January, 2nd, 2019

By Christopher J. Stankus

We find ourselves reflecting on 2018’s patent law developments as we welcome the New Year. One notable advancement is the USPTO’s efforts to aid examiners and clarify the law on Section 101, patentable subject matter. Federal Circuit judges in 2018 filed concurrences and dissents explaining the uncertain nature of the law and calling for change. Although a statutory change to Section 101 would be the most effective solution, it’s refreshing to know the USPTO is working hard to provide additional guidance and clarity within the confines of Supreme Court and Federal Circuit precedent.

The USPTO issued to its examiners two new guidance memos on Section 101 this year. In April, guidance was issued that deals with the “conventionality” step in the Mayo/Alice framework. This guidance was drafted in response to the Federal Circuit’s Berheimer v. HP, Inc. decision, which held it is not always appropriate to use the broadest independent claim as representative, and underlying questions of fact concerning patent eligibility may preclude summary judgment. The second guidance, issued in June, was drafted in response to the Federal Circuit’s Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals decision. In Vanda, the Federal Circuit held certain pharmaceutical dosage adjustment claims eligible subject matter because the claims were an application of the body’s natural relationship to metabolize the drug, and not merely a recitation of the natural relationship as the Supreme Court found in Mayo.

In September, Director Iancu stated that “significantly more work needs to be done, especially on the ‘abstract idea’ exception,” to bring clarity to the issue. According to Director Iancu, recent case law has blurred the distinction between categories of invention under Section 101 and conditions for patentability under Sections 102, 103, and 112:

How can a claim be novel enough to pass 102 and nonobvious enough to pass 103, yet lack an ‘inventive concept’ and therefore fail 101? Or, how can a claim be concrete enough so that one of skill in the art can make it without undue experimentation, and pass 112, yet abstract enough to fail 101? How can something concrete be abstract? These problems confound the most sophisticated practitioners in our patent system.

Director Iancu proposed reverting to the 1952 Patent Act to restore the categories v. conditions distinction. His vision can be found here, which includes defining three categories of abstract ideas: Mathematical Equations, Certain Methods of Organizing Human Interactions, and Mental Processes.

This leaves us wondering—what’s in store for 2019? Congress is not going to legislate in this area anytime soon. However, the Berheimer and Vanda decisions give hope to owners of computer implemented and pharmaceutical inventions, respectively. It’s encouraging to see that Director Iancu is doing everything he can within the confines of the law to bring clarity to this subject, even though it is unknown how his proposal will impact examination until the new guidance is published. We’ll be on the lookout for it and will provide a report as soon as it publishes.


Don’t let any uncertainty of Section 101 stop you from protecting your inventions. WHIPgroup attorneys regularly counsel innovators on the most effective and efficient means to protect their technology. We enter 2019 eager to continue representing our clients with superior value. We are thankful to our clients for putting their trust in us and look forward to delivering even better results in the new year. If you are interested in patenting your technology or have any questions regarding your portfolio, please contact us. We can provide a courtesy consultation and estimate.

WHIPgroup wishes everyone a happy, healthy, and productive New Year!

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