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Archived updates for Thursday, August 12, 2004

Partial Sequence Not Enough to Claim DNA for Encoding Protein

In In re Wallach (Fed. Cir., August 11, 2004), the court noted that "A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, . . . because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property."

"Until Appellants obtained the complete amino acid sequence of TBP-II, they had no more than a wish to know the identity of the DNA encoding it.
As Appellants point out, we have recognized that the written description requirement can in some cases be satisfied by functional description. See, e.g., Enzo, 296 F.3d at 1324 ("It is not correct, however, that all functional descriptions of genetic material fail to meet the written description requirement."). Nonetheless, such functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art."

"As we explained above, such a well-known relationship exists between a nucleic acid molecule's structure and its function in encoding a particular amino acid sequence: Given the amino acid sequence, one can determine the chemical structure of all nucleic acid molecules that can serve the function of encoding that sequence. Without that sequence, however, or with only a partial sequence, those structures cannot be determined and the written description requirement is consequently not met. As we explained in Enzo, the Guidelines for Examination of Patent Applications under the 35 U.S.C. § 112, 1, "Written Description" Requirement, 66 Fed. Reg. 1099 (Jan. 5, 2001) ("Guidelines"), state that the written description requirement can be met by "show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics . . . i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics."

"Appellants have provided no evidence that there is any known or disclosed correlation between the combination of a partial structure of a protein, the protein's biological activity, and the protein's molecular weight, on the one hand, and the structure of the DNA encoding the protein on the other.The Board therefore correctly affirmed the examiner's determination that the specification of the '129 application does not provide an adequate written description of the pending claims."

Click here for more on "Structure, Function, and the Spectrum of Claim-Type Differentiation"
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