IPR2022-00964 - Eyenovia Inc v. Sydnexis Inc

Details
PATENT NUMBER
9770447 Medical
APPL. NUMBER
15208537
PETITIONER
Eyenovia Inc
SME
PATENT OWNER
Sydnexis Inc
Operating Company
STATUS
Not Instituted - Procedural § 325(d)
FILING DATE
2022-05-03
INSTITUTION DATE
2022-11-07
TERMINATION DATE
2022-11-07
PET. COUNSEL
Mintz, Levin, Cohn, Ferris, Glovsky, & Popeo P.C.
P.O. COUNSEL
Wilson, Sonsini, Goodrich & Rosati
AUTHOR JUDGE
Timeline
Petition
Notice of Filing Date
Preliminary Response
Institution Decision
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2023
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2024
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Docket
Paper No.
Date
Party
Type
Name
12022-05-03PetitionerPetitionPetition for Inter Partes Review of U.S. Patent No. 9,770,447
22022-05-03PetitionerPower of AttorneyPetitioner's Power of Attorney
10012022-05-03PetitionerU.S. Patent No. 9,770,447 to Ostrow et al.
10022022-05-03PetitionerDeclaration of Dr. Stephen Byrn, Ph. D.
10032022-05-03PetitionerChia et al., Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2), OPHTHALMOLOGY 119(2): 347���354 (2012)
10042022-05-03PetitionerAlbert A. Kondritzer & Peter Zvirblis, Stability of Atropine in Aqueous Solution, J. AM. PHARM. ASS���N 46(9):531���535 (1957)
10052022-05-03PetitionerJohn D. Mullins & Gerald Hecht, Pharmaceutical Necessities and Ophthalmic Preparations, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY, VOLUME II 1380���1416, 1563���1576 (Alfonso R. Gennaro ed., 19th ed. 1995)
10062022-05-03PetitionerSiegel et al., Stability of Procaine in Deuterium Oxide, J. PHARM. SCIS. 53(8):978���979 (1964)
10092022-05-03PetitionerMcBrien et al., Point-Counterpoint. How does atropine exert its anti-myopia effects?, OPHTHALMIC & PHYSIOL OPT. 33:373���378 (2013)
10102022-05-03PetitionerChua et al., Atropine for the Treatment of Childhood Myopia, OPHTHALMOLOGY 113(12):2285���2291 (2006)
10112022-05-03PetitionerShih et al., An intervention trial on efficacy of atropine and multi-focal glasses in controlling myopic progression, ACTA OPHTHALMOLOGICA SCANDINAVICA 79:233���236 (2001)
10122022-05-03PetitionerU.S. Patent Publication No. 2007/0254914 to Wu et al.
10132022-05-03PetitionerLee et al., Prevention of Myopia Progression with 0.05% Atropine Solution, J OCUL PHARMACOL THER. 22(1):41���46 (2006)
10142022-05-03PetitionerFang et al., Prevention of Myopia Onset with 0.025% Atropine in Premyopic Children, J OCUL PHARMACOL THER. 26(4):341���345 (2010)
10152022-05-03PetitionerShih et al., Effects of Different Concentrations of Atropine on Controlling Myopia in Myopic Children, J OCUL PHARMACOL THER. 15(1):85���90 (1999)
10162022-05-03PetitionerWu et al., The Long-Term Results of Using Low-Concentration Atropine Eye Drops for Controlling Myopia Progression in Schoolchildren, J OCUL PHARMACOL THER. 27(5):461���466 (2011)
10172022-05-03PetitionerChia et al., Atropine for the Treatment of Childhood Myopia: Changes after Stopping Atropine 0.01%, 0.1% and 0.5%, AM. J. OPHTHALMOLOGY 157(2):451���457.e1 (2014)
10182022-05-03PetitionerInternational Publication No. WO 2012/161655 to Donald Tan and Wei Han Chua
