US 6605635B1
· Bai
· 2003
[cited by examiner]
US 8541464B2
· Elliott
· 2013
[cited by examiner]
US 8637566B2
· Elliott
· 2014
[cited by applicant]
US 20100273236A1
· Filpula et al.
· 2010
[cited by applicant]
US 20110020868A1
· Coleman et al.
· 2011
[cited by applicant]
US 20150361405A1
· Retallack et al.
· 2015
[cited by applicant]
CN 1939298A
· 2007
[cited by applicant]
WO 0142204A1
· 2001
[cited by applicant]
WO 2011062903A2
· 2011
[cited by applicant]
WO 2011062906A2
· 2011
[cited by applicant]
WO 2018137686A1
· 2018
[cited by applicant]
WO 2020123824A1
· 2020
[cited by applicant]
“Drugs in Japan,” Medicinal Drug Collection, Jiho Takeda, 27th Edition, 2004, p. 2631, p. 2386.
[cited by applicant]
“Guidance of Industry—Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers,” U.S. Department of Health and Human Services, Pharmacology and Toxicology, Jul. 2…
[cited by applicant]
Anonymous, A Phase 1, randomised, double-blind, placebo-controlled, serial cohort dose-escalation study of intravenously administered HBI-3000. Clinicaltrials.gov study # NCT03397641 (2018).
[cited by applicant]
Anonymous, Abstracts from the 2009 Annual Meeting of the International Society for Heart Research North American Section: New Discoveries for Prevention and Treatment of Heart Disease. Baltimore, MD, United States. May …
[cited by applicant]
Anonymous, HUYA Bioscience Int'l Announces First Pre-Ind Outcome for a Development Stage Compound Sourced From China—Hbi-8000, Promising New Cancer Compound. [Press release] https://www.huyabio.com/huya-bioscience-intl-…
[cited by applicant]
Bai et al., Discovery of N-(3,5-bis(1-pyrrolidylmethyl)-4-hydroxybenzyl)-4-methoxybenzenesulfamide (sulcardine) as a novel anti-arrhythmic agent. Acta Pharmacologica Sinica 33(9):1176-1186 (2012).
[cited by applicant]
Berge, et al., “Pharmaceutical salts,” Journal of Pharmaceutical Sciences, vol. 66, No. 1, Jan. 1977, pp. 1-19.
[cited by applicant]
Chen et al., Characteristics of hERG and hNav1.5 channel blockade by sulcardine sulfate, a novel anti-arrhythmic compound. European Journal of Pharmacology 844:130-138 (2019).
[cited by applicant]
Chen, Qian, et al. “Pharmacokinetics, safety, and tolerability of sulcardine sulfate: an open-label, single-dose, randomized study in healthy Chinese subjects.” Fundamental & clinical pharmacology 31.1 (2017): 120-125.
[cited by applicant]
Chinese Search Report for CN2010800519066, dated Jun. 13, 2014, (1 Page).
[cited by applicant]
David C. Lee and Michael L. Webb, Pharmaceutical Analysis, Wiley-Blackwell, Feb. 2009, pp. 255-257.
[cited by applicant]
Genbank Acccession No. CP001836 “Dickeya zeae Ech586 chromosome, complete genome” Aug. 30, 2017: https://wwwncbi.nlm.nih.gov/nuccore/CP001836.
[cited by applicant]
GenBank Accession No. LM996150, May 9, 2015: https://www.ncbi.nlm.nih.gov/nuccore/LM996150.
[cited by applicant]
Gervais et al.: RADAR (Research Archive and Digital Asset Repository); Validation of a 30-year-old process for the manufacture of L-asparaginase from Erwinia Chrysanthemi; Bioprocess and Biosystems Engineering; 36(4); p…
[cited by applicant]
Glazyrina et al.: High cell density cultivation and recombinant protein production with Escherichia coli in a rocking-motion-type bioreactor; Microbial Cell Factories; 9:42 (2010).
[cited by applicant]
Guo et al., Electrophysiologic effect of HBI-3000: A novel antiarrhythmic compound with multiple channels blocking characteristics in human atrial and ventricular myocytes. Journal of Molecular and Cellular Cardiology 4…
[cited by applicant]
Guo et al., Electrophysiological properties of HBI-3000: a new antiarrhythmic agent with multiple-channel blocking properties in human ventricular myocytes. Journal of Cardiovascular Pharmacology 57(1):79-85 (2011).
[cited by applicant]
Huser et al.: Cloning, sequence analysis, and expression of ansB from Pseudomonas fluorescens, encoding periplasmicglutaminase/asparaginase; FEMS microbiology letters; vol. 178, No. 1, pp. 327-335 (Sep. 1, 1999).
[cited by applicant]
International Application No. PCT/US2018/056374 International Search Report and Written Opinion dated Jan. 11, 2019.
[cited by applicant]
International Application No. PCT/US2018/056375 International Search Report and Written Opinion dated Jan. 17, 2019.
[cited by applicant]
International Application No. PCT/US2018/056376 International Search Report and Written Opinion dated Feb. 19, 2019.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US19/066003, mailed on Mar. 20, 2020, 9 pages.
[cited by applicant]
Japanese Decision of Refusal for JP2012-539070, dated Apr. 2, 2015, (4 pages with English Translation).
