In
The Technology and Patent Claims
The '751 and '931 patents claim inventions from the 1996 discoveries of Drs.
Representative claim 1 of the '751 patent recites:
1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
(c) analyzing a genetic locus in the fraction of DNA produced in (b).
Representative claim 1 of the '931 patent recites:
1. A method, comprising:
(a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 300 base pairs,
wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
(c) analyzing DNA fragments in the fraction of DNA produced in (b).
The 101 Analysis
In framing its decision, the Federal Circuit reiterated the current state of the law regarding patent eligibility. The Majority noted that while laws of nature and natural phenomena are not patentable, "applications and uses of such laws and phenomena may be patentable. A claim to otherwise statutory subject matter does not become ineligible by its use of a law of nature or natural phenomenon. See Diamond v. Diehr,
The court then applied the Alice two-part test set forth by the Supreme Court to evaluate the patent eligibility of claims. "First, we examine whether the claims are "'directed to' a law of nature or natural phenomenon.
The court then characterized the claims as neither diagnostic nor treatment claims. Rather, the claims are directed to methods of preparation. The court distinguished its prior decisions with similarly constructed claims. In contrast to the prior claims (diagnostic or treatment) and decisions that determined that they are patent ineligible (diagnostic) or eligible (treatment), the '751 and '931 claims focus on the discovery that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother's bloodstream and the utilization of this natural phenomenon. The court focused on the process-specific steps of the methods, e.g., "size discriminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample." Slip Op at 10. The court determined that these process-specific steps distinguish the examined claims from claims that may solely focus on the observation that fetal DNA is present in maternal plasma or serum.
The court also looked to its prior CellzDirect opinion (see Rapid Litig. Mgmt. Ltd. v.
In sum, the Majority held:
Rather than focusing on what the inventors of the '751 and '931 patents did not invent, we focus our Alice/Mayo step one analysis on what the inventors did purport to invent and what they claimed in their patents: methods for preparing a fraction of cell-free DNA by the physical process of size discriminating and selectively removing DNA fragments longer than a specified threshold. Those methods are 'directed to' more than merely the natural phenomenon that the inventors discovered. Accordingly, we conclude at step one of the Alice/Mayo test that the claims are not directed to a patent-ineligible concept, and we need not reach step two of the test.
Slip Op. at 14.
Dissent - The Claims Are Not Patent Eligible
The Federal Circuit's decision indicates that certain discoveries that support personalized medicine diagnostics may be patent eligible. Claims that exploit discoveries with specific process steps that transform an observation of a natural phenomenon to defined steps that provide a new and useful result are more likely to withstand a Section 101 challenge. This decision, as well as the Federal Circuit's CellzDirect decision are useful tutorials for patent practitioners.
Footnotes
1 See e.g., See
2 See e.g.,
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