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The U.S. Patent and Trademark Office’s Dec. 21 request for comments on interim examiner guidelines pertaining to the utility and written description requirements, 64 Fed. Reg. 244 (1999), has provoked a considerable amount of discussion, particularly with regard to biotech patents. Although the PTO is currently reviewing the public comments on the interim guidelines, and U.S. patent examiners and the courts will provide their own interpretations, practitioners should be aware that some guidance is already available. In particular, on March 1, companion examiner training documents to the guidelines were published on the PTO’s Web site, www.uspto.gov. Although these documents are being finalized based on public comments, no substantive changes are expected by the PTO and finalized guidelines should be published by this Fall, according to Q. Todd Dickinson’s statement before the House Subcommittee on Courts and Intellectual Property July 13. The training documents shed light on counseling clients as to patentability, strategies for pursuing protection for various subject matter, and the extent of disclosure required. UTILITY MATERIALS The Revised Interim Utility Guidelines Training Materials, currently available at www.uspto.gov/web/ offices/pac/utility/utilityguide.pdf, contains a synopsis of the revised interim guidelines, guidance for various examination situations, definitions of terms, a review flowchart, and training examples. The training examples involving biotechnological inventions include therapeutic proteins, uncharacterized proteins, partially characterized proteins, therapeutic antibodies, chemical therapeutics, therapeutics not associated with a disease, DNA fragments, DNA fragments with full open reading frame (ORF), animals with uncharacterized human genes, receptors, and enlarged chemical groups. The training materials explain that the utility requirement is satisfied when an application states a specific, substantial, and credible utility, or contains a well-established utility. Examples 9 and 10 involve DNA fragments. In Example 9, a claim is directed to “a cDNA consisting of the sequence set forth in SEQ ID NO: 1″ and the specification discloses that SEQ ID NOS: 1-4332 are believed by the applicant to be fragments of full length genes. The specification further discloses that each of these sequences is useful as a probe to obtain the full length genes that correspond to nucleic acid sequences that can be used to make a corresponding protein through recombinant technology. According to the materials, a rejection for lack of utility should be made in this case because (1) there is no well-established utility for the claimed invention, and (2) it is neither specific nor substantial to merely assert that a cDNA can be used as a probe to obtain a full length gene that corresponds to that cDNA and that full length gene can be used to provide, through recombinant technology, the corresponding protein. The failure to disclose any utility for the corresponding proteins is not substantial and the overly broad claiming of a DNA fragment that may read on numerous unidentified genes is not specific. In contrast, in Example 10 a claim is directed to “an isolated and purified nucleic acid comprising SEQ ID NO: 2″ and the specification discloses that SEQ ID NO: 2 encodes a DNA ligase. In this case, a utility rejection should not be made because there is a well-established utility for DNA ligases and the claimed sequence specifically codes for that ligase. An assertion of a utility is unnecessary where there is already a well-established utility associated with the claimed invention. However, where it is questionable as to whether a well-established utility is associated with the claimed invention, it is advisable to assert a specific and substantial utility for the claimed invention, for example, by identifying the utility of a protein encoded by a DNA sequence. The comparison of these two examples elucidates what may initially appear to be subtle differences. For instance, if we change the facts of Example 9 slightly and claim a sequence with a full open reading that codes for proteins having either a well-established or a credible, specific and substantial utility, then the utility rejection would appear to be improper. WRITTEN DESCRIPTION MATERIALS The Revised Interim Written Description Guidelines Training Materials, currently available at www.uspto.gov/web/ offices/pac/writtendesc.pdf, also provides a synopsis of the written description guidelines, as well as a decision tree for applying the guidelines and training examples. The training examples include genes, ESTs, DNA fragments encoding a full length open reading frame, hybridization, process claims, allelic variants, bioinformatics, protein variants, product by function, antisense, antibodies, genus-species with widely varying species, and process claims where the novelty is in the method steps. Example 7 is comparable to Example 9 in the utility materials and Example 8 is comparable to Example 10 in the utility materials. In Example 7, a claim is directed to “an isolated DNA comprising SEQ ID NO: 16″ and the specification discloses that SEQ ID NO: 16 is a partial cDNA which will specifically hybridize with the complement of the coding sequence of the gene of an infectious yeast. Here, the written description is not satisfied because the claimed genus encompasses genes yet to be discovered. In Example 8, a claim is directed to an isolated and purified nucleic acid comprising SEQ ID NO: 2 and the specification discloses that SEQ ID NO: 2 is a complete open reading frame for a sequence which encodes a ligase. The written description requirement is satisfied here because the sequence claimed is a full open reading frame corresponding to a specific protein rather than merely a DNA fragment that may be common to a broad number of genes potentially encoding various proteins. Again, a comparison of these two examples delineates a very important boundary in similar cases involving claims directed to DNA sequences. Examiners are coming under a great deal of pressure to scrutinize applications with regard to the utility and written description requirements. In the absence of a clear consensus as to how they may apply the new guidelines, the examples in the training materials provide a good starting point for practitioners. Scott Yarnell is in the Washington, D.C. office of Hunton & Williams, where he prosecutes chemical and biotech patents.

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