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July 02, 2015

Comments

Agree with PC regarding the various stages of the process at which it can be seen that one is not working with a product of nature.

"...it is disturbing that subject matter held inventive by the EPO should be summarily dismissed as ineligible in the U.S. under §101." Oh, that British predilection for understatement!

Even if concentration is focused on the short sequences to the exclusion of other relevant process and composition of matter features, the short sequence copies are a wholly artificial creation, being the result of the synthetic chain reaction and to describe them as a natural product gives rise to an error, on the figures of the slip opinion, of 103-106 which is on any view an exuberant margin. They have new utility compared to the original blood or serum sample insofar as they are present at levels that are detectable in subsequent test procedures whereas the original cffDNA is not.

This seems to me exactly how the analysis should run in section 101 cases. Unfortunately, I can sympathize with Judge Linn's point that some of the language in Mayo does not sit easy with such an analysis.

Incidentally, it is not clear to me what Justice Thomas meant in Alice when he said that claims must be considered "both individually and in combination." I think that the way that most of us read that passage is that if the claim as a whole defines something that is not an abstract idea or a product of nature, then the claim is eligible. If you look, however, at how this analysis is applied in Mayo, one is left with the impression that what is intended is that if the claim considered either as a whole, or as a series of individual elements can be read as defining an abstract idea or product of nature, then the claim is ineligible. Certainly that appears to be how the Ariosa court is reading Mayo and Alice.

Whoops, I meant to put Dr. Cole's words in quotes, but I appear to have omitted them.

@ Greg

When I checked, the key passages in Alice were copied from Prometheus. If I am wrong, please pull me up on this.

Judge Linn said:

"In applying the second part of the test, the Supreme Court in Mayo discounted, seemingly without qualification, any “[p]ost-solution activity that is purely conventional or obvious,” id. at 1299 (original alterations omitted). This was unnecessary in Mayo, because doctors were already performing in combination all of the claimed steps of administering the drug at issue, measuring metabolite levels, and adjusting dosing based on the metabolite levels, id."

I think that this although fundamentally correct overstates what was known prior to the patent in issue in Mayo. The Mayo opinion rightly draws attention to an earlier study by Cuffari, Théorêt, Latour, & Seidman, 6-Mercaptopurine Metabolism in Crohn’s Disease: Correlation with Efficacy and Toxicity,39 Gut 401 (1996), two of the individuals being inventors of the patents in issue including US 6355623 and which suggested that measurement of 6–MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6–MP. The final paragraph of the 1996 paper explains:

"Our recent preliminary investigative efforts to measure 6-TG in leucocytes has shown a correlation between neutrophil 6-TG levels and responsiveness to treatment as well as drug induced leucopenia. Further research is needed to identify a therapeutic regimen for 6-MP treatment allowing clinicians to establish a balance between drug responsiveness and toxicity."

The truth is that that everything in the representative claim was known except for the numerical values of the limits which were pure information, there was NO new post-solution activity of any kind whatsoever, and ALL the activity considered by the Court was pre-solution. I do not think that we need to go over-deeply in this since the test of novelty + new utility was explained in Hartranft which was approved both in Chakrabarty and in Myriad. Hartranft utility is, I think, a very important and inadequately emphasized test.

If Judge Linn had studied not just Mayo but also Chakrabarty and Myriad, I think he might have found an escape route.

Justice Thomas, I think, intended that you look at the features one-by-one and then look at all of them together. The usual test for features to be a true combination and not a mere aggregation is that they produce a combined result - hence the paragraph emphasizing high sensitivity/test for a wide range of conditions.

The mere aggregation test does not require you to perform an in depth analysis of the individual steps per se. This bit of "scrivining" causes more harm than good as it appears to violate the direction to take the claim as a whole. It is understood - and goes without saying - that claim elements are bits and pieces of the whole. For 101 purposes, it matters that if something goes without saying, then "saying" should not be said.

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