Sequenom’s En Banc Petition

Sequenom’s Petition for Rehearing En Banc – Panel Ignored “Inventive Concept” in Combined Steps of the Claimed Method

For any of us practitioners encountering increasing numbers of s. 101 rejection rejections of diagnostic claims based on Mayo and the March 2014 PTO Guidance – and that is pretty much any life sciences patent attorney – this brief is a “must read.” (A copy of this brief is available at the end of this post.) This brief puts it all out there, both criticizing the panel, proposing a new rule for method claims incorporating natural phenomenon and illustrating how the panel’s application of the Mayo Rule threatens method of medical treatment claims as well as diagnostic method claims.

If I start trying to summarize the Brief, I will not be able to stop. Instead of arguing that the Mayo Supreme Court decision was wrong, the Brief distinguishes the regimen claims in Mayo from the Sequenom claims – that were based on the discovery of cffDNA in maternal serum which, in turn permitted the non-invasive determination of the condition of the fetus. The opinion of the Brief’s authors is that the Sequenom claims adhere to the rationale of Diehr, a decision ignored by the panel. I will quote two paragraphs below, but picking just one to quote is like having to stop after eating a single M&M or one potato chip – nearly impossible:

“That the [Sequenom] inventors’ discovery of a natural phenomenon motivated that new combination of steps makes this case no different that Diehr or any other invention. Indeed, while the source of [the inventors’] ‘inventive concept’ was of course the discovery of cffDNA in maternal plasma, it is indisputable that their inventive concept was ultimately embodied in a method that taught researchers to apply the combined techniques of fractionation, amplification, and detection to waste materials in essentially the opposite of the conventional fashion.”

So the ultimate diagnostic conclusion is embodied in a method claim reciting steps that may all be available to the art, but add up to a patent-eligible method claim due to the embedded discovery of what the [per se unpatentable] natural phenomenon means.

This is a bit more sophisticated than my argument that the diagnostic conclusion should be viewed apart from the in vivo correlation and be given weight as a claim element, but it scales the same analytical mountain. Here is the next paragraph from the Brief:

“To see this more clearly–and demonstrate the problem in the panel’s understanding of a method’s ‘inventive concept’–consider a case in which a researcher serendipitously discovers that a randomly-selected combination of well-known lab techniques allows him to reliably detect a disease from a urine sample, but he has no idea why. This method is plainly patent-eligible: It claims a highly novel and useful process, and recites no natural phenomenon apart from the fact that the method works…. Ironically, the panel’s rule would hold that if this researcher did understand his method–if he knew the phenomenon that explained it, and the techniques involved would be routine to someone with that knowledge–the method suddenly becomes ineligible subject matter. This is absurd: No rationale patent system can punish inventors for understanding or explaining why their novel methods works. That is why, per Diehr, a method’s ‘inventive concept’ inheres in the novelty of the combined steps, not the discovery that motivates them.”

It only gets better. Now let’s hope that the Fed. Cir. and the PTO can get it.

Sequenom en banc petition Aug13 2015

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One Response to Sequenom’s En Banc Petition

  1. Paul Cole says:

    The Ariosa opinion contains errors of both fact and law which it is hoped can be corrected en banc.

    It will be recalled from the opinion that in 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. Amplifying cffDNA resulted in a single copy, or a few copies, of a piece of cffDNA being multiplied across several orders of magnitude, generating thousands to millions of copies of that particular DNA sequence to achieve detectable levels. In an embodiment of the detection step a lab technician added the amplified cffDNA to an agarose gel and used ethidium bromide to visualize the paternally inherited cffDNA.

    The first step of the court’s analysis, that the starting-point cffDNA was a natural phenomenon is uncontroversial. However, the opinion goes on to conclude that the method ends with paternally inherited cffDNA, which it found as a fact is also a natural phenomenon, so that the the claimed method both began and ended with a natural phenomenon and the claims were directed to matter that is naturally occurring. If there is any doubt about the importance that Judge Reyna attached to his factual finding, that doubt is resolved by the fact that he stated it twice.

    From the reference to sex determination, it appears that Judge Reyna was focusing on Example 1 of US 6258540. In that example 10µl of maternal plasma or serum was placed in an Eppendorf tube. Reagents were added to carry out PCR amplification, including a pair of primers designed to amplify a region from the Y-chromosome only 198 base pairs long and sex was determined by the presence or absence of staining. It follows that what was present in the Eppendorf tube prior to placement on the agarose gel was plasma or serum which in the case of a male foetus contained multiple copies of the amplified short sequence. There was nothing natural about these amplified sequences – they are the result of PCR synthesis which is a chemical reaction using single nucleotides as polymerization monomers, and to describe them as a “natural phenomenon” is wrong on the face of the opinion by a factor of between 1000 and 1000000.

    From the legal standpoint, following the reasoning in Myriad, mere isolation of the 198 bp of the Y-chromosome would give rise to a molecule having no practical utility. However, amplification of it by PCR gives rise to a product of Hartranft utility because the sequence has not only been isolated but has been multiplied to a concentration where it is detectably useful e.g. by gel electrophoresis followed by ethidium bromide staining. Hartranft utility is recognised in American Fruit Growers, Chakrabarty and Myriad itself. The contrary conclusion would cast doubt on established case law such as the adrenalin case, and have wide-ranging and unintended consequences for natural product-based inventions.

    It will be recalled that the experience of Judges Wallach and Reyna was in the field of international trade, and that neither of them had prior to their appointment any deep knowledge of biotechnology or patents. It is foreseeable that the patents that we write will go before a non-technical audience, and judges who have to consider them will also lack both technical insight and experience of patent law. Only isolated portions of the technical evidence are referred to in the opinion, but one of the take-away lessons from this unfortunate case is that everything we draft should be made as clear as possible to the non-technical readers who may have to make decisions based on them.

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