Patenting Diagnostic Methods: Navigating the Evolving Court Treatment, USPTO Guidance

Dr. Scarpati’s practice spans all major areas of intellectual property law, including patent prosecution, due diligence investigations, district court litigation involving patents, trademarks, and copyrights, and post-grant proceedings before the U.S. Patent and Trademark Office. He has extensive experience drafting patent invalidity, non-infringement and freedom-to-operate opinions, conducting prior art searches, and analyzing patent portfolios. Dr. Scarpati has advanced degrees in the areas of molecular biology, which he leverages to draft and prosecute patent applications related to biotechnology, pharmaceuticals, diagnostics, agricultural products, medical devices, and related life sciences subject matter. He also has a degree in computer science, providing cross-disciplinary expertise necessary for the prosecution of software patents. In that regard, he has experience drafting and prosecuting patents directed to software and business methods that implement machine learning, blockchain-based ledgers and other cutting-edge technologies. In addition to the above, Dr. Scarpati also has several years of experience prosecuting and litigating utility and design patents related to consumer products technology, and has counseled clients regarding intellectual property issues at all stages of the product development life cycle.

For over 25 years, Ms. Mueller has provided strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology, and chemistry sectors. She brings in-depth knowledge and extensive experience to her work, advising clients on the global patent protection, freedom to operate, and validity of blockbuster drugs they aim to produce and distribute. With a background in chemistry and biology, she provides advice on the full spectrum of global intellectual property portfolio management, including patent prosecution, opposition, and other post-grant proceedings, and diverse regulatory matters. Since 2001, she has worked closely with in-house legal departments of global pharmaceutical firms regarding their patent development and enforcement strategies. In this partnership, Ms. Mueller provides training to new in-house counsel. She meets with scientists and other business development to anticipate and resolve a wide array of problems, including navigation of FDA approval. A thought leader on pharmaceutical and biopharmaceutical patent law, Ms. Mueller frequently speaks to legal and industry groups and publishes widely.