Download How to Claim your Biotech-Based Invention

How to Claim your BiotechBased Invention
Deborah Reynolds
Detailee, TCPS1600
571-272-0734
[email protected]
How to Claim your BiotechBased Invention
• DNA or protein inventions (with a focus on
utility)
• Antisense nucleic acid inventions
What is the Invention?
• The famous quote from
Brenner v. Manson, 383 U.S. 519 (1966):
– “[A] patent is not a hunting license. It is
not a reward for the search, but
compensation for its successful
conclusion.”
Claim Analysis
• Consider the following claim:
An isolated and purified nucleic acid
comprising SEQ ID NO 1.
Question
• What does the application disclose?
• Full Open Reading Frame (ORF)
• Application further asserts that the encoded
protein is a member of a family of proteins that is
already known based upon amino acid sequence
homology (i.e. comparison of entire sequence or
determination of a consensus sequence).
The Protein
• Two possibilities
– The search may support the assignment
of the protein to a particular family, or
may be inconclusive.
– The search may reveal that the protein
more likely belongs to a family other
than that asserted in the application.
Example
• Example:
– Applicant asserts that the protein is an interleukin
receptor because it is 85% identical at the amino
acid level with other IL-receptors.
– A search confirms the asserted identity and that the
next closest match is a 50% identity to beta-actin.
– No reason to doubt assertion that the protein is
an IL-receptor.
Example
• Utility
– Is there a well-established utility for IL-receptors?
• No. Different receptors would have different
functions and the artisan would have to
determine such.
Example
Is the utility specific?
Maybe. The use would be particular to a
general class of receptors, but the limited
amount of information present would apply
equally to all IL-receptors.
Example
• Is the utility substantial?
– No. The artisan would need to prepare,
isolate, and analyze the protein in order to
determine its function and use. Therefore,
the invention is not in readily available
form.
Example
• In the absence of an alternative utility that meets
the requirements of 35 U.S.C. §101, with these
facts, the claimed invention would be rejected
under 35 U.S.C. §101 as failing to have patentable
utility.
Example
• Is there an alternative utility?
– Probe?
• It is possible that the DNA encoding the
protein would have utility as a probe.
However, the probe must have a specific,
substantial and credible utility under 35
U.S.C. 101.
Key Theme for Antisense
Patent Examining
• Structure-Function Relationships
– Antisense Oligo +
– Target Nucleic Acid +
– Delivery Scheme +
– Cell Type +
– Organism =
– Modulation of Target and/or Therapy
“Enablement” Requirement
• Commonly cited unpredictable factors for antisense:
– predicting target accessibility
• target folding/structure
• antisense/target protein interactions
• lack of correlation between in vitro and in vivo
– efficient delivery to cells and cell targeting for specific disorders
– oligo affinity/stability in vivo
– “modulation” of target
• inhibition
• up-regulation
– in vitro (cell culture) results generally  in vivo success
– animal model shown is not art recognized
Gene Walk Conclusions
• Probability of finding functional antisense oligo is high.
– A broad claim to “An isolated antisense oligonucleotide that
inhibits the expression of gene X” may be enabled by providing
the sequence for gene X and gene walk data (no magic number)
• Predictability of any single antisense being effective is low
– claim to specific antisense oligonucleotide may require evidence of
function
• The current state of predictability for antisense may
support that breadth/scope claimed is enabled
– but this may also raise prior art issues depending on what was
known at the time of filing
Obviousness
• Broad antisense claims to known genes would be
considered obvious if the prior art suggested inhibiting
the gene and the gene sequence was known.
• The current knowledge and level of skill in the art is high
such that one of ordinary skill in the art would expect at
least an antisense against every known gene (i.e. at
mRNA initiation site), absent evidence to the contrary.
• Narrow claims to specific antisense oligos may be free of
the art, when there would be no motivation to modify the
prior art to achieve the specific antisense sequence
claimed.
Recommendations
• Claim functional antisense oligos by specific
sequence.
• List results of “gene walk”
– showing activity of each oligo
– “gene walk” data may provide a representative number
of species to enable/describe a broad generic claim, but
there is no magic number
Recommendations
• Provide objective evidence that in vitro results are
representative of in vivo applicability.
• Respond to examiner-cited unpredictable factors with
objective evidence to the contrary.
• Expert opinions are more favorably viewed when
supported using objective evidence.
• Provide objective evidence that a particular animal model
is generally accepted as representative of disease or
methods of treating, particularly for humans.
• Objective evidence includes arguments, case law, journal
articles, and experimental data and comparisons
commensurate with the disclosure as filed.
Questions?
Deborah Reynolds
Detailee, TCPS1600
571-272-0734
[email protected]