In the recent case Illumina, Inc. v. Ariosa Diagnostics, Inc., the Federal Circuit found that claims directed to methods of preparing DNA samples for analysis satisfy the patent eligibility requirement of 35 USC § 101.
The patents at issue covered subject matter directed to distinguish and separate the little amount of fetal DNA from the maternal DNA.
As it is now generally known, laws of nature and natural phenomena are not patentable, but applications and uses of such laws and phenomena may be patentable.
Laws of Nature — Patentable Or Not?
However, according to the two-step analysis, a claim is first examined to see whether it is directed to a law of nature or to a natural phenomenon. If the answer is YES, then the limitations of the claims are analyzed to see whether — considered individually and as an ordered combination — they [the claims] amount to “something more” than the law of nature or the natural phenomenon.
The Federal Circuit also divided the “diagnostic” cases to the “method of treatment” cases. Diagnostic claims have been held unpatentable, while method of treatment claims are patentable.
Following this reasoning, the Federal Circuit noted that this was not a diagnostic method, nor a method of treating, but rather a method of preparing.
In particular, the Court found that the claims were directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA. The claimed steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood. The methods include specific process steps to change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood. Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.
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Silvia Salvadori, PhD