CV-KKarelLambert

Curriculum Vita

K Karel Lambert, US Patent Agent Reg No 51,912
Cell: 206 949-1168; E-Mail: KLambert@4iPT.com.

Kal" Karel Lambert - has a professional and scientific background in patent law, pharmacology, molecular biology, microbiology, medical technology, biochem-istry, and chemical engineering. After studying liberal arts 2 years at the Honor's College, University of Oregon, he earned a BS in Biological Science at University of California at Irvine, and graduated with an MS in Microbiology (with Thesis) from San Diego State University in 1981.
US Patents - 9; Scientific publications - 20. MS (Microbiology) Admitted to the Patent Bar in 2002. Bar No. 51,912.
Scientific Career - Since 1991, Lambert's scientific career in industry has focused on intellectual property. Lambert was principal inventor on two pharmaceutical products, which he took from discovery to commercialization. Sonus Pharmaceuticals’ Tocosol® was recently funded by Schering AG in a deal valued at $160M (SNUS/NASDAQ). Optison® is aggressively marketed by Amersham in the US and Europe and by Chugai Pharmaceuticals in the Far East. Lambert also wrote fundamental patents on the engineering for commercial manufacture of Optison® and Tocosol®, and on NCE's and chemical synthetic methods.
Lambert worked for 2 years in a molecular proteomics laboratory at UCSD, where he assisted in pioneering work on the molecular and genomic characterization of the erythrocyte cytoskeleton, 2 years in a medical research laboratory at UCSD specializing in bile acids, 2 years on biofilms in a marine engineering lab (NOSC), a year in a dairy making fermented products, and 2 years writing service manuals for microprocessor-controlled electrohydraulic medical devices. In pharmaceuticals, he lead an organic synthesis team, made new drug discoveries (NCEs), and for several years specialized in developing drug delivery systems. He has extensive bench experience as a medical technologist. Throughout his industrial career, he focused heavily on discovery phase and intellectual property issues.
Intellectual Property Career: Since 1991, Lambert has written more than 40 patent applications, has consulted as an expert witness in patent litigation, and has prosecuted patent applications, meeting with Patent Examiners to discuss patent allowance and with inventors and management on proactive prosecution strategy in private practice, both for corporate and solo inventors. He has worked with executive management and outside counsel to formulate corporate intellectual property strategy, and contributed in meetings with potential partners regarding out-licensing and partnering.
Personal: Mr Lambert was born in Oregon and raised in Canada. He is married, practices fishing, Japanese and woodcarving when possible.
Professional Interests: As a Patent Agent, principal areas of practice include Pharmaceuticals, Biotechnology, Mechanical Devices, and Microbiology, including process patents. Also serves as a member of WBBA's patent legislative advisory committee on matters of patent reform under consideration in Congress this year.

Scientific Publications:

Principal areas of investigation:

· Biphasic systems (solid/water; air/water; oil/water and fluorocarbon/water) of microparticles, including microspheres, encapsulated microdroplets, emulsions, microemulsions and micellar solutions, including:

(a) Lipids, including bile acids, tocopherols, tocotrienols, phospholipids, retinoids, carotenoids, and novel synthetics, such as tocopheramine conjugates, principally for drug delivery or as pharmaceutical actives,

(b) Solids, including proteins, polypeptides, drug microcrystals, and polycarboxylic acids,

· Emulsion parenteral drug delivery, excipients, including polymers, surfactants, co-solvents and mfg processes, including process engineering;

· Lipid membrane physiology and electron transport;

· Pre-clinical, CMC and IND studies, and method validation;

· Biofilms in the marine environment;

· Clinical laboratory testing and assay validation;

· Cloning and expression of erythrocyte cytoskeletal proteins;

· Cyanobacterial role in formation of inceptisols from Hawaiian lavas;

· Fermentation processes and selective enrichment for natural product screening.

