In Re Graeme I. Bell, Leslie B. Rall and James P. Merryweather
991 F.2d 781, 26 U.S.P.Q. 2d (BNA) 1529, 93 Daily Journal DAR 5248 (1993)
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Rule of Law:
A specific nucleic acid sequence is not rendered obvious by the prior art's disclosure of the amino acid sequence of the protein it encodes, due to the degeneracy of the genetic code, which creates a vast number of potential, non-obvious nucleotide sequences.
Facts:
- Scientists Rinderknecht et al. published the full amino acid sequences for human insulin-like growth factors I and II (IGF-I and IGF-II).
- The genetic code is degenerate, meaning most amino acids are specified by more than one three-nucleotide sequence (codon).
- Due to this degeneracy, the known amino acid sequence for IGF could theoretically be coded for by more than 10^36 different nucleotide sequences.
- A prior art patent by Weissman et al. disclosed a general method for isolating a gene by creating a nucleotide probe based on a known portion of the encoded protein's amino acid sequence.
- The Weissman patent taught that it was advantageous to design probes based on amino acids specified by unique codons (codons with no synonyms).
- The IGF-I protein has only one amino acid specified by a unique codon, and IGF-II has none.
- Graeme I. Bell, Leslie B. Rail, and James P. Merryweather (Bell) successfully isolated the specific, native human nucleic acid sequences that code for IGF-I and IGF-II.
Procedural Posture:
- Bell filed patent application Serial No. 065,673 for nucleic acid molecules encoding human IGF-I and IGF-II with the U.S. Patent and Trademark Office (PTO).
- The PTO patent examiner issued a final rejection of claims 25-46 as unpatentable on the ground of obviousness under 35 U.S.C. § 103.
- Bell (the Applicants) appealed the examiner's rejection to the PTO Board of Patent Appeals and Interferences.
- The Board affirmed the examiner's rejection, concluding that a prima facie case of obviousness had been established.
- Bell (the Appellants) appealed the Board's decision to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does knowledge of a protein's amino acid sequence, combined with a general method for cloning genes, render the specific nucleic acid molecule encoding that protein obvious and therefore unpatentable under 35 U.S.C. § 103?
Opinions:
Majority - Lourie, Circuit Judge
No. The claimed nucleic acid molecules would not have been obvious because the prior art fails to render the claimed invention obvious. The PTO's position that a gene is prima facie obvious over its correspondent protein is incorrect. The degeneracy of the genetic code means that a vast number of nucleotide sequences, over 10^36 in this case, could code for the IGF protein. The prior art from Rinderknecht did not suggest which of these nearly infinite possibilities was the correct human sequence. Furthermore, the Weissman patent did not fill this gap, as its general method actually taught away from Bell's approach by emphasizing the use of unique codons, which were almost entirely absent in the IGF sequences. Without a specific teaching or suggestion in the prior art to guide a researcher to the specific claimed sequences, the PTO failed to establish a prima facie case of obviousness.
Analysis:
This case significantly strengthened patent protection for newly isolated genes in the early days of biotechnology. It established that the mere knowledge of a protein does not make its corresponding gene obvious, rejecting an 'obvious to try' standard. The court's focus on the 'degeneracy of the genetic code' created a high bar for obviousness rejections of DNA sequence claims, recognizing the immense technical challenge of isolating a specific gene from a vast library of possibilities without a clear roadmap in the prior art. This holding incentivized companies to undertake the difficult and expensive work of gene sequencing by assuring them that their discoveries would be patentable.
