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It won’t be long before micromolecular robots will treat major illnesses. And holders of the first patents could dominate the industry Imagine a micromolecular cell-repair machine — call it a nanobot — swimming purposefully in the vicious, pink dimness of the human bloodstream. It’s one of the smallest things there. White blood cells and red blood cells are swimming around it. From the nanobot’s perspective, a white blood cell is as large as a zeppelin; the red blood cells, though smaller than their white cousins, still dwarf the nanobot. The nanobot and millions of its brethren are focused on one task. They’re hunting for damaged and diseased cells that they can slip into and repair. When our particular nanobot finds a diseased cell, it pushes through the cell’s outer membrane, seeking damaged DNA in the cell’s nucleus — a stringy molecule it begins to edit, splice, and ultimately repair. The nanobot renders the cell’s basic instruction set complete and healthy again. This futuristic vision of medicine — based on an infant science known as nanotechnology — may become reality within the lifetimes of those reading this page, say nanotechnology theorists including Eric Drexler and Robert Freitas. Nanotechnology may end disease as we know it and delay or eliminate old age and death. Welcome to the bleeding edge of IP law. Patent lawyers today are already thinking about how they will draft applications tomorrow. In order to get the broadest protection, should the invention be classified as a drug, process, or machine? Others are worried that nanotechnology patents may chill innovation if they cover basic essential scientific concepts. If this sounds a lot like the debate over software, business method, and biotechnology patents, it’s not too soon to start thinking about patenting nanobots. THINKING NANOTHOUGHTS Fifteen years ago, when Drexler, the most prominent nano-technology theorist, published “Engines of Creation”, he defined nanotechnology as that which “[can] handle individual atoms and molecules with control and precision.” Compared to, say, semiconductor manufacturing, which takes place on the micrometer (millionth of a meter) scale, nanotechnology begins at a scale a thousand times smaller. (The word “nanometer” means “billionth of a meter.”) What gets the nanotechies’ juices really flowing is “nanomedicine,” a field even younger than nanotechnology. And nanomedicine’s biggest booster is Robert Freitas, a physicist and research scientist at the Richardson, Texas�based Zyvex Corporation, which is developing nanomolecular manufacturing technologies for commercial use. Freitas, who also happens to be a lawyer, is midway through publishing a three-volume work titled Nanomedicine. He says that when he first heard of nanotechnology, “it occurred to me almost immediately that it would have its most important effect in medicine.” Drexler, too, was struck by the potential of nanotechnology to revolutionize medicine. Compared to what nanomedicine might do, he has written that even the most delicate of today’s microsurgery “is still a butcher job.” As a result, “[o]nly the ability of cells to abandon their dead, regroup, and multiply makes healing possible.” Nanotech theorists foresee, and are now working to craft, tiny machines that would be subject to directed human programming and control. CELL-SIZED COMPUTERS Since to some extent disease and old age are functions of cellular damage, the ability to direct intracellular repairs holds immense promise. Nanotechnology may “eliminate cancer, infections, clogged arteries, and even old age,” says Ralph Merkle, a principal fellow at Zyvex. Nanotechnologists believe this revolution is coming sooner rather than later. Freitas expects that what he calls biological robots — engineered and programmed bacteria that generate usable substances within human bodies — will become commonplace in the next five to ten years. Actual nanobots may appear in 20 years, especially now that the U.S. government is helping the research along. The Clinton administration in its last year called for doubling the budget for basic nanotech research to just under half a billion dollars. It has labeled the cluster of programs it funds the “National Technology Initiative.” The Bush administration’s initial budget allocates a comparable amount. (To get a sampling of all the pies the federal National Nanotechnology Initiative has its fingers in, see http://www.nano.gov.) PATENTING (NANO)MEDICINE So what does this mean for patent lawyers? How will the U.S. Patent and Trademark Office treat nanotech patent applications? Practitioners generally agree that patenting nanotechnology will be no more controversial than patenting any other new technology — and probably less controversial than patenting transgenic animals and transgenic plants. As long as a nanotech invention is “novel, nonobvious, and useful,” says Sam Vermont, a patent associate with Washington, D.C.’s Stevens, Davis, Miller & Mosher and editor in chief of the “Patent Strategy & Management” newsletter, an American Lawyer Media, Inc. publication, the patent process should be straightforward. It’s how these inventions are classified which may prove to be significant for patent counsel — whether as a process, a drug, or a machine. While the patentability of nanotech inventions will not depend on the classification, the scope of the patent may be affected, says one patent attorney. “In the patent office, rules have developed for how to handle different technologies,” says Louis Meyer, a patent partner with Boston’s Fish & Richardson who specializes in biotech. He says