment. Ex.
`
`1002, 1:25-29. The 044 Patent teaches that pen injectors should meet several
`
`criteria, including being robust in construction while 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; Ex. 2107, ¶ 64.
`
`
`
`The 044 Patent discloses a pen injector having a novel arrangement of
`
`mechanisms that meet these criteria. See Ex. 1002, Ex. 2107, ¶ 64. In particular,
`
`the 044 Patent is specifically targeted at reducing the injection force needed for
`
`dispensing medicine. Id., 3:64-67 (“The illustrated embodiment . . . helps reduce
`
`the overall force required for a user to cause medicinal product to be dispensed.”);
`
`see also Ex. 1005, 1:66-2:3 (“Surprisingly it was found that the drive mechanism
`
`according to instant invention without having a unidirectional coupling provides a
`
`
`
`
`6
`
`

`

`valuable technical alternative for drive mechanisms, wherein reduced force is
`
`needed to actuate the mechanism.”).1 The figures below depict an embodiment of
`
`an improved injection pen. Additionally, an animation of the embodiment’s
`
`operation has been submitted as Exhibits 2117 and 2218. S