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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