By Donald Zuhn --
Last month, the U.S. Patent and Trademark Office announced that it had updated the training materials to be used by examiners in the examination of patent applications for compliance with the written description requirement of 35 U.S.C. § 112, first paragraph. The revised training materials supersede and replace the previous set of training materials issued by the Patent Office in 1999. The new training materials provide seventeen examples, of which fourteen are specifically related to biotech inventions. In particular, the biotech-specific examples address expressed sequence tags (ESTs) (example 4), a partial protein structure (example 5), DNA hybridization (example 6), allelic variants (example 7), bioinformatics (example 8), protein variants (example 9), a product claimed by its function (example 10), a polynucleotide or polypeptide sequence sharing percent identity with another sequence (example 11), antisense oligonucleotides (example 12), antibodies to a single protein (example 13), antibodies to a genus of proteins (example 14), a genus with widely varying species (example 15), a process claim where novelty resides in the process steps (example 16), and methods of using compounds claimed by functional limitations, methods of identifying compounds, and compounds identified by such methods (example 17). Patent Docs will discuss these examples in a series of articles. Today, we address examples 4 and 5.
Example 4
Example 4 concerns claims that are directed to an expressed sequence tag (EST), which the training materials define as a cDNA that corresponds to only part of a protein-encoding open reading frame (ORF). The example is divided into two sections: one that discusses the effect of open transitional language (example 4A), and one that discusses the effect of closed transitional language (example 4B). The first section of this example provides a single exemplary claim:
Claim 1: An isolated DNA comprising SEQ ID NO: 16.
Because this claim uses "open" transitional language (i.e., recites a DNA comprising the recited sequence), the claim encompasses a genus of DNAs in which additional DNA sequences may be attached to either end of the DNA sequence of SEQ ID NO: 16. The claimed genus would thus include the full-length gene of which the DNA sequence of SEQ ID NO: 16 was a part. Nevertheless, because the DNA sequence of SEQ ID NO: 16 is a structural feature common to all members of the genus, and the exemplary specification discloses the complete sequence of SEQ ID NO: 16, the specification satisfies the written description requirement with respect to claim 1. It is important to note, however, that while the above claim would not be rejected under 35 U.S.C. § 112, first paragraph, it would most likely be rejected for failing to comply with the utility requirement of 35 U.S.C. § 101 (see Example 9 of the Revised Interim Utility Guidelines Training Materials).
The second section of Example 4 provides two exemplary claims:
Claim 1: An isolated nucleic acid comprising SEQ ID NO: 1.
Claim 2: An isolated nucleic acid consisting of SEQ ID NO: 1.
Because claim 2 uses "closed" transitional language (i.e., recites a nucleic acid consisting of the recited sequence), this claim only encompasses a single species. Moreover, the exemplary specification discloses the complete sequence of this species. Thus, the specification satisfies the written description requirement with respect to claim 2. The analysis of claim 1 in Example 4B is identical to that of claim 1 in Example 4A, and therefore, because the exemplary specification of Example 4A satisfies the written description requirement with respect its claim 1, the exemplary specification of Example 4B likewise satisfies the written description requirement with respect its claim 1.
Example 5
Example 5 concerns claims directed to partial protein structures. According to the training materials, Example 5 is based on In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004). This example provides two exemplary claims:
Claim 1: An isolated protein comprising Protein A,
wherein said Protein A includes the amino acid sequence of SEQ ID NO: 1 in the N-terminal portion of the protein, and has the same ability to bind to and activate Protein X as Protein A from human urine, and
wherein said Protein A is purified by subjecting a crude protein recovered from a dialyzed concentrate of human urine to affinity chromatography on a column of immobilized Protein X, and elutes from a reversed-phase HPLC column as a single peak in a fraction corresponding to about 31% acetonitrile and shows a molecular weight of about 22 kDa when measured by SDS-PAGE under reducing conditions.
Claim 2: An isolated DNA comprising a DNA that encodes Protein A,
wherein said Protein A includes the amino acid sequence of SEQ ID NO: 1 in the N-terminal portion of the protein, and has the same ability to bind to and activate Protein X as Protein A from human urine, and
wherein said Protein A is purified by subjecting a crude protein recovered from a dialyzed concentrate of human urine to affinity chromatography on a column of immobilized Protein X, and elutes from a reversed-phase HPLC column as a single peak in a fraction corresponding to about 31% acetonitrile and shows a molecular weight of about 22 kDa when measured by SDS-PAGE under reducing conditions.
According to the training materials, the exemplary specification discloses a sequence of 10 amino acids (SEQ ID NO: 1) that corresponds to the amino-terminal end of Protein A, but does not disclose the complete sequence of Protein A. The training materials also note, however, that the exemplary specification discloses other relevant identifying characteristics of Protein A (e.g., its ability to bind and activate Protein X, its approximate molecular weight, and the concentration of acetonitrile at which Protein A will elute from a reverse phase HPLC column), as well as a method of isolating Protein A from urine and a working example in which Protein A was isolated from urine using this method. In view of this disclosure, the training materials conclude that the specification satisfies the written description requirement with respect to claim 1.
Concerning claim 2, the training materials note that the exemplary specification fails to disclose either the complete nucleotide or complete amino acid sequence of Protein A. In drawing a comparison between the isolated protein of claim 1 and the isolated DNA claim 2, the training materials state that while the exemplary specification provides relevant identifying characteristics for the protein, it does not provide sufficient relevant identifying characteristics for the DNA. The training materials also state that because the exemplary specification fails to support even one species of DNA in the claimed genus, it is apparent that a representative number of species is not disclosed. Thus, the training materials conclude that the specification fails to satisfy the written description requirement with respect to claim 2.
For additional information on this topic, please see:
• "DNA Hybridization & Percent Identity," May 6, 2008
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