Jeffrey A. Lefstin

Allosteric effects of DNA on transcriptional regulators

Selective gene transcription is mediated in part by regulatory proteins that bind to DNA response elements. These regulatory proteins receive global information from signal-transduction events. But transcriptional regulators may also be modified in an allosteric manner by response elements themselves to generate the pattern of regulation that is appropriate to an individual gene.

Three-dimensional organization of chromosomes studied by in-situ hybridization and optical-sectioning microscopy

We have examined the three-dimensional arrangement of chromosomes in embryos of Drosophila melanogaster at the syncytial blastoderm stage using three-dimensional optical sectioning microscopy. High-resolution optical sectioning in fixed embryos, in conjunction with in situ hybridization, has revealed the location of specific chromosomal regions within diploid interphase nuclei, as well as the spatial arrangement of mitotic chromosomes. Time-lapse in vivo optical sectioning has revealed the dynamic behavior of chromosomes throughout the mitotic cycle. Combination of these observations has provided insights into the dynamic aspects of three-dimensional chromosome behavior.

Don't Throw Out Fetal-Diagnostic Innovation with the Bathwater: Why Ariosa v. Sequenom Is an Ideal Vehicle for Constructing a Sound Patent-Eligibility Framework

Over the past five years, the U.S. Supreme Court has reinvigorated patentable subject-matter limitations, issuing four significant decisions after nearly three dormant decades. These decisions reflect justifiable concerns about the patenting of abstract business methods and laws of nature. Just as importantly, they reveal internal inconsistencies and confusion about the scope of patentable subject matter and tension with the centuries-old fabric of patent-eligibility jurisprudence. As Justice Breyer remarked at the oral argument in Alice Corp. v. CLS Bank Int’l (2014), the Mayo (2012) decision did no more than “sketch an outer shell of the content” of the patent-eligibility test, leaving much of the substance to be developed by the patent bar in conjunction with the Federal Circuit.The Federal Circuit’s recent decision in Ariosa v. Sequenom uncritically accepts an expansive reading of Mayo that conflicts with insights from Myriad and Alice, thereby jeopardizing patent protection for diagnostic testing and other vital fields of biomedical research and possibly others. This amicus brief urges the Federal Circuit to grant en banc review in Ariosa v. Sequenom to ventilate critical issues left unanswered by the Supreme Court’s patent-eligibility decisions. Although some language in Mayo could be interpreted to set forth unconventional or inventive application as a possible test for patent-eligibility, Mayo suggests two other possibilities for an “inventive concept”: non-preemptive application; and non-generic application – that is, more than a statement of a natural law coupled with an instruction to apply it. While the panel was correct to perceive that Mayo describes preemption as the underlying justification for the patent-eligibility doctrine, not the operative test, we believe that the panel was incorrect to conclude that Mayo dictates unconventional or inventive application.

IN RE ROSLIN INSTITUTE: PRODUCTS OF NATURE AND SOURCE LIMITATIONS

The Federal Circuit’s recent opinion in In re Roslin Institute 2 is the court’s first decision on the patent-eligibility of natural products after the Supreme Court’s Myriad decision, which denied patent-eligibility to isolated genomic DNA. The holding itself is probably not significant; cloned animals have little commercial significance at present. But the court’s requirement that inventions be “markedly different” from their natural sources casts doubt the patent-eligibility of other biotechnological inventions, such as isolated human stem cells. This comment addresses two issues with the Federal Circuit’s analysis in Roslin: the court’s interpretation of Chakrabarty 3 and Funk Brothers, 4 and Roslin’s requirement that structural or functional differences between natural and synthetic products must be explicitly recited by the claims. Unaltered by the hand of man: Judge Dyk’s opinion in Roslin unfortunately perpetuates the view, now found in the PTO’s Myriad guidelines, that Chakrabarty requires a claimed invention to be “markedly different” from a natural product for patent-eligibility under § 101. Myriad itself imposed no such requirement: the Court found BRCA cDNAs patent-eligible without determining that they were “markedly different” from natural sequences. And though Myriad reiterated the “markedly different” language from Chakrabarty, Chakrabarty’s discussion of “products of nature” was entirely dictum. Only the question of whether living organisms were patent-eligible was before the Court in Chakrabarty; the “product of nature” rejection in the case had not been sustained by the Patent Office Board of Appeals. The Chakrabarty Court noted the claimed bacteria differed “markedly”

Inventive Application: A History

The Supreme Court’s recent cases on patent-eligible subject matter have struggled to draw the line between unpatentable fundamental principles, such as laws of nature and abstract ideas, and patentable inventions. In Mayo v. Prometheus, the Court suggested that only “inventive applications” of fundamental principles fell within the domain of the patent system. Both Mayo and its intellectual forebear, Parker v. Flook, anchored this doctrine in Neilson v. Harford, the famous “hot blast” case decided by the Court of Exchequer in 1841.But the Supreme Court has founded the inventive application doctrine on a basic misapprehension. Neilson’s patent on the hot blast was sustained not because his application was inventive, but because it was entirely conventional and obvious. In both England and the United States, the hot blast cases taught that inventors could patent any practical application of a new discovery, regardless of the application’s novelty or inventiveness. And for over one hundred years, American authority consistently maintained that practical application distinguished unpatentable discovery from patentable invention.The inventive application test in fact originated in 1948, in Funk Brothers v. Kalo Inoculant, which departed radically from the established standard of patent eligibility. In the wake of Funk Brothers, the lower courts struck down a series of patents unquestionably within the technological arts — arguably the precise innovations the patent system sought to promote. This history is largely forgotten today, but it should serve as a cautionary tale of the patents that could be invalidated if the Court maintains inventive application as the test for patent eligibility.