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Pharmaceutical Composition Claims and Enablement. Robert J. Hill, Jr. Quality Assurance Specialist Technology Center 1600 703-308-4314 Robert.Hill@uspto.gov. MPEP 2164.01(c).

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pharmaceutical composition claims and enablement

Pharmaceutical Composition Claims and Enablement

Robert J. Hill, Jr.

Quality Assurance Specialist

Technology Center 1600

703-308-4314

Robert.Hill@uspto.gov

mpep 2164 01 c
MPEP 2164.01(c)
  • “When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that use.”
example 1
Example 1
  • Claim:
  • “A composition for use in treating Alzheimer’s Disease in humans comprising compound X.”
example 2
Example 2
  • Claim:
  • “A pharmaceutical composition comprising compound X.”
pharmaceutical
Pharmaceutical
  • Steadman’s Medical Dictionary (24th Edition, 1982)
  • “pharmaceutical” means “relating to pharmacy or to pharmaceutics”
pharmacy
Pharmacy
  • Steadman’s Medical Dictionary (24th Edition, 1982)
  • 1. The practice of preparing and dispensing drugs.
  • 2. A drugstore.
  • Clinical p., a branch of p. practice that emphasizes the therapeutic use of drugs rather than the preparation and dispensing of drugs.
slide7
Drug
  • Steadman’s Medical Dictionary (24th Edition, 1982)
  • A therapeutic agent; any substance, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in man and animal.
slide8
Drug
  • Ansel et al (Pharmaceutical Dosage Forms and Drug Delivery Systems, Seventh Edition)
  • An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals.
pharmaceutical use
Pharmaceutical Use
  • A working definition:
  • Any use, other than as food, wherein a substance is used on or in the body to prevent, diagnose, alleviate, treat, or cure a disease in humans or animals.
pharmaceutical use examples
Pharmaceutical Use Examples
  • Administering vitamin supplements (preventing disease)
  • Using labeled antibodies for in vivo imaging (diagnosing disease)
  • Administering a substance to alleviate a symptom of a disease (alleviating or treating disease)
  • Administering an antibiotic (curing bacterial infection)
an interesting example
An Interesting Example
  • Administering an antigenic substance:

Vaccination

versus

Antibody Collection

example 3
Example 3
  • Claim:
  • “A pharmaceutical composition comprising protein X.”
  • Two disclosed uses for compound X:
  • Curing skin cancer.
  • Producing antibodies which can then be used in an in vitro assay to diagnose skin cancer.
mpep 2164 01 c1
MPEP 2164.01(c)
  • “In contrast, when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient”
take home lesson
Take Home Lesson
  • Try to avoid reciting a use in compound/composition claims.
  • Make sure there is at least some enabled in vitro use for the compound/composition.
enablement vs art rejection
EnablementVs.Art Rejection
  • Not necessarily contradictory
    • Enablement training materials
    • Part III.C.
    • http://www.uspto.gov/web/offices/pac/dapp/oppd/1pecba.htm
  • Breathe life and meaning?
example 4
Example 4
  • Claim:
  • “A composition for use in curing Alzheimer’s Disease in humans comprising compound X.”
take home lesson reprise
Take Home Lesson (Reprise)
  • Try to avoid reciting a use in compound/composition claims.
  • Make sure there is at least some enabled in vitro use for the compound/composition.