In 1996, Doctors Dennis Lo and James Waincoats discovered cell-free fetal DNA, particularly in maternal plasma and serum. Previous researchers had earlier discarded this portion of maternal blood samples as a waste. They applied and obtained a patent in 2001. The patent claimed paternity inherited in pregnancy.

In 2015, the United States’ court held the patent to be invalid in law as it was a matter that was naturally occurring under 35 USC 101. However, the present case involved two patents that were unrelated to those that the court invalidated. 

The claim had priority in the European patent. The application of which was filed in 2003. The patents were labelled “751” and “931”. However, unlike the earlier patent, both were related. They also had essentially identical specifications. The patents also brought problems subject to further research.

They showed that pregnant woman extracellular fetal DNA were present in maternal circulation. Thus, it could be detected in maternal circulation.


Illumina instituted an action at the northern district court of California against Ariosa Diagnostics and two other companies, alleging infringement on their patents “751” and “931”. One of the defendants applied for summary judgment, alleging that the patents were invalid under 35 USC 101. The application was granted as the district court invalidated the patents. Therefore, the claims were said to be an ineligible subject matter.

The judgement was held in favour of the defendants. This led to an appeal before the US Court of Appeal of the Federal Circuit of the Court of Appeal reversed the district court by a panel majority. Although, a panel member dissented. The court further held the patents eligible.

One of the defendants subsequently filed a combined petition before the Federal Circuit for rehearing before the panel and en banc. In 2020, panel rehearing was granted but the full court denied rehearing en banc.

In the original opinion, Illumina’s patents were held as specific process steps. Therefore, not a natural phenomenon that was invalid. However, in the modified opinion, the panel’s majority decision remained the same but emphasized parameters indicating non-natural phenomenal.

Roche’s argument was rejected in the original and modified opinions as it did not fall under the Ariosa case of 2015. The panel’s majority stated that the claims were not patent-ineligible concepts because analyzing fetal chromosomal aberrations were not a natural phenomenon.

Unlike Judge Lourie and Moore, Judge Reyna dissented in both original and modified opinions.

In his original opinion, he said there were only mere changes to the natural phenomenon. Thus, the claims were patent ineligible.

In his modified opinion, he added that the process did not alter the natural phenomenon. He proceeded that the processes involved were naturally occurring. Judge Reyna criticized the panel’s majority as they failed to address the claimed advanced inquiry subsequently.


The full court denied hearing en banc subsequent to the issuance of the panel rehearing. Quite strangely, none of the Judges stated reasons for denial of hearing en banc.


Disclaimer: The views and opinions expressed throughout this blog are the views and opinions of the individual author(s) and/or contributor(s) and do not necessarily reflect the views and opinions of our firm, CIONCA IP Law. P.C. 

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  • CIONCA IP TEAM (SE)10/15/2021 4:55:32 PM

    DNA of Patents

Marin Cionca | Founder of CIONCA IP

Marin Cionca, Esq.

Registered Patent Attorney

USPTO Reg. No. 63899

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About CIONCA® IP Law firm: We are an Irvine, Orange County, California based boutique intellectual property law firm with a focus on patent and trademark application, prosecution, opinion, licensing and IP enforcement services, including IP litigation, offering its IP services, other than IP litigation, primarily at flat fee rates. We serve local OC (Orange County) clients, as well as clients from the Los Angeles, San Diego and Riverside Counties and clients throughout the state of California, the United States and also international clients, such as EU clients.

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