By Donald Zuhn --
In a forum held January 21 on the U.S. Patent and Trademark Office's Alexandria campus, Office representatives discussed the Interim Guidance on Patent Subject Matter Eligibility, which was released in December, and received additional input from the public regarding that guidance. The forum, which ran almost four and a half hours, began with some opening remarks by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy at the USPTO, and then Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration at the USPTO, followed Mr. Hirshfeld's presentation with an overview of the Interim Guidance. The remainder of the forum was devoted to two groups of public presentations -- in which the presenters were essentially divided into those on the life sciences side (group one) and those on the hi-tech side (group two) -- and an "open participation/question/answer" session, in which attendees were allowed to give statements or ask questions of USPTO representatives participating in the forum.
Leading off the forum, Mr. Hirshfeld provided a few highlights regarding changes to the Interim Guidance relative to the Myriad/Mayo guidance that was released by the Office in March. First, he noted that the Interim Guidance "narrows the funnel" in that the new guidance applies only to claims that are directed to (or recite) a judicial exception, as opposed to claims that involve a judicial exception. Mr. Hirshfeld also noted that the Interim Guidance permits applicants to establish subject matter eligibility using markedly different characteristics other than just structure. He suggested that by removing the 12-factor test from the Myriad/Mayo guidance, the Office had made the Interim Guidance less complex than the Office's earlier guidance. Finally, he pointed out that the Office had responded to public feedback, and would be providing more examples, including examples that were not based on actual claims discussed in the case law. Before turning the lectern over to Mr. Tamayo, Mr. Hirshfeld reminded attendees that the development of the guidance was an iterative process, and that the Office would continue to collect and evaluate comments from the public, and make changes to the guidance where necessary.
Mr. Tamayo's overview of the Interim Guidance also focused on the changes the Office had made to the subject matter eligibility analyses set forth in the Myriad/Mayo guidance and the Preliminary Examination Instructions released by the Office in June (a copy of Mr. Tamayo's presentation can be obtained here). By presenting a "comprehensive view" of subject matter eligibility, combining the previously separate analyses for claims reciting abstract ideas (Alice/Bilski) and claims reciting natural products (Myriad/Mayo), Mr. Tamayo suggested that this represented a change in itself. According to Mr. Tamayo, the best overview of the Interim Guidance was provided by the flowchart in the guidance (click on flowchart to expand):
He noted that the examination procedure set forth in the flowchart relied on the two-step test set forth in Mayo, which the Court then applied in Alice. Mr. Tamayo explained that there was "nothing new" about the first step in the flowchart (i.e., whether the claim is directed to a statutory class of subject matter), which had "been around for a while." The second step of the Interim Guidance test, divided on the flowchart into Steps 2A and 2B, set forth the two-step framework of Mayo/Alice. Mr. Tamayo noted that the examination procedure outlined in the Interim Guidance's flowchart also constituted a change from the Office's prior guidance.
As Mr. Hirshfeld had discussed earlier, Mr. Tamayo indicated that a further change to the Interim Guidance could be found in Step 2A, which requires an analysis of whether the claim is directed to a judicial exception, as opposed to the Myriad/Mayo guidance which applied to claims that recited or involved a judicial exception. Mr. Tamayo also indicated that by "directed to," the Office means "sets forth" or "describes." The Interim Guidance itself states that "[a] claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim" (emphasis added), so it would appear that claims involving a judicial exception will be exempt from consideration under the new guidance. How the Office will distinguish in practice between claims that are directed to, recite, set forth, or describe a judicial exception and those that "merely" involve a judicial exception is not entirely clear.
With respect to claims directed to nature-based products, Mr. Tamayo noted that such claims "require closer scrutiny," and that in another change in the new guidance, this scrutiny would take place during Step 2A. In yet another change, Mr. Tamayo noted that nature-based products would be scrutinized using markedly different characteristics other than just structure, which had been the sole focus of the Myriad/Mayo guidance. He also explained that the Office had looked to Federal Circuit and Supreme Court decisions to compile a non-exhaustive list of the types of characteristics that could be considered in assessing whether there is a marked difference, including biological or pharmacological functions or activities, chemical and physical properties, phenotype, and structure and form (see slide 12 below from Mr. Tamayo's presentation).
Moving on to Step 2B, Mr. Tamayo indicated that this step addressed the question of whether any limitation (or limitations) in the claim ensured that the claim as a whole amounts to something that is significantly more than the judicial exception itself. Mr. Tamayo then provided a list of examples of limitations that either qualified or did not qualify as amounting to something that is significantly more than the judicial exception (see slides 15 and 16 below from Mr. Tamayo's presentation).
Mr. Tamayo concluded his presentation by noting one last change in the new guidance: a streamlined eligibility analysis, which the Interim Guidance explains "can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it" (see slide 19 below from Mr. Tamayo's presentation). Whether the streamlined eligibility analysis will play a role in the Office's eligibility analyses, however, remains to be seen.
For additional information regarding this topic, please see:
• "USPTO Issues Post-Alice Abstract Idea Examples," January 28, 2015
• "Impact of Interim Guidance on Business Method and Software Claims," December 17, 2014
• "USPTO Issues Interim Guidance on Subject Matter Eligibility," December 16, 2014
• "USPTO to Release Revised Subject Matter Eligibility Guidance," December 15, 2014