throbber
US008293284B2
`
`
`
`
`
`
`
`(12) United States Patent
`Baldassarre et al.
`
`
`
`
`
`
`(10) Patent N0.:
`
`
`(45) Date of Patent:
`
`
`
`
`US 8,293,284 B2
`
`
`
`*Oct. 23, 2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The NIH (Critical Care Therapy and Respiratory Care Section; Nitric
`
`
`
`
`
`
`
`
`
`Oxide Therapy, May 2000, 13 pages).*
`
`
`
`
`
`Bolooki (Clinical Application of the Intra-Aortic Balloon Pump
`
`
`
`
`
`
`
`1998, 3rd Ed. pp. 252-253).*
`
`
`
`
`
`Henrishsen (Journal of Pediatrics 1996, 129(1) p. 183).*
`
`
`
`
`
`
`Krohn (The Journal of Thoracic and Cardiovascular Surgery 1999,
`
`
`
`
`
`
`
`117(1) pp. 195-196).*
`
`
`
`Semigren (Abstract of J Am Coll Cardiol 1994; 24: 982-988).*
`
`
`
`
`
`Hayward (Cardiovascular Research 1999; 43:628-638).*
`
`
`
`
`
`Bocchi (The American Journal ofCardiology 1994, 74, pp: 70-72. 4
`
`
`
`
`
`
`
`
`
`pages).*
`Beghetti et al. (the Journal of Pediatrics 1997 p. 844).*
`
`
`
`
`
`
`
`Davidson et al. (Pediatrics 1998, 101 (3) pp. 325-334).*
`
`
`
`
`
`
`
`
`The Neonatal Inhaled Nitric Oxide Study Group (The New England
`
`
`
`
`
`
`
`
`
`Journal of Medicine 1997, 336(9), pp. 597-604).*
`
`
`
`
`
`
`Macrae (Semin Neonatal 1997, 2, 49-58).*
`
`
`
`
`
`Miller et al. (Achives of Disease in Childhood 1994, 70, F47-F49).*
`
`
`
`
`
`
`
`Weinberger et al. (Toxicology Sciences 2001, 59, 5-16).*
`
`
`
`
`
`
`
`Hurford et al. (Nitric Oxide: Biology and Pathobiology 2000 Aca-
`
`
`
`
`
`
`
`
`
`demic Press, Chapter 56, pp. 931-945).*
`
`
`
`
`
`
`Kazerooni et al. (Cardiopulmonary Imaging 2004, Lippincott Will-
`
`
`
`
`
`
`
`iams & Wilkins, pp. 234-235).*
`
`
`
`
`Wheeler et al. (Pediatric Critical Care Medicine 2007, Springer, p.
`
`
`
`
`
`
`
`
`278).*
`
`Moss et al. (Moss andAdams’ Heart Disease in Infants, Children, and
`
`
`
`
`
`
`
`
`Adolescents, 2007, vol. 1, p. 991 in part).*
`
`
`
`
`
`
`Bocchi et al. The American Journal of Cardiology 1994, 74, pp:
`
`
`
`
`
`
`
`
`
`70-72. 4 pages).*
`
`
`“Inhaled Nitric Oxide and Hypoxic Respiratory Failure in Infants
`
`
`
`
`
`
`
`
`With Congenital Diaphragmatic Hernia”, The Neonatal Inhaled
`
`
`
`
`
`
`
`Nitric Oxide Study Group (NINOS), Pediatrics, vol. 99, No. 6, Jun. 6,
`
`
`
`
`
`
`
`
`
`
`1997, pp. 838-845.
`
`
`
`“Inhaled Nitric Oxide in Full-Term and Nearly Full-Term Infants
`
`
`
`
`
`
`
`with Hypoxic Respiratory Failure”, The Neonatal Inhaled Nitric
`
`
`
`
`
`
`
`Oxide Study Group, N Engl J Med, 1997, vol. 336, No. 9, pp.
`
`
`
`
`
`
`
`
`
`597-605.
`
`Adatia, et al, “Inhaled Nitric Oxide and Hemodynamic Evaluation of
`
`
`
`
`
`
`
`
`Patients With Pulmonary Hyptertension Before Transplantation”,
`
`
`
`
`
`
`Journal of the American College of Cardiology, Elsevier, New York,
`
`
`
`
`
`
`
`
`NY, vol. 25, No. 7, Jun. 1, 1995, p. 1663.
`
`
`
`
`
`
`
`Al-Alaiyan S et al., “Inhaled nitric oxide in persistent pulmonary
`
`
`
`
`
`
`
`hypertension of the newborn refractory to high-frequency ventila-
`
`
`
`
`
`
`tion”, Crit Care, vol. 3, No. 1, 1999, pp. 7-10.
`
`
`
`
`
`
`
`
`Argenziano, et al ., “Inhaled Nitric Oxide is not a Myocardial Depres-
`
`
`
`
`
`
`
`sant in a Porcine Model of Heart Failure”, The Journal of Thoracic
`
`
`
`
`
`
`
`
`and Cardiovascular Surgery, 1998, vol. 115, pp. 700-704.
`
`
`
`
`
`
`
`
`Atz AM et al., “Combined Effects of Nitric Oxide and Oxygen
`
`
`
`
`
`
`
`
`
`During Acute Pulmonary Vasodilator Testing”, Journal ofthe Ameri-
`
`
`
`
`
`
`
`can College of Cardiology (JACC), vol. 33, No. 3, Mar. 1, 1999, pp.
`
`
`
`
`
`
`
`
`
`
`813 -819.
`
`
`Barrington, et al., Inhaled Nitric Oxide for Preterm Infants: A Sys-
`
`
`
`
`
`
`
`
`tematic Review, Pediatrics 2007; 120; 1088-1099, DOI: 10.1542/
`
`
`
`
`
`
`
`
`peds.2007-0726.
`
`Barst et al., “Nitric Oxide in Combination with Oxygen versus Either
`
`
`
`
`
`
`
`
`
`Oxygen Alone or Nitric Oxide Alone for Acute Vasodilator Testing in
`
`
`
`
`
`
`
`
`Children with Pulmonary Hypertemsion: A Multicenter, Random-
`
`
`
`
`
`
`ized Study”, INO Therapeutic s/Ikaria, Baltimore Convention Center,
`
`
`
`
`
`
`
`
`May 3, 2009, 2 pages, Abstract, downloaded Jul. 2, 2009 from http://
`
`
`
`
`
`
`
`
`
`127.0.0.129080/PAS09A1/view.y?nu:PAS09L1_1507.
