Exhibits: Patent Owner's Response Leinsing Deposition Exhibit 2100: Thomas van der Burg, Injection Force of SoloSTAR¿¿ Compared with Other Disposable Insulin Pen Devices at Constant Volume Flow Rates Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focuse on the Next Generation FlexPen¿¿ 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 Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices Arthritis & Diabetes, What do diabetes and arthritis have in common? Andreas Bode, Development of the SoloSTAR insulin pen device design verification and validation 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 Sherwyn Schwartz, Correct Use of a New Reusable Insulin Injection Pen by Patients with Diabetes: A Design Validation Study 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 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 Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus Jerome S. Fischer et al., United States Patient Preference and Usability for the New Disposable Insulin Device Solostar¿¿ versus Other Disposable Pens U.S. Provisional Patent Application 60/073820 Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes 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 Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing Accuracy with a Novel Pen Device (SoloSTAR) as Performed by Patients with Diabetes in a Clinical Setting ISO 11608-1, Pen-injectors for medical use Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens Lantus SoloSTAR Pen Guide Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus Douglas Merritt et al., Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes Novo Nordisk Form 6-K (Feb. 9, 2009), Part One Novo Nordisk Form 6-K (Feb. 9, 2009), Part Two Novo Nordisk History, Part Two Novo Nordisk History, Part One W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels John Shelmet et al., Preference and resource utilization in elderly patients: InnoLet versus vial/syringe Prix Galien USA Announces 2009 Final Candidates EXPUNGED Prix Galien USA Announces 2009 Final Candidates 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 Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of a novel disposable insulin pen US Lantus SoloSTAR Launch Book Lantus COMPASS Study Report, Part One Lantus COMPASS Study Report, Part Two 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 Declaration of Chris Langley Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen 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 Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices SoloSTAR Principles of Operation 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 Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus, Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study Considering Insulin Pens for Routine Hospital Use Trigger Finger Overview (Mayo Clinic) Bone and joint problems associated with diabetes (Mayo Clinic) Peripheral Neuropathy (Mayo Clinic) Charles E. Buban, A pen that seeks to improve diabetes care Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award 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 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 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design 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 M¿¿ller First Embodiment Animation M¿¿ller Second Embodiment Animation Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs Collar Friction Model Demonstrator Animation Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition Excerpts from Alexander H. Slocum, Precision Machine Design Collar Friction Model Demonstration 1 Collar Friction Model Demonstration 2 Collar Friction Model Demonstration 3 SoloSTAR Dial Inject Video
IPR2018-01680, No. 2141-2 Exhibit - EXPUNGED (P.T.A.B. Jun. 24, 2019)
Exhibits: Patent Owner's Response Leinsing Deposition Exhibit 2100: Thomas van der Burg, Injection Force of SoloSTAR¿¿ Compared with Other Disposable Insulin Pen Devices at Constant Volume Flow Rates Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focuse on the Next Generation FlexPen¿¿ 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 Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices Arthritis & Diabetes, What do diabetes and arthritis have in common? Andreas Bode, Development of the SoloSTAR insulin pen device design verification and validation 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 Sherwyn Schwartz, Correct Use of a New Reusable Insulin Injection Pen by Patients with Diabetes: A Design Validation Study 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 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 Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus Jerome S. Fischer et al., United States Patient Preference and Usability for the New Disposable Insulin Device Solostar¿¿ versus Other Disposable Pens U.S. Provisional Patent Application 60/073820 Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes 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 Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing Accuracy with a Novel Pen Device (SoloSTAR) as Performed by Patients with Diabetes in a Clinical Setting ISO 11608-1, Pen-injectors for medical use Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens Lantus SoloSTAR Pen Guide Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus Douglas Merritt et al., Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes Novo Nordisk Form 6-K (Feb. 9, 2009), Part One Novo Nordisk Form 6-K (Feb. 9, 2009), Part Two Novo Nordisk History, Part Two Novo Nordisk History, Part One W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels John Shelmet et al., Preference and resource utilization in elderly patients: InnoLet versus vial/syringe Prix Galien USA Announces 2009 Final Candidates EXPUNGED Prix Galien USA Announces 2009 Final Candidates 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 Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of a novel disposable insulin pen US Lantus SoloSTAR Launch Book Lantus COMPASS Study Report, Part One Lantus COMPASS Study Report, Part Two 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 Declaration of Chris Langley Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen 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 Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices SoloSTAR Principles of Operation 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 Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus, Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study Considering Insulin Pens for Routine Hospital Use Trigger Finger Overview (Mayo Clinic) Bone and joint problems associated with diabetes (Mayo Clinic) Peripheral Neuropathy (Mayo Clinic) Charles E. Buban, A pen that seeks to improve diabetes care Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award 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 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 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design 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 M¿¿ller First Embodiment Animation M¿¿ller Second Embodiment Animation Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs Collar Friction Model Demonstrator Animation Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition Excerpts from Alexander H. Slocum, Precision Machine Design Collar Friction Model Demonstration 1 Collar Friction Model Demonstration 2 Collar Friction Model Demonstration 3 SoloSTAR Dial Inject Video
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