Download Homology Claims

Homology Language
Biotechnology/Chemistry/Pharmaceutical Customer Partnership
U.S. Patent and Trademark Office
Arlington, Va
July 29, 2003
Brian R. Stanton
Quality Assurance Specialist
Technology Center 1600
U.S. Patent and Trademark Office
(703) 308-2801
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[email protected]
Language
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% identical
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Homology, identity, similarity
Hybridization
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Sample Claims
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An isolated and purified nucleic acid
comprising the nucleotide sequence set
forth in SEQ ID NO: 1.
An isolated and purified nucleic acid
comprising the nucleotide sequence set
forth in SEQ ID NO: 1 wherein said nucleic
acid encodes a protein having activity X.
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Sample Claims
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An isolated and purified nucleic acid comprising a
nucleotide sequence that is 90% identical to SEQ ID
NO: 1.
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An isolated and purified nucleic acid comprising a
nucleotide sequence that is 90% identical to SEQ ID
NO: 1, wherein said nucleic acid encodes a protein
having activity X.
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The specification provides sufficient support that isolated
protein has a specific, substantial, and credible use related
to activity X.
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Written Description
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An isolated and purified nucleic acid
comprising a nucleotide sequence that
is 90% identical to SEQ ID NO: 1.
An isolated and purified nucleic acid
comprising a nucleotide sequence that
is 90% identical to SEQ ID NO: 1,
wherein said nucleic acid encodes a
protein having activity X.
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Functional language
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If the specification provides sufficient
support that the isolated protein has a
specific, substantial, and credible use
related to activity X, limiting the claims to
proteins having activity X may help resolve
a scope of enablement issue.
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Enablement
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How to make?
How to find?
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Scope of enablement
(some considerations)
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Consensus sequences
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State of the Art
Specification Support
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Critical Residues
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Alignments?
What to change and what not to change
Variations
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What substitutions, deletions, insertions may be made?
Where can changes be made?
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Enablement: Claim language
(some considerations)
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Consensus sequence in claim?
Critical residues in claim?
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e.g. An isolated and purified nucleic acid comprising a
nucleotide sequences that is 90% identical to SEQ ID
NO: 1, wherein said nucleic acid encodes a protein
having activity X, and further wherein said nucleic acid
includes SEQ ID NO: 2.
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SEQ ID NO: 2 is the nucleotide sequence that encodes the
catalytic domain (SEQ ID NO: 3) of a protein having activity
X.
SEQ ID NO: 3 is sufficient to endow a protein with catalytic
activity X.
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What % homology is
appropriate?
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Distinguish over prior art
Technology based
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Do alignments yield information that
suggests an appropriate amount of
variation?
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Consensus Sequence Example
Consensus
A G C T T C C G G C T T A T A A A C G T
A C T A T C C A G T A T A A A T A C T T
A x x x T C C x G x x T A x A x A C x T
11/20 = 55% homology between the two molecules.
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Do they both have the desired function?
Are there teachings re: the permitted changes for the degenerate positions?
What is the homology at the amino acid level?
Are there teachings re: the permitted changes at the amino acid level?
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Enablement (cont.)
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Assay
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How to find?
How to screen for operative embodiments?
Wands analysis
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