`
`
`
`
`
`(Continued)
`
`
`
`Primary Examiner — Ernst Arnold
`
`
`
`(74) Attorney, Agent, or Firm — Fish & Richardson P.C.
`
`
`
`
`
`
`
`
`
`
`(57)
`
`ABSTRACT
`
`
`
`The invention relates methods ofreducing the risk or prevent-
`
`
`
`
`
`
`
`
`ing the occurrence of an adverse event (AE) or a serious
`
`
`
`
`
`
`
`
`adverse event (SAE) associated with a medical treatment
`
`
`
`
`
`
`
`comprising inhalation of nitric oxide.
`
`
`
`
`
`30 Claims, No Drawings
`
`
`
`
`
`001
`
`PRAXAIR ET AL. 1001
`
`(54) METHODS OF REDUCING THE RISK OF
`
`
`
`
`
`OCCURRENCE OF PULMONARY EDEMA IN
`
`
`
`TERM OR NEAR-TERM NEONATES IN NEED
`
`
`
`
`OF TREATMENT WITH INHALED NITRIC
`
`
`
`
`
`OXIDE
`
`
`(75)
`
`
`Inventors: James S. Baldassarre, Doylestown, PA
`
`
`
`
`(US); Ralf Rosskamp, Chester, NJ (US)
`
`
`
`
`
`
`(73) Assignee:
`
`
`
`INO Therapeutics LLC, Hampton, NJ
`
`
`
`
`(US)
`
`
`( * ) Notice:
`
`
`
`
`Subject to any disclaimer, the term of this
`
`
`
`
`
`
`patent is extended or adjusted under 35
`
`
`
`
`U.S.C. 154(b) by 0 days.
`
`
`
`This patent is subject to a terminal dis-
`
`
`
`
`
`claimer.
`
`
`
`
`
`(21) Appl.No.: 12/821,041
`
`(22)
`
`
`
`Filed:
`
`
`Jun. 22, 2010
`
`
`
`
`(65)
`
`
`
`Prior Publication Data
`
`
`
`US 2010/0331405 A1
`Dec. 30, 2010
`
`
`
`
`
`
`
`Related U.S. Application Data
`
`
`
`
`(63) Continuation of application No. 12/494,598, filed on
`
`
`
`
`
`
`Jun. 30, 2009, now abandoned.
`
`
`
`
`
`
`(51)
`
`
`Int. Cl.
`
`
`(2006.01)
`A01N 59/00
`
`
`
`(2006.01)
`A61K 33/00
`
`
`
`(2006.01)
`C01B 21/24
`
`
`
`(2006.01)
`A6]M 16/00
`
`
`
`(52) U.S. Cl.
`.................. .. 424/718; 128/200.24; 423/405
`
`
`
`
`
`
`(58) Field of Classification Search ...................... .. None
`
`
`
`
`
`
`See application file for complete search history.
`
`
`
`
`
`
`
`
`(56)
`
`
`References Cited
`
`
`U.S. PATENT DOCUMENTS
`
`
`
`2/1999 Zapol et al.
`5,873,359 A
`
`
`
`
`5/2000 Zapol et al.
`6,063,407 A
`
`
`
`
`8/2003 Bloch et al.
`6,601,580 B1
`
`
`
`
`
`7/2009 Rothbard et al.
`7,557,087 B2
`
`
`
`
`
`6/2004 Whitehurst et al.
`2004/0106954 A1
`
`
`
`
`
`
`2009/0018136 A1
`1/2009 Oppenheimer et al.
`
`
`
`
`
`1/2009 Elliott
`2009/0029371 A1
`
`
`
`
`6/2009 Starket al.
`2009/0149541 A1
`
`
`
`
`7/2009 Blackburn et al.
`2009/0176772 A1
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`1682672 A1
`7/2000
`
`
`
`WO2005004884 A2
`1/2005
`
`
`
`WO2006127907 A2
`11/2006
`
`
`
`WO2010019540 A1
`2/2010
`
`
`OTHER PUBLICATIONS
`
`
`The American Illustrated Medical Dictionary (Dorland, 1914, 7th Ed,
`
`
`
`
`
`
`
`
`p. 113).*
`
`Beghetti et al. (Journal of Pediatrics, 1997, p. 844).*
`
`
`
`
`
`
`Macrae et al. (Intensive Care Med 2004, 30, pp. 372-380).*
`
`
`
`
`
`
`
`
`
`Atz et al. (Seminars in Perinatology 1997, 21(5), pp. 441-455).*
`
`
`
`
`
`
`
`
`Kinsella et al. (The Lancet 1999, 354, pp. 1061-1065).*
`
`
`
`
`
`
`
`
`
`
`
`EP
`
`WO
`
`WO
`
`WO
`
`
`001
`
`

`
`
`
`US 8,293,284 B2
`Page 2
`
`
`
`
`OTHER PUBLICATIONS
`
`
`Bland, “Pulmonary vascular dysfuction in preterm lambs with
`
`
`
`
`
`
`
`
`chronic lung disease”, Am J Physical Lung Cell Mol Physiol 285:
`
`
`
`
`
`
`
`
`
`L76-L85, 2003.
`
`
`Bocchi EA et al.,“Inhaled Nitric Oxide Leading to Pulmonary Edema
`
`
`
`
`
`
`
`in Stable Severe Heart Failure”, The American Journal ofCardiology,
`
`
`
`
`
`
`
`
`
`vol. 74, Jul. 1, 1994, pp. 70-72.
`
`
`
`
`
`
`
`Budts W et al., “Residual pulmonary vasoreactivity to inhaled nitric
`
`
`
`
`
`
`
`oxide in patients with severe obstructive pulmonary hypertension and
`
`
`
`
`
`
`
`
`Eisenmenger syndrome”, Heart, vol. 86, 2001, pp. 553-558.
`
`
`
`
`
`
`
`
`Clark RH et al., “Low-Dose Nitric Oxide Therapy for Persistent
`
`
`
`
`
`
`
`
`
`Pulmonary Hypertension: 1-Year Follow-up”, Journal of Perinatol-
`
`
`
`
`
`
`ogy, (2003) 23:300-303.
