On April 18th, the Senate Judiciary Subcommittee on Intellectual Property released a “Draft Outline of Section 101 Reform” that is intended to provide the basis of legislative amendments to the requirements for patent reform. Apart from the proposal to effectively eliminate the phrase “new and” from s. 101, the Outline proposes that “exclusive categories of statutory subject matter which alone should not be eligible for patent protection.”
These include categories that are relatively non-controversial such as “fundamental scientific principles” (such as gravity, I presume) as well as categories that still leave room for interpretation by the PTO and the courts, such as “products that exist solely and exclusively in nature.” This “in nature” requirement could be read as overturning the Funk Bros. opinion and resurrecting Bergy II — the CCPA holding that cultures of pure strain microorganisms were found to not be natural products.
However, the Outline also contains a paragraph stating that “generic technical” or “generic functional language” will not salvage an otherwise patent ineligible claim. So, if a diagnostic method claim is based on the recognition of the utility of certain levels of an in vivo marker, is the claim “safe” because the measurement and correlation take the claim out of the “exist solely and exclusively in nature” category or is the claim barred if the steps used to carry out the test are expressed in generic technical language? Certainly, the courts have barred claims “directed to” phenomena of nature on this basis, but the outline seems to protect claims to natural products, while not mentioning claims reciting naturally-occurring processes.
The Outline aligns with the recent PTO Guidance that endorses claims that pass a practical application test, but is that sufficient to protect claims to diagnostic methods, especially since the Outline would black list “Mental Activities.” This is relevant since courts and the PTO routinely disregard steps in claims that involve “thinking”, e.g., the mental activity of the actor who interprets the results of the test as indicative of a medical condition. Is this a weakness in the Outline or is the “practical application” requirement strengthened by the requirement that claims be considered as a whole, considering “each and every element?” But what if a claim element employs “generic technical language” that is “well-known and conventional” – like obtaining a sample or measuring a marker?
If you feel that I am beginning to fall victim to circular logic, please remember that these are my first impressions. However, while the Outline seems to take two steps forward and one step back, it does recognize and seek to address most of the thorniest issues surrounding the role of Section 101. Given the level of Congressional drama gripping the Government as I type, we should be grateful for any attention at all to our little section of U.S.C.