Knobbe attorneys presented "Patentable Subject Matter in Biotechnology" at a recent seminar held in Japan.
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1. A method of optimizing therapeutic efficacy for treatment of [a specific] disorder, comprising: (a) administering a drug providing 6-TG to a subject having said … disorder; and (b) determining the level of 6-TG in said subject having said … disorder, wherein the level of 6-TG less than about 230 [units] indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-TG greater than about 400 [units] indicates a need to decrease the amount of said drug subsequently administered to said subject.
• Claims are not patent eligible under 35 U.S.C. § 101
• The administering and detecting steps are not sufficient to transform correlations into specific patentable applications
• “Transformation” alone is not sufficient
– In “stating that the ‘machine-or-transformation’ test is an ‘important and useful clue’ …, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion.”
• Limiting claims to a particular technological field is not the same as reciting a specific application and is insufficient
– “It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. … The “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.” (Diehr)
– “[Diehr] nowhere suggested that all these steps…were in context obvious, already in use, or purely conventional. …--they transformed the process into an inventive application of the formula.” (Prometheus)
Association for Molecular Pathology v USPTO (“Myriad”)
Isolated DNA Claims
• An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
Method Claims
• A method for detecting a germline alteration in a BRCA1 gene . . . which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample . . .
Association for Molecular Pathology v USPTO (“Myriad”)
Method Claims
• A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises . . . comparing a first sequence . . . made from mRNA from said tumor sample with a second sequence . . . .
• A method for screening potential cancer therapeutics which comprises: growing a trans-formed eukaryotic host cell containing an altered BRCA1 gene . . . , growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth . . . , wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
• One Judge Concurring-in-Part, One Judge Dissenting-In-Part
• “[T]he [isolated DNA] claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from those found in nature.”
• The method claims that recite only “‘comparing’ or ‘analyzing’ two gene sequences fall outside the scope of §101 because they claim only abstract mental processes.”
• The method claims for screening potential cancer therapeutics satisfies§101 because the “growing” step is transformative and does more than simply apply a law of nature.