`
`
`
`Clark, et al., Low-Dose Nitric Oxide Therapy for Persistent Pulmo-
`
`
`
`
`
`
`
`
`nary Hypertension: 1-Year Follow-up, Journal of Perinatology 2003;
`
`
`
`
`
`
`
`23: 300-303.
`
`
`Cockrill BA et al., “Comparison of the Effects of Nitric Oxide,
`
`
`
`
`
`
`
`
`
`Nitroprusside, and Nifedipine on Hemodynamics and Right
`
`
`
`
`
`
`
`Ventricular Contractibility in Patients With Chronic Pulmonary
`
`
`
`
`
`
`
`Hypertension”, Chest, vol. 119, No. 1, Jan. 2001, pp. 128-136.
`
`
`
`
`
`
`
`
`
`Cornfield DN et al., “Randomized, Controlled Trial of Low-dose
`
`
`
`
`
`
`
`Inhaled Nitric Oxide in the Treatment of Term and Near-term Infants
`
`
`
`
`
`
`
`
`
`With Respiratory Failure and Pulmonary Hypertension”, Pediatrics,
`
`
`
`
`
`
`
`vol. 104, No. 5, pp. 1089-1094 (Nov. 5, 1999).
`
`
`
`
`
`
`
`Cujec, et al., “Inhaled Nitric Oxide Reduction in Systolic Pulmonary
`
`
`
`
`
`
`
`
`Artery Pressure is Less in Patients with Decreased Left Ventricular
`
`
`
`
`
`
`
`
`Ejection Fraction”, Canadian Journal of Cardiology, 1997, vol. 13
`
`
`
`
`
`
`
`
`(9), pp. 816-824.
`
`
`
`Davidson D et al., “Inhaled nitric oxide for the early treatment of
`
`
`
`
`
`
`
`
`
`persistent pulmonary hypertension of the term newborn: a random-
`
`
`
`
`
`
`
`double-masked,
`placebo-controlled,
`dose-response,
`ized,
`
`
`
`
`multicenter study”, Pediatrics, Mar. 1998; 101(3 Pt 1):325-34.
`
`
`
`
`
`
`
`Davidson D et al., “Safety of Withdrawing Inhaled Nitric Oxide
`
`
`
`
`
`
`
`Therapy in Persistent Pulmonary Hypertension of the Newborn”,
`
`
`
`
`
`
`
`Pediatrics, vol. 104, No. 2, Aug. 2, 1999, pp. 231-236.
`
`
`
`
`
`
`
`
`Day RW et al., “Pulmonary Vasodilatory Effects of 12 and 60 Parts
`
`
`
`
`
`
`
`Per Million Inhaled Nitric Oxide in Children with Ventricular Septal
`
`
`
`
`
`
`
`
`
`Defect”, The American Journal of Cardiology, vol. 75, Jan. 15, 1995,
`
`
`
`
`
`
`
`
`
`
`pp. 196-198.
`
`
`Dickstein, et al., “A Theoretic Analysis of the Effect of Pulmonary
`
`
`
`
`
`
`
`
`Vasodilation on Pulmonary Venous Pressure:
`Implications for
`
`
`
`
`
`
`
`Inhaled Nitric Oxide Therapy”, The Journal ofHeart and Lung Trans-
`
`
`
`
`
`
`
`
`
`
`plant Jul. 1996, pp. 715-721.
`
`
`
`
`
`Ivy, et al., “Dipyridamole attenuates rebound pulmonary hyperten-
`
`
`
`
`
`
`
`
`sion after inhaled nitric oxide withdrawal in postoperative congenital
`
`
`
`
`
`
`
`
`heart disease”, J Thorac Cardiovasc Surg 1998; 115:875-882.
`
`
`
`
`
`
`
`Dorling, “Neurodevelopmental outcome following Nitric Oxide
`
`
`
`
`
`
`Therapy for Persistent Pulmonary Hypertension in Term Newborn
`
`
`
`
`
`
`
`Infants”, Neonatal Intensive Care Unit, Leicester Royal Infirmary,
`
`
`
`
`
`
`
`
`Aug. 8, 2003, modified Nov. 12, 2003, 3 pages.
`
`
`
`
`
`
`
`Ferguson, et al., “Inhaled nitric oxide for hypoxemic respiratory
`
`
`
`
`
`
`
`
`failure: Passing bad gas?”, Canadian Medical Association Journal,
`
`
`
`
`
`
`
`
`Jan. 11, 2000; 162 (1), pp. 85-86.
`
`
`
`
`
`
`Field, Neonatal Ventilation With Inhaled Nitric Oxide Versus Venti-
`
`
`
`
`
`
`
`
`
`latory Support Without Inhaled Nitric Oxide for Preterm Infants With
`
`
`
`
`
`
`
`
`
`Severe Respiratory Failure: The INNOVO Multicentre Radomised
`
`
`
`
`
`
`
`Controlled Trial
`(ISRCTN 17821339),
`“Pediatrics”
`Journal
`
`
`
`
`
`
`2005: 1 152926-936, DOI: 10.1542/peds.2004-1209.
`
`
`Findlay, “Paradoxical Haemodynamic Response to Inhaled Nitric
`
`
`
`
`
`
`Oxide”, International Journal of Intensive Care 1998 GB, vol. 5, No.
`
`
`
`
`
`
`
`
`
`4, 1998, pp. 134-139.
`
`
`
`
`Finer NN et al., “Randomized, Prospective Study of Low-Dose Ver-
`
`
`
`
`
`
`
`sus High-Dose Inhaled Nitric Oxide in the Neonate With Hypoxic
`
`
`
`
`
`
`
`
`
`Respiratory Failure”, Pediatrics, vol. 108, No. 4, Oct. 4, 2001.
`
`
`
`
`
`
`
`
`Greenough, “Inhaled nitric oxide in the neonatal period”, Expert
`
`
`
`
`
`
`
`
`Opinion on Investigational Drugs, 2000 Ashley Publications Ltd,
`
`
`
`
`
`
`
`1354-3784, 9 pages.
`
`
`Hayward CS et al., “Effect ofInhaled Nitric Oxide on Normal Human
`
`
`
`
`
`
`
`
`LeftVentricular Function,”JACC,vol. 30,No. 1, Jul. 1997, pp.49-56.
