Director's Forum: A Blog from USPTO's Leadership
Thursday May 05, 2016

Update to Examiner Guidance on Patent Subject Matter Eligibility

Guest blog by Deputy Commissioner for Patent Examination Policy Robert Bahr

The USPTO is committed to providing the most current and robust training for our patent examiners, and we have just released our next iteration of examiner guidance on patent subject matter eligibility, as described in our Federal Register notice.

In our July 2015 Federal Register notice, the USPTO issued an update to the patent subject matter eligibility guidance to assist examiners in evaluating claims under 35 U.S.C. § 101, in view of the U.S. Supreme Court’s decisions in Alice Corp., Myriad, and Mayo. Using the comments we received from the public along with feedback from the patent examining corps and other stakeholders, we prepared this latest examiner guidance, 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. We encourage members of the public to submit comments on issues related to subject matter eligibility. All related documents can be viewed on the Subject Matter Eligibility page of the USPTO website.

Our newest examiner guidance includes new life science examples, which use hypothetical fact scenarios 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. Further, the examples cover certain technologies specifically requested by our stakeholders, including vaccines and diagnostics.

The examiner memorandum included in our new guidance seeks to improve the quality and consistency of subject matter eligibility determinations and rejections (when appropriate) by explaining that a reasoned rationale must be provided in the Office action, and provides guidance 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. The guidance in the memorandum and subsequent training should lead to greater consistency throughout the patent examining corps in evaluating whether the claimed subject matter is eligible for patenting, more thorough office actions that will assist applicants in determining how to respond to subject matter eligibility rejections, and greater assurance that applicant responses are thoughtfully considered by the examiner in determining whether to maintain a subject matter eligibility rejection.

We will be providing comprehensive training on this new guidance in 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. In the memorandum training, examiners will evaluate a hypothetical subject matter eligibility rejection and hypothetical applicant remarks to the rejection, allowing them to clarify the grounds of rejection, while considering all of the applicant’s remarks and each of the amendments in determining whether to maintain the rejection. This training directly addresses the public feedback we received about the adequacy and consistency of subject matter eligibility rejections across technology centers. All training materials will be available to the public on the Subject Matter Eligibility page of the USPTO website when training is conducted.

Providing more specific guidance and training on subject matter eligibility to our examiners supports the USPTO’s dedication to issuing patents of the highest clarity and quality possible. We appreciate our stakeholders’ comments and find them to be an invaluable resource in further developing guidance in this evolving area of the law. We welcome and will consider all viewpoints as we continue to refine our examination procedures for claims for subject matter eligibility. Comments will be accepted on an ongoing basis and can be sent via email to 2014_interim_guidance@uspto.gov.

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