Date Field | Doc. No. | Party | Description |
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May 2, 2019 | 1 | | Petitioner's Power of Attorney Download |
May 2, 2019 | 2 | | IPR Petition '069 Download |
May 2, 2019 | 3 | | MOTION FOR JOINDER Download |
May 21, 2019 | 4 | | Notice of Accord Filing Date Download |
May 23, 2019 | 5 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download |
May 23, 2019 | 6 | | Patent Owner¿¿¿s Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download |
Jun 3, 2019 | 7 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download |
Jun 3, 2019 | 8 | | Patent Owner's Response to Petitioner's Motions for Joinder Download |
Jun 3, 2019 | 9 | | Waiver of Patent Owner's Preliminary Response Download |
Jun 24, 2019 | 10 | | Reply in Support of Petitioner's Motion for Joinder Download |
Jul 30, 2019 | 11 | | Order Conduct of the Proceeding Download |
Aug 15, 2019 | 12 | | Trial Instituted Document Download |
Aug 15, 2019 | 13 | | SCHEDULING ORDER Download |
Aug 29, 2019 | 14 | | Patent Owner's Objections to Documents Served with the Petition Download |
Oct 30, 2019 | 15 | | Patent Owner's Notice of Deposition of Charles E. Clemens Download |
Nov 1, 2019 | 16 | | Petitioner's Unopposed Motion for Pro Hac Vice Admission of Charles B. Klein and Dan. H. Hoang Download |
Nov 8, 2019 | 17 | | Patent Owner's Response Download |
Nov 15, 2019 | 18 | | Petitioner's Objections to Evidence Submitted with Patent Owner Response Download |
Nov 18, 2019 | 19 | | ORDER Granting Petitioner's Unopposed Motion for Admission Pro Hac Vice of Charles B. Klein and Dan H. Hoang Download |
Jan 31, 2020 | 20 | | Download |
Jan 31, 2020 | 21 | | Download |
Feb 6, 2020 | 22 | | SUBMISSION OF CORRECTED EXHIBIT Download |
Feb 20, 2020 | 23 | | ORDER
Changing Due Date 8 Download |
Feb 24, 2020 | 24 | | Download |
Mar 13, 2020 | 25 | | Patent Owner's Sur-Reply Download |
Mar 18, 2020 | 26 | | PETITIONER'S OBJECTIONS TO EVIDENCE SUBMITTED WITH PATENT OWNER SUR-REPLY Download |
Apr 3, 2020 | 27 | | Patent Owner's Request for Oral Argument Download |
Apr 3, 2020 | 28 | | PETITIONER'S NOTICE REGARDING ORAL ARGUMENT Download |
Apr 7, 2020 | 29 | | PETITIONER'S MANDATORY CHANGE-OF-INFORMATION NOTICES Download |
Apr 16, 2020 | 30 | | Granting Patent Owners Motion for Withdrawal of Counsel
37 C.F.R. sec 42.10(e) Download |
Apr 17, 2020 | 31 | | Download |
Apr 24, 2020 | 32 | | Petitioner's Motion to Exclude Evidence Download |
Apr 24, 2020 | 33 | | Petitioner's Motion to Exclude Evidence Download |
Apr 29, 2020 | 34 | | Order - Conduct of the Proceeding - 37 CFR 42.5 Download |
May 1, 2020 | 35 | | Patent Owner's Opposition to Petitioner's Motion to Exclude Download |
May 6, 2020 | 36 | | Patent Owner's Updated Exhibit List Download |
May 8, 2020 | 37 | | Petitioner's Reply In Support Of Petitioner's Motion To Exclude Download |
Aug 11, 2020 | 38 | board | Termination Decision Document Download |
Aug 14, 2020 | 39 | patent_own | Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a) Download |
May 2, 2019 | 1001 | | Ex. 1001 - U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014) Download |
