How to Claim your Biotech-Based Invention

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How to Claim your Biotech-Based Invention

• Deborah Reynolds
• Detailee, TCPS1600
• 571-272-0734
• Deborah.Reynolds_at_uspto.gov

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How to Claim your Biotech-Based Invention

• DNA or protein inventions (with a focus on
  utility)
• Antisense nucleic acid inventions

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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.

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Discovery Genetics

• Expressed Sequence Tags (ESTs)
• Genomics
• Genome sequencing
• Bacterial
• Viral
• Mammalian
• Single Nucleotide Polymorphisms (SNPs)
• Directed cloning

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Claim Analysis

• Consider the following claim
• An isolated and purified nucleic acid comprising
  SEQ ID NO 1.

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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).

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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.

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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.

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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.

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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.
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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.

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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.

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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.

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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

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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

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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

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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.

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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

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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.

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Questions?

• Deborah Reynolds
• Detailee, TCPS1600
• 571-272-0734
• Deborah.Reynolds_at_uspto.gov