Opinion ID: 4552768
Heading Depth: 3
Heading Rank: 1

Heading: The Claimed Method Steps

Text: Involve a Natural Phenomenon The first step of the Alice test requires that we determine whether the claims at issue are “directed to” a natural phenomenon. Alice Corp. Pty. Ltd. v. CLS Bank Intern, 573 U.S. 208, 217–18 (2014). To make this determination, the Supreme Court has analyzed whether the claims “involved” patent-ineligible subject matter. Id. at 219; see also id. at 218–20 (citing Gottschalk v. Benson, 409 U.S. 63, 71– 72 (1972), and Bilski v. Kappos, 561 U.S. 593, 599 (2010)). In Alice, the Court determined that the claims were directed to an abstract idea because the claims “involve” the abstract idea of “intermediated settlement,” a concept the Court deemed a “fundamental economic practice.” Alice, 573 U.S. at 219. Like in Alice, the claims here are directed to a natural phenomenon because they involve a fundamental natural phenomenon, that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood, to produce a “mixture” of naturally-occurring substances. For example, the preamble of claim 1 of the ’751 patent informs us that the patent claims a method for preparing a DNA “fraction” from a pregnant human female that can be used for diagnostic purposes. 2 The remainder of claim 1 2 Claim 1 recites: Case: 19-1419 Document: 64 Page: 21 Filed: 08/03/2020 4 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. recites the method steps for producing the fraction and analyzing it. Each step involves the DNA taken from the blood plasma or serum of a pregnant human female. The DNA itself is not changed or altered. The first step is achieved by (a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum taken from a pregnant female. That sample is then A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female use- ful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
cell-free sample of blood plasma or blood se- rum of a pregnant human female to obtain extracellular circulatory fetal and mater- nal DNA fragments;
tracted in (a) by:
lar circulatory DNA fragments, and
fragments greater than approxi- mately 500 base pairs, wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extra- cellular circulatory fetal and ma- ternal DNA; and
of DNA produced in (b). ’751 patent at col. 7 ll. 54-67, col. 8 ll. 53-57; cf. ’931 patent at col. 7 ll. 58-67, col. 8 ll. 57-63 (claim 1). Case: 19-1419 Document: 64 Page: 22 Filed: 08/03/2020 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. 5 used to (b) produce a “fraction” of the DNA extracted in the first step (a). The fraction is produced via (i) size discrimination of the extracellular circulatory DNA fragments, and (ii) selective removal of DNA fragments greater than approximately 500 base pairs. Claim 1 states that after the extraction, size discrimination, and selection and removal steps are completed, the fraction comprises “a plurality of genetic loci of the extracellular circulator fetal and maternal DNA.” ’751 patent at col. 8 ll. 53–55. The Majority describes the resulting fraction as “a mixture enriched in fetal DNA.” Maj. Op. at 12. But this mixture is made of the same natural substances present in the original sample. In sum, the claimed method begins with extracting a sample of blood plasma or serum from a pregnant mother that consists wholly of various naturally occurring substances, including cff-DNA. ’751 patent at col. 7. ll. 58–61. The claimed method separates those naturally occurring substances by size, leaving a “fraction” of the original sample that is predominantly cff-DNA. Id. at col. 7 ll. 63–67, col. 8 ll. 53–55. The claimed method ends with analyzing the components of the “fraction,” which contains cff-DNA. Id. at col. 8 ll. 56–57. The substances present throughout the process are naturally occurring substances, and the claimed method steps do not alter those substances. Thus, under the Supreme Court’s step-one analysis, the claimed method steps “involve” natural phenomenon and are, therefore, directed to a natural phenomenon. 3 3 The dependent claims add detail such as tech- niques for conducting each method step and the detection of specific chromosomal aberrations. For example, claim 7 of the ’751 patent specifies centrifugation for the size discrimination step and claim 10 specifies for the detection of a fetal chromosomal aberration causing Down Syndrome. ’751 patent at col. 9 ll. 1-2, 7-8. Case: 19-1419 Document: 64 Page: 23 Filed: 08/03/2020 6 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC.