Data processing: database and file management or data structures – Database design
Reexamination Certificate
2011-07-19
2011-07-19
LeRoux, Etienne P (Department: 2161)
Data processing: database and file management or data structures
Database design
Reexamination Certificate
active
07984069
ABSTRACT:
The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or device is analyzed to identify new essential adverse events associated with the product or device. At least one database of new essential adverse event information is created and utilized, and new characteristics of or uses for the product or device related to the new essential adverse event information are determined. Adverse event information is gathered for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers and/or distributors can include the proprietary information in consumer safety information, which accompanies the product or device, or which is provided to patients, users, consumers and the like, or in the case of certain medical products or devices, to prescribers of those products or devices. The system and methods also provide for commercializing the essential adverse event information.
REFERENCES:
patent: 3885566 (1975-05-01), Jacob
patent: 5181394 (1993-01-01), Schea et al.
patent: 5386829 (1995-02-01), Diamond
patent: 5642731 (1997-07-01), Kehr
patent: 5678234 (1997-10-01), Colombo et al.
patent: 5723283 (1998-03-01), Classen
patent: 5726884 (1998-03-01), Sturgeon et al.
patent: 5728385 (1998-03-01), Classen
patent: 5737539 (1998-04-01), Edelson et al.
patent: 5833599 (1998-11-01), Schrier et al.
patent: 5845255 (1998-12-01), Mayaud
patent: 5876926 (1999-03-01), Beecham
patent: 5908383 (1999-06-01), Brynjestad
patent: 5950630 (1999-09-01), Portwood et al.
patent: 5970463 (1999-10-01), Cave et al.
patent: 5991751 (1999-11-01), Rivette et al.
patent: 6000828 (1999-12-01), Leet
patent: 6018714 (2000-01-01), Risen et al.
patent: 6097995 (2000-08-01), Tipton et al.
patent: 6112182 (2000-08-01), Akers et al.
patent: 6219674 (2001-04-01), Classen
patent: 6221851 (2001-04-01), Feldman
patent: 6243615 (2001-06-01), Neway et al.
patent: 6323242 (2001-11-01), Mueller
patent: 6458958 (2002-10-01), D'Ambra et al.
patent: 6465463 (2002-10-01), Cohn et al.
patent: 6584472 (2003-06-01), Classen
patent: 6696924 (2004-02-01), Socinski
patent: 6784177 (2004-08-01), Cohn et al.
patent: 6944776 (2005-09-01), Lockhart et al.
patent: 2001/0001144 (2001-05-01), Kapp
patent: 2002/0039990 (2002-04-01), Stanton, Jr.
patent: 2002/0082930 (2002-06-01), Park
patent: 2002/0138305 (2002-09-01), Watanabe et al.
patent: 2003/0004965 (2003-01-01), Farmer et al.
R.T. Chen, et al., “Vaccine Safety Datalink Project: A New Tool For Improving Vaccine Safely Monitoring in the United States,”Pediatrics, 99:[6] 765-773, 1997.
DeStefano, et al., “Timing of Hepatitis B Vaccination and Risk of Insulin-Dependent Diabetes Mellites,”Pharma. And Drug Safety6[2] (1997).
Classen, J.B., “New Patents for Older Products Through Patenting Product Safety Information,” www.vaccines.net, (2005).
Fiala, T.C. and Wright, J.E., “Drug Labeling Patents: A New Line of Defense for Protecting Old Drugs?,” The Intellectual Property Strategist, LJN (2005).
Bakerv.Secy of Dept. of Health and Human Servs., No. 99-653V , 2003 WL 22416622, (Ct. Fed. Cl. Sep. 26, 2003).
A. Bate, et al., “A Bayesian neural network method for adverse drug reaction signal generation,”Eur J Clin Pharmacol54(4) (Jun. 1998) 315-321.
C. Baum, et al., “The Spontaneous Reporting System in the United States,”Pharmacoepidemiology, 2nd ed. New York: John Wiley & Sons, 1994, 125-137.
D. Bradbury, “A Bitter Pill to Swallow,”Computing, 34-35, Feb. 9, 1995.
D. Classen et al., “Adverse Drug Events in Hospitalized Patients,” 277JAMA, 301-306 (1997).
D. Classen et al., “Computerized Surveillance of Adverse Drug Events in Hospital Patients,” 266JAMA2847-2851 (1991).
D. Classen et al., “Description of a Computerized Adverse Drug Event Monitor Using a Hospital Information System,” 27Hosp. Pharm.774, 776-779, 783 (1992).