Table of Publications:

exp. 2005	Hofmann, AF et al. Novel biotransformation and physiological functions of norursodeoxycholic acid in man (ms in preparation).
2005	Lambert, K. Role of the cyanobacterial community of the high Southwest Rift, Mauna Loa in soil formation: Interactions of Stignonema var. Mauna Loa with Stereocaulon volcanii in inceptisols. (ms in prep)
2000	Constantinides, P., K Lambert, A Tustian, B Schneider, S Lalji, W Ma, B Wentzel, D Kessler, D Worah and SC Quay. 2000. Formulation development and antitumor activity of a filter-sterilizable emulsion of paclitaxel. Pharm Res 17(2):175-82.
1999	Constantinides P, D Kessler, AK Tustian, KJ Lambert, D Worah, SC Quay, S Weitman and Rowinsky EK. 1999. Comparative antitumor activity of a novel injectable emulsion of paclitaxel (QW8184) and Taxol in the B16 melanoma and IGROV-1 human ovarian tumor xenograft in nude mice. Clin Cancer Res 11S:449 (abstract).
1999	Constantinides P, D Kessler, AK Tustian, KJ Lambert, D Worah and SC Quay. 1999. Pharmacokinetics of Taxol and QW8184, an injectable paclitaxel emulsion, in rats following a single dose intravenous administration. AAPS Nov 99 (abstract).
1998	Constantinides P, K Lambert, A Tustian, W Ma, D Kessler, D Worah and S Quay. 1998. Reduced toxicity and improved efficacy of paclitaxel incorporated in oil-in-water emulsions. AAPS Nov 1998 (abstract).
1996	Sung LA, S Chien, YS Fan, CC Lin, K Lambert, L Zhu, JS Lam and LS Chang. 1996. Human erythrocyte protein 4.2: isoform expression, differential splicing and chromosome assignment. Blood 79(10):2763-70.
1992	Sung LA, VM Fowler, K Lambert, MA Sussman, D Karr and S Chien. 1992. Molecular cloning of human fetal liver tropomodulin, a tropomyosin-binding protein. J Biol Chem 267(4):2616-21.
1992	Lira M, CD Schteingart, JH Steinbach, K Lambert, JA McRoberts and AF Hofmann. 1992. Sugar absorption by the biliary ductular epithelium of the rat: evidence for two transport systems. Gastroenterology 102(2):563-71.
1990	Sung LA, S Chien, L-S Chang, K Lambert, SA Bliss, EE Bouhassira, RL Nagel, RS Schwartz and AC Rybicki. 1990. Molecular cloning of human protein 4.2: a major component of the erythrocyte membrane. Proc Natl Acad Sci (USA) 87(3):955-959.
1990	Xia Y, K Lambert, CD Schteingart and AF Hofmann. 1990. Biliary concentrative secretion of ceftriaxone. Inhibition of lipid secretion and precipitation of calcium ceftriaxone in bile. Gastroenterology 99:454-464.
1989	Sung LA, S Chien, L-S Chang, K Lambert, SA Bliss, EE Bouhassira, RL Nagel, RS Schwartz and AC Rybicki. 1989. cDNA sequence for human red cell protein 4.2. FASEB J (abstract).
1989	Oude Elferinck RPJ, J de Haan, KJ Lambert, LR Hagey, AF Hofmann and PLM Jansen. 1989. Selective hepatobiliary transport of nordeoxycholate side chain conjugates in mutant rats with canalicular transport defect. Hepatology 9(6):861-865.
1988	Lake, JR, EL Renner, BF Scharschmidt, EJ Cragoe Jr, LR Hagey, KJ Lambert, D Gurantz and AF Hofmann. 1988. Inhibition of Na+/K+ exchange in the rat is associated with decreased ursodeoxycholate hypercholeresis, decreased secretion of unconjugated ursodeoxycholate, and increased ursodeoxycholate glucuronidation. Gastroenterology 95(2):151-163.
1987	Lira, M, C Schteingart, KJ Lambert, JA McRoberts and AF Hofmann. 1987. Active absorption of monosaccharides by biliary ductules in the isolated perfused rat liver. Hepatology 7:1039 (abstract).
1987	Zakko, S, M Lira, C Clerici, K Lambert, D Gurantz, C Schteingart and AF Hofmann. 1987. Novel metabolism and hypercholeretic effect of norursodeoxycholic acid in man. Gastroenterology 92:1792 (abstract).
1986	Lambert, K, and N Fox. 1986. IVAC Volumetric Pump - Model 560 Series Service Manual. IVAC Corp, San Diego CA.
1986	Fox, N. and K Lambert. 1986. IVAC Vital Check Vital Signs Monitoring System- Model 4000 A/C Service Manual. IVAC Corp, San Diego CA.
1985	Lambert, K, and S Isenhour. 1985. IVAC MultiDose Intermittent Medication Delivery System - Model 460 Service Manual. IVAC Corp, San Diego CA.
1981	Lambert, K. 1981. Pretreatment of cells of Klebsiella pneumoniae with 50% (v/v) dimethylsulfoxide yields purified deoxyribonucleic acid of low polysaccharide content. Agric Biol Chem 46:3079-80.
1981	Lambert, K. 1981. Phospholipid Physiology of Klebsiella pneumoniae. Masters Thesis, San Diego State University, San Diego CA.

