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John Doll likes to talk about snake food. Doll, who heads the U.S Patent and Trademark Office’s Biotechnology Patent Examination Group, has been the star attraction at a road show that the PTO has presented around the nation. He uses snake food as a metaphor when discussing the new utility guidelines for biotech patents, and he has been drawing overflow crowds at conferences in cities such as Seattle, San Francisco and San Diego, after East Coast presentations earlier this year. The road show is not new; when Bruce Lehman was patent commissioner, he spoke nationwide to stress that the PTO wanted to serve its “customers” — patent applicants. In continuing that theme, Doll emphasizes that “it’s our job to help the applicant get a patent.” GUIDELINES COMING But patent practitioners are listening in hope of parsing the meaning of new guidelines for proving utility in biotech patents that should be published in the Federal Register this month. Those guidelines were posted on the PTO’s Web site (at http://www.uspto.gov/) at the end of last year, and the agency spent much of the spring and early summer soliciting and reviewing public comment. This summer, Q. Todd Dickinson, the undersecretary of Commerce for Intellectual Property, told a House Judiciary Committee Subcommittee that the comments have been favorable. “The general consensus from the major parties involved indicates that we have set the utility standard at an appropriate level to ensure incentives for both research and the efficient dissemination of valuable data,” he said. The core issue is whether the new guidelines will bar the issuance of patents for very early-stage biotechnological innovations — specifically, very small DNA sequences — unless a precise use can be shown. Some practitioners, such as Gerald P. Dodson of the Menlo Park, Calif., office of San Francisco’s Morrison & Foerster, have said that the products of the early-stage research are important tools that deserve patent protection. Others say that granting patents this early in the process could allow patent-holders to block others from conducting more advanced research unless they pay a hefty licensing fee. Under patent law, an applicant must show an invention’s identifiable uses, and claiming that a DNA snippet could be used as a probe to look for some undefinable other thing may not be sufficiently useful, critics say. In demonstrating how an applicant can demonstrate “specific, substantial and credible” utility for a patent in the biotech area, Doll said, applicants must demonstrate a “real world” context. “Throwaway” utilities would not pass muster, he said. To highlight the PTO’s intent, Doll cites the hypothetical application of a transgenic mouse (one with altered genes or DNA from another species) for use as snake food. That alone would not indicate sufficient utility to win patent protection. But, he said, an applicant who tries to patent a transgenic mouse designed to enhance specific qualities of a snake’s nutrition might well meet utility thresholds. The San Francisco presentation was co-sponsored by the Northern California Pharmaceutical Discussion Group and was chaired by Benjamin Borson, an associate at San Francisco’s Flieshler Dubb Meyer & Lovejoy, who spent 30 years as a research physiologist before becoming a lawyer. Borson said that in the past, “the PTO has been all over the place” on utility issues. Although the agency strictly enforced utility rules in the early 1990s, he explains, the PTO later relaxed its standards. But more recently, examiners have again used the failure to meet utility standards as a basis to reject applications, especially those regarding small DNA sequences. Professor Rebecca S. Eisenberg of the University of Michigan Law School said that it remains unclear how the PTO will apply its new utility requirements. She’s not terribly impressed with the “snake food” metaphor used by Doll: “Why would [the use of transgenic animals for] snake food not be sufficient, but for some more narrow purpose, sufficient? It’s not clear to me they articulated a coherent rationale.” Ultimately, the courts will determine the utility threshold. The Patent Office will welcome such a determination, Doll said.

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