D. Classen & S. Pestotnik, “The Computer-Based Patient Record,”Hospital Epidemiology and Infection Control, 141-154 (2nd Ed., New York: Lippincott Williams & Williams 1999).
R. Evans et al., “A Computer-Assisted Management Program for Antibiotics and Other Antiinfective Agents,” 338The New England Journal of Medicine, 232-238 (1998).
R. Evans et al., “Development of Computerized Adverse Drug Event Monitor,”15thAnnual Symposium on Computer Applications in Medical Care, 23-27 (1992).
R. Evans et al., “Evaluation of a Computer-Assisted Antibiotic-Dose Monitor,” 33,Annals. Pharm., 1026-1031 (1999).
R. Evans et al., “Preventing Adverse Drug Events in Hospitalized Patients,” 28Ann. Pharm.523-527 (1994).
R. Evans et al., “Prevention of Adverse Drug Events through Computerized Surveillance,”16thAnnual Symposium of Computer Applications in Medical Care, 437-441 (1993).
R. Evans et al., “Using a Hospital Information System to Assess the Effects of Adverse Drug Events,”Seventeenth Annual Symposium on Computer Applications in Medical Care, 161-165 (1994).
G. Faich, US Adverse Drug Reaction Surveillance 1989-1994,Pharmacoepidemiology and Drug Safety5:393-398 (1996).
Federal Register, vol. 58, No. 105, (Jun. 3, 1993).
Finney, D. J. Systematic Signalling of Adverse Reactions to Drugs,Methods of Information in Medicine, 13 (1974) 1-10.
International Reporting of Adverse Drug Reactions, Final Report of CIOMS Working Group, 1990.
Jim Kling, “From hypertension to angina to Viagra,”Modern Drug Discovery1(2) (1998), available at http://pubs.acs.org/hotartcl/mdd/98
ovdec/viagra.htm.
M. Lindquist et al., “From Association to Alert—A Revised Approach to International Signal Analysis,”Pharmacoepidemiology and Drug Safety8:S15-S25 (Apr. 1999).
David J. Morrow, “New Profits in Old Bottles,”N. Y. Times, Mar. 19, 1999.
U.S. Appl. No. 90/007,638, filed Jul. 22, 2005, Classen.
U.S. Appl. No. 90/007,639, filed Jul. 22, 2005, Classen.
C.A. Naranjo et al., “A method for estimating the probability of adverse drug reactions,” 30Clin. Pharmacol. Ther.(2):239-45 (1981).
V. Pinkston & E. J. Swain, “Management of Adverse Drug Reaction and Adverse Event Data through Collection, Storage and Retrieval,”Detection of New Adverse Drug Reactions, 281-296 (Apr. 1998) (4th Ed., London: Macmillan Reference Ltd.).
“Post-marketing surveillance for adverse events after vaccination: the national Vaccine Adverse Event Reporting System (VAERS),” MEDWATCH Continuing Education Article (1998).
Statement of Susan S. Ellenberg before the U.S. House of Representatives, available at www.fda.gov/ola/1999/anthrax.html (Jul. 21, 1999).
A. Szarfman, “Discussion: A Report on the Activities of the Adverse Events Working Groups: Focus on Improving the Detection of Rare but Serious Events,” 1999 Proceedings of the Biopharmaceutical Section, American Statistical Association, Alexandria (VA),American Statistical Association, 12-13 (1999) (Szarfman/abstract).
A. Szarfman, “New Methods for Signal Detection,”15thInternational Conference on Pharmacoepidemiology, Boston, Mass., Aug. 28, 1999 (Szarfman/ppt).
U.S. Food and Drug Administration, “What Is A Serious Adverse Event?,” http://www.fda.gov/medwatch/report/DESK/advevnt.htm.
Vaccine Safety Forum, Summaries of Two Workshops, Washington, DC (National Academy Press 1997).
Browdy and Neimark PLLC
Classen Immunotherapies, Inc.
LeRoux Etienne P
LandOfFree
Computer algorithms and methods for product safety does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Computer algorithms and methods for product safety, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Computer algorithms and methods for product safety will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2727105