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May 201620
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USPTO Updates Examiner Guidance on Patent Subject Matter Eligibility – Section 101

The last update to the USPTO’s guidance to examiners on patent subject matter eligibility was issued in July of 2015. The USPTO recently provided the next iteration, which includes a new set of life science examples, a memorandum to the patent examining corps with instructions on formulating subject matter eligibility rejections and responding to applicant’s replies, an index of eligibility examples, and an appendix of subject matter eligibility court decisions. Copies of these documents can be obtained from the USPTO’s Subject Matter Eligibility page.

The new life science examples use hypothetical fact scenarios (such as vaccines and diagnostics) to illustrate exemplary analyses for subject matter eligibility in view of the Supreme Court decisions in Alice Corp., Mayo, and Myriad. The examples are designed to show various ways that patent claims can be drafted for eligibility, and thus assist patent applicants and patent examiners in resolving subject matter eligibility issues in the life science areas.

The examiner memorandum lays out what is required for a proper rejection and provides guidance to the examining corps on how to effectively communicate that rationale to the applicant. The memorandum also reinforces that examiners must carefully consider all of an applicant’s arguments and evidence rebutting the subject matter eligibility rejection, and either withdraw the rejection when the response is persuasive, or provide a rebuttal when the rejection is maintained.

In addition to this new update, the USPTO has stated that it will continue to conduct interactive workshops where examiners will receive hands on experience evaluating eligibility and have the opportunity to facilitate discussions with subject matter experts. The life science training will follow the same format as the abstract idea workshops given this past year, using worksheets to analyze the eligibility of claims from select life science examples.

The ultimate goal is to efficiently issue subject matter rejections where appropriate and provide a sound basis for those rejections, but also to remove those rejections where appropriate arguments and/or amendments are presented. As the post-Alice case law continues to evolves, this is certainly a difficult task.

To learn more about subject matter eligibility and how it can affect currently issued patents or the pursuit of future patents, feel free to contact one of our attorneys.