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Advances in the biotech industry have caused a flood of applications. Many of those applications simply recite raw DNA sequence data or genes with no known function that, in turn, encode predicted amino acid sequences with no known bioactivity. Many were also filed with claims to thousands of Expressed Sequence Tags (ESTs) that are disclosed as useful simply for locating coding regions within a genome. Those days are over. The PTO recently finalized two sets of examination guidelines (available at www.uspto.gov) that raise the standards for applications claiming biological inventions, particularly DNA and peptide sequences, including ESTs and Single Nucleotide Polymorphisms (SNPs). The PTO will soon distribute detailed materials to train its examiners in applying the guidelines. What these materials will say is important because just how high the new standards go essentially depends on how they are interpreted. MORE ‘UTILITY’ The first set of guidelines replaces the 1995 guidelines that brought consistency to the examination process and broke up the logjam in the examination of biotech applications. The new guidelines increase the amount of information or “utility” that applicants must provide about the uses for the invention. While strongly affirming that isolated DNA molecules and the proteins they encode are patentable, the new guidelines (unlike the 1995 guidelines) require that the utility be “specific” as well as “credible” and “substantial.” These terms are not clearly defined in the guidelines, but it is safe to say they exclude trivial or “throwaway utilities” that lack a “practical purpose.” It is also safe to say the specificity requirement entails more than a clear statement of a general utility. The requirement will not be satisfied by general statements that the compounds are useful for “basic research,” “further testing” and the like. Another example of a nonspecific utility is a disclosure that a DNA sequence is useful only as a “probe” or “primer.” A disclosure that a transgenic mouse is useful as snake food, as opposed to as a model for a particular pathology, is now considered both nonspecific (all mice can be fed to snakes) and insubstantial (transgenic mice are too expensive for snake food). For many classes of invention, how much specificity is enough will remain uncertain for quite some time. The specific utility also cannot be a general utility that “applies to every member of a class” of invention. To what extent a utility must apply to every member of a class to render it nonspecific is also unclear. Using an organic compound as a carbon source or as landfill certainly seems nonspecific, but what about the general use of a transgenic mouse for drug screening or a transgenic plant as food or feed? No court decisions have interpreted the utility requirement to be so product-specific; in fact, the courts have held that inventors need not discover new or even improved utilities. Also, the requirement that a substantial utility have a “practical purpose” comes perilously close to requiring that any disclosed utility be commercially viable when the application is filed. This is just the sort of roadblock to patenting early-stage technology that the biotech industry opposed in 1995. In short, while inventors should disclose a substantial utility if at all possible, the PTO should interpret the guidelines as simply requiring a utility that is somewhat functional or that exceeds de minimis utility. The PTO should also deem a utility specific if it is clearly stated, and not require a linking of it to some unique characteristic of the invention. This softer reading of the guidelines would promote real advances in biotechnology, while eliminating the PTO’s burden of examining reams of sequence print-outs. MORE STRUCTURE, LESS FUNCTION While the patent statutes require the application to contain a “written description,” until recently the claims as filed defined this requirement, and the specification was only examined to determine if it adequately disclosed how to make and use what the claims defined. The second set of new guidelines steers applicants away from claiming solely in functional terms (i.e., bioactivities) and toward claiming in structural terms. Compounds must now be claimed by structural formulae derived from isolated materials, or by pointing out “sufficient relevant identifying characteristics,” such as molecular weight, binding affinity and other physiochemical properties. Inventors can also meet the stronger written-description requirement by providing detailed drawings or generic structural formulas. Most conventional pharmaceuticals take this approach, but it is difficult to write a broad claim based on a single DNA sequence or amino acid sequence without using some functional language. GLASS HALF FULL Yet, we must keep perspective. The PTO has facilitated allowance of broader claims by approving claims directed to subunits of characterized sequences or to isolated sequences “comprising” characterized sequences. It has also allowed claims to sequences that are X percent identical to a reference sequence or that hybridize to a known complementary sequence under specific conditions, provided that some biological activity is retained by the members of the genus. In addition, broad claims regularly issue to biologicals — such as antibodies, vaccines and cell lines — that use a mixture of structural, functional and/or processing terms. And some recent court decisions have approved of functional language for other types of chemical compositions. In sum, in view of the evolution of technologies that rapidly identify and characterize entire families of genes and proteins, in the end the challenges presented by the new guidelines may not seriously impede protection for biotech inventions. For example, although the guidelines make it clear that the utility standards may be difficult — even impossible — to meet for applications claiming polypeptides (and the DNA sequences that encode them) with no known biological function or medical use, as bioinformatics progresses an applicant may succeed by using sequence comparisons that suggest membership of a new polypeptide in a known family of proteins, thereby also meeting the utility requirement for the parent DNA sequence that codes for the polypeptide. Warren D. Woessneris a partner with Minneapolis’ Schwegman Lundberg Woessner & Kluth.

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