US Patents and Applications (as Inventor):

2005, 2004, 2003, 1999	Karel Lambert, et al. Emulsion Vehicle for Poorly Soluble Drugs. Issued - US 6660286; 6667048; 6479540; WO98/30205A1; EP98/1328A1; WO71163A1; WO00071163. Continuing prosecution - US 20050142189, 20040202712, 20040053993, 20030170279, 20030147959, 20030109575, 20030105156, 20030104015, 20030087954, 20030087953, 20030065024, 20030027858.
2001	Karel Lambert, et al. Novel Carboxy-Benzopyran Derivatives and Compositions Thereof. Application in prosecution.
2001	Karel Lambert, et al. Novel Derivatives of Tocopherol Succinate and Compositions Thereof. Application in prosecution.
2001	Karel Lambert, et al. Novel Amino-Benzopyran Derivatives and Compositions Thereof. Application in prosecution.
1999	Karel Lambert, et al. Emulsion Vehicle for Poorly Soluble Drugs. Issued - US 6458373.
1999	Constantinides P, Karel Lambert, et al. Compositions of Tocol Soluble Therapeutics. Issued - US 6479540.
1998	Karel Lambert, et al. Method of Making Encapsulated Gas Microspheres from Heat Denatured Protein. Issued - US 5855865.
1997	Karel Lambert and E Jablonski. Liquid Core Microdroplets. Issued - US 5606973.
1997	Jablonski E and Karel Lambert. Gas-exchange method of making gas-filled microspheres. Issued - 5674469.
1996	Karel Lambert, et al. Method of Making Encapsulated Gas Microspheres Useful as an Ultrasound Imaging Agent. Issued - US 5552133.

Patent Drafting Work Product:

