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University of Utah Research Foundation v. Ambry Genetics Corporation

Representative Claim(s)

Composition of Matter – U.S. 5,747,282

16. A pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction,

the sequence of said primers being derived from human chromosome 17q,

wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

Methods – U.S. 5,753,441

7. [Revised to include the language of claim 1, from which it depends]  A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject,

wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.

8. [Identical to claim 7, but with a second step directed to PCR amplification and sequencing instead of hybridization]

…wherein a germline nucleic acid sequence is compared by amplifying all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids.

Posture:

Appeal from decision of the District Court

Exception Categories: Abstract Idea, Natural Phenomenon

Composition of Matter claims:

“Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature.”

Method claims:

“We have already addressed the first paragraphs—the comparison step—in our own 2012 Myriad decision.  Claims 7 and 8 at issue here depend from claim 1.  Claim 1, which is the first paragraph of claims 7 and 8, is the comparison step.3 In our 2012 decision, we held that claim 1 was patent ineligible because it claimed an abstract mental process of ‘comparing’ and ‘analyzing’ two gene sequences.”  The court next moved on to the question of whether the additional steps (hybridization or PCR amplification/sequencing) added enough of an inventive concept to render the claims patent-eligible.

Significantly More: No

As to the composition of matter claims, the Appellant presented two arguments to assert patentability over naturally-occurring DNA:

  1. Appellant argued that single-stranded DNA primers do not occur naturally in the human body. The court applied the rationale of Myriad, which held that “separating [DNA] from its surrounding genetic material is not an act of invention.”  The court held that just as breaking covalent bonds to separate out a naturally-occurring DNA fragment from its chromosomal environment does not confer patent eligibility, the court held that neither does separating naturally-occurring short, single-stranded primer from its chromosomal environment.
  1. Appellant also argued that the primers have a significantly different function (serving as a starting material for DNA polymerization) than when they are part of a naturally-occurring DNA strand (storing biological information). The court dismissed this argument by stating that “one of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other.”  Finding that the primers also bind complementary nucleotide sequences, the court held that the primers do not perform a significantly different function.

As to the method claims, the court affirmed the District Court, holding that, “Nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques [hybridization or PCR amplification/sequencing] were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.”