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  • Patenting Isolated Human Enhancer Elements & the Utility Requirement Problem

    The Human Genome Project was initiated in October 1990 with the goal of identifying all the roughly 25,000 genes in the human genome and sequencing the three billion nucleotide base pairs that comprise human deoxyribonucleic acid (DNA). Hundreds of genes have been linked with specific clinical phenotypes since the Project was completed two years ahead of schedule in April 2003. The vast majority of such phenotypes have been connected to mutations in DNA that code for a protein product. Other diseases have been linked with noncoding DNA, which was once commonly described as “junk DNA.” The study of noncoding DNA is now at the forefront of genetics studies because research has revealed that various noncoding regulatory elements, such as enhancers, repressors, and insulators, may alter gene expression in a tissue-specific manner.