logging in or signing up RHill PC BeatRoot Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 180 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: August 22, 2007 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript 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. Drug: 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. Drug: 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(c): 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. EnablementVs.Art Rejection: Enablement Vs. 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. You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
RHill PC BeatRoot Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 180 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: August 22, 2007 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript 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. Drug: 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. Drug: 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(c): 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. EnablementVs.Art Rejection: Enablement Vs. 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.