Recently
'724 claim 1
A method for determining genetic data for DNA from a first individual in a biological sample of a second individual, the method comprising:
(a) amplifying a plurality of polymorphic loci on cell-free DNA extracted from the biological sample to generate amplified products;
(b) measuring an amount of the amplified products by sequencing-by-synthesis to obtain genetic data at the plurality of polymorphic loci;
(c) determining the most likely genetic data for DNA from the first individual based on allele frequencies in the genetic data at the plurality of polymorphic loci.
'180 claim 14
A method for measuring an amount of DNA in a biological sample, the method comprising:
(a) performing a targeted PCR amplification for more than 100 SNP loci on one or more chromosomes expected to be disomic in a single reaction mixture using more than 100 PCR primer pairs, wherein the reaction mixture comprises cell- free DNA extracted from a biological sample of a subject comprising DNA of mixed origin, wherein the DNA of mixed origin comprises DNA from the subject and DNA from a genetically distinct individual, wherein neither the subject nor the genetically distinct individual is a fetus, wherein the DNA of mixed origin comprises DNA from a transplant, and wherein the amplified SNP loci comprise SNP loci on at least chromosome 1, 2, or 3;
(b) measuring a quantity of each allele at a plurality of amplified SNP loci that comprise an allele present in the genetically distinct individual but not the subject, wherein the quantity of each allele at a plurality of amplified SNP loci are measured by high-throughput sequencing;
(c) measuring an amount of the DNA from the genetically distinct individual in the biological sample using the quantity of each allele at the SNP loci and an expected quantity of each allele at the SNP loci for different DNA fractions, wherein the method is performed without prior knowledge of genotypes of the genetically distinct individual.
'544 claim 21
A method for preparing a preparation of amplified DNA derived from a biological sample of a second individual useful for determining genetic data for DNA from a first individual in the biological sample, the method comprising:
(a) extracting cell-free DNA from the biological sample;
(b) preparing a preparation of amplified DNA by amplifying a plurality of target loci on the cell-free DNA extracted from the biological sample to generate amplified DNA;
(c) analyzing the preparation of amplified DNA by sequencing the amplified DNA using sequencing-by-synthesis to obtain genetic data of the plurality of target loci, and determining the most likely genetic data f or DNA from the first individual based on allele frequencies in the genetic data at the plurality of target loci.
'724 representative patent claim ineligible
Accordingly, the Court granted
'180 patent - Material fact in dispute
Summary judgment was denied because Natera challenged the
'544 representative claim patent eligible
The '544 claims recited "a method for preparing a preparation ... ."
The Court's reliance on claim language is instructive since many of the commentators have criticized prior decisions by considering the invention rather than what is claimed.
The key lesson from Natera (and
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