By Christopher P. Singer --
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). Continuing our review, Patent Docs provides an overview of the example covering aspects of antisense oligonucleotides.
Example 12 – Antisense Oligonucleotides
Example 12 relates to claims directed to an antisense oligonucleotide complementary to an mRNA that encodes a "newly discovered growth factor" (NDG). This Example is essentially identical to the guidance in the former written description guidelines (presented therein as Example 15). The exemplary claim in the new training materials recites:
Claim 1: An antisense oligonucleotide complementary to all or a portion of a messenger RNA having SEQ ID NO: 1 and encoding NDG, wherein said antisense oligonucleotide inhibits the production of NDG.
The hypothetical specification provides the mRNA sequence encoding NDG as SEQ ID NO: 1 and states that the invention includes antisense oligonucleotides that inhibit NDG production. While no sequences of such antisense oligonucleotide are provided in the specification, it does describe several art-recognized screening methods for identifying target mRNA sequences for candidate antisense molecules (e.g., gene walking, randomized oligo libraries, and DNA arrays). The specification also describes the use of chemically modified nucleotides that reduce the amount or rate of degradation by nucleases. While the specification fails to provide any explicit example of an antisense oligonucleotide to SEQ ID NO: 1, the training materials reason that one of skill would understand that complementary sequences that approach the full length of an mRNA (such as SEQ ID NO: 1) are more likely to have antisense activity as compared to smaller sequence fragments. Therefore, one of skill would acknowledge that the specification does provide one species of the claimed genus, that being the full-length complement to SEQ ID NO: 1. Moreover, the structure of all possible antisense oligonucleotides falling within the scope of the claim are bound and limited by the full-length complement to SEQ ID NO: 1. Given the art-recognized correlations between antisense function and structure of the target mRNA (e.g., as provided by certain computer mRNA modeling software packages), certain fragments having antisense activity can be identified and screened to confirm or assess inhibitory activity. Thus, when the high level of skill and knowledge in the art relating to antisense technology is combined with the disclosure of an mRNA sequence (SEQ ID NO: 1), there exists sufficient written description support for the full scope of claim 1.
For additional information on this topic, please see:
• "Antibodies to a Single Protein & Antibodies to a Genus of Proteins," May 12, 2008
• "ESTs & Partial Protein Structures," May 8, 2008
• "DNA Hybridization & Percent Identity," May 6, 2008
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