Monday, January 11, 2016

Patent Docs rates Ariosa number one patent story of 2015

Patent Docs named Ariosa the number one patent story of 2015:

1. Federal Circuit Decides Ariosa v. Sequenom and Denies Rehearing En Banc

In June, the Federal Circuit decided Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the District Court's decision granting Ariosa's summary judgment motion for invalidity on the grounds that the claims of of U.S. Patent No. 6,258,540 were patent ineligible. Although the Federal Circuit appreciated that the inventors had found cell-free fetal DNA (cffDNA) in maternal plasma or serum "that other researchers had previously discarded as medical waste," the panel stated that "[a]pplying a combination of known laboratory techniques to their discovery," the inventors "implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender." In affirming the District Court decision, the opinion concluded that "[t]he method . . . begins and ends with a natural phenomenon," and "[t]hus, the claims are directed to matter that is naturally occurring."

The first claim of the patent in question is succinct:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.


The paternal DNA is inherently in the serum. The inventors recognized that one could detect this paternal DNA, and recited known techniques to amplify the paternally-inherited nucleic acid. The important discovery was knowing that
"paternally inherited nucleic acid of fetal origin " was in the maternal [blood] serum or plasma.

See for example:

**For reference to the discussion below, the Supreme Court case of Diamond v. Diehr related to a patent method claim applying the [prior art] Arrhenius equation to operation of a rubber molding press.

The Supreme Court in Alice v. CLS Bank, a unanimous opinion, stated:

In Diehr, by contrast [with Flook], we held that a computer-implemented process for curing rubber was patent eligible, but not because it involved a computer. The claim employed a "well-known" mathematical equation, but it used that equation in a process designed to solve a technological problem in "conventional industry practice." The invention in Diehr used a "thermocouple" to record constant temperature measurements inside the rubber mold — something "the industry ha[d] not been able to obtain." The temperature measurements were then fed into a computer, which repeatedly recalculated the remaining cure time by using the mathematical equation. These additional steps, we recently explained, "transformed the process into an inventive application of the formula." Mayo, supra, at ___, 132 S.Ct., at 1299. In other words, the claims in Diehr were patent eligible because they improved an existing technological process, not because they were implemented on a computer.

One observes that the Alice interpretation of Diehr, emphasizing the use of a thermocouple in a previously undisclosed manner, is a bit different than what one has in Ariosa, wherein the method steps of detecting and amplifying are not new. The novelty is in determining that paternal DNA is in the serum or plasma. That recognized, one has a useful test employing standard methodology.

**There is no doubt that this case has attracted a lot of attention. Dennis Crouch at PatentlyO had written:

My former boss Kevin Noonan is counsel of record for a group of 23 law professors, including Adam Mossoff, Dan Burk, Tim Holbrook, and Richard Epstein. The brief makes two main arguments: (1) the genetic diagnostic tests developed and commercialized here are the type “historically unforeseen invention” that the patent system is designed to promote; and (2) the panel’s approach here of requiring novelty beyond straightforward application of excluded natural phenomenon “would call into question nineteenth century patented innovation the Supreme Court deemed valid.”Read Ariosa.lawprof. The sentiment of the Law Professor Brief is consistent with the brief filed by Matthew Dowd on behalf of JYANT Tech, explaining that “in Diamond v. Diehr … the [Supreme] Court explained that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” Read Ariosa.JYANT

As we will discuss in a parallel post, the brief of Professors Lefstin and Menell provide their reading of recent Supreme Court cases of Mayo and Alice — arguing that (1) a close reading shows that inventive application of a law of nature is not required but instead a non-preemptive or non-generic application; and (2) the Flook-type claim dissection is prohibited. Read Ariosa.Leftsin. This analyze-it-as-a-whole sentiment was repeated by the IPO Brief field by Tiege Sheehan as well as the brief from Amarantus filed by Gideon Schor. Read Ariosa.IPO and Ariosa.Amarantus.

My Fellow Missouri Professor Chris Holman filed a brief on behalf of the major industry organizations BIO and PhRMA making the credible argument that all this is a very big deal in the diagnostic space and that the resulting uncertainty is having a negative impact on research. Read Ariosa.BIO.


One brief mentioned in PatentlyO emphasized the claim element of serum or plasma (meaning cell free):

Myriad‘s counsel Benjamin Jackson filed a brief on behalf of the industry organization21st Century Medicine that challenges the “gist” method of determining whether a claim encompasses excluded subject matter and suggests that the claim here is simply a technological improvement over the prior art.

Sequenom’s patent teaches it was known in the art that fetal cells can pass into the mother’s blood. Diagnostic techniques had been devised to isolate these cells and analyze fetal DNA extracted from them, but these techniques were expensive and time consuming. The phrase “cell-free fetal DNA” was therefore not an attempt to claim a natural phenomenon but instead a key claim limitation to distinguish over the art. Fifteen years ago, back when patent claiming and examination focused on prior art rather than ill-defined “natural phenomena,” Sequenom appropriately emphasized that its methods used cell-free fetal DNA rather than the cell-derived fetal DNA known in the art.

Thus, the claimed invention is a significant technical improvement in the laboratory process for prenatal diagnosis, allowing laboratories to eliminate the costly and labor-intensive step of isolating fetal cells and then fetal DNA. Such an inventive improvement to the technical performance of an existing technological process is precisely what patents are for.

Wikipedia notes of blood plasma: Blood plasma is the pale yellow liquid component of blood that normally holds the blood cells in whole blood in suspension; this makes plasma the extracellular matrix of blood cells. It makes up about 55% of the body's total blood volume. (...) Blood serum is blood plasma without clotting factors

Wikipedia notes of blood serum: In blood, the serum is the component that is neither a blood cell (serum does not contain white or red blood cells) nor a clotting factor; it is the blood plasma not including the fibrinogens. Serum includes all proteins not used in blood clotting (coagulation) and all the electrolytes, antibodies, antigens, hormones, and any exogenous substances (e.g., drugs and microorganisms).


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