May 2, 2019 | 1002 | | Ex. 1002 - U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013) Download |
May 2, 2019 | 1003 | | Ex. 1003 - U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015) Download |
May 2, 2019 | 1004 | | Ex. 1004 - U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016) Download |
May 2, 2019 | 1005 | | Ex. 1005 - U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug Delivery Devices (issued Mar. 28, 2017) Download |
May 2, 2019 | 1006 | | Ex. 1006 - File History for U.S. Patent 8,679,069 Download |
May 2, 2019 | 1007 | | Ex. 1007 - File History for U.S. Patent 8,603,044 Download |
May 2, 2019 | 1008 | | Ex. 1008 - File History for U.S. Patent 8,992,486 Download |
May 2, 2019 | 1009 | | Ex. 1009 - File History for U.S. Patent 9,526,844 Download |
May 2, 2019 | 1010 | | Ex. 1010 - File History for U.S. Patent. 9,604,008 Download |
May 2, 2019 | 1011 | | Ex. 1011 - Declaration of Mr. Charles E. Clemens Download |
May 2, 2019 | 1012 | | Ex. 1012 - Cirriculum Vitae of Charles E. Clemens Download |
May 2, 2019 | 1013 | | Ex. 1013 - U.S. Patent 6,221,046 - A. Burroughs et al. Download |
May 2, 2019 | 1014 | | Ex. 1014 - U.S. Patent 6,235,004 - S. Steenfeldt-Jensen & S. Hansen Download |
May 2, 2019 | 1015 | | Ex. 1015 - U.S. Patent Application US 2002/0052578 A1- C.S. Moller Download |
May 2, 2019 | 1016 | | Ex. 1016 - U.S. Patent 6,932,794 B2 - L. Giambattista & A. Bendek Download |
May 2, 2019 | 1017 | | Ex. 1017 - U.S. Patent 6,582,404 B1 - P.C. Klitgaard et al Download |
May 2, 2019 | 1018 | | Ex. 1018 - File History for U.S. Patent 6,582,404 Download |
May 2, 2019 | 1019 | | Ex. 1019 - Plaintiffs' Preliminary Claim Constructions and Preliminary Identification of Supporting Intrinsic and Extrinsic Evidence, Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) Download |
May 2, 2019 | 1020 | | Ex. 1020 - U.S. Patent 4,865,591 - B. Sams Download |
May 2, 2019 | 1021 | | Ex. 1021 - U.S. Patent 6,248,095 B1 - L. Giambattista et al., Download |
May 2, 2019 | 1022 | | Ex. 1022 - U.S. Patent 5,921,966 B1 - A.A. Bendek et al Download |
May 2, 2019 | 1023 | | Ex. 1023 - U.S. Patent 5,226,895 - D.C. Harris Download |
May 2, 2019 | 1024 | | Ex. 1024 - U.S. Patent 5,851,079 - R.L. Horstman et al. Download |
May 2, 2019 | 1025 | | Ex. 1025 - Application as filed: U.S. Patent App. 14/946,203 -R.F. Veasey Download |
May 2, 2019 | 1026 | | Ex. 1026 - GB 0304822.0 - "improvements in and relating to a pen-type injector" (filed Mar. 3, 2003) ('844 Priority Doc.) Download |
May 2, 2019 | 1027 | | Ex. 1027 - WO 99/38554 - S.Steenfeldt-Jensen & S.Hansen Download |
May 2, 2019 | 1028 | | Ex. 1028 - Mylan GmbH and Biocon's Preliminary Claim Constructions and Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis U.S., LLC v. Mylan N.V., C.A. No. 17-cv-09105 Download |
May 2, 2019 | 1029 | | Ex. 1029 - Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018) Download |
May 2, 2019 | 1030 | | Ex. 1030 - Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and Co., No. 14-cv-113 (filed Jan. 20, 2015) Download |
