Section 101 at the AIPLA Midwinter Meeting

Railroad tracks - istockAlthough the primary focus of this four day meeting was licensing, there were two simultaneous tracks that contained at least a section of the effect/uncertainty of the recent judicial decisions and PTO Guidelines on licensor/licensee relationships. (I spoke at one of them, and my short slideshow is posted on the AIPLA website, along with a longer “law review”-type article that is, by now, a bit out of date.)

What got me out of bed this morning was the “President’s Forum –What’s Next for Patent Eligibility: Federal Circuit and the USPTO Gloss.” It was chaired by Sharon Israelson, current AIPLA president and included Jerry Selinger – who is heading up an AIPLA working group on the issue, Myra McCormack of J&J, Nate Kelly, Solicitor, USPTO and Jim Crowne of AIPLA. Of course, this was too many speakers for an hour-long forum.

Little of substance – or I should say, little that was unexpected – was put on the table. Myra “got real” by presenting three examples which she felt could no longer be patented under the current law and Guidelines: a) a small molecule therapeutic derived from a sea squirt that was not useful if chemically altered; b) specific, characterized human antibodies that provide an anti-Alzheimer’s disease effect; and c) the results of microbiome studies that demonstrate, e.g., that gut flora could be refined into useful therapeutics.

Mr. Kelly admitted that the Office was “shuffling the deck and re-dealing it to you.” He stated that Examiners were being trained as effectively as possible (by whom? Mr. Hirschfeld?) and that the best response to a 101 rejection was to differentiate the closest judicial decisions and not simply argue that the S. Ct. was wrong.

When I tried to ask what standards were being used to examine claims to diagnostic tests, in view of the absence of any mention of diagnostics in the December 15th Guidelines that superseded the March 4th Guidelines, I did not get an answer. (In fact, I think that Examiners are applying the two-step Mayo test as best they can – but that will always lead to a rejection of simple diagnostic assays, which will be subjected to a 101/103 analysis of their recited steps for an “inventive step” that should not be a part of a 101 analysis, etc. etc.) In fact, there were only two other questions taken and I don’t think that the answers got beyond, “We’re studying that.” Well, school is in. Now would someone tell us how many “credits” it will take for our claims to “graduate”?

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