Expert Details
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
ID: 723840
California, USA
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.
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 |
|---|---|---|---|
| Years: 2012 to Present | Employer: Undisclosed | Title: Patent Attorney | Department: Patent Associate |
Responsibilities:Legal practice focusing on intellectual property. |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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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
intellectual property, intellectual property dispute, law, patent law, legal practice, biocompatibility, bioengineering, biomechanical engineering, biomechanics, biomedical device, biomedical device design review, biomedical device manufacturing, biomedical engineering, biomedical product development, canons of claim construction, claim (patent), patent claim construction, patent claim construction brief, clinical engineering, device code, diagnostics, direct infringement, drug delivery, drug development, drug regulation, Food and Drug Administration, FDA medical device regulation, Food and Drug Administration regulation, Food and Drug Administration validation, induced infringement, medical device, medical device reliability testing, medical device testing, medical instrument, patent infringement, pharmaceutical drug, medical device coding, medical device patent, biomedical instrumentation, electronic medical device, in vitro diagnostics Food and Drug Administration code, medical diagnostics, chemical intellectual property, home diagnostics, dispute, expert witness, patent claim chart, patent prosecution, patent specification, contributory infringement, biological engineering, clinical laboratory regulation, medical device clinical research, medical device package testing, disposable medical device, medical device endurance testing, safety, medical device manufacturing, Federal Food, Drug, and Cosmetic Act, failure analysis, electromagnetic bioengineering