May 2, 2019 | 1031 | | Ex. 1031 - N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, "Twenty Screw Devices" (3d ed., July 2, 2001) Download |
May 2, 2019 | 1032 | | Ex. 1032 - EP 0 608 343 B1 - L. Petersen & N. A. Hansen Download |
May 2, 2019 | 1033 | | Ex. 1033 - A.G. Erdman & G.N. Sandor, "Mechanical Advantage", section 3.7 in 1 Mechanism Design: Analysis and Synthesis (1984) Download |
May 2, 2019 | 1034 | | Ex. 1034 - WO 01/83008 - S. Hansen & T.D. Miller Download |
May 2, 2019 | 1035 | | Ex. 1035 - K.J. Lipska et al., 320 J. Am. Med. Ass'n 53-62 (2018) Download |
Nov 1, 2019 | 1036 | | Ex. 1036 - Declaration of Charles B. Klein in Support of Motion for Pro Hac Vice Admission Download |
Nov 1, 2019 | 1037 | | Ex. 1037 - Declaration of Dan H. Hoang in Support of Motion for Pro Hac Vice Admission Download |
Jan 31, 2020 | 1044 | | Ex. 1044 - Nat'l. Diabetes Statistic Report 2017, Estimates of Diabetes and Its Burden in the United States, CDC, p.1-20 Download |
Jan 31, 2020 | 1045 | | Ex. 1045 - Teresa L. Pearson, "Practical Aspects of Insulin Pen Devices", Journal of Diabetes Science and Technology, Vol. 4, Issue 3, May 2010, p.522-531 Download |
Jan 31, 2020 | 1046 | | Ex. 1046 - Nancy J.V. Bohannon, "Insulin Delivery Using Pen Devices", Postgraduate Medicine, Vol. 106, No.5, Oct. 15, 1999, p. 57-68, ISSN: 0032-5481 (Print) 1941-9260 Download |
Jan 31, 2020 | 1047 | | Ex. 1047 - Marilyn R. Graff, RN, CDE et al., "Assessment by Patients with Diabetes Mellitus of Two Insulin Pen Delivery Systems Versus a Vial and Syringe", Clinical Therapeutics, Vol. 20, No. 3, 1998, P.486-196 Download |
Jan 31, 2020 | 1048 | | Ex. 1048 - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Download |
Jan 31, 2020 | 1049 | | Ex. 1049 - Curriculum Vitae of William Curtis Biggs Download |
Jan 31, 2020 | 1050 | | Ex. 1050 - Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration of Alexander Slocum Ph.D.) Download |
Jan 31, 2020 | 1051 | | Ex. 1051 - Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism Download |
Jan 31, 2020 | 1052 | | Ex. 1052 - Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157 Download |
Jan 31, 2020 | 1053 | | Ex. 1053 - Deposition of Alexander H. Slocum, Ph.D., August 27, 2019 Download |
Jan 31, 2020 | 1054 | | Ex. 1054 - Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019 Download |
Jan 31, 2020 | 1055 | | Ex. 1055 - Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019 Download |
Jan 31, 2020 | 1056 | | Ex. 1056 - Deposition of Robin Goland, Sep. 10, 2019 Download |
Jan 31, 2020 | 1057 | | Download |
Jan 31, 2020 | 1058 | | Ex. 1058 - Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 18, 2004) Download |
Jan 31, 2020 | 1059 | | Ex. 1059 - M. Eledrisi, et al., "Twice-Daily Insulin Glargine for Patients with Uncontrolled Type 2 Diabetes Mellitus", Journal of Clinical & Translational Endocrinology 15 (2019), p. 35-36 Download |
Jan 31, 2020 | 1060 | | Ex. 1060 - Declaration and c.v. of DeForrest McDuff, Ph.D. Download |
Jan 31, 2020 | 1061 | | Ex. 1061 - 2011 Orange Book (Excerpts) Download |