`
`
`
`
`
`
`Hayward CS et al., “Inhaled Nitric Oxide in Cardiac Failure: Vascular
`
`
`
`
`
`
`
`
`Versus Ventricular Effects”, Journal of Cardiovascular Pharmacol-
`
`
`
`
`
`
`
`ogy, vol. 27, 1996, pp. 80-85, Abstract Only.
`
`
`
`
`
`
`
`
`
`002
`
`Hayward et al., “Left Ventricular Chamber Function During Inhaled
`
`
`
`
`
`
`
`
`Nitric Oxide in Patients with Dilated Cardiomyopathy”, J. Cardio-
`
`
`
`
`
`
`
`vascular Pharmacology, vol. 34, Iss. 5, Nov. 1999, pp. 749-754,
`
`
`
`
`
`
`
`
`
`
`Abstract.
`
`Henrichsen, et al., “Inhaled Oxide Can Cause Severe Systemic
`
`
`
`
`
`
`
`
`Hypotension”, Journal of Pediatrics, Mosby-Year Book, St. Louis,
`
`
`
`
`
`
`MO, vol. 129, No. 1, Jul. 1996, p. 183.
`
`
`
`
`
`
`Inglessis I et al., “Does inhaled nitric oxide support the hemodynamic
`
`
`
`
`
`
`
`
`
`of spontaneous breathing patients with cardiogenic shock related to
`
`
`
`
`
`
`
`
`right ventricular myocardial infarction? Reply”, JACC, vol. 45, No.
`
`
`
`
`
`
`
`
`
`6, Mar. 15, 2005, pp. 965-966.
`
`
`
`
`
`
`Inglessis I et al., “Hemodynamic effects of inhaled nitric oxide in
`
`
`
`
`
`
`
`
`
`right ventricular myocardial
`infarction and cardiogenic shock”,
`
`
`
`
`
`
`
`JACC, vol. 44, No. 4, Aug. 18, 2004, pp. 793-798.
`
`
`
`
`
`
`
`
`
`“Inhaled Nitric Oxide (INO) in Hypoxic Respiratory Failure”, Study
`
`
`
`
`
`
`
`
`description, study sponsored by INO Therapeutics, ClinicalTrials.
`
`
`
`
`
`
`gov Identifier NCT00922532, Jun. 16, 2009, 4 pages.
`
`
`
`
`
`
`
`Krasuski RA et al., “Inhaled Nitric Oxide Selectively Dilates Pulmo-
`
`
`
`
`
`
`
`
`nary Vasculature in Adult Patients With Pulmonary Hypertension,
`
`
`
`
`
`
`
`Irrespective of Etiology”, Journal of the American College of Cardi-
`
`
`
`
`
`
`ology (JACC), vol. 36, No. 7, Dec. 2000, pp. 2204-2211.
`
`
`
`
`
`
`
`
`
`Lipshultz, “Ventricular dysfunction clinical research in infants, chil-
`
`
`
`
`
`
`
`dren and adolescents”, Progress in Pediatric Cardiology 12 (2000)
`
`
`
`
`
`
`
`1-28.
`Loh, et al., “Cardiovascular Effects of Inhaled Nitric Oxide in
`
`
`
`
`
`
`
`
`Patients with Left Ventricular Dsyfunction,” Circulation, Aug. 7,
`
`
`
`
`
`
`
`1994, 90, pp. 2780-2785.
`
`
`
`
`Magee et al., “Comparison of Supplemental Oxygen and Nitric
`
`
`
`
`
`
`
`Oxide for Inhalation plus oxygen in the evaluation ofthe reactivity of
`
`
`
`
`
`
`
`the pulmonary vasculature during Acute PulmonaryVasodilator Test-
`
`
`
`
`
`
`
`ing”, Oct. 1, 2004-Oct. 31, 2006, Reserach project description,
`1
`
`
`
`
`
`
`
`
`page, http://www.rbht.nhs.uldresearch.
`
`
`Matsumoto A et al., “Effect of Inhaled Nitric Oxide on Gas Exchange
`
`
`
`
`
`
`
`
`in Patients with Congestive Heart Failure”, Annals of Internal Medi-
`
`
`
`
`
`
`
`
`
`cine, vol. 130, No. 1, 1999140-44.
`
`
`
`
`
`Morales-Blanhir J et al., “Clinical value of vasodilator test with
`
`
`
`
`
`
`
`
`inhaled nitric oxide for predicting long-term response to oral
`
`
`
`
`
`
`
`
`vasodilators in pulmonary hypertension”, Respiratory Medicine, vol.
`
`
`
`
`
`98, 2004, pp. 225-234.
`
`
`
`
`Murray, et al., “Nitric Oxide and Septic Vascular Dysfunction”,
`
`
`
`
`
`
`
`Anesth Analg 2000; 90189-101.
`
`
`
`
`Natori S et al., “Inhaled Nitric Oxide Modifies Left Ventricular Dias-
`
`
`
`
`
`
`
`
`
`tolic Stress in the Presence of Vasoactive Agents in Heart Failure”,
`
`
`
`
`
`
`
`
`Am J Respir Crit Care Med, vol. 167, pp. 895-901, 2003.
`
`
`
`
`
`
`
`
`
`
`Ovodov, et al., “Nitric Oxide: Clinical Applications”, Seminars in
`
`
`
`
`
`
`
`Aneshesia, Saunders, CO, NewYorkNY, vol. 19, No. 2, Jun. 1,2000,
`
`
`
`
`
`
`
`
`
`pp. 88-97.
`
`
`Pepke-Zaba J et al., “Inhaled nitric oxide as a cause of selective
`
`
`
`
`
`
`
`
`pulmonary vasodilation in pulmonary hypertension”, ’ The Lancet,
`
`
`
`
`
`
`vol. 338, Nov. 9, 1991, pp. 1173-1174.
`
`
`
`
`
`
`Ricciardi MJ et al., Inhaled Nitric Oxide in Primary Pulmonary
`
`
`
`
`
`
`
`
`Hypertension: A Safe and Effective Agent for Predicting Response to
`
`
`
`
`
`
`Nifedipine, Journal of the American College of Cardiology (JACC,)
`
`
`
`
`
`
`vol. 32, No. 4, Oct. 1998, pp. 1068-1073.