10192022-05-03PetitionerZvirblis et al., The Kinetics of the Hydrolysis of Atropine, J. AM. PHARM. ASS���N 45(7): 450���454 (1956)
10202022-05-03PetitionerSchier et al., Preparing for Chemical Terrorism: Stability of Injectable Atropine Sulfate, ACAD. EMERG. MED. 11(4):329���334 (2004)
10212022-05-03PetitionerKushner et al., Pharmacological uses and perspectives of heavy water and deuterated compounds, CAN. J. PHYSIOL. PHARMACOL. 77:79���88 (1999) - Part 1
10222022-05-03PetitionerBlake et al., Studies with Deuterated Drugs, J. PHARM. SCIS. 64(3):367���391 (1975)
10232022-05-03PetitionerThomas G. Gant, Using Deuterium in Drug Discovery: Leaving the Label in the Drug, J. MED. CHEM. 57(9):3595���3611 (2014)
10242022-05-03PetitionerAllan B. Foster, Deuterium Isotope Effects in the Metabolism of Drugs and Xenobiotics: Implications for Drug Design, ADVANCES IN DRUG RESEARCH 14:1���40 (1985)
10252022-05-03PetitionerKatherine B. J. Schowen, Solvent Hydrogen Isotope Effects, TRANSITION STATES OF BIOCHEM. PROCESSES 225���283 (Richard D. Gandour & Richard L. Schowen eds., 1978)
10262022-05-03PetitionerPaul K. Glasoe & F. A. Long, Use Of Glass Electrodes To Measure Acidities In Deuterium Oxide, J. PHYS. CHEM. 64(1):188���190 (1960)
10272022-05-03PetitionerSen et al., Role of heavy water in biological sciences with an emphasis on thermostabilization of vaccines, EXPERT REV. VACCINES 8(11): 1587���1602 (2009) - Part 1
10282022-05-03PetitionerU.S. Patent Publication No. 2011/0076331 to Bayerl
10292022-05-03PetitionerKho Kiat Nee, The Use Of Deuterium Oxide To Stabilize Pharmaceuticals Against Chemical Degradation, Slide Serve - Theophilus Stavros (2014)
10302022-05-03PetitionerPeter Krumbiegel, Large deuterium isotope effects and their use: a historical review, ISOTOPES IN ENVTL. & HEALTH STUDIES 47(1):1���17 (2011)
10312022-05-03PetitionerAmanda Yarnell, Heavy-Hydrogen Drugs Turn Heads, Again, CHEMICAL & ENG���G NEWS 87(25):36���39 (2009)
10322022-05-03PetitionerGraham S. Timmins, Deuterated drugs; where are we now?, EXPERT OPIN. THER. PAT. 24(10):1067���1075 (2014)
10332022-05-03PetitionerAnschel et al., Parenteral Formulation VI: Hydrolytic Degradation of Esters in Parenteral Solutions, BULLETIN OF THE PARENTERAL DRUG ASS���N 26(6):271���289 (1972)
10342022-05-03PetitionerFiled Application of U.S. Patent No. 9,421,199, May 29, 2015
10352022-05-03PetitionerU.S. Patent No. 9,421,199, Non-Final Rejection, March 7, 2016
10362022-05-03PetitionerU.S. Patent No. 5,716,952 to WoldeMussie et al.
10372022-05-03PetitionerU.S. Patent Publication No. 2012/0015035 to Wildsoet et al.
10382022-05-03PetitionerU.S. Patent Publication No. 2012/0203161 to Herekar
10392022-05-03PetitionerU.S. Patent No. 9,421,199, Response to Non-Final Rejection, April 5, 2016
10402022-05-03PetitionerU.S. Patent No. 9,421,199, Interview Summary, April 13, 2016
10412022-05-03PetitionerU.S. Patent No. 9,421,199, Notice of Allowance, June 13, 2016
10422022-05-03PetitionerU.S. Patent No. 9,770,447, Advisory Action, April 13, 2017
10432022-05-03PetitionerProvisional Patent Application No. 60/016,502
10442022-05-03PetitionerProvisional Patent Application No. 62/096,433
10452022-05-03PetitionerCertified English Translation of CN 101049287A to Wu Peichang et al.
