Written Description Analysis and Capon v' Eshhar

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Written Description Analysis and Capon v. Eshhar

• Jeffrey Siew
• Supervisory Patent Examiner AU 1645
• USPTO
• [phone]
• Jeffrey.Siew_at_uspto.gov

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35 U.S.C. 112 first paragraph

• The specification shall contain a written
  description of the invention, and of the manner
  and process of making and using it, in such full,
  clear, concise, and exact terms as to enable any
  person skilled in the art to which it pertains,
  or with which it is most nearly connected, to
  make and use the same, and shall set forth the
  best mode contemplated by the inventor of
  carrying out his invention.

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Written Description Guidelines

• Federal Register
• (http//www.access.gpo.gov/su_docs/aces/aces140.ht
  ml)
• Written Description Guidelines
• 66 FR 1099 (January 5, 2001)
• Applies to all pending applications

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General Principles

• Basic inquiry Can one skilled in the art
  reasonably conclude that the inventor was in
  possession of the claimed invention at the time
  the application was filed?
• Written description requirement is separate and
  distinct from the enablement requirement

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Analysis

• If a skilled artisan would have understood the
  inventor to be in possession of the claimed
  invention at the time of filing, even if every
  nuance of the claim is not explicitly described
  in the specification, then the requirement for an
  adequate written description is met.

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Examples of Acceptable Showings of Possession

• Actual reduction to practice
• Reduction to practice normally not required
• Deposit of biological materials
• Clear depiction of the claimed invention in
  detailed drawings
• What is conventional or well known to one skilled
  in the art need not be disclosed in detail

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Evidence of Possession

• Written description describing sufficient
  relevant identifying characteristics
• Weigh factual considerations in view of level of
  skill and knowledge in the art
• The less mature the technology, the more evidence
  is required to show possession
• Level of skill and knowledge in the art increases
  over time

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Evidence of Possession

• Sufficient distinguishing identifying
  characteristics
• Weigh factual considerations in view of level of
  skill and knowledge in the art
• Complete or partial structure
• Physical and/or chemical properties
• Functional characteristics
• Correlation between structure and function
• Method of making
• Combinations of the above

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Capon v. Eshar, 418 F.3d 1349 (Fed. Cir. 2005)

• Claims directed to chimeric genes made from known
  DNA sequences of known functions using known
  procedures
• The Board found that persons having ordinary
  skill would not have been able to visualize and
  recognize the identity of the claimed genetic
  material without considering additional knowledge
  in the art, performing additional
  experimentation, and testing to confirm results.

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Capon (cont.)

• The Capon court reversed, explaining
• Descriptive text needed . varies with the nature
  and scope of the invention at issue, and with the
  scientific and technologic knowledge already in
  existence
• the written description requirement states that
  the patentee must describe the invention it does
  not state that every invention must be described
  in the same way.
• as each field evolves, the balance also evolves
  between what is known and what is added by each
  inventive contribution

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Written DescriptionSupport of claims

• Determination of what is needed to support
  generic claims to biological subject matter
• Existing knowledge in the particular field
• Extent and content of the prior art
• Maturity of the science or technology
• Predictability of the aspect at issue
• Other considerations appropriate to the subject
  matter.

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35 USC 112, 1st Paragraph

• Example 1

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The Typical Reach-through Situation

• Consider the following claim
• A therapeutic compound for inhibiting cancer
  growth in a mammal, said compound being capable
  of binding to UPINCANCER polypeptide.

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The Specification Discloses

• Isolated UPINCANCER polypeptide comprising SEQ ID
  NO 1.
• UPINCANCER polypeptide is highly over-expressed
  in malignant tissues.
• No compounds have been identified which bind to
  UPINCANCER and inhibit cancer cell growth.
• No structures of compounds which would
  predictably bind UPINCANCER and inhibit cancer
  cell growth are taught.
• The effect of compound binding to UPINCANCER on
  cancer cell growth has not been demonstrated.

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35 U.S.C.112 First Paragraph Conclusions

• The claim lacks written description for the
  compounds encompassed
• The claim is also not enabled for how to make the
  compound.
• The claim is not enabled for how to use the
  compound because it is unpredictable that binding
  to the polypeptide would inhibit cancer cell
  growth.

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• Consider the following claim
• A method of treating a tumor by administering a
  Tamal peptide that is bound to a blood brain
  permeable group

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The specification discloses

• Tamal peptide is SEQ ID NO2
• Tamal peptide targets brain tumors. However, the
  peptide by itself cannot cross the blood brain
  barrier alone.
• The specification has tested only two chemicals
  that act as blood brain permeable groups when
  attached to Tamal peptide allows crossing the
  barrier. The chemicals do not have common
  structure.
• The specification then cites a laundry list of
  blood brain barrier groups including OH groups,
  phenols, polar groups such as polysaccharides
  amino acids

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35 U.S.C.112 First Paragraph Conclusions

• The claim lacks written description for the
  compounds encompassed

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THANK YOU!

• Jeffrey Siew
• Supervisory Patent Examiner AU 1642
• USPTO
• [phone]
• Jeffrey.Siew_at_uspto.gov