`
`
`
`
`
`
`
`Roberts, Inhaled Nitric Oxide and Persistent Pulmonary Hyperten-
`
`
`
`
`
`
`
`
`sion ofthe Newborn, The New England Journal of Medicine, Feb. 27,
`
`
`
`
`
`
`
`
`
`1997, vol. 336, No. 9, pp. 605-610.
`
`
`
`
`
`
`Rosales, et al., “Hemodynamic Effects Observed with Inhaled Nitric
`
`
`
`
`
`
`
`Oxide After Surgical Repair of Total Anamolous Pulmonary Venous
`
`
`
`
`
`
`
`Return”, Pediatric Cardiology, 1999, vol. 20, pp. 224-226.
`
`
`
`
`
`
`
`
`Sadiq HF et al., “Inhaled Nitric Oxide in the Treatment of Moderate
`
`
`
`
`
`
`
`
`Persistent Pulmonary Hypertension of the Newborn: A Randomized
`
`
`
`
`
`Controlled, Multicenter Trial”, Journal of Perinatology, 2003; 23:98-
`
`
`
`
`
`
`
`103.
`
`Sehgal A et al., “Experience with Inhaled Nitric Oxide Therapy in
`
`
`
`
`
`
`
`
`Hypoxic Respiratory Failure of the Newborn”, Indian J Chest Dis
`
`
`
`
`
`
`
`
`Allied Sci, 2005; 47:245-49.
`
`
`
`
`Semigran et al., “Hemodynamic Effects of Inhaled Nitric Oxide in
`
`
`
`
`
`
`
`Heart Failure”, Journal of American College of Cardiology (JACC),
`
`
`
`
`
`
`
`vol. 24, No. 4, Oct. 1994, pp. 982-988.
`
`
`
`
`
`
`
`Singh, et al., “Nitric Oxide, the biological mediator of the decade:
`
`
`
`
`
`
`
`
`fact of fiction?”, Eur Respir J 1997; 10: 699-707.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`002
`
`

`
`
`
`US 8,293,284 B2
`Page 3
`
`
`Fish & Richardson P.C., Statement of Substance of Interview and
`
`
`
`
`
`
`
`Comments on Examiner’s Interview Summary, in U.S. Appl. No.
`
`
`
`
`
`
`
`12/821,020, filed Apr. 23, 2012, 8 pages.
`
`
`
`
`
`
`INO Therapeutics, “Comparison ofInhaled Nitric Oxide and Oxygen
`
`
`
`
`
`
`
`
`in Patient Reactivity during Acute Pulmonary Vasodilator Testing,”
`
`
`
`
`
`
`
`
`downloaded from clinicaltrials.gov on Apr. 23, 2012; first received on
`
`
`
`
`
`
`
`
`
`Feb. 20, 2008; last updated on Oct. 18, 2010.
`
`
`
`
`
`
`
`
`Barst et al., “Vasodilator Testing with Nitric Oxide and/or Oxygen in
`
`
`
`
`
`
`
`
`
`Pediatric Pulmonary Hypertension,” Received: Sep. 14, 2009 /
`
`
`
`
`
`
`
`Accepted: Jan. 19, 2010 Springer Science+ Business Media, LLC,
`
`
`
`
`
`
`
`
`
`2010, 9 pages.
`
`
`Beggs et al., “Cardiac Failure in Children,” 17th Expert Committee
`
`
`
`
`
`
`
`
`on the Selection and Use of Essential Medicines, Geneva, Mar. 2009,
`
`
`
`
`
`
`
`
`
`31 pages.
`
`Canadian Office Action mailed May 31, 2011 for Canadian patent
`
`
`
`
`
`
`
`
`application No. 2671029, a counterpart foreign application of U.S.
`
`
`
`
`
`
`
`Appl. No. 12/494,598.
`
`
`
`UTMB Respiratory Care Services, “Delivery of Inhaled Nitric Oxide
`
`
`
`
`
`
`
`Therapy through an Adult or Pediatric Nasal Carmula,” (4 pages) Jul.
`
`
`
`
`
`
`
`2003.
`
`Douwes et al., “The Maze of Vasodilator Response Criteria,” Pub-
`
`
`
`
`
`
`
`
`lished online: Nov. 26, 2010, Pediatr Cardiol, (201 1) 32: pp. 245-246.
`
`
`
`
`
`
`
`
`
`
`
`Frai sse et al., “Acute pulmonary hypertension in infants and children:
`
`
`
`
`
`
`
`
`
`cGMP-related drugs,” Pediatric Crit Care Med 2010, vol. 11, No. 2
`
`
`
`
`
`
`
`
`
`
`(Suppl.), 4 pages.
`
`
`Fraisse et al., “Doppler echocardiographic predictors of outcome in
`
`
`
`
`
`
`newborns with persistent pulmonary hypertension,” Cardiol. Young,
`
`
`
`
`
`
`
`vol. 14, pp. 277-283, 2004.
`
`
`
`
`
`Ichinose et al., “Inhaled Nitric Oxide, A Selective Pulmonary
`
`
`
`
`
`
`
`
`Vasodilator: Current Uses and Therapeutic Potential,” Circulation,
`
`
`
`
`
`
`
`vol. 109, pp. 3106-3111, Feb. 11, 2011.
`
`
`
`
`
`
`
`INOmax (nitric oxide) for inhalation 100 and 800 ppm (parts per
`
`
`
`
`
`
`
`
`
`
`million), drug label insert, 2007, 2 pages.
`
`
`
`
`
`
`Kay et al., “Congestive heart failure in pediatric patients,” From the
`
`
`
`
`
`
`
`
`Department of Pediatrics, Duke University Medical Center, 2001, by
`
`
`
`
`
`
`
`Mosby, Inc., 6 pages.
`
`
`
`Konduri et al., “A Randomized Trial ofEarlyVersus Standard Inhaled
`
`
`
`
`
`
`
`Nitric Oxide Therapy in Term and Near-Term Newborn Infants With
`
`
`
`
`
`
`
`
`
`Hypoxic Respiratory Failure,” Pediatrics, vol. 113, pp. 559-564,
`
`
`
`
`
`
`
`
`2004.
`
`Malloy, “Nitric Oxide Weaning, RT: For Decision Makers in Respi-
`
`
`
`
`
`
`
`
`
`ratory Care,” http://rtn1agazine.com/issues/articles/2000-12_05.
