Expert Details

Expert in Electrical Medical Device Manufacturing Processes and Patent Examination

Expert ID: 728625 Wisconsin, USA

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For many years Expert was a Manufactruing Engineer in the medical device industry. She took that industry experience and went to work as a Patent Examiner of electrical / electronic / electromechanical medical devices for the United States Patent and Trademark Office (USPTO). She attended and successfully completed extensive classroom training, which included Patent Academy and additional courses that covered patent related legal matters associated with the patent process (e.g. the rules of 37 CFR; the laws of 35 U.S.C., and the case law from court decisions on intellectual property related issues). Additionally, she learned and applied the law as detailed in the Manual of Patent Examining Procedures (MPEP) to examining her patent applications. All of the training provided her with practical examples of the application of patent-related administrative and legal matters which enabled her to efficiently and proficiently examine patent applications on a daily basis. These applications consisted of device patents, method patents, system patents, process patents, etc. She progressively increased her production as well as developed an increased understanding of the administrative and legal matters associated with the patent application examination process by efficiently and proficiently prosecuting patent applications. Prosecution included choosing the most important documents from thousands of paper documents that make up an application that were critical to performing the prosecution; reading, understanding, and interpreting specifications and claims; evaluating the claimed invention for patentability; creating claim charts for the claims; and searching the claimed invention. Expert later did contract patent application examining from home for a private company which consisted strictly of Patent Cooperation Treaty (PCT) applications. The private company was contracted with the USPTO.

She is currently reviewing an invention for a small corporation. Upon learning that she is a former Patent Examiner for the USPTO, she was hired to critique the invention as well as the application. The corporation wants her to apply her inside knowledge of the patent review process to their application to help increase their chances of getting through the examination process with few to no rejections and subsequently obtain the desired patent for their invention.She is currently reviewing a process and procedure developed by a local Reflexologist to determine if it is patentable.

Expert may consult nationally and internationally, and is also local to the following cities: Saint Paul, Minnesota - Duluth, Minnesota - Eau Claire, Wisconsin

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Education

Year Degree Subject Institution
Year: 1983 Degree: BS Subject: Electrical Engineering Institution: Georgia Institute of Technology

Work History

Years Employer Title Department Responsibilities
Years: 2008 to 2010 Employer: Rockwell Automation Title: Manufacturing Quality Engineer Department: Responsibilities: She investigated product quality issues, determined probable cause, recommended/developed solutions and corrective action utilizing tools such as CAPA’s, FMEA’s, 8D’s, process and product audits, etc.
She gathered and analyzed product data/metrics to drive process improvement with concentration on injection molding area
She teamed with management, engineering, and manufacturing associates to implement product/process improvement measures
She executed the company’s Quality Program initiatives (e.g., ISO Certification/Compliance, Lean Six-sigma)
Years: 2008 to 2008 Employer: Cardinal Intellectual Properties, Inc. Title: Patent Examiner Department: Responsibilities: She reviewed PCT patent applications to assess if they complied with the basic format, rules and legal requirements.
She determined the scope of protection claimed by the inventor and researched relevant technologies to compare similar prior inventions with the invention claimed in the patent applications.
She communicated findings to her superiors with justification(s) on the patentability of applicants’ inventions.
She was responsible for the quality, productivity and timely processing of patent applications.
Years: 2004 to 2008 Employer: United States Patent and Trademark Office Title: Patent Examiner Department: Responsibilities: She reviewed patent applications to assess if they complied with the basic format, rules and legal requirements.
She determined the scope of protection claimed by the inventor and researched relevant technologies to compare similar prior inventions with the invention claimed in the patent applications.
She communicated findings to patent attorneys/ practitioners/ inventors with justification(s) on the patentability of applicants’ inventions.
She was responsible for the quality, productivity and timely processing of patent applications.
Years: 1998 to 1998 Employer: Aerotek (assigned to Rehabilicare) Title: Contract Manufacturing Engineer Department: Responsibilities: She set up all operations in support of Demand Flow Manufacturing (DFM) for electrical medical devices.
She developed simplified method sheets for use in Production and Shipping areas.
She upgraded manufacturing procedures by introducing improved tools, fixtures, methodologies, and automation.
She facilitated the introduction of new product lines into production (included proper line balancing, setting up SMD, discrete and final assembly methods, testing, etc.).
She initiated implementation of an Operations-wide bar code system to track inventory and time standards.
Years: 1994 to 1998 Employer: Medtronic Incorporated Title: Senior Manufacturing Engineer Department: Responsibilities: She developed manufacturing processes that ensured efficient use of time, operator safety, and rendered a quality product.
She directed design/fabrication of production tooling/test equipment to ensure their timely introduction into production.
She continuously improved processes to enhance the functionality of the product.
She developed, implemented and maintained production layouts assuring proficient product flow.
She implemented documentation in compliance with GMP, FDA and QA requirements.
She provided approval sign-off on manufacturing, Material Review Board and Product Review Board documentation
She utilized JIT, DOE, and SPC techniques throughout the production areas.
She developed, tested and implemented new product designs, and worked with outside vendors.
She supported product development through the development of manufacturing equipment and methods for new products.

Additional Experience

Vendor Selection
When suppliers went out of business or when new business was acquired, she successfully sought out, located, evaluated, verified and qualified new suppliers for various products and devices.
Other Relevant Experience
She has strong team building and team participation skills. She has an uncanny knack for making people feel valuable and appreciated which ultimately leads them to perform and work together as an extraordinary and amazing team.

Fields of Expertise

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