that in the biotech arena, the PTO tends to recognize patent claims that are narrower than those recognized in the more traditional “mechanical” area. Because “mechanical inventions and mechanical means are seen to be quite predictable,” Meyer says, a patent prosecutor may need to adduce “only one or two examples of uses” to establish a broad claim. “Now, let’s go to the biotech world,” he says. “Suppose you had a drug, and that drug cleared out clogged arteries — you couldn’t get a patent claim to any drug that did that.” Instead, he says, “your claims will have to be narrower, specific to the drug.” So what are the implications for prosecuting a nanotech patent? Simple, says Meyer: “You’d want to characterize it and present it as a device, as opposed to a modified chemical compound.”Assuming you can do that, you may be in the catbird seat at the outset. “If you could get a broad claim, you could dominate a large part of the industry early on,” Meyer says. For example, the “Cohen-Boyer” patents in gene splicing, which launched the biotech field just over 20 years ago, were so broad that other gene-research-based companies, including Amgen Inc. and Genentech Inc., had to obtain licenses to use technologies covered by the Cohen-Boyer patents. “Fortunately for the industry,” says Meyer, “they licensed that at a pretty reasonable rate.” TECHNOLOGY LOCK-UP And it’s the threat of a potential nanotech patent lock-up — where the holder of a broad patent forces subsequent inventors and companies to pay huge licensing fees — that has some in the industry up in arms. It’s a possibility that haunts Christine Peterson, who is the president of Foresight Institute, an educational nonprofit organization that promotes the understanding of new technologies, including nanotech. “We have real issues” with the prospect of very broad nano-tech patent claims, she says. “We’re going to try to persuade the patent office that just because something is nanotech it doesn’t deserve a broad patent.” One argument she advances is that, once the basic theory for how a nanomachine could function usefully is worked out — as nanotech researchers are trying to do now, in anticipation of the day when manufacturing such devices becomes practical — the most basic techniques and inventions would become “obvious.” This would limit the zone of what’s patentable to narrower and more specific inventions. But Vermont thinks broad patents resulting from early research won’t foreclose the possibility of obtaining patents later. “If you can’t make something, you can’t prevent someone who can from patenting it,” he says. Prior art, he says, must make it possible for someone of “ordinary skill in the art” to make and use the invention “without undue experimentation.” So, if the prior art does not “enable” the invention, the prior art cannot prevent a later inventor from patenting it. “The patent office is not much interested in discovery, theory, or the underlying principles of an invention,” Vermont says. “Just how to bring it into the real world.” Even if some kinds of prior art narrow the space in which new nanotech patents will be granted, says Bruce Hayden, an Arizona-based patent attorney for computer hardware and software company Bull HN Information Systems, Inc., a good patent prosecutor will aim to obtain the broadest measure of patent protection for the client. Take, for example, a nanotech molecular machine that clears out blocked arteries. A patent attorney will seek protection for “the process of making the machine itself, its use in the body, and the by-products [if the invention breaks down in the bloodstream into useful components].” Says Hayden: “This is one of those areas in which it makes a difference whether you have a good patent attorney or a bad patent attorney.” Freitas notes that he’s been publishing papers for some time that outline the design of useful nanotechnology inventions. Among his designs is the “respirocyte,” an artificial red blood cell. “With five [cubic centimeters] in your body, they would collectively have more oxygen-carrying ability than all of your blood,” he says. Such an invention might be crucial for someone to whom a well-oxygenated bloodstream matters a lot — such as a marathon runner or a heart attack victim. Still another outline is for the “microbivore” — a nanorobot that hunts invading organisms in your bloodstream and eats them. Freitas does not maintain that his designs enable anyone to “reduce to practice” his designs (that is, to take a description of an invention and manufacture the invention from it), which, he admits, are not complete. But he stresses that he’s gone into enough detail that “I have made sure that whoever does [create one of my nanomachines] is going to have to take it to the next step.” Freitas’ work, like that of other academic researchers in this area, has been primarily to advance the general field. “I’m not designing each gear and each lever and each logic rod and each component of each subsystem,” he says. “I think there will be plenty there to be patented.” Given how likely revolutionary nano-technology seems to be, Freitas’ prediction sounds safe. But the underlying question is: Just how imminent is the nanotech revolution? Perhaps the best guide is to imagine someone in 1901 trying to imagine jet aircraft, penicillin and interferon, nuclear power, and the digital revolution. Peterson of the Foresight Institute puts it succinctly: “If you’re trying to look far ahead, and what you see seems like science fiction, it might be wrong. But if it doesn’t seem like science fiction, it’s definitely wrong.”

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