`
`
`
`asp, 3 pages, Dec. 2000.
`
`
`
`
`Rosenberg, “Inhaled nitric oxide in the premature infant with severe
`
`
`
`
`
`
`
`
`
`hypoxemic respiratory failure: A time for caution,” The Journal of
`
`
`
`
`
`
`
`
`Pediatrics, vol. 133, pp. 720-722, Dec. 1998.
`
`
`
`
`
`
`
`Advances in Pulmonary Hypertension, vol. 7(4), pp. 1-418, Winter
`
`
`
`
`
`
`
`2008-2009 (entire issue).
`
`
`
`Non-final Office Action in U.S. Appl. No. 12/820,866, mailed Jun. 8,
`
`
`
`
`
`
`
`
`
`2011, 33 pages.
`
`
`Lee & Hayes, Amendment in Reply to Office Action in U.S. Appl.
`
`
`
`
`
`
`
`No. 12/820,866, mailed Jun. 8,2011, filed Jul. 8, 2011, 105 pages.
`
`
`
`
`
`
`
`
`
`
`Final Office Action in U.S. Appl. No. 12/820,866, mailed Aug. 24,
`
`
`
`
`
`
`
`
`
`2011, 27 pages.
`
`
`Fish & Richardson P.C., Brief on Appeal
`
`
`
`
`
`12/820,866, filed Oct. 4, 2011, 211 pages.
`
`
`
`
`
`
`Examiner Answer in U.S. Appl. No. 12/820,866, mailed Nov. 1,
`
`
`
`
`
`
`
`
`2011, 27 pages.
`
`
`Fish & Richardson P.C., Reply Brief in U.S. Appl. No. 12/820,866,
`
`
`
`
`
`
`
`
`filed Dec. 16,2011, 21 pages.
`
`
`
`
`Non-Final Office Action for U.S. Appl. No. 12/820,980, mailed Jun.
`
`
`
`
`
`
`
`
`
`10, 2011, 30 pages.
`
`
`
`Lee & Hayes, Amendment in Reply to Office Action in U.S. Appl.
`
`
`
`
`
`
`
`
`No. 12/820,980, mailed Jun. 10, 2011, filed Jul. 11, 2011, 99 pages.
`
`
`
`
`
`
`
`
`
`
`
`Final Office Action in U.S. Appl. No. 12/820,980, mailed Sep. 9,
`
`
`
`
`
`
`
`
`
`2011, 26 pages.
`
`
`Bates, “Inhaled Nitric Oxide: A Selective Pulmonary Vasodilator,”
`
`
`
`
`
`
`2004, 9 pages.
`
`
`Definition of “Contraindication” on Medicine.net.com; http://www.
`
`
`
`medterms.com/script/main/art.asp?articlekey:17824; retrieved Mar.
`
`
`14, 2011; 2 pages.
`
`
`
`
`in U.S. Appl. No.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Smyth RL, “Inhaled nitric oxide treatment for preterm infants with
`
`
`
`
`
`
`
`
`
`hypoxic respiratory failure”, Thorax, 2000;55(Suppl 1):S51-S55.
`
`
`
`
`
`
`Steinhorn, RH, “Pulmonary Hypertension, Persistent-Newborn”,
`
`
`
`
`
`Updated Apr.
`19, 2007, http://emedicine.medscape.com/article/
`
`
`
`
`
`898437-overview.
`
`Steinhorn, et al., “Inhaled nitric oxide enhances oxygenation but not
`
`
`
`
`
`
`
`
`
`survival in infants with alveolar capillary dysplasia”, The Journal of
`
`
`
`
`
`
`
`
`Pediatrics, Mar. 1997, pp. 417-422.
`
`
`
`
`
`“Use of Inhaled Nitric Oxide”, American Academy of Pediatrics—
`
`
`
`
`
`
`
`Committee on Fetus and Newborn, Pediatrics vol. 106, No. 2, Aug.
`
`
`
`
`
`
`
`
`
`2000, pp. 344-345.
`
`
`
`Watson, et al., “Clinical and Economic Effects of iNO in Premature
`
`
`
`
`
`
`
`
`Newborns With Respiratory Failure at 1Year”, Pediatrics 2009; 124;
`
`
`
`
`
`
`
`
`1333-1343.
`
`Steinhorn, “Persistent Pulmonary Hypertension in the Newborn and
`
`
`
`
`
`
`
`Infant” 1 (2)1287-299 (1987). [downloaded from www.emedicine.
`
`
`
`
`
`
`com on Jun. 10, 2008].
`
`
`
`
`Roberts, et al., Nitric Oxide and the Lung, Marcel Dekker, Inc., New
`
`
`
`
`
`
`
`
`
`York, NY, p. 333-363 (1997).
`
`
`
`
`Meyler’s Side Effects of Drugs: The International Encyclopedia of
`
`
`
`
`
`
`
`Adverse Drug Reactions and Interactions, Nitric Oxide, Fifteenth
`
`
`
`
`
`
`
`
`Edition, Elsevier B.V (2006).
`
`
`
`
`Ichinose, et al., Circulation, 109:3106-3111 (2004).
`
`
`
`
`
`INO Therapeutics, NCT00041548 at ClinicalTrials. gov (2005).
`
`
`
`
`
`
`INO Therapeutics, NCT00551642 at ClinicalTrials. gov (2007).
`
`
`
`
`
`
`Eunice Kennedy Shriver National Institute of Child Health and
`
`
`
`
`
`
`
`
`
`Human Development (NICHD), NCT00005773 at ClinicalTrials.
`
`
`
`
`
`gov (2005).
`
`
`University of Alabama, NCT00732537 at ClinicalTrials.gov (2008).
`
`
`
`
`Troncy, et al., Can J Anaesth, 44 (9): 973-988 (1997).
`
`
`
`
`
`
`
`Bloch, et al., Cardiovasc. Res. 2007, 75(2): 339-348 (Jul. 15, 2007).
`
`
`
`
`
`
`
`
`
`
`Azeka, et al., “Effects of Low Doses of Inhaled Nitric Oxide Com-
`
`
`
`
`
`
`
`
`
`bined with Oxygen for the Evaluation of Pulmonary Vascular Reac-
`
`
`
`
`
`
`
`
`tivity in Patients with Pulmonary Hypertension,” Pediatric Cardiol,
`
`
`
`
`
`
`
`Vol. 23, pp. 20-26 (2002).
