Strategies for biotech and medtech startups: Successfully navigating the USPTO and FDA

Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER) where he directs the operations of more than a thousand employees in the review and oversight of drug development and marketing of novel therapeutics. Prior to his current role, from May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the U.S. Government’s Department of Health and Human Services (HHS) and Department of Defense (DOD) operation formerly known as Operation Warp Speed. Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development. Kevin received a Bachelor of Science degree in Biology and Chemistry from Virginia Tech in 2005, a Master of Science degree in Biotechnology from American University in 2006, and a Doctorate, Ph.D., in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in U.S. regulatory affairs (RAC) and participates in numerous policy and regulatory science program working groups across the FDA.

Laure Clark has 15 years of experience in federal policy, specializing in health care and life sciences policy. She currently serves as Senior Director, Federal Policy & Government Affairs for Biocom California, the trade association representing the life science industry of California. Laure joined Biocom California in 2013 to open and run their Washington D.C. office to better represent the interests of Biocom California members in our nation’s capital. In her role, she is responsible for managing and implementing Biocom California’s federal legislative and regulatory policy agenda. Prior to Biocom California, Laure served in the U.S. House of Representatives, overseeing healthcare policy. Laure holds a Bachelor of Arts in Political Science and a Master of Public Policy from Sciences Po Bordeaux. She also graduated from the Institute on Business and Government Affairs at Georgetown University.

Tom Cowan is a partner in the San Diego office of Knobbe Martens, an intellectual property (IP) law firm with close to 300 attorneys and scientists. Tom has a master’s degree in biomedical engineering and serves clients worldwide in medical technologies. He counsels clients on overall IP strategy, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies. Tom has particular experience in assisting medical device startups with IP alignment for financings and acquisitions. In one recent example, he prosecuted the patent portfolio and provided defensive patent diligence for a medical device startup, which resulted in investments and an acquisition by Boston Scientific totaling $540M.

Brandon Fetterolf started at the United State Patent and Trademark Office (USPTO) as an examiner in 2003, where he examined patent applications directed towards antibodies and antibody conjugates for treating cancer. He became a supervisor in 2010 where he supervised patent examiners working with small molecules for treating a variety of different diseases and later supervised patent examiners working in process chemistry. Recently, he has been Acting Director for Technology Center 1600. Brandon has a bachelor’s degree in Biology, a doctorate, Ph.D., in Chemistry, and worked as a post doc at National Institute of Health (NIH) for two years. 

Linda Horner was appointed as an Administrative Patent Judge at the Patent Trial and Appeal Board (PTAB) in 2006. While at the PTAB, she has served as a lead Administrative Patent Judge from 2007-2011 and as an Acting Vice Chief Judge from 2013-2014. She recently completed a one-year detail assignment as Senior Legal Advisor to the Director. She is currently serving as an Acting Senior Lead Administrative Patent Judge and supports the USPTO’s collaboration initiatives with the FDA. At the Board, Judge Horner handles America Invents Act (AIA) trial proceedings and appeals. Prior to her appointment, Judge Horner was a Director at an intellectual property law firm in Washington, D.C., where she prosecuted and litigated patent matters for twelve years.

Stephen Koziol, Acting Director of the USPTO's Silicon Valley regional office, carries out the strategic direction and advances the policies of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO. A veteran of the USPTO for nearly 15 years, Mr. Koziol established and leads the USPTO's west coast regional office in San Jose - a region covering California, Washington, Oregon, Nevada, Arizona, Hawaii and Alaska. Focusing on actively engaging with communities across his region, Mr. Koziol ensures the USPTO’s initiatives and programs are tailored to the region's unique ecosystem of industries and stakeholders.

Dr. Kimberly Miller is a partner in the San Diego office of Knobbe Martens and serves as a single point of contact for all intellectual property (IP) related matters her clients face. A past chair of the firm’s International Department, Kim has conducted patent prosecution in more than 45 jurisdictions throughout the world. She offers a diverse practice in IP portfolio management and development, due diligence, and landscape analysis, as well as licensing initiatives and obtaining design patents. Kim’s clients include individual inventors, venture funded start-ups, university spin-offs, and publicly traded companies. Her practice spans a variety of technical disciplines, including chemistry, pharmaceuticals, polymers and biotechnology. As a speaker on both IP law matters and gender issues, for which she studied at the graduate and undergraduate levels, Kim has organized and participated in various presentations across the country and before a variety of legal, business and other professional and community organizations.

Jonathan Teixeira Moffat joined the USPTO in 2005. As an examiner, he worked in Measuring and Testing: Data Processing arts of TC 2800 and with the Patent Training Academy as a teaching assistant. He was selected as a Supervisory Patent Examiner (SPE) in TC 2800 in 2012 guiding examiners in his native art. In his tenure, he also oversaw development of patent examiner rating software tools, and assisted with disaster recovery planning for the Office of the Chief of Information Officer (OCIO) and the Office of Patent Information Management (OPIM) systems. Beginning in 2016, Mr. Teixeira Moffat took over as Operations Subject Matter Expert (SME) and eventually Operations Management Quality Assurance Specialist (MQAS) for Technology Center 2800 focusing on data reporting, data analytics, hiring, and supervisor award planning. Mr. Teixeira Moffat was promoted to the Special Executive Service in February 2022 as a Technology Center Group Director in the medical devices and processes area. Mr. Teixeira Moffat holds a Bachelor of Science degree in Electrical and Computer Engineering from Worcester Polytechnic Institute in Worcester Massachusetts. He spends his off-duty hours trying to keep up with his three young children and running a small game publishing company.

Mary C. Till is a Senior Legal Advisor in the Office of Patent Legal Administration (OPLA) at the USPTO. During her 17 year tenure in OPLA, Ms. Till has administered the Hatch-Waxman Act provisions found in 35 U.S.C. 156, worked on implementing the First Inventor to File provisions of the America Invents Act (AIA), co-drafted the guidance on first inventor to file, implemented case law, developed pilot programs, drafted responses and position papers on White House Executive Actions, acted as liaison with the Office of Data Management, updated the Manual of Patent Examining Procedure (MPEP), provided input and analysis on various congressional inquiries/proposed legislation, and briefed USPTO executives for congressional testimony. Recently, she has worked with a multidisciplinary team to implement the World Intellectual Property Organization's (WIPO) new standard (ST.26) for presenting biotechnology information in patent applications to the USPTO. Ms. Till received a Bachelor of Science degree in Chemistry from Gannon University, her Master of Science in Organic Chemistry from Virginia Tech, and her Juris Doctorate, J.D., from American University’s Washington College of Law. She is admitted to the bar of Virginia to practice before the USPTO.

Barbara Zimmerman is the Deputy Director in the Office of Regulatory Programs (ORP) in Office of Product Evaluation and Quality (OPEQ) in FDA’s Center for Devices and Radiological Health (CDRH) where she is responsible for policy development, maintenance, and improvement across all regulatory programs for the total product life cycle. Ms. Zimmerman began her career at the FDA in 1994 as a lead reviewer in the pacing and electrophysiology devices branch in the Division of Cardiovascular Devices. Since that time, she has served CDRH in many capacities, including Orthopedic Devices Branch Chief, Deputy Director in the Division of Cardiovascular Devices, and Deputy Director in the Office of Device Evaluation. A few of her key roles as Deputy Director in ORP include serving on the negotiating and implementation team for the Medical Device User Fee Amendments (MDUFA) and serving on the strategic team for CDRH’s Digital Transformation. Ms. Zimmerman has a Bachelor of Science degree in Electrical Engineering from Drexel University.