Remarks by Director Michelle K. Lee at the Patent Subject Matter Eligibility Roundtable

Good afternoon, everyone, and thank you for coming. That goes to all of you participating remotely and at our four regional office locations, in Dallas, Denver, Detroit, and San Jose. I appreciate your attendance.

Our patent system relies on the full and active involvement of the public to help us not only succeed, but to lead in today’s global innovation economy. That’s the guiding principle behind many of our efforts, including the Enhanced Patent Quality Initiative we launched early last year with a first-ever patent quality summit held here at our headquarters. Our agency remains committed to improving patent quality and our patent system more broadly. Like you, we want our patent system to work efficiently and effectively for all users so we can continue to promote the innovation that drives our nation’s economy and creates jobs.   

Today’s roundtable is the first of two discussion sessions on a topic that is of great importance to our stakeholders. It’s focused on how we can improve our examination guidance and training on patent subject matter eligibility under section 101. We thought it would be helpful to convene these sessions to help begin the public discussion on this topic, to create a record of where there is agreement or disagreement and what improvement, if any, is needed.

Before we begin that discussion and hear your feedback, I want to set the stage by, first, briefly describing some of our eligibility guidance so you know where we stand today and what our plans are for the future; and second, drawing your attention to some areas where we are still eager to receive more public feedback. On this second point, let me just stress that everything I mention here is open to discussion today. When I say that we want more input, I really mean we want more input. Your opinions matter to us. So don’t be shy. We welcome your participation on this important and complex issue.

And as many of you know, we’ve already spent a fair amount of effort on this issue in recent years. Following major court rulings, we’ve revised our examination guidance, with input from our stakeholders, multiple times and trained our examiners on the new guidance. For example, several Supreme Court decisions in the last few years reminded us of the role the judicial exceptions doctrine plays in determining subject matter eligibility. That includes the Myriad and Mayo cases, each of which concerns the eligibility of naturally occurring things, and Alice, which concerns the eligibility of computer-implemented inventions. Alice and Mayo also set forth a test for evaluating the subject matter eligibility of patent claims.

As a result of these cases, we provided our examiners guidance that allows them to conduct complete and thorough examinations of subject matter eligibility in accordance with the current state of the law. In December 2014, we issued eligibility guidance that resulted from many months of careful deliberation, including analysis of the Supreme Court decisions and the feedback we received from our stakeholders on the pertinent law and our pre-Alice guidance. We also held a public forum like today’s event and solicited written comments, which we used to further refine our guidance in July 2015 and again in May of this year. And we continued to respond to the developing case law. For example, the U.S. Court of Appeals for the Federal Circuit has applied the Supreme Court’s eligibility test to a variety of claims over the last two and a half years. Their decisions have assisted us in further interpreting the law on eligibility. Accordingly, we provided more than 30 training examples to illustrate how the Supreme Court’s eligibility test, and USPTO guidance implementing that test, should be applied to claims during the patent examination process. These examples have addressed a variety of inventions and claim types in multiple technology areas, including nature-based products and computer-implemented inventions concerning abstract ideas.

In May 2016, we issued a set of life sciences examples that cover technological fields specifically requested from the public, such as vaccines and diagnostics, which have not been directly addressed by the courts, and we showed various ways that claims can be drafted for eligibility. And we are currently developing new guidance and examples that illustrate the application of the Supreme Court’s eligibility test to inventions in the business method area and respond to some of the recent case law, including the Enfish and McRO decisions, in which the Federal Circuit identified eligible subject matter. I invite you all to provide us feedback on what you would like us to address in the new guidance and examples. Again, the more input the better. 

Another important aspect of our efforts on subject matter eligibility is our ongoing examiner training.  Each time we’ve updated our eligibility guidance, we provided comprehensive training for our examiners. After the most recent update in May, we conducted workshop training for the entire corps on how to perform the eligibility analysis, formulate eligibility rejections that clearly inform applicants of the reasons for the rejection, and evaluate and respond to applicant arguments on eligibility issues. We also conducted examiner training in the chemical, biological and pharmaceutical areas on the life sciences examples that we issued this year. These training modules are part of our Enhanced Patent Quality Initiative. They emphasize the clarity of the patent record while providing the legal content necessary for patent examiners to do their jobs. All of our training materials are publicly released and posted on our 101 guidance web page. While we received a lot of input on previous guidance, we’ve only received a handful of comments on our May 2016 Update and the Life Sciences Examples. We welcome your feedback on those materials and your suggestions for how we can improve the training process on existing and future 101 guidance iterations, including what types of additional examples you believe would be helpful.

We’re also interested in hearing your suggestions on how the recent decisions highlighting eligible subject matter should be incorporated into our eligibility guidance. In addition to working with the public on guidance development, I’ve made it a priority to study how our examiners are implementing the section 101 guidance, as part of our Enhanced Patent Quality Initiative. In particular, we launched three section 101-related case studies that were chosen based on stakeholder input: the clarity of the written section 101 rejections, consistency of practice across art units, and whether Office Actions with section 101 rejections are practicing compact prosecution. We expect those case studies to wrap up in the coming months and will use those results to improve examination of 101 issues. As a result, we’ll have more targeted and relevant training for our examiners, increased consistency in eligibility analyses and work product across the entire examination corps, and greater transparency for the public and within the Agency on standards for eligibility analyses and related reviews.

To be the best agency we can, and to have the best patent system we can, we need a real 360-degree perspective on how we’re doing. We need your perspectives. We need to hear from innovators (big and small), patent litigators, prosecutors, in-house counsel, academics, and anyone else with a stake in our patent system—which, when you get right down to it, is everyone. So I want to thank you all again for attending today and for your contributions to the larger discussion on subject matter eligibility. Please let us know what you think about what we are doing, and how you think we can improve in the future.

And with that, I’m going to turn it over to the moderator of today’s program, our Deputy Commissioner for Patent Examination Policy, Bob Bahr. He will be accompanied by: Jack Harvey, Assistant Deputy Commissioner for Patent Operations; Amy Nelson, Associate Solicitor; and Mary Critharis Senior Patent Counsel for the Office of Policy and International Affairs.

Thank you, all.

#  #  #