THE WRITTEN DESCRIPTION REQUIREMENT

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THE WRITTEN DESCRIPTIONREQUIREMENT

• Michael R. Dzwonczyk
• (mdzwonczyk_at_sughrue.com)
• Sughrue Mion, PLLC
• www.sughrue.com

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The Disclosure Requirements of 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 make and use
  the same . . .and shall set forth the best mode .
  . .

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U.S. Disclosure Requirements

• The Written Description Requirement
• Serves a teaching function
• "quid pro quo" in which the public is given
  "meaningful disclosure in exchange for
  patentees limited monopoly
• must "describe the claimed invention so that one
  skilled in the art can recognize what is claimed"
• Must show possession of the claimed invention as
  of the time of the filing of the patent
  application
• Prevents the introduction of new matter in a
  patent application beyond the scope of the
  originally filed specification

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U.S. Disclosure Requirements

• The Enablement Requirement
• the requirement is satisfied if, given the
  knowledge of those of ordinary skill, the
  specification teaches those skilled in the art
  how to make and use the invention without undue
  experimentation
• undue experimentation defined by 8 factors set
  forth in In re Wands, 858 F.2d 731, 737 (Fed.
  Cir. 1988)
• enablement related to written description but a
  separate requirement of patentability under 112

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MPEP Examination Guidelines Adopt Federal Circuit
Rules

• Written description requires detail sufficient
  for one skilled in the art to reasonably conclude
  that the inventor had possession of the claimed
  invention.
• Show possession by descriptive means
• words, structures, figures, diagrams, and
  formulas
• description of an actual reduction to practice
• disclosure of drawings or structural chemical
  formulas
• In haec verba description not required
• MPEP 2163

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Written Description Metrics

• How much disclosure is necessary?
• Information well known in the art need not be
  described in detail in the specification
• The specification is not a blueprint or a
  manufacturing specification
• Degree of detail necessary depends on the
  technological art

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RECENT CASES INVOLVING THE WRITTEN DESCRIPTION
REQUIREMENT

• Where Knowledge In The Art Was Outcome
  Determinative
• Amgen Inc. v. Hoechst Marion Roussel, Inc., 314
  F.3d 1313 (Fed. Cir. 2003)
• Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir.
  2004)
• Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)
• Where Predictability Of The Art Was Outcome
  Determinative
• Rochester v. Searle, , 358 F.3d 916 (Fed. Cir.
  2004)
• In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)

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Written Description Rejections

• Issued when claims are broadened or narrowed
  after filing
• Issued when applicant seeks to alter a numerical
  range limitation
• Issued when applicant seeks to use claim language
  which is not synonymous with the terminology used
  in the original disclosure
• Issued when genus claims are supported by an
  insufficient number of species

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For Biological Inventions. . .

• a deposit made in accordance with 37 CFR 1.801
• identifying characteristics sufficient to show
  possession (sequence, structure, binding
  affinity, binding specificity, molecular weight,
  length)
• A definition by function alone does not
  sufficiently describe a coding sequence "because
  it is only an indication of what the gene does,
  rather than what it is."
• functional characteristics when coupled with a
  known or disclosed correlation between function
  and structure

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• Thank You
• Michael R. Dzwonczyk
• (mdzwonczyk_at_sughrue.com)
• Sughrue Mion, PLLC
• www.sughrue.com