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« Ariosa v. Sequenom -- Ariosa's Responsive Brief | Main | BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance »

November 12, 2014


It is unclear why the Office is unable to publish the proposed new guidance as a working draft open to public comments. That would be democratic, whereas doing everything in-house and presenting the public with a fait accompli would be autocratic and more befitting George III and Lord North than Thomas Jefferson.

Given what was said in the Myriad oral arguments, refusal to withdraw the Amazonic Acid example with immediate effect is inexplicable.

The extraordinarily low level of technical competence underlying the present guidance is amply illustrated by the gunpowder example which incorporates errors of technical fact unbefitting a graduate in the chemical sciences, and arguably also unbefitting a schoolchild with elementary knowledge of human history. If it has taken many months for the Office to find a way for gunpowder to be patent-eligible, that raises significant doubts about the technical and legal competence of the team working on the guidance.

On reflection, the real issue is not that the Office got the guidance wrong. People often make mistakes or ill-judgments, and people who do not make mistakes rarely make anything.

It is different, however, when something is wrong, the error is very clear once pointed out, but is allowed to persist on the record for a long time. Damage accumulates daily, and the longer the error is allowed to persist the less pardonable it becomes.

"Given what was said in the Myriad oral arguments, refusal to withdraw the Amazonic Acid example with immediate effect is inexplicable."

Exactly right. I remember when I first read the Guidance, I had to page through my transcript of the Myriad argument to make sure that I was not misremembering Justice Alito's hypothetical. The funny part about that exchange was that even the ACLU's lawyer agreed that making the Amazonic acid "substantially more concentrated than it was in nature" would be enough to confer patentability, but the Guidance took that example and ran in exactly the opposite direction with it.

One almost has to admire the nerve of whoever wrote that example in the Guidance. To take an example that Justice Alito intended as a clear example of something 101 eligible and use it as a didactic example of something INeligible--that takes guts.

The PTO could have avoided these problems by starting with public notice and comment before formulating the guidelines.

Now I have to respond to final rejections under the old guidelines, knowing that the new guidelines will be very different.

We have spent the better part of a year and lot of money going around in a circle.

I think that the Office should consider a guideline making non-final all rejections under the old guidelines, and giving applicants a new, non-final rejection under the new guidelines to address any remaining issues. The PTO can do this before they issue the new 101 guidelines.

"To those who have asked why the Office, in issuing the Guidance, went beyond Myriad, Ms. Cohan replied that "Myriad is not a case that stands alone," but rather "relies on earlier Supreme Court precedent including Chakrabarty, Funk Brothers, and Mayo.""

Funk Brothers was pre-1952. Anything the court said in it is irrelevant. Ms. Cohan's and her cohorts' persistence in feeling beholden to a court interpretation that was statutorily overruled is as puzzling as it is astonishing. And it is detrimental to investment and commercialization in the life sciences.

Unfortunately we cannot ignore Funk Brothers because the Supreme Court has cited it recently and with approval. What we can do, though, is to try to understand it and identify any relevant rules of law applied by the Court.

Unfortunately the opinion of William O Douglas is confused and legal interpretation is blisteringly difficult. The opinion cites Cuno and hence appears to be related to obviousness, but recent decisions have reinterpreted it in the context of eligibility. However, the fact that a Supreme Court justice thinks that the opinion was an eligibility opinion does not make it so: it is impossible to re-write the past. What is needed is to study the facts of the case and figure out the true rule of law. That means looking at the patent in issue, the particular claim in issue, the earlier Appeals Court opinion and the opinions in the Supreme Court. And much as we might prefer the opinion of Justice Frankfurter, the majority opinion was that of Douglas and the rule of law must be derived from what he wrote.

It was known to mix strains of Rhizobium bacteria, and the claim was limited by the result that the bacteria were non-interfering without the inclusion of any feature in the claim that made this happen ("selected" in context was meaningless). Justice Douglas was not prepared to give any weight to the result because the existence of non-interfering strains was the discovery of a law of nature. The application of this principle in the empirical state of the art was the discovery of particular non-interfering strains identifiable e.g. by deposit in a culture collection, but that was not in issue. What Justice Douglas did was notionally to cross out the non-interference wording as mere expression of a law of nature and to hold that there was nothing else that amounted to invention. Something similar is done in Europe for business method and computer patents where non-technical features are ignored. Interestingly though, this approach was expressly disapproved in Mayo.

Beyond concluding that judicial exclusions within statutory rights should be interpreted narrowly, there is not much more that can be added. We can all try to psycho-analyse William O Douglas, but there are likely to be as many outcomes as there are people undertaking the analysis. Perhaps the best way forward would be to say that beyond some unexceptionable statements of general principle no clear rule of law is derivable and that the decision should merely stand on its own facts. Pre-1952 many more patent cases reached the Supreme Court than nowadays, and it should not be expected that every decision would have wide-ranging and fundamental implications. But certainly it is not a case that provides any clear precedent that provides straightforward guidance for the USPTO.

Mr. Cole,

Your past admonitions of careful, thoughtful and limited application of our Supreme Court jurisprudence were completely ignored in today's release of Ultramerical III.

Sometimes it is painful to say "I told you so," but - I told you so.

To quote Brody: you're going to need a bigger boat


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