Jan 31, 2020 | 1062 | | Download |
Jan 31, 2020 | 1063 | | Ex. 1063 - 2011-02-09 - Sanofi SA Earnings Conference Call Download |
Jan 31, 2020 | 1064 | | Download |
Jan 31, 2020 | 1065 | | Download |
Jan 31, 2020 | 1066 | | Download |
Jan 31, 2020 | 1067 | | Download |
Jan 31, 2020 | 1068 | | Ex. 1068 - Aventis 2002 20-F Form Download |
Jan 31, 2020 | 1069 | | Ex. 1069 - Aventis 2034 20-F Form Download |
Jan 31, 2020 | 1070 | | Ex. 1070 - Sanofi-Aventis 2006 20 F Form Download |
Jan 31, 2020 | 1071 | | Download |
Jan 31, 2020 | 1072 | | Ex. 1072 - Carter, Alan W., "Analysis of the 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, Jan. 2011, p. 156-157 Download |
Jan 31, 2020 | 1073 | | Ex. 1073 - "About Diabetes", CDC Basics, p.1-2, Download |
Jan 31, 2020 | 1074 | | Ex. 1074 - David, J. et al. "Commercial Success: Economic Principles Applied to Patent Litigation", NERA Economic Consulting (copyrighted material), p. 159-160 Download |
Jan 31, 2020 | 1075 | | Ex. 1075 - "Top Ten Tips on Writing Effectiveness Case Studies", By Design Business Association, May 23, 2016, p.1-5 Download |
Jan 31, 2020 | 1076 | | DiMasi, J., et al. "Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs", J. of Health Economics 47 (2016), p. 20-33 Download |
Jan 31, 2020 | 1077 | | Ex. 1077 - Grabowski, H., et al. "Returns on Research and Development for 1990s New Drug Introductions", Pharmacoeconomics 2002; 20 Suppl. 3: p. 11-29 Download |
Jan 31, 2020 | 1078 | | Ex. 1078 - Pietrangelo, Ann "Levemir vs. Lantus: Similarities and Differences", Healthline, Oct. 19, 2016, p.1-14 Download |
Jan 31, 2020 | 1079 | | Ex. 1079 - U.S. Patent 6,100,376 Download |
Jan 31, 2020 | 1080 | | Download |
Jan 31, 2020 | 1081 | | Ex. 1081 - Lantus, "Get to Know the Lantus SoloStar Insulin Pen, p. 1-7 Download |
Jan 31, 2020 | 1082 | | Download |
Jan 31, 2020 | 1083 | | Ex. 1083 - Lantus SoloStar Brochure: "Your Guide to the Lantus SoloStar
Insulin Pen" (2010) Download |
Jan 31, 2020 | 1084 | | Ex. 1084 - McDuff, et al., "Thinking Economically About Commercial Success",
Landslide, March/April 2017, p. 37-40 Download |
Jan 31, 2020 | 1085 | | Ex. 1085 - Nonaka, H., "FTO (Freedom to Operate) in the Pharmaceutical Industry", JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018), p. 9-59 Download |
Jan 31, 2020 | 1086 | | Ex. 1086 - Senate Comm. On Finance Questions for the Record, "Drug Pricing in America": A Prescription for Change Part II, Questions for Olivier Brandicourt, CEO Sanofi, Feb. 26, 2019, p. 1-460 Download |
Jan 31, 2020 | 1087 | | Ex. 1087 - S.G. Cowen, "Perspectives", Pharmaceutical Therapeutic Categories Outlook, Oct. 2001, p.134-148 Download |
Jan 31, 2020 | 1088 | | Ex. 1087 - Cowen and Co., "Diabetes: Many New Drugs, But Insulin Still Dominant", Therapeutic Categories Outlook, Feb. 2015, p.477-491 Download |
Feb 6, 2020 | 1088 | | Download |
Jan 31, 2020 | 1089 | | Ex. 1089 - UBS Large Cap Pharmaceuticals Handbook, "U.S. Pharmaceuticals",
Apr. 6, 2018, p.45-53 Download |
Jan 31, 2020 | 1090 | | Ex. 1090 - Campbell, K., "Insulin Costs Are Skyrocketing. This is Why", U.S.
