Expert Details

Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals

Expert ID: 723840 California, USA

Request Expert

Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and
nationally for patent issues through the USPTO.

In addition to filing and prosecuting patents, he also has experience working with other attorneys in various US and European intellectual property
disputes.

Because he can draw upon both his extensive technical and business background, and his legal and IP background, he is particularly good at
identifying underlying issues and legally relevant facts that might otherwise be missed.

Before becoming a patent attorney, Expert was a medical-device and biotechnology executive with a strong R&D background in
biotechnology, and medical electronics.

At Johnson and Johnson (LifeScan), he played an important management role in the team that developed the original One-Touch(tm) blood
glucose monitoring system (medical device for diabetes therapeutic drug monitoring), which eventually had sales of over a billion-dollars per
year.

He then subsequently founded a VC backed medical device (cardiovascular therapeutic drug monitoring) company. As founding CEO (later
Chairman and CTO), he took the concept from the initial “gleam in the eye” stage through fund raising, team formation, development, clinical
trials, 510(k) approval, launch and final sale.

His responsibilities included anything that impacted the technical competence of the company. In addition to being a member of the board of
directors, his executive responsibilities included heading up Research and Development, managing the company’s intellectual property
portfolio, ensuring that clinical trials were conducted properly, supervising the VP of quality assurance and regulatory affairs to be sure that the
company met all FDA mandates, supervising the VP of operations to be sure that the company’s products were manufacturable, and reviewing
and approving all marketing materials and product labeling for accuracy.

Expert's unusually broad background has given him a unique perspective and understanding of how nearly all aspects of medical device
technology, regulation, finance, business and legal issues interrelate.



Development of a vaccine stability monitoring device for a major (international) vaccine company. Evaluate vaccine stability profile, devise algorithm that best fits this profile, deliver & validate monitor.Evaluate patent infringement case for major medical instrumentation company. Research design of infringing device, research patents, prepare opinion documents. Extensive on-site experience with Beckman-Coulter. Biomedical instrumentation design and review, Intellectual property review, design of new immunochemical reagents (resulting in a patent assigned to Beckman-Coulter). Extensive on-site experience with Panasonic. Biomedical instrumentation design review. Software algorithm development. Expert witness for various intellectual property and product safety design cases.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

Request Expert

Education

Year Degree Subject Institution
Year: 1974 Degree: BA Subject: Physics, Biology Institution: University of California, Santa Barbara
Year: 1980 Degree: PhD Subject: Molecular Biology/Biophysics Institution: University of California, San Diego
Year: 2011 Degree: JD Subject: Law Institution: Taft Law School

Work History

Years Employer Title Department Responsibilities
Years: 2012 to Present Employer: Undisclosed Title: Patent Attorney Department: Patent Associate Responsibilities: Legal practice focusing on intellectual property.
Years: 2002 to 2012 Employer: CliniSense Corporation Title: CEO Department: Responsibilities: Founded medical device and IP consulting company, focusing on stability monitoring technology, medical diagnostics instrumentation, and intellectual property
Years: 1991 to 2001 Employer: Avocet Medical, Inc. Title: CTO Department: Responsibilities: Chief Technology Officer of venture backed point-of-care medical device (diagnostics) instrumentation company. Responsible for all technical operations, managing company IP patent portfolio
Years: 1985 to 1991 Employer: LifeScan (Johnson & Johnson) Title: Director Department: R&D Responsibilities: LifeScan a J&J company focused on point-of-care medical diagnostics (blood glucose) monitoring. 1: Led operations group that developed the original One-Touch manufacturing process; 2: Led R&D team that developed technology for successful SureStep product.
Years: 1984 to 1985 Employer: Bayer (Miles Laboratories) Title: Senior Research Scientist Department: R&D Responsibilities: R&D troubleshooter for manufacturing and quality control problems for Bayer point-of-care diagnostics products
Years: 1982 to 1984 Employer: Baylor College of Medicine Title: Assistant Professor Department: Pharmacology Responsibilities: Taught medical students. Research in structure of cell nucleus using monoclonal antibody technology and computer bioinformatics technology.
Years: 1980 to 1982 Employer: National Institutes of Health Title: Arthritis Foundation Postdoctoral Fellow Department: Laboratory of Immunology Responsibilities: Studied function of immune system "Ia" regulatory molecules using monoclonal antibody technology

Government Experience

Years Agency Role Description
Years: 1980 to 1982 Agency: National Institutes of Health Role: Postdoctoral Fellow Description: Immunology research

Career Accomplishments

Associations / Societies
American Association for the Advancement of Science, American Intellectual Property Law Association, IEEE
Licenses / Certifications
California Bar registration, USPTO Patent Bar registration.
Professional Appointments
Reviewer, Vaccine journal. Adviser University of California, Santa Barbara CCS.
Awards / Recognition
Best research paper award by AAMI (American Association of Medical Instrumentation). SBIR grant awards, UCSB distinguished alumnus,
Medical / Professional
Arthritis Foundation Postdoctoral Fellow at the National Institutes of Health
Publications and Patents Summary
He has 19 publications and 26 patents (25 issued, 1 pending).

Additional Experience

Expert Witness Experience
Experience evaluating other products for potential patent infringement, and writing opinion briefs based upon analysis of technology and analysis of patent claims. Also experience doing expert witness for due diligence and process negligence.
Training / Seminars
Taught course in high-tech company formation at the University of California, Santa Barbara (2006).

Lectured in biomedical instrumentation design at Keck Institute (2006).

Many in-house seminars for Beckman-Coulter, Panasonic, Avocet Medical, and Johnson & Johnson
Vendor Selection
Extensive vendor selection experience: Have had 20+ years as highest level person responsible for selecting/authorizing/approving components and vendors for biomedical instrumentation and reagents.
Marketing Experience
Founded two medical device companies: This requires researching market needs, devising plan to meet market needs, and supporting product launch with publications and seminars.
Other Relevant Experience
15+ years intellectual property (IP) experience managing medical device patent portfolios. Registered patent agent. Personal portfolio of 30 patents (20 issued, 10 pending).

Extensive experience with FDA regulations and quality assurance.

Fields of Expertise

Request Expert

Dev Tool:

Request: expert/patent-law-law-medical-device-design-drug-perishable-material-stability-510k-approvals
Matched Rewrite Rule: expert/([^/]+)(?:/([0-9]+))?/?$
Matched Rewrite Query: experts=patent-law-law-medical-device-design-drug-perishable-material-stability-510k-approvals&page=
Loaded Template: single-experts.php