10462022-05-03PetitionerChowhan et al., Ophthalmic Preparations, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 907929 (22nd ed. 2013)
10472022-05-03PetitionerLallemand et al., Successfully Improving Ocular Drug Delivery Using the Cationic Nanoemulsion, Novasorb, J. DRUG DELIVERY 2012:1���16 (2012)
10482022-05-03PetitionerRajpal et al., Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence, PATIENT PREFER ADHERENCE 8:925���31 (2014)
10492022-05-03PetitionerKirchhoff et al., Analysis of atropine, its degradation products and related substances of natural origin by means of reversed-phase high-performance liquid chromatography, J. CHROMATOGRAPHY A 1046:115���120 (2004)
10502022-05-03PetitionerGarcia-Valldecabres et al., pH Stability of ophthalmic solutions, OPTOMETRY 75(3):161���168 (2004)
10512022-05-03PetitionerPB Patel et al., Ophthalmic Drug Delivery System: Challenges and Approaches, SYSTEMATIC REVIEWS IN PHARMACY 1(2):113���120 (2010)
10522022-05-03PetitionerEuropean Patent Publication No. 0332826 to Zev Tashma
10532022-05-03PetitionerPHYSIOCHEMICAL PRINCIPLES OF PHARMACY 56���92 (4th ed. 2006)
10542022-05-03PetitionerStephen S. Minor & Richard L. Schowen, One-Proton Solvation Bridge in Intramolecular Carboxylate Catalysis of Ester Hydrolysis, J. AM. CHEM. SOC. 95(7):2279���2281 (1973)
10552022-05-03PetitionerDRUG REPOSITIONING BRINING NEW LIFE TO SHELVED ASSETS AND EXISTING DRUGS 53���64, 291���343 (Michael J. Barratt & Donald E. Frail eds., 2012)
10562022-05-03PetitionerCath O���Driscoll, Heavyweight drugs, CHEM. & INDUS. 24���26 (2009)
10572022-05-03PetitionerUK Patent Application GB 2293100 to Ian George Stephen Furminger & Philip James Sizer
10582022-05-03PetitionerU.S. Patent No. 7,691,099 to Berry
10592022-05-03PetitionerU.S. Patent Publication No. 2012/0135084 to Bayerl
10602022-05-03PetitionerJune G. Winter and J. M. W. Scott, Studies in Solvolysis. Part IV. Substituent and Solvent Isotope Effects in the Solvolysis of a Series of Benzyl Trifluroacetates, CAN. J. CHEM. 50:1886���90 (1972)
10612022-05-03PetitionerWilliam P. Jencks & Joan Carriuolo, General Base Catalysis of Ester Hydrolysis, J. AM. CHEM. SOC. 83(7):1743���50 (1961)
10622022-05-03PetitionerBender et al., Deuterium Oxide Solvent Isotope Effects in the Nucleophilic Reactions of Phenyl Esters, J. AM. CHEM. SOC. 84(4):595���599 (1962)
10632022-05-03PetitionerJune G. Winter & J. M. W. Scott, Studies in solvolysis. Part I. The neutral hydrolysis of some alkyl trifluoroacetates in water and deuterium oxide, CANADIAN J. CHEM. 46:2887���2894 (1968)
10642022-05-03PetitionerBradley A. Hanson et al., A Mechanistic and Kinetic Study of the E-Ring Hydrolysis and Lactonization of a Novel Phosphoryloxymethyl Prodrug of Camptothecin, PHARM. RESEARCH 20(7):1031���1038 (2003)
10652022-05-03PetitionerEnglish Translation of Jinshen Li, Preparation and Quality Control of 0.04% Atropine Sulfate Eye Drops, CHINA PHARMACY 17(2):111���113 (2006)
10662022-05-03PetitionerAtropine Sulfate Ophthalmic Solution, Highlights of Prescribing Information, Revised July 2014
10672022-05-03PetitionerCertified English Translation of Yuanda Wen, Preparation and Clinical Curative Effects of 0.05% Atropine Sulfate Eye Drops, CHINA PHARMACIST 11(2):194���196 (2008)
10682022-05-03PetitionerRonald F. Donnelly & C��line Corman, Physical Compatibility and Chemical Stability of a Concentrated Solution of Atropine Sulfate (2 mg/mL) for Use as an Antidote in Nerve Agent Casualties, INT���L J. PHARM. COMPOUNDING 12(6):550���552 (2008)
10692022-05-03PetitionerM. R. W. Brown & D. A. Norton, The Preservation of Ophthalmic Preparations, J. SOC. COSMETIC CHEMISTS 16:369���393 (1965)
10702022-05-03PetitionerA. J. Kresge, Solvent Isotope Effect in H2O-D2O Mixtures, PURE APPL. CHEM. 8(3-4):243���258 (1964)
10712022-05-03PetitionerDriver et al., The Stability of Atropine Sulfate Solutions Stored in Plastic Syringes in the Operating Room, ANESTH. ANALG. 89:1056���1058 (1999)
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10732022-05-03PetitionerDICTIONARY OF CHEMISTRY (2nd ed. 2003)
10742022-05-03PetitionerSodium phosphate monobasic Safety Data Sheet, Version 1.1, G-BIOSCIS. (Jan. 9, 2012)
10752022-05-03PetitionerSodium Phosphate Dibasic, Anhydrous Material Safety Data Sheet, SCHOLAR CHEM. (Jan. 23, 2009)
10762022-05-03PetitionerPfannkoch, The Preparation of Buffers and Other Solutions: A Chemist���s Perspective, MOLECULAR BIOLOGY PROBLEM SOLVER: A LABORATORY GUIDE Ch. 3:31���47 (Alan S. Gerstein ed., 2001)
10772022-05-03PetitionerHANDBOOK OF PHARMACEUTICAL EXCIPIENTS 5���7, 193���196, 281���284, 351���352, 741���742, 984���989 (Raymond C. Rowe et al. eds., 7th ed. 2012) - Part 1
10782022-05-03PetitionerInternational Patent Publication No. WO 2013/167865 to Purandare
10792022-05-03PetitionerU.S. Patent Publication No. 2008/0300316 to Gant et al.