News and World Report, Jun. 29, 2018, p.1-7 Download |
Jan 31, 2020 | 1091 | | Ex. 1091 - U.S. Patent 5,656,722 Download |
Jan 31, 2020 | 1092 | | Ex. 1092 - U.S. Patent 7,476,652 Download |
Jan 31, 2020 | 1093 | | Ex. 1093 - U.S. Patent 7,713,930 Download |
Jan 31, 2020 | 1094 | | Ex. 1094 - WebMD, "Types of Insulin for Diabetes Treatment", p.1-7 Download |
Jan 31, 2020 | 1095 | | Ex. 1095 - Reply Declaration of Charles Clemens Download |
Nov 8, 2019 | 2012 | | MP4 file of Sanofi¿¿¿s Patented Pen animation Download |
Nov 8, 2019 | 2013 | | Excerpts from McGraw Hill Dictionary of Scientific and Technical
Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873 Download |
Nov 8, 2019 | 2014 | | Excerpts from Merriam-Webster¿¿¿s Collegiate Dictionary (10th
edition, Merriam-Webster, Inc. 2001), p. 538 Download |
Nov 8, 2019 | 2015 | | The New Oxford American Dictionary (Oxford University Press
2001), p. 789-90 Download |
Nov 8, 2019 | 2016 | | 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.) Download |
Nov 8, 2019 | 2026 | | International Patent WO 99/38554 Download |
Nov 8, 2019 | 2027 | | Animation depicting M¿¿ller¿¿¿s first embodiment Download |
Nov 8, 2019 | 2028 | | Animation depicting M¿¿ller¿¿¿s second embodiment Download |
Nov 8, 2019 | 2100 | | 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) Download |
Nov 8, 2019 | 2101 | | 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) Download |
Nov 8, 2019 | 2102 | | Leinsing Deposition Exhibit 2102: Hand drawings Download |
Nov 8, 2019 | 2103 | | Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of
Burroughs Download |
Nov 8, 2019 | 2104 | | Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of
the 486 Patent Download |
Nov 8, 2019 | 2105 | | Leinsing Deposition Exhibit 2105: Hand drawings Download |
Nov 8, 2019 | 2106 | | Leinsing Deposition exhibit 2106: Annotations of Figures 11 and
12 of Giambattista Download |
Nov 8, 2019 | 2107 | | Declaration of Alexander Slocum, Ph.D. Download |
Nov 8, 2019 | 2108 | | Curriculum Vitae of Alexander Slocum, Ph.D. Download |
Nov 8, 2019 | 2109 | | Declaration of Henry R. Grabowski, Ph.D. Download |
Nov 8, 2019 | 2110 | | Curriculum Vitae of Henry R. Grabowski, Ph.D. Download |
Nov 8, 2019 | 2111 | | Declaration of Dr. Robin S. Goland Download |
Nov 8, 2019 | 2112 | | Curriculum Vitae of Dr. Robin S. Goland Download |
Nov 8, 2019 | 2113 | | 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) Download |
Nov 8, 2019 | 2114 | | Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices,
EMJ Diabet., 58-64 (2014:2) Download |
Nov 8, 2019 | 2115 | | Arthritis & Diabetes, What do diabetes and arthritis have in
common? Plenty., Download |
Nov 8, 2019 | 2116 | | Andreas Bode, Development of the SoloSTAR insulin pen device
design verification and validation, 6 Expert Opinion on Drug
Delivery 103-112 (2008) Download |
Nov 8, 2019 | 2117 | | Sanofi¿¿¿s Patented Pen animation Download |
Nov 8, 2019 | 2118 | | 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) Download |
Nov 8, 2019 | 2119 | | 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) Download |
Nov 8, 2019 | 2120 | | Estelle Davis, et. al., An evaluation of prefilled insulin pens: a
focus on the Next Generation FlexPen, Med. Devices: Evidence &
Research, 41-50 (2010:3) Download |
Nov 8, 2019 | 2121 | | DBA Design Effectiveness Awards 2009 Download |
Nov 8, 2019 | 2122 | | SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009) Download |
Nov 8, 2019 | 2123 | | Arnd Friedrichs et al., Dose Accuracy and Injection Force of
Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech. 1346-
1353 (2013) Download |
Nov 8, 2019 | 2124 | | 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) Download |
Nov 8, 2019 | 2125 | | 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) Download |
Nov 8, 2019 | 2126 | | 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) Download |
Nov 8, 2019 | 2127 | | U.S. Provisional Patent Application 60/073820 Download |
Nov 8, 2019 | 2128 | | Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens
for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-123
(2008) Download |
Nov 8, 2019 | 2129 | | 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) Download |
Nov 8, 2019 | 2130 | | 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) Download |