`
`
`
`
`
`Barst et al., “Vasodilator Testing with Nitric Oxide and/or Oxygen in
`
`
`
`
`
`
`
`
`
`Pediatric Pulmonary Hypertension,” Pediatr. Cardiol., vol. 31, pp.
`
`
`
`
`
`
`
`
`598-606 (2010).
`
`
`Beghetti et al., “Inhaled nitric oxide and congenital cardiac disease,”
`
`
`
`
`
`
`
`
`Cardiol. Young, vol. 11, pp. 142-152 (2001).
`
`
`
`
`
`
`
`Bichel et al., “Successful weaning from cardiopulmonary bypass
`
`
`
`
`
`
`
`after cardiac
`surgery using inhaled nitric oxide,” Pediatric
`
`
`
`
`
`
`
`
`Anaesthesia, vol. 7, pp. 335-339 (1997).
`
`
`
`
`
`Bin-Nun et al., “Role of iNO in the modulation of pulmonary vascu-
`
`
`
`
`
`
`
`
`lar resistance,” Journal ofPerinatology, vol. 28, pp. S84-S92 (2008).
`
`
`
`
`
`
`
`
`
`Dickstein et al., “A theoretic analysis of the effect of pulmonary
`
`
`
`
`
`
`
`
`
`
`vasodilation on pulmonary venous pressure: Implications for inhaled
`
`
`
`
`
`
`
`nitric oxide therapy,” J Heart Lung Transplant, vol. 15, pp. 715-721
`
`
`
`
`
`
`
`
`
`
`(1996).
`
`Haddad et al., “Use of inhaled nitric oxide perioperatively and in
`
`
`
`
`
`
`
`
`intensive care patients,” Anesthesiology, vol. 92, pp. 1821-1825
`
`
`
`
`
`
`
`
`(2000).
`
`Hayward et al., “Inhaled Nitric Oxide in Cardiac Failure: Vascular
`
`
`
`
`
`
`
`
`Versus Ventricular Effects,” Journal of Cardiovascular Pharmacol-
`
`
`
`
`
`
`
`ogy, vol. 27, pp. 80-85 (1996).
`
`
`
`
`
`
`Kieler-Jensen et al., “Inhaled nitric oxide in the evaluation of heart
`
`
`
`
`
`
`
`
`transplant candidates with elevated pulmonary vascular resistance,” J
`
`
`
`
`
`
`
`Heart Lung Transplant, vol. 13, pp. 366-375 (1994).
`
`
`
`
`
`
`
`
`Kulik, “Inhaled nitric oxide in the management of congenital heart
`
`
`
`
`
`
`
`
`disease,” Current Opinion in Cardiology, vol. 11, pp. 75-80 (1996).
`
`
`
`
`
`
`
`
`
`Madriago M.D. et al., “Heart Failure in Infants and Children,” Pedi-
`
`
`
`
`
`
`
`
`
`atrics in Review, Fol. 31, pp. 4-12 (2010).
`
`
`
`
`
`
`
`Steudel et al., “Inhaled nitric oxide,” Anesthesiology, vol. 91, pp.
`
`
`
`
`
`
`
`
`1090-1121 (1999).
`
`
`Wessel et al., “Managing low cardiac output syndrome after congeni-
`
`
`
`
`
`
`
`
`
`tal heart surgery,” Crit. Care Med., vol. 29(10) pp. S220-S230 (2001).
`
`
`
`
`
`
`
`
`
`
`
`Interview Summary in U.S. Appl. No. 12/821,020, mailed Jan. 25,
`
`
`
`
`
`
`
`
`
`2012, 4 pages.
`
`
`Fish & Richardson, PC., Statement ofthe Substance of the Interview
`
`
`
`
`
`
`
`and Comments on Examiner’ s Interview Summary, in U.S. Appl. No.
`
`
`
`
`
`
`
`
`12/821,020, filed Feb. 27, 2012, 7 pages.
`
`
`
`
`
`
`Interview Summary in U.S. Appl. No. 12/821,020, mailed Apr. 17,
`
`
`
`
`
`
`
`
`
`2012, 12 pages.
`
`
`
`
`
`
`
`
`
`003
`
`003
`
`

`
`
`
`US 8,293,284 B2
`Page 4
`
`
`
`
`
`
`
`
`
`
`
`
`Murray et al., “Angiotensin Converting Enzyme Inhibitory Peptides
`
`
`
`
`
`
`
`Derived from Food Proteins: Biochemistry, Bioactivity and Produc-
`
`
`
`
`
`
`
`
`tion,” Current Pharmaceutical Design, 2007, vol. 13, pp. 773-791.
`
`
`
`
`
`
`
`
`
`NIH CC: Critical Care Services, http://www.cc.nih.gov/ccmd/clini-
`
`
`
`
`
`
`cal_services.html; retrieved Mar. 10, 2011, 3 pages.
`
`
`
`
`
`
`Guidelines for Industry: Clinical Safety Data Management<<www.
`
`
`
`
`
`
`
`fda.gov/downloads/Drugs/
`
`GuidanceComplianceRegulatoryInformation/Guidance/
`
`ucm073087.pdf>>, Mar. 1995, 17 pages.
`
`
`
`
`
`UCI General Clinical Research Center, <<http://www.gcrc.uci.edu/
`
`
`
`
`
`rsa/aer.cfm>>, retrieved Sep. 13, 2010, 2 pages.
`
`
`
`
`
`
`Office Action inU.S. Appl. No. 12/821,020, mailedAug. 13, 2010, 24
`
`
`
`
`
`
`
`
`pages.
`
`Lee & Hayes, Replacement Reply Amendment in U.S. Appl. No.
`
`
`
`
`
`
`
`
`12/821,020, mailed Aug. 13, 2010, filed Feb. 14,2010, 18 pages.
`
`
`
`
`
`
`
`
`
`Lee & Hayes, Supplemental Reply Amendment in U.S. Appl. No.
`
`
`
`
`
`
`
`12/821,020, filed Apr. 12, 2011, 9 pages.
`
`
`
`
`
`
`Final Office Action in U.S. Appl. No. 12/821,020, mailed Aug. 13,
`
`
`
`
`
`
`
`
`
`
`2010,32 pages.
