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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).

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Pharmaceutical Composition Claims and Enablement

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

  2. 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.”

  3. Example 1 • Claim: • “A composition for use in treating Alzheimer’s Disease in humans comprising compound X.”

  4. Example 2 • Claim: • “A pharmaceutical composition comprising compound X.”

  5. Pharmaceutical • Steadman’s Medical Dictionary (24th Edition, 1982) • “pharmaceutical” means “relating to pharmacy or to pharmaceutics”

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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)

  11. An Interesting Example • Administering an antigenic substance: Vaccination versus Antibody Collection

  12. 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.

  13. 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”

  14. 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.

  15. 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?

  16. Example 4 • Claim: • “A composition for use in curing Alzheimer’s Disease in humans comprising compound X.”

  17. 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.

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