Ashley is Director of Patent Strategy at Aurora Consulting and a USPTO-registered patent practitioner who specializes in the development and management of patent portfolios for startup ventures and emerging growth companies. As the owner and Director of Patent Strategy at Aurora Consulting LLC, Ashley has over 10 years of experience in patent application drafting and prosecution in a wide variety of technological areas including robotic systems, intracardiac devices, wireless healthcare technologies, physical activity equipment, biotechnologies, surgical training systems, topical drug formulations, drug repurposing, and other medical and consumer product devices. Aurora Consulting currently serves clients, ranging in size and technological field, throughout the U.S. and internationally.
Ashley earned her Ph.D. in the biomedical sciences from the University of Michigan. In addition to her research in immune-mediated disorders, Ashley also worked as a technology transfer fellow in the Office of Technology Transfer at the U of M. There she analyzed nascent technology for commercialization potential (marketability, challenges, competitors, potential licensees) and patentability. After earning her Ph.D., Ashley served as a patent infringement researcher for the U of M and a regulatory writer for an Ann Arbor-based, early stage pharmaceutical company, in particular, drafting documents for approval by the European Medicines Agency.
The United States Supreme Court is set to hear opening arguments in Amgen Inc. v. Sanofi on March 27. This is a case that could have profound impacts both on the invention enablement issues that have been plaguing life science patenting, but also more broadly on defining the contemporary role that the patent system will play in our innovation economy going forward. Specifically at issue will be the question of what genus claims require from an enablement perspective. Will the enablement standard be governed by the black and white, codified Section 112 statutory requirement that the specification must only teach those skilled in the art how to “make and use” the claimed invention? Or will the Supreme Court lean on lower court-based additions to the standard that the specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation?
The patent world is full of trap doors that lie waiting for unsuspecting inventors. Without a good map and an intentional path, mistakes and missteps can be plentiful and costly. Some of these mistakes are reversible with limitations. Others have no undo button. When is it safe to talk about your idea or sell your invention? How do you hedge against invalidation and rejection from blind spots with competitor IP and prior art? How do you ensure you actually own your invention when working with employees and contractors? The answers to these questions – and even knowing to ask them in the first place – goes a long way toward keeping inventors on solid ground. Long term success will depend on the steps taken – or not – very early in the journey. This timing is unfortunate for many inventors, however, since it’s also when they know the least about the process.
Inventors and practitioners alike are continually trying to push the bounds of protection on innovations. Whether it’s describing a telegraph as a means for communication or a lightbulb as a means for lighting an environment, using broad language, like “means for” language, to cover all the possible workarounds might seem more advantageous than disadvantageous, at first glance. In patent law, this broad language or “means for” phraseology is called functional language because it describes the device or system in terms of what it accomplishes rather than the actual structure. However, using functional language has lost favor over time. For example, a blog published by Patently-O in 2011 shows that the use of “means for” language has dropped precipitously from about 1990 to present day. What has turned this seemingly advantageous practice into a disadvantageous one?In this episode of Patently Strategic, the panel walks through several court cases that either: invalidated a patent for failing to define structures in the specification for the all the means-plus-function claim terms or maintained validity of the patent because the specification provided sufficient structure for all the means-plus-function claim terms.
You have your big idea and now it’s time to breathe it into existence, but you need some help with the development. Like many others, you may turn to the aid of an engineering firm or dev shop. This relationship is a marriage of sorts. But it’s a marriage that is designed to inevitably end in divorce. How cleanly, smoothly, and successfully this separation goes depends on the steps that you take before it officially begins. The end goals are a great product and clean asset separation. You’ll want your IP and any newly created devices, infrastructure, etc. – and the engineering firm will want to not be inhibited from doing their job with other clients going forward.
The life sciences are currently facing at least two major plagues in our patent world. The first is that many life science innovations have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that the patent laws are not meant to protect these innovations. The second plague is that the courts believe that many life science patents are not enabled. In other words, they are not described in sufficient detail to enable one of skill in the art to make and use the invention.