`
`
`Final Office Action in U.S. Appl. No. 12/821,020, mailed Jun. 27,
`
`
`
`
`
`
`
`
`
`
`2011,29 pages.
`
`
`Fish & Richardson P.C., Supplement to the Reply Brief, U.S. Appl.
`
`
`
`
`
`
`
`
`No. 12/820,866, filed Jan. 3, 2012, 3 pages.
`
`
`
`
`
`
`Fish & Richardson P.C., Amendment in Reply to Final Office Action,
`
`
`
`
`
`
`
`
`U.S.Appl. No. 12/821,020, n1ai1edJun. 27, 2011, fi1edDec. 27, 2011,
`
`
`
`
`
`
`
`
`
`153 pages.
`
`
`Office Action in U.S.App1.No. 12/821,020, mailed Jan. 31, 2012, 30
`
`
`
`
`
`
`
`
`
`
`pages.
`
`Krohn, “Effect of inhaled nitric oxide on left ventricular and pulmo-
`
`
`
`
`
`
`
`
`
`nary vascular function,” The Journal of Thoracic and Cardiovascular
`
`
`
`
`
`
`
`
`Surgery, vol. 117(1), pp. 196-196 (1999).
`
`
`
`
`
`
`Fish & Richardson P.C., Supplemental Amendment in U.S. Appl. No.
`
`
`
`
`
`
`
`12/821,020, filed Apr. 30, 2012, 10 pages.
`
`
`
`
`
`
`Fish & Richardson P.C., Supplemental Remarks in U.S. Appl. No.
`
`
`
`
`
`
`
`12/821,020, filed May 9, 2012, 22 pages.
`
`
`
`
`
`European Patent Office minutes of oral proceedings in EP 09 251
`
`
`
`
`
`
`
`
`949.5, with allowable claims (7 pages), dated May 23, 2012.
`
`
`
`
`
`
`
`
`Behera, et al., Nesiritide Improves Hemodynamics in Children with
`
`
`
`
`
`
`
`Dilated Cardiomyopathy: A Pilot Study, Pediatr Cardiol (2009)
`
`
`
`
`
`
`
`30:26-34.
`
`Bhagavan, et al., Potential role of ubiquinone (coenzyme Q10) in
`
`
`
`
`
`
`
`
`pediatric cardiomyopathy, Clinical Nutrition (2005) 24, 331-338, pp.
`
`
`
`
`
`
`
`
`331-338.
`
`Bublik, et al., Pediatric cardiomyopathy as a chronic disease: A
`
`
`
`
`
`
`perspective on comprehensive care programs, Progress in Pediatric
`
`
`
`
`
`
`Cardiology 25 (2008) 103-111.
`
`
`
`Cox, et al., Factors Associated with Establishing a Causal Diagnosis
`
`
`
`
`
`
`
`
`for Children with Cardiomyopathy, Pediatrics vol. 118, No. 4, Oct.
`
`
`
`
`
`
`
`
`
`2006, pp. 1519-1531.
`
`
`
`Dermatological Cryosurgery in Primary Care with Dimethyl Ether
`
`
`
`
`
`
`
`Propane Spray in Comparison with Liquid Nitrogen, Martinez, et al.,
`
`
`
`
`
`
`
`
`Atnecion Primaria, vol. 18, No. 5, (211, 216), Sep. 30, 1996.
`
`
`
`
`
`
`
`
`
`
`Dronedarone is Less Effective, But Safer Than Amiodarone in Atrial
`
`
`
`
`
`
`
`
`Fibrillation, Oct. 27, 2009, p. 3, <<http://www.npci.org.uldblog/
`
`
`
`
`
`
`?p:778>>.
`
`Ehrenkranz RA, “Inhaled Nitric Oxide in Full-Term and Nearly
`
`
`
`
`
`
`
`
`Full-Term Infants with Hypoxic Respiratory Failure”, The Neonatal
`
`
`
`
`
`
`
`
`Inhaled Nitric Oxide Study Group, NEngl J Med, 1997, vol. 336, No.
`
`
`
`
`
`
`
`
`
`
`
`9, pp. 597-605.
`
`
`
`Elbl, et al., Long-term serial echocardiographic examination of late
`
`
`
`
`
`
`
`anthracycline cardiotoxicity and its prevention by dexrazoxane in
`
`
`
`
`
`paediatric patients, Eur J Pediatr (2005) 164: 678-684.
`
`
`
`
`
`
`
`The Encarta Webster’s Dictionary of the English Language (2004) is
`
`
`
`
`
`
`
`the second edition of the Encarta World Dictionary, published 1999,
`
`
`
`
`
`
`
`
`<<http://encarta.msn.com/encnet/features/dictionary/
`
`dictionaryhome.aspx>>; used to look up the definitions of “precau-
`
`
`
`
`
`tion” and “exclusion”.
`
`
`
`Green, “Patent Ductus Ateriosus Demonstrating Shunting of Blood”,
`
`
`
`
`
`
`Figure from presentation given Jan. 10, 2011, pp#1.
`
`
`
`
`
`
`
`
`Hare, et al., Influence of Inhaled Nitric Oxide on Systemic Flow and
`
`
`
`
`
`
`
`
`
`Ventricular Filling Pressure in Patients Receiving Mechanical Circu-
`
`
`
`
`
`
`
`latory Assistance, Circulation, 1997; 95:2250-2253.
`
`
`
`
`
`
`
`
`Harrison’s Principles of Internal Medicine, Fauci, et al., p. 1287-
`
`
`
`
`
`
`
`
`
`1291 and 1360, 12th edition, McGraw Hill, 1998.
`
`
`
`
`
`
`
`
`Hayward, et al., Inhaled nitric oxide in cardiology practice, Cardio-
`
`
`
`
`
`
`
`
`vascular Research 43 (1999) 628-638.
`
`
`
`
`Huddleston,
`Indications
`for heart
`transplantation in children,
`
`
`
`
`
`
`Progress in Pediatric Cardiology 26 (2009) 3-9.
`
`
`
`
`
`James, et al., Treatment of heart
`failure in children, Current
`
`
`
`
`
`
`
`
`
`Paediatrics (2005) 15, 539-548.
`
`
`
`
`JP 2009-157623 Office Action dated Feb. 15, 2011, 3 pages.
`
`
`
`
`
`
`
`
`
`Lavigne, et al., Cardiovascular

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket