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September 30, 2014


"Noting that there are different ways to interpret relevant Supreme Court decisions on subject matter eligibility, she noted that the revised Guidance would not be confined to DNA because the Court's Myriad decision 'does not stand alone.'"

Honestly, post-Roslin this is not even an open question. The PTO has to follow the holdings of precedential CAFC rulings, and Roslin held that Myriad compelled a holding of ineligibility for a cloned organism. Not to put too fine a point on it, but an organism is not an isolated DNA molecule. In other words, the view that Myriad is only applicable to DNA has been untenable for at least a few months now.

I do not think, however, that either Myriad or Roslin compel the conclusion that all isolated biomolecule claims are per se ineligible. I see nothing in either Myriad or Roslin to convince me that, for example, Bergy has been over-ruled. That is to say, the Bergy rule--i.e., an isolated/purified organism (or, by extension, biomolecule) is 101 eligible if the isolation/purification imparts a new functionality that the unisolated/impure composition did not have--should still be applied when assessing subject matter eligibility. The problem with Roslin's clone is that its functionalities (breeding, meat, wool production) are all the same as the prior art livestock.

On the interpretation of Myriad see my comments on this blog: Myriad -- An Obvious and Patent-Friendly Interpretation


On Roslin see the submissions that Tim Roberts and I made to the USPTO concerning TRIPS compliance,


see also my comments on Funk Brothers.

It may not be the best way forward to point out that Federal judges are wrong, even where they are. Better to find a narrow interpretation that leaves their dignity intact whilst removing the sting from the observation in question, especially where it is not essential to the rule of law applied by the court and is a mere dictum. Arguably the remarks in Roslin apply only to unchanged microorganisms in their natural environment, otherwise there is conflict with the opinion in Chakrabarty which to the best of my knowledge is still good law and was followed rather than distinguished in Myriad.

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