Nov 8, 2019 | 2131 | | ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15, 2000) Download |
Nov 8, 2019 | 2132 | | Meike Krzywon et al., Study on the Dosing Accuracy of Commonly
Used Disposable Insulin Pens, 14 Diabetes Tech. & Therapeutics
804-809 (2012) Download |
Nov 8, 2019 | 2133 | | LANTUS SoloSTAR Pen Guide Download |
Nov 8, 2019 | 2134 | | Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in
Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989) Download |
Nov 8, 2019 | 2135 | | 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) Download |
Nov 8, 2019 | 2136 | | Novo Nordisk Form 6-K (Feb. 9, 2009) Download |
Nov 8, 2019 | 2137 | | Novo Nordisk History Download |
Nov 8, 2019 | 2138 | | W. Schady et al, Observations on Severe Ulnar Neuropathy in
Diabetes, 12 J Diabetes and Its Complications 128-132 (1998) Download |
Nov 8, 2019 | 2139 | | Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn
Between SoloSTAR and FlexPen at Three Different Dose Levels, 10
Diabetes Tech. & Therapeutics 359-362 (2008) Download |
Nov 8, 2019 | 2140 | | 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) Download |
Nov 8, 2019 | 2141 | | John Shelmet et al., Preference and resource utilization in elderly
patients: InnoLet versus vial/syringe, 63 Diabetes Res. and Clinical
Prac. 27-35 (2004) Download |
Nov 8, 2019 | 2142 | | Prix Galien USA Announces 2009 Final Candidates (Prix Galien
USA, August 7, 2009) Download |
Nov 8, 2019 | 2143 | | 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) Download |
Nov 8, 2019 | 2144 | | 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) Download |
Nov 8, 2019 | 2145 | | US LANTUS SoloSTAR Launch Book, 2007, PTX-0705,
Document bates stamped SANOFI_00232909-45 Download |
Nov 8, 2019 | 2146 | | Part 1 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 8, 2019 | 2146 | | Part 1 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 8, 2019 | 2146 | | Part 2 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 8, 2019 | 2147 | | Steenfeldt-Jensen 5th Embodiment Animation Download |
Nov 8, 2019 | 2148 | | Steenfeldt-Jensen 1st Embodiment Animation Download |
Nov 8, 2019 | 2149 | | Steenfeldt-Jensen 2nd Embodiment Animation Download |
Nov 8, 2019 | 2150 | | Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation Download |
Nov 8, 2019 | 2151 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
Animation Download |
Nov 8, 2019 | 2152 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
Collar Friction Animation Download |
Nov 8, 2019 | 2153 | | International Patent Application WO999038554A1 Download |
Nov 8, 2019 | 2158 | | Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen, 957-967 (The Diabetes EDUCATOR) Download |
Nov 8, 2019 | 2159 | | 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 Download |
Nov 8, 2019 | 2160 | | Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices Download |
Nov 8, 2019 | 2161 | | SoloSTAR Principles of Operation Download |
Nov 8, 2019 | 2162 | | Sanofi Patent Drive Sleeve and Piston Rod Animation Download |
Nov 8, 2019 | 2163 | | Deposition of Karl R. Leinsing Download |
Nov 8, 2019 | 2164 | | Deposition of Karl R. Leinsing, dated June 4, 2019 Download |
Nov 8, 2019 | 2165 | | Opinion and Order regarding Claim Construction, Sanofi-Aventis U.S. LLC v. Mylan Download |
Nov 8, 2019 | 2166 | | Memorandum and Order regarding Claim Construction, Sanofi- Aventis U.S. LLC v. Merck Download |
Nov 8, 2019 | 2167 | | Giambattista Animation (1) Download |
Nov 8, 2019 | 2168 | | Giambattista Animation (2) Download |
Nov 8, 2019 | 2169 | | U.S. Patent No. 4,648,872 Download |
Nov 8, 2019 | 2170 | | U.S. Patent No. 4,747,824 Download |
Nov 8, 2019 | 2171 | | U.S. Patent No. 6,248,093 Download |
Nov 8, 2019 | 2172 | | Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc. Download |
Nov 8, 2019 | 2173 | | Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy Download |
Nov 8, 2019 | 2174 | | Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome Download |
Nov 8, 2019 | 2175 | | A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy Download |
Nov 8, 2019 | 2176 | | Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus Download |
Nov 8, 2019 | 2177 | | Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes Download |