[cited by applicant]
Japanese Decision of Refusal for JP2012-539071, dated Apr. 22, 2015, (5 pages with English Translation).
[cited by applicant]
Japanese Decision of Refusal for JP2012-539071, drafted Apr. 22, 2015, (5 pages with English Translation).
[cited by applicant]
Jia et al., “Determination of the novel antiarrhythmic drug sulcardine sulfate in human plasma by liquid chromatography tandem mass spectrometry and its application in a clinical pharmacokinetic study,” Biomedical Chrom…
[cited by applicant]
Lapointe, et al., “Continuous intravenous quinidine infusion for the treatment of atrial fibrillation or flutter: A case series.” American Heart Journal 139.1, Jan. 2000, pp. 114-121.
[cited by applicant]
Latifi et al.: The Cytoplasmic and Periplasmic Expression Levels and Folding of Organophosphorus Hydrolase Enzyme in
[cited by applicant]
Lee at al., HBI-3000 prevents secondary sudden cardiac death. Journal of Cardiovascular Pharmacology and Therapeutics 18(5):453-459 (2013).
[cited by applicant]
Lee et al., “Antifibrillatory actions of HBI-3000 in the conscious canine model of sudden cardiac death”, The Faseb Journal, Federation of American Societies for Experimental Biology, US, vol. 23, Issue S1, Apr. 1, 2009…
[cited by applicant]
Lee et al., HB1-3000 Prevents Sudden Cardiac Death in a Conscious Canine Model., Cardiac Electro physiology Society, CES Annual Meeting. Chicago, IL, United States. Nov. 23, 2010-Nov. 13, 2010; Heart Rhythm 7(11), p. 17…
[cited by applicant]
Lu et al., Oral bioavailability and mass balance studies of a novel anti-arrhythmic agent sulcardine sulfate in Sprague- Dawley rats and beagle dogs. European Journal of Drug Metabolism and Pharmacokinetics 42(3):453-45…
[cited by applicant]
Mason, et al. “HBI-3000: A Novel Drug for Conversion of Atrial Fibrillation-Phase 1 Study Results.” HUYA Bioscience International, Circulation 140, Suppl, 1, 2019, p. A11495.
[cited by applicant]
Nakamura et al.: On the Productivity and Properties of L-Asparaginase from Escherichia coli A-1-3; Agr. Biol. Chem., vol. 36, No. 12, p. 2251-2253 (1972).
[cited by applicant]
PCT/US2020/015370 International Search Report and Written Opinion dated Jun. 6, 2020 (17 Pages).
[cited by applicant]
PCT/US2020/015370 Invitation to Pay Additional Fees dated May 15, 2020 914 Pages).
[cited by applicant]
PCTUS2018056376 PCT Invitation to Pay Additional Fees dated Dec. 18, 2018.
[cited by applicant]
Qi, et al., “Innovative drug R&D in China,” Nature Reviews Drug Discovery, vol. 10, No. 5, May 2011, pp. 333-334.
[cited by applicant]
Roberts et al.: New Procedures for Purification of L-Asparaginase with High Yield from Escherichia coli; Journal of Bacteriology; vol. 95, No. 6; pp. 2117-2123 (1968).
[cited by applicant]
Singh, et al., “N-Acylated sulfonamide sodium salt: A prodrug of choice for the bifunctional 2-hydroxymethyl-4-(5-phenyl-3-trifluoromethyl-pyrazol-I-yl) benzenesulfonamide class of COX-2 inhibitors,” Bioorganic & Medici…
[cited by applicant]
Streitwiesser et al., “Introduction to Organic Chemistry”, Macmillan Publishing Co., 1992, p. 736.
[cited by applicant]
Supplementary European Search Report for EP10832056, dated Apr. 22, 2013, (3 pages).
[cited by applicant]
U.S. Appl. No. 16/775,142 Non Final Office Action dated May 26, 2021.
[cited by applicant]
UniProtKB Accession No. A0A120G5C7_PSEFL, Apr. 13, 2016: https://www.uniprot.org/uniprot/A0A120G5C7.
[cited by applicant]
UniProtKB Accession No. AOA109LCE2 “Asparaginase from Pseudomonas fluorescens” (Apr. 13, 2016) [Retrieved from the internet on Mar. 6, 2019 -< https://www.uniprot.org/uniprot/A0A109LCE2].
[cited by applicant]
Wang et al., Multiple dose pharmacokinetics and safety of sulcardine sulfate in healthy Chinese male subjects: an open-label phase I clinical study. European Journal of Drug Metabolism and Pharmacokinetics 42(4):593-599…
[cited by applicant]
Wang, et al., “Effect of Sulcardine on cardiac electrophysiology in anesthetized rabbits,” Chinese Pharmacological Society Communication vol. 19, No. 4, Nov. 4, 2002, pp. 63-64.
[cited by applicant]
Wang, et al., “Electrophysiological Characterization of a Novel Artiarrhythmic Agent-Sulcardine Salts,” AACTA Pharmacologica Sinica, Jul. 2006. vol. 27, Suppl. 1, p. 123.
[cited by applicant]
Wink, et al.: “Comparison between Two Erwinia carotovora L-Asparaginase II Constructions: cloning, Heterologous Expression, Purification, and Kinetic Characterization” JMBT vol. 2 Issue 1 (7 pages).
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/066003, mailed on Jun. 24, 2021, 7 pages.
[cited by applicant]