Patent Title/ Appl #	Technology Description	Work Product
Awaiting publication, multiple applications.		Patent Applications, prosecution, and development.
See Sample: Shopping Aid. US 2005/0140119 to Wong	Folding combination shopping basket and cart.	Patent Application, prosecution and development
See Sample: Administration of acetylcholinesterase inhibitors to the CSF. USPA 2003/0225031	Intranasal delivery technology, multiple drugs. Overflow corporate client contract work on 5 patents.	Overflow contract work on 5 patents. Assisted Woodcock Washburn partners Wendy Choi in preparing rush patent application on intranasal Donepezil (US 60/382122) and Jeff King in contract work for corporate Pharma client.
Carboxy-Benzopyran Derivatives and Compositions. WO 02/076938.	Novel chemicals with surfactant properties. Synthetic prodrugs.	Authored patent application, figures examples. Performed formulation work and some chemical syntheses. Drafted patent application and claims with supervision of Joel Ackerman of Townsend Townsend & Crew.
Aminobenzopyran derivatives and compositions. WO 02/076938.	Novel chemicals with surfactant properties. Chemistry of tocopherols and like molecules. Potential NCEs. Recent work has shown these compounds to be active apoptotic agents in mitochondria that are selective for cancer cells [J Neuzil et al. 2004. Vitamin E analogues: a new class of inducers of apoptosis with selective anti-cancer effects. Current Cancer Drug Targets 2004:355-372]. Other work suggests possible applications in reduction of reperfusion injury [Koufaki M et al. 2004. Synthesis of chroman analogues of lipoic acid. Bioorg Med Chem 12:4835-41].	Authored patent application, figures, examples. Performed formulation work and some syntheses. Managed outside contract for new synthetic route to aminotocols.
Novel derivatives of tocopherol succinate and Compositions Thereof. WO 02/076970.	Novel chemicals with surfactant properties. Synthetic prodrugs.	Authored patent application, figures, examples. Performed formulation work and some syntheses. Drafted patent application and claims with supervision of Joel Ackerman of Townsend Townsend & Crew.
Tocol-based compositions containing Amiodarone. US PA, WO 01/030320.	Broad claims to emulsified formulations of Amiodarone, an amine of use as an anti-arrhythmia agent in advanced cardiovascular disease. Market $200 M.	Assisted in patent preparation.
Gas-filled amino acid block co-polymer microspheres useful as ultrasound contrast agents. EP96/0831929; WO96/040279; JP11509837; US 5820850.	Describes peptides comprising alternating blocks of hydrophilic and hydrophobic amino acids that form micelles and microspheres on emulsification.	Co-authored sections of the specification and examples of manufacturing processes. Prepared photomicrographs.
Compositions of tocol-soluble therapeutics. WO01/022937; US 6479540.	Describes tocophilic ion pairs as emulsion species useful for parenteral drug delivery.	Authored specification, examples, figures. Prepared anticipatory US filings to be filed concurrently to cover future research directions.
Emulsion vehicle for poorly soluble drugs. WO98/30205A1; EP98/001328;WO 98/071163; WO00071163; US 6458373, US 6479540, US 6660286, US 6667048.	Formulations for parenteral administration of tocophilic drugs with emulsified excipients. Emphasis on Taxol, Market $1.7 B.	Drafted patent application, examples, claims. Contracted key preclinical animal work. Appeared for interviews at US PTO with counsel to discuss Examiner's rejection.
Concentrated stabilized microbubble-type ultrasonic imaging agent and method of production. JP94/062445; EP94/0324938; US 4844882.	Discloses an ultrasonic manufacturing process for microbubbles encapsulated with cysteine-crosslinked proteins.	Patent was challenged in EPO by Swiss competitor complaining that the disclosure's support for broad claims was not enabling. Authored technical reply defending against "Observation". Patent issued.
Liquid core microdroplets for ultrasound imaging. WO96/040280; US 5606973.	Composition and method of manufacture of microspheres comprising a cysteine-crosslinked shell and a liquid perfluorocarbon or oil core.	Authored patent application, examples, figures, graphs. Issued.
Process for making gas-filled microspheres containing a liquid hydrophobic barrier. US 5730955; 5965109; 6063362.	Describes a microbubble comprising a gas core, polymeric shell, and internal coat of a liquid or solid condensate inside the shell.	Authored sections of specification and examples. Issued.
Gas-filled microspheres with fluorine-containing shells. EP 95/927536; WO 95/604018; US 5562893.	Describes a microbubble comprising a gas core, polymeric shell, and internal fluorinated layer inside the shell.	Drafted sections of specification and examples. Issued.
Emulsions as contrast agents and method of use. WO 94/28939; JP 11193247; US 5536489; 5716597; 6030603.	Emulsions of fluorocarbon microdroplets capable of phase shift when insonated.	Drafted sections of specification and examples, and assisted with apparatus and conception. Issued.
Protein encapsulated insoluble gas microspheres and their preparation and use as ultrasonic imaging agents. EP 88/05615; 95/633030, JP 2905598, WO 95/001187.	Describes protein-encapsulated perfluorocarbon microbubbles formed by cavitation. Both ultrasonic and colloid mill manufacturing processes are disclosed.	Drafted sections of specification, examples, graphs and tables, drafted illustrations, assisted with claims. Issued.
Method of making encapsulated gas micro-spheres useful as an ultrasound imaging agent. EP 93/0554213; WO 93/05819; US 5552133; 5855865.	Describes protein encapsulated perfluorocarbon microbubbles formed by cavitation. Both ultrasonic and colloid mill manufacturing processes are disclosed.	Drafted sections of specification, examples, graphs and tables, drafted illustrations, assisted with claims. Issued.
Gas exchange method of making gas-filled microspheres. US 5674469.	Blocking patent, prevents commer-cialization of a post-process gas enrichment method for manufacturing perfluorocarbon gas microspheres.	Drafted patent application, specification and examples. Issued.

Professional Organizations and Licenses:

2005 -	Member, WBBA Patent Legislative Advisory Team
2003 -	Notary Public (State of Washington)
2002 -	Registered Patent Agent, United States Patent and Trademark Office, Reg No. 51,912
1988 -	Member, American Chemical Society [ACS]
1981 -90	Member, Japan Society for Bioengineering, Biotechnology and Agrochemistry [formerly Agricultural Chemical Society of Japan].
1976 -	Member, American Society for Microbiology [ASM]
1974 -	Licensee, as Medical Technologist, with the American Society of Clinical Pathologists [ASCP], License #MT095974
1974 -96	Licensee, as Medical Technologist, for the State of California Department of Health, Laboratory Field Services (inactive since 1996).

For more information, see Employment History and Technical Skills at this link.