Nov 8, 2019 | 2178 | | Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis Download |
Nov 8, 2019 | 2179 | | Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study Download |
Nov 8, 2019 | 2180 | | Considering Insulin Pens for Routine Hospital Use - Consider This... (ISMP article) Download |
Nov 8, 2019 | 2181 | | Trigger Finger Overview (Mayo Clinic) Download |
Nov 8, 2019 | 2182 | | Bone and joint problems associated with diabetes (Mayo Clinic) Download |
Nov 8, 2019 | 2183 | | Peripheral Neuropathy (Mayo Clinic) Download |
Nov 8, 2019 | 2184 | | Charles E. Buban, A pen that seeks to improve diabetes care Download |
Nov 8, 2019 | 2185 | | "Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award" Download |
Nov 8, 2019 | 2186 | | Select Injectable Insulin Drugs Approved by the FDA in the U.S. Download |
Nov 8, 2019 | 2187 | | U.S. Dollar Sales of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2188 | | U.S. New Prescriptions of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2189 | | U.S. Total Prescriptions of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2190 | | U.S. Share of Sales by Drugs in the LANTUS Franchise Download |
Nov 8, 2019 | 2191 | | Formulary Placement of Long-Acting Insulin Pen Products: Commercial Plans Download |
Nov 8, 2019 | 2192 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicare Plans Download |
Nov 8, 2019 | 2193 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicaid Plans Download |
Nov 8, 2019 | 2194 | | Formulary Placement of Long-Acting Insulin Pen Products in Healthcare Exchanges Download |
Nov 8, 2019 | 2195 | | U.S. Share of Long-Acting Pens Among All Pens Download |
Nov 8, 2019 | 2196 | | U.S. Dollar Sales of Long-Acting Pens Download |
Nov 8, 2019 | 2197 | | U.S. New Prescriptions of Long-Acting Pens Download |
Nov 8, 2019 | 2198 | | U.S. Total Prescriptions of Long-Acting Pens Download |
Nov 8, 2019 | 2199 | | U.S. Share of Long-Acting Pen Products Download |
Nov 8, 2019 | 2200 | | Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic syndrome Download |
Nov 8, 2019 | 2201 | | 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design Download |
Nov 8, 2019 | 2203 | | U.S. Total Marketing Expenditure of Long Acting Insulin Franchises Download |
Nov 8, 2019 | 2204 | | U.S. Total Marketing Expenditures of Long-Acting Insulin Pens Download |
Nov 8, 2019 | 2205 | | U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs Download |
Nov 8, 2019 | 2206 | | M¿¿ller First Embodiment Animation Download |
Nov 8, 2019 | 2207 | | M¿¿ller Second Embodiment Animation Download |
Nov 8, 2019 | 2208 | | Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction Download |
Nov 8, 2019 | 2209 | | Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions Download |
Nov 8, 2019 | 2210 | | Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs Download |
Nov 8, 2019 | 2211 | | Collar Friction Model Demonstrator Animation Download |
Nov 8, 2019 | 2212 | | Excerpts from Ernest Rabinowicz, Friction And Wear of Materials Download |
Nov 8, 2019 | 2214 | | Excerpts from Alexander H. Slocum, Precision Machine Design Download |
Nov 8, 2019 | 2215 | | Collar Friction Model Demonstration 1 Download |
Nov 8, 2019 | 2216 | | Collar Friction Model Demonstration 2 Download |
Nov 8, 2019 | 2217 | | Collar Friction Model Demonstration 3 Download |
Nov 8, 2019 | 2218 | | SoloSTAR Dial Inject Video Download |
Nov 8, 2019 | 2223 | | SoloSTAR Wins 2008 Good Design Award Download |
Mar 13, 2020 | 2224 | | Expert Opinion on Drug Delivery, Instructions for Authors Download |
Mar 13, 2020 | 2317 | | Deposition of William C. Biggs, dated October 15, 2019 Download |
Mar 13, 2020 | 2318 | | Deposition of DeForest McDuff, dated October 9, 2019 Download |
Nov 8, 2019 | 2450 | | Deposition of Charles E. Clemens (November 1, 2019) Download |
Mar 13, 2020 | 2451 | | Transcript of Telephonic conference between Sanofi, the Board, Pfizer and Mylan, dated Nov. 18, 2019, in IPR2018-1670, -1676, -1678, -1679, -1680, and -1682 Download |
May 1, 2020 | 2452 | | Transcript of Telephone Conference on 6.19.19 Download |
May 1, 2020 | 2453 | | Email from Patent Owner to Petitioner re: Supplemental Evidence Download |
May 6, 2020 | 2454 | | Record of Oral Hearing Held on 1.15.2020 Download |
Apr 29, 2020 | 3001 | | Ex. 3001 Download |