10802022-05-03PetitionerWaterman et al., Hydrolysis in Pharmaceutical Formulations, PHARM. DEV. & TECH. 7(2):113���146 (2002)
10812022-05-03PetitionerLin et al., Formulation and stability of an extemporaneous 0.02% chlorhexidine digluconate ophthalmic solution, J. FORMOSAN MED. ASS���N 114:1162���1169 (2015)
10822022-05-03PetitionerSusina et al., Effect of Deuterium Oxide on Local Anesthetic Activity of Procaine, J. PHARM. SCIS. 51(12):1166���1169 (1962)
10832022-05-03PetitionerDimitrios Stefanidis & William P. Jencks, General Base Catalysis of Ester Hydrolysis, J. AM. CHEM. SOC. 115:6045���6050 (1993)
10842022-05-03PetitionerBerton et al., Stability of Ophthalmic Atropine Solutions for Child Myopia Control, PHARMACEUTICS 12(8):781 (2020)
10852022-05-03PetitionerJohn D. Mullins & Gerald Hecht, Tonicity, Osmoticity, Osmolality and Osmolarity and Stability of Pharmaceutical Products, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY, VOLUME I 613���627, 639���647 (Alfonso R. Gennaro ed., 19th ed. 1995)
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10892022-05-03PetitionerU.S. Application No. 16/805,612, Information Disclosure Statement, March 2, 2020
10902022-05-03PetitionerU.S. Patent No. 9,770,447, Preliminary Amendment and Response to Notice to File Missing Parts, August 3, 2013
10912022-05-03PetitionerU.S. Patent No. 9,770,447, Non-Final Office Action, September 30, 2016
10922022-05-03PetitionerU.S. Patent No. 9,770,447, Information Disclosure Statement and International Search Report, November 17, 2016
10932022-05-03PetitionerU.S. Patent No. 9,770,447, Final Rejection, January 25, 2017
10942022-05-03PetitionerU.S. Patent No. 9,770,447, Response to Final Office Action, March 21, 2017
10952022-05-03PetitionerU.S. Patent No. 9,770,447, AFCP2.0 Response to Final Office Action Dated and Advisory Action, April 21, 2017
10962022-05-03PetitionerPeter Zvirblis & Robert I. Ellin, Kinetics and Stability of a Multicomponent Organophosphate Antidote Formulation in Glass and Plastic, J. PHARM. SCIS. 71(3):321���325 (1982)
10972022-05-03PetitionerU.S. Patent No. 9,770,447, Notice of Allowance, May 30, 2017
10982022-05-03PetitionerU.S. Patent No. 9,770,447, Certificate of Correction
32022-05-11BoardNotice of Filing DateNotice: Notice filing date accorded
42022-05-17Potential Patent OwnerMandatory NoticePatent Owner's Mandatory Notices
52022-05-17Potential Patent OwnerPower of AttorneyPatent Owner's Power of Attorney
62022-08-11Potential Patent OwnerPreliminary ResponsePatent Owner's Preliminary Response
20012022-08-11Potential Patent OwnerEX2001 - US 9,421,199 File History
20022022-08-11Potential Patent OwnerEX2002 - Lund et al
20032022-08-11Potential Patent OwnerEX2003 - US 9,770,447 File History
20052022-08-11Potential Patent OwnerEX2005 - US 10,251,875 File History
20062022-08-11Potential Patent OwnerEX2006 - IPR2022-00384 EX1002 - Byrn Declaration
72022-11-07BoardInstitution DecisionInstitution Decision: Denying Institution of Inter Partes Review 35 U.S.C. sec. 314
82022-11-22PetitionerOtherPetitioner's Request for Refund of Post-Institution Fee
Grounds Asserted

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