ENABLING DISCLOSURE Claim Supporting Disclosures vs' Claim Anticipating Disclosures

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ENABLING DISCLOSUREClaim Supporting Disclosures
vs. Claim Anticipating Disclosures

• Jennifer M. Hayes

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Anticipation

• Under 35 USC 102, a claimed invention may be
  anticipated if it was previously
• known or used in the U.S. or
• patented or described in a qualifying prior art
  reference.

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Anticipatory Prior Art

• A single prior art reference
• Each and every element of the claim
• Explicitly or inherently
• Enabling disclosure

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Claim Supporting Enablement vs. Claim
Anticipating Enablement

• The standard for what constitutes proper
  enablement in support of a claim for a patent
  under 35 USC 112, 1st paragraph, differs from
  what is required for an enabling disclosure in a
  prior art reference necessary to anticipate a
  claim under 35 USC 102.

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Claim Supporting Enablement

• To satisfy the enablement requirement, the
  specification must describe the invention in
  terms such that one of ordinary skill in the art
  can make and use the claimed invention. 35 USC
  112, 1st paragraph.

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Claim Supporting Enablement

• The test of enablement for claim support is
• whether the specification, as of its filing date,
  contained sufficient information to enable one
  skilled in the art to make and use the claimed
  invention without undue experimentation.

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Undue Experimentation Factors

• Breadth of the claims
• Nature of the invention
• State of the prior art
• Level of skill of the ordinarily skilled artisan
• Level of predictability in the art
• Amount of guidance and direction provided in the
  specification
• Existence of working examples
• Quantity of experimentation needed

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The Meaning of Enabling for Purposes of
Anticipation

• An enabling anticipatory prior art reference must
  provide a sufficient description to place the
  invention in the possession of the public.

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Possession

• Possession is effected if one of ordinary skill
  in the art could have combined the publications
  description with his own knowledge or the
  remainder of the prior art to make the claimed
  invention.

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Possession

• For anticipation, the claimed subject matter
  must be in possession of the public before the
  critical date of invention as defined in section
  102, (e.g., more than one year before the filing
  date of the application under 102(b).

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Sufficient Description

• A description in such a full and intelligible
  manner as to enable persons skilled in the art to
  comprehend it, make it, or repeat the process
  claimed.

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Compounds

• In re Donahue (Fed. Cir. 1985)
• Compound claims rejected over reference
  disclosing the claimed compounds in view of
  references teaching how to make the compounds.
• Additional references could be used to show that
  the anticipatory reference placed the invention
  in possession of the public and, therefore, was
  enabling even though there was evidence that the
  disclosed compounds were not actually made.

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Compounds (Cont.)

• In re Schoenwald (Fed. Cir. 1992)
• Compound claims rejected over reference, which
  undisputedly adequately described and enabled the
  claimed compound but did not disclose a utility.
• It was held that no utility need be disclosed for
  a reference to anticipate a claim to an old
  compound.

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New Uses/New Methods

• Is it a new use or method or just a new benefit ?
• New Use
• Mehl/Biophile International Corp. v. Milgraum (8
  F.Supp.2d 434 (1998), affd. Fed. Cir. 1999)
• Method of removing hair using known laser
  dermatology method (found to be a new use and not
  a new benefit)
• Since the process steps were the same
  anticipation could only be rebutted by showing
  that the prior art did not enable application of
  the process to hair removal.

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• New Benefit
• BMS v. Ben Venue Laboratories, Inc. (Fed. Cir.
  2001)
• Method of treatment for a taxol-sensitive tumor
  and method of treatment for taxol-sensitive tumor
  associated with hematologic toxicity (found to be
  a new benefit of process).
• Prior art which disclosed the same process but
  did not show anti-tumor effects was found to
  enable the performance of the steps and therefore
  anticipate the claims since a favorable outcome
  was not required based upon the construction of
  the claims.
• Additional references after date of anticipatory
  prior art but more than one year prior to the
  application filing date can be considered to
  establish enablement of anticipatory prior art
  reference.

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Inherent Anticipation and Enablement

• Schering Corp. v. Geneva Pharmaceuticals, Inc.
  (Fed. Cir. 2003)
• Claims directed to a metabolite (DCL) inherently
  made upon ingestion of a compound (loratadine)
  found to be anticipated by an earlier patent
  disclosing administration of loratadine.
• Since administration of loratadine inherently
  results in the formation of DCL, the enabled
  disclosure of administration of loratadine was an
  enabling disclosure of how to make the metabolite
  DCL and therefore a person of ordinary skill in
  the art could practice the invention without
  undue experimentation.

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Priority

• In re Hafner (CCPA 1969)
• Claims in CIP application rejected as anticipated
  by intervening published priority application
  where US parent and priority documents were found
  not to be enabled and therefore Applicant was not
  entitled to priority

Hafner 4/27/1961
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Interference

• Rasmusson v. SKB (Fed. Cir. 2005)
• Method of treatment for prostate cancer involving
  administration of finasteride.
• Earlier Rasmusson applications found not to
  demonstrate sufficient utility and therefore also
  found to be non-enabling.
• Case remanded to determine if corresponding
  published EP application was sufficiently
  enabling to anticipate later filed applications
  of both Rasmusson and SKB.

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Sufficient Enabling Description

• Mere naming of a chemical compound may not be
  enough.
• May be supplemented by knowledge in the art.
• Utility is not required.
• Effectiveness is not required.
• Inherent properties do not have to be recognized.

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Enabling Support Enabling Prior Art

• Anytime the before critical date.
• Any subject matter within the scope of the
  claims.
• No experimentation
• Recited use may be ignored.
• Utility, effectiveness not required.

• Determined at the time of the invention.
• Must be enabling for the full scope of the
  claims.
• Undue Experimentation
• Recited use is considered for determining
  enablement.
• Utility is required.