USPTO Throws a Lifeline to the Life Sciences Industry

By Mary An Merchant, JD, PhD, & Richard T. Timmer, PhD

U.S. Supreme Court decisions in Alice Corp., Myriad, and Mayo invalidated claims in critical life sciences and computer technology areas in finding that many inventions are not eligible patent subject matter, meaning that a patent cannot be granted for certain types of technologies. The U.S. Patent and Trademark Office (USPTO) has applied these decisions to patent examination, and in doing so, many pending patent application claims have been rejected as not being patent-eligible subject matter. On May 4, 2016, the USPTO published guidance that updates the procedures for determining patent-eligible subject matter. The guidance includes a memorandum to the Patent Examining Corps on best practices in making a rejection on grounds of patent eligibility and evaluating an Applicant’s response to such a rejection, along with additional patent subject matter eligibility examples in life sciences technologies.

The memorandum requires that the Examiner specifically identify and explain the grounds for the rejection of the claims for patent ineligible subject matter. The memorandum also provides hints for Applicants in responding to these rejections. Importantly, the guidance provides six new examples of patent-eligible and patent ineligible claims in life sciences technologies. These examples include:

  • nature-based product examples (vaccines and dietary sweetener; examples 28 and 30, respectively);
  • one law of nature example (diagnosing and treating a disease; example 29);
  • one abstract idea example (screening for gene alterations; example 31); and
  • two examples of the application of streamlined analysis in making a rejection (paper making machine and fat hydrolysis; examples 32 and 33, respectively).

One of the most-affected technologies has been medical and companion diagnostics, which were the focus of the Mayo decision. The guidance provides an example of patent-eligible claims for such diagnostic technologies, which is good news for these patent applications, but the Supreme Court may weigh in again on this type of technology and its patent eligibility if it chooses to review the Federal Circuit’s Sequenom ruling. So, the new clarity at the USPTO does not resolve all of the strategy considerations necessary when applying for patent protection for these inventions.

The guidance provides much-needed additional direction for both Examiners and Applicants in formulating, understanding, and responding to patent eligibility rejections, in particular for those in the life sciences arena. We are available to discuss your concerns, review your technology and claims, and provide strategic advice for navigating the uncertain waters of patent-eligible subject matter.

Links to the documents published May 4, 2016: