Compliance with the Written Description Requirement

1
Compliance with the Written Description
Requirement
Raymond R. Mandra, Esq.Partner

• FITZPATRICK, CELLA, HARPER SCINTO
• 30 Rockefeller Plaza
• New York, NY

2
Compliance with the Written Description
Requirement

• Look To
• 35 U.S.C. 112, First Paragraph
• The Case Law
• The PTO Guidelines (And Training Materials)

3
Written Description Statute

• 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. (emphasis added)

35 U.S.C. 112, 1
4
Written Description Basics

• An adequate written description means describing
  the invention in sufficient detail that one
  skilled in the art can conclude that the inventor
  invented the claimed invention. Lockwood v.
  American Airlines, Inc., 107 F.3d 1565, 1572
  (Fed. Cir. 1997).
• An adequate written description means describing
  the invention in sufficient detail so that one
  skilled in the art can conclude the inventor had
  possession of the claimed invention. Purdue
  Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323
  (Fed. Cir. 2000).
• Possession is shown by describing the invention
  with all its claim limitations, even if they are
  obvious, and is measured as of the filing date
  sought. Lockwood v. American Airlines, Inc., 107
  F.3d 1565, 1571-72 (Fed. Cir. 1997).

5
Written Description Basics

• Fact question reviewed for clear error
• Meaningful and adequate disclosure is quid pro
  quo to public for being excluded from practicing
  the invention for limited period
• An application itself must describe an
  invention, and do so in sufficient detail that
  one skilled in the art can clearly conclude that
  the inventor invented the claimed invention as of
  the filing date sought.
• Lockwood v. American Airlines, Inc., 107 F.3d
  1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir.
  1997)

6
Written Description v. Enablement

• Written description means describing the
  invention in sufficient detail that one skilled
  in the art can conclude that the inventor
  invented the claimed invention
• Enablement means one skilled in the art is taught
  by the patent how to make and use the invention,
  without undue experimentation

7
Some Relevant Cases

• Written description
• In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967).
• The Regents of California v. Eli Lilly Co., 119
  F.3d 1559 (Fed. Cir. 1997)
• Gentry Gallery v. Berkline Corp., 134 F.3d 1473
  (Fed. Cir. 1998)
• Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d
  1013 (Fed. Cir. 2002)
• Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
  1316 (Fed. Cir. 2002)
• University of Rochester v. G.D. Searle Co.,
  2003 U.S. Dist. LEXIS 3030 (W.D.N.Y. 2003)
• Moba, B.V. v. Diamond Automatic, 325 F.3d
  1306(Fed. Cir. 2003)

8
Written Description Basics

• Often applied to a priority situation, e.g., new
  matter added
• However, the written description requirement also
  applies to original claims.
• The Regents of the University of California v.
  Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997)

9
Lilly Facts

• Patent specification disclosed
• rat insulin cDNA sequences
• method for obtaining them
• amino acid sequences of human insulin
• Claims in dispute were to vertebrate, mammalian
  and human insulin cDNA

10
Lilly Holdings
Court affirmed judgment that both human cDNA and
genus cDNA patent claims were invalid for lack of
written description

• Human cDNA claims
• patent describes only general method for
  obtaining human insulin-encoding cDNA, but not
  cDNAs relevant structural or physical
  characteristics
• description of human insulin amino acid sequences
  does not describe cDNA that encodes them (because
  of redundancy of genetic code)

11
Lilly Holdings (continued)

• Genus cDNA claims
• disclosure of rat cDNA sequences does not
  describe structure of sufficient members of broad
  functional classes of vertebrate or
  mammalian insulin cDNA
• A definition by function does not suffice to
  define the genus because it is only an indication
  of what the gene does, rather than what it is

Lilly, 119 F.3d at 1568
12
Lilly Consequences

• How should one properly describe cDNA genus?
• According to Lilly
• One way is to recite the nucleotide sequences of
  a representative number of cDNAs (silent as to
  what is representative)
• Another way is to recite structural features
  common to genus members, which features
  constitute a substantial portion of genus

Lilly, 119 F.3d at 1569
13
Gentry Gallery

• The patent disclosed that recliner controls were
  located on the console of a sectional sofa having
  two independent recliner seats facing in the same
  direction
• Broadest claim covered control means mounted on
  the double reclining seat sofa section
• The court concluded that the patent did not
  support claims where the recliner controls were
  not located on the console since that location
  was an essential element of the invention when
  viewing the disclosure in its entirety

14
Enzo Facts

• Detection of bacteria that causes gonorrhea
  difficult because of high degree of homology
  between N. gonorrhoeae and meningitidis
• Specification referred to ATCC deposit of three
  sequences that preferentially hybridize to six
  common strains of N. gonorrhoeae over six common
  strains of N. meningitidis (also deposited)

Enzo Bichem, Inc. v. Gen-Probe Inc., 296 F.3d
1316 (Fed. Cir. 2002)
15
Enzo Facts (continued)

• Patent claims nucleotide sequence that
  preferentially hybridizes to N. gonorrhoeae over
  N. meningitidis by ratio of greater than 51
• Dependent claims were drawn to the three
  deposited probe sequences and discrete
  subsequences, mutations, and mixtures

16
Enzo Procedural Background

• Original panel decision (Lourie Prost Dyk,
  dissenting) affirmed judgment claims were invalid
  for failure to meet written description
  requirement of 35 U.S.C. 112
• rejected argument that deposit inherently
  disclosed inventors were in possession of claimed
  sequences
• On rehearing, panel unanimously vacated that
  decision and reversed and remanded

17
Enzo Holdings

• On rehearing, Court faced with two main
  questions
• Whether Enzos deposits of claimed sequences of
  dependent claims constituted an adequate written
  description?
• Issue of first impression
• Reference in specification to a deposit in a
  public depository, when it is not otherwise
  available in written form, may constitute an
  adequate written description
• Remanded - fact issue of whether subsequences,
  mutations, and mixtures were described by
  reference to the deposited sequences

Enzo, 296 F.3d at 1325
18
Enzo Holdings (contd.)

• Whether written description requirement is met
  for all claims on basis of functional ability of
  three deposited probe sequences to hybridize to
  deposited strains of N. gonorrhoeae?
• Depends on whether three deposited sequences are
  representative of the scope of the genus under
  Lilly
• PTO written description Training Example 9
  provides that nucleic acid genus claims may be
  adequately described if nucleic acids hybridize
  under highly stringent conditions to known
  sequences
• Remanded issue to be decided consistent with
  Lilly and PTOs written description Guidelines
• Enzo, 296 F.3d at 1324, 1327-28

19
Enzo Additional Issues

• Whether reference to deposit of six strains of N.
  gonorrhoeae inherently describes claimed
  sequences that hybridize to them (i.e., by
  showing function/structure correlation) is a fact
  issue
• Ipsis verbis inclusion of claim words in
  specification does not necessarily satisfy the
  written description requirement, e.g., an
  anti-inflammatory steroid or an antibiotic
  penicillin

20
Enzo Additional Issues

• Even if three deposited probe sequences indicated
  Enzo possessed invention, possession may not
  be sufficient to describe invention
• compare Lockwood, One shows that one is in
  possession of the invention by describing the
  invention, with all its claimed limitations, not
  that which makes it obvious.
• Lockwood 107 F.3d at 1572, emphasis omitted
• Reduction to practice without adequate
  description is insufficient to describe invention

21
Enzo En Banc Rehearing Denial

• Only Rader, Gajarsa and Linn voted for rehearing
  (PTO filed brief as amicus in favor of rehearing)
• Dyk, who voted against rehearing, nevertheless
  said Court would benefit from further
  percolation of the issues

Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed.
Appx. 439 (Fed. Cir. 2002)
22
Enzo En Banc Rehearing Denial

• Those for en banc rehearing
• based on statute, there is no separate written
  description requirement only an enablement
  requirement
• separate written description requirement
  introduced by CCPA in 1967 only for determining
  priority
• Lilly was first CAFC case to apply written
  description outside of a priority context
• Lilly and Enzo result in heightened disclosure
  requirement making enablement irrelevant

23
Enzo En Banc Rehearing Denial

• Those against en banc rehearing
• Written description is separate requirement from
  enablement
• Statute says and between mentions of written
  description and enablement
• Supreme Court in Festo said patent application
  must describe, enable and set forth the best mode
  of carrying out the invention
• Fact that prior written description cases may
  have dealt only with priority is circumstantial

24
Post-Enzo Written Description Decisions

• University of Rochester v. G.D. Searle Co.,
  2003 U.S. Dist. LEXIS (W.D.N.Y. 2003).
• Moba B.V. v. Diamond Automatic, 325 F.3d 1306
  (Fed. Cir. 2003).

25
Searle Facts

• Cox-1 helps protect stomach lining
• Cox-2 associated with inflammation stimuli
• Prior art drugs (NSAIDs) inhibited both Cox-2
  and Cox-1

26

• University of Rochester claim 1
• A method for selecting inhibiting PgHS-2 activity
  in a human host, comprising administering a
  non-steroidal compound that selectively inhibits
  activity of the PGHS-2 gene product to a human
  host in need of such treatment.

27
Searle Facts (continued)

• Patent describes screening assays useful for
  development of drugs that selectively inhibit
  inflammation without producing side effects due
  to inhibition of Cox-1
• Patent says assays are for screening compounds
  including peptides, polynucleotides and small
  organic molecules
• Patent claims method of administering to humans a
  non-steroidal compound that selectively inhibits
  Cox-2 activity and has minimal effect on Cox-1
  activity

28
Searle Holding

• Court held (Larimer, J.) patent failed to
  provide written description of claimed invention
• patent only describes the function of compound
  called for but no showing of correlation between
  function and structure (relying on PTO written
  description Guidelines)
• inventors did not identify even one suitable
  compound
• patent is merely research plan that describes
  tests to run on wide spectrum of compounds in
  hope at least one will work
• Court rejected plaintiffs contention that Enzo
  and Lilly limited to claims directed to nucleic
  acid sequences
• Lillys holding that the inventors must
  adequately describe invention is not limited to
  genetic material

29
Searle Additional Issues

• Court rejected plaintiffs argument that written
  description requirement doesnt apply to method
  of treatment claims
• claimed method depends upon finding a compound
  that selectively inhibits COX-2
• It means little to invent a method if one does
  not have possession of the substance that is
  essential to practicing that method

University of Rochester, 2003 U.S. Dist. LEXIS
3030 at 31.
30
Moba

• Patent claimed a method of processing eggs
• The alleged infringer argued that since the court
  had construed the patent claim at issue to
  encompass lifting eggs from a moving conveyor,
  then the claim must be invalid for lack of
  written description because the specification did
  not disclose any such conveyor mechanisms

31
Moba (continued)

• Per curium (Judges Rader, Schall and Bryson)
• The test for compliance with 112 has always
  required sufficient information in the original
  disclosure to show that the inventor possessed
  the invention at the time of the original
  filing.

32
Moba Holdings

• Gentry Gallery was not controlling because there
  was no allegation that the patent disclosure did
  not show possession of a later-filed claim.
• The Lilly disclosure rule was not applicable
  because one skilled in the art could determine
  from the as-filed specification that the inventor
  possessed the invention.

33
Moba (Judge Rader concurring)

• it is a mistake to apply the written description
  doctrine beyond priority
• The Lilly rule requires the nucleotide by
  nucleotide recitation of an entire sequence and
  this rule unnecessarily increases the cost and
  time required to prepare and prosecute a biotech
  application
• to enable is to show possession and to show
  possession is to enable
• the Lilly rule requires en banc correction.

34
Moba (Judge Bryson concurring)

• Does not believe you can separate Lilly from In
  re Ruschig based on priority because 112, first
  paragraph, makes no such distinction.
• Are the Ruschig line of cases based on a flawed
  construction of 35 USC 112, first paragraph?

35
Status of Written Description Requirement

• Genus may be adequately described by identifying
  sufficient number of species or structural
  features common to substantial portion of genus
  (Lilly)
• Functional descriptions are not enough unless
  there is shown a clear correlation between
  function and structure (Enzo)
• Written description requirement applies to
  pharmaceuticals, nucleic acids, methods of
  treatment, and compositions (Searle)
• PTO Written Description Guidelines are important
  reference for prosecutors, opinion givers and
  litigators (Enzo/Searle)

36
The PTO Written Description Guidelines

• 66 Fed. Reg. 1099, 1104 (Jan. 5, 2001)
• Purpose is to assist the PTO in the examination
  of patent applications for compliance with the
  written description requirement
• Do not constitute substantive rulemaking
  (perceived failure to follow neither appealable
  or petitionable)
• Synopsis of Application of Written Description
  Guidelines available at http//www.uspto.gov/web/p
  atents/guides.htm

37
Written Description Guidelines

• General Principals
• The written description requirement of the
  Patent Act promotes the progress of the useful
  arts by ensuring that patentees adequately
  describe their inventions in their patent
  specifications in exchange for the right to
  exclude others from practicing the invention for
  the duration of the patent term.
• 66 Fed. Reg. at 1104

38
Written Description Guidelines

• General Principals (continued)
• An applicant shows possession of the claimed
  invention by describing the claimed invention
  with all of its limitations using such
  descriptive means as words, structures, figures,
  diagrams, and formulas that fully set forth the
  claimed invention. Possession may be shown in a
  variety of ways including description of an
  actual reduction to practice, or by showing that
  the invention was ready for patenting such as
  by the disclosure of drawings or structural
  chemical formulas that show that the invention
  was complete, or by describing distinguishing
  identifying characteristics sufficient to show
  that the applicant was in possession of the
  claimed invention.
• 66 Fed. Reg. at 1104

39
Written Description Guidelines

• General Principals (continued)
• The issue of an adequate written description may
  arise when
• an original claim is not described sufficiently
• a new or amended claim which adds or removes a
  limitation
• a claim to benefit of an earlier priority date or
  effective filing date
• 66 Fed. Reg. at 1104

40
Written Description Guidelines

• I.A. Original Claims
• strong presumption of adequate written
  description for an original claim
• but, originally claimed invention may not be
  adequately described if the claims require an
  essential or critical feature which is not
  adequately described in the specification and
  which is not conventional in the art or known to
  one of ordinary skill in the art. (emphasis
  added)
• 66 Fed. Reg. at 1105

41
Written Description Guidelines

• I.B. New or Amended Claims
• New or amended claims which introduce elements
  or limitations which are not supported by the
  as-filed disclosure violate the written
  description requirement.
• Support must be either express, implicit or
  inherent
• 66 Fed. Reg. at 1105

42
Written Description Guidelines

• I.B. New or Amended Claims (continued)
• obvious errors may be corrected if one skilled in
  the art recognizes
• (i) the existence of the error and (ii) the
  appropriate correction
• deposits made after the filing date cannot
  support additions to or correction of information
  in the as-filed application.
• 66 Fed. Reg. at 1105

43
Written Description Guidelines

• I.B. New or Amended Claims (continued)
• omission of a limitation may raise an issue did
  the inventor have possession of a broader, more
  generic invention?
• a claim that omits an element which applicant
  describes as an essential or critical feature of
  the invention originally disclosed does not
  comply with the written description requirement.
• 66 Fed. Reg.at 1105

44
Written Description Guidelines

• Methodology
• Read and Analyze the Specification (question of
  fact determined on a case-by-case basis)
• For each claim determine what the claim as a
  whole covers.
• Review the entire application to understand how
  applicant provides support for the claimed
  invention including each element and/or step.
• Determine whether there is sufficient written
  description to inform a skilled artisan that
  applicant was in possession of the claimed
  invention as a whole at the time the application
  was filed.
• 66 Fed. Reg. at 1105

45
Written Description Guidelines

• Methodology (continued)
• Original Claims possession may be shown by
• actual reduction to practice (but see Enzo)
• detailed drawings
• structural chemical formula or
• sufficient relevant, identifying characteristics
  from which a person skilled in the art would
  recognize that the inventor had possession.
• 66 Fed. Reg. at 1105-06

46
Written Description Guidelines

• Methodology (continued)
• For a single species or embodiment, the Examiner
  is to determine if an actual reduction to
  practice, detailed drawings or structural
  chemical formula shows possession of the claimed
  invention. If not, are there sufficient
  relevant, identifying characteristics?
• if the complete structure (or acts of a process)
  is disclosed then adequate description.
• if not, are there other relevant identifying
  characteristics sufficient to adequately describe
  the invention?
• 66 Fed. Reg. at 1106

47
Written Description Guidelines

• Methodology (continued)
• Features for determining if other relevant
  identifying characteristics are sufficient
• level of skill and knowledge in the art
• partial structure
• physical and/or chemical properties
• functional characteristics alone or coupled with
  a known or disclosed correlation between
  structure and functions
• method of making the claimed invention
• 66 Fed. Reg. at 1106

48
Written Description Guidelines

• Methodology (continued)
• if the technology is mature and the level of
  skill is high then disclosure even of only a
  method of making and a function should be
  adequate to support a product claim
• if the technology is emerging or unpredictable
  greater evidence is needed to show possession
• 66 Fed. Reg. at 1106

49
Written Description Guidelines

• Methodology (continued)
• The written description requirement for a claimed
  genus may be satisfied through sufficient
  description of a representative number of
  species, i.e., the species which are adequately
  described are representative of the entire genus.
• the higher the skill and the knowledge in the art
  the smaller the representative number of species
  needed.
• the more unpredictable the art the greater the
  representative number of species needed.
• 66 Fed. Reg. at 1106

50
Written Description Guidelines

• Methodology (continued)
• New claims, amended claims or claims asserting a
  priority benefit must be expressly, implicitly,
  or inherently supported by the original
  application.
• If the original application does not support the
  new claim limitation or if element described as
  essential or critical is missing from the claim,
  then lack of adequate written description.
• 66 Fed. Reg. at 1107

51
Some Suggestions

• Avoid unsupported provisos to obtain allowance
• If an element of the invention is described as
  critical or essential then it should be included
  in the claims
• When drafting an application be certain that the
  elements of your invention are accurately
  described
• Consider describing an alternative embodiment
  with the phrase consisting essentially of in
  the specification
• When drafting a provisional remember that the
  disclosure must meet the requirements of 35
  U.S.C. 112, first paragraph

52
Suggestions For Biotech Claims

• CLAIM THE HUMAN SEQUENCES (cDNA, GENOMIC, AMINO
  ACID) SPECIFICALLY FOR EXAMPLE
• SEQ ID NO 1 cDNA
• SEQ ID NO 2 GENOMIC
• SEQ ID NO 3 AMINO ACID (Perhaps active
  fragments of this protein)
• CLAIM cDNA (SEQ ID NO 1) OPERABLY LINKED TO AN
  EXPRESSION CONTROL SEQUENCE
• CLAIM HOST CELL CONTAINING OPERABLY LINKED cDNA

53
Suggestions For Biotech Claims (continued)

• CLAIM NUCLEIC ACIDS THAT SPECIFICALLY HYBRIDIZE
  TO SEQ ID NOs 1 AND 2 UNDER HIGHLY STRIGENT
  CONDITIONS and identify highly stringent
  conditions in specification or claim
• CLAIM ANTISENSE NUCLEOTIDES THAT INHIBIT THE
  EXPRESSION OF SEQ ID NOs 1 AND 2
• CLAIM ANTIBODIES THAT BIND TO THE PROTEIN (SEQ ID
  NO 3)
• CLAIM TRANSGENIC and/or KNOCKOUT ANIMALS (based
  on SEQ ID NOs 1 AND 2)

54
Suggestions For Biotech Claims (continued)

• IF AWARE OF PARTICULAR FUNCTIONAL DOMAINS OR
  CONSERVED SEQUENCES, CLAIM THEM SPECIFICALLY
  Amino Acid and Nucleotide sequence
• CLAIM ANALOGS (SHOULD BE TIED TO FUNCTION OR
  OTHER DISTINGUISHING ATTRIBUTES, e.g., degeneracy
  of condons for SEQ ID NO 3)
• CLAIM ALLELIC VARIANTS -- as possible support,
  discuss single nucleotide polymorphisms (SNPs) -
  (identify fact that some particular number of
  SNPs within the gene is known (e.g., in the
  public SNP database(s)) specifically identify
  those SNPs present within the coding sequence)

55
Thank You