Surgery – Miscellaneous – Methods
Reexamination Certificate
2001-08-24
2003-06-17
Lacyk, John P. (Department: 3736)
Surgery
Miscellaneous
Methods
C600S300000
Reexamination Certificate
active
06578582
ABSTRACT:
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FIELD OF THE INVENTION
The present invention relates generally to a method and apparatus using IDS™ (Intelligent Dosing System™) technology for multi-agent therapy. More particularly, the present invention relates to a method and apparatus for use in treating a patient with multiple agents to optimize therapy and to prevent an adverse response. The present invention can utilize either biological substance levels or other surrogate markers to determine the effectiveness of the dosing regimen and, if necessary, to suggest a new more optimal regimen.
The term “agent” as used herein includes, but is not limited to: vaccines; serums; drugs; adjuvants to enhance or modulate a resulting immune response; vitamin antagonists; medications; autologous whole-cell vaccines (using cells derived from a patient's own tumor); allogenic whole-cell vaccines (using cancer cell lines established in vitro and then used to vaccinate multiple patients); tumor specific antigen/tumor associated antigen (TSA/TAA) based vaccines and hormonal autoimmunization approaches; all other cancer vaccines; Melacine; CancerVax; immune-boosting interferon; peptides; dendritic cells having melanoma protein thereon; interleukin-12; substances which stimulate or energize blood cells known as CD8 T cells; genes which make interleukin-12; tumor cells weakened by genes which make interleukin-12; substances which block blood-vessel formation to prevent growth of tumors; immunized cells; recombinant subunit vaccines; DNA vaccines; live recombinant viral vector vaccines; live recombinant bacterial vector vaccines; live-attenuated vaccines; whole-inactivated vaccines; virus-like particle vaccines; synthetic peptide vaccines; “Jennerian” vaccines; complex vaccines; and combinations of two or more of the foregoing.
The term “surrogate marker” as used herein means all surrogate markers and includes, but is not limited to: a measurement of biological activity within the body which indirectly indicates the effect of treatment on a disease state or on any condition being treated; and any measurement taken on a patient which relates to the patient's response to an intervention, such as the intervention of a biological substance introduced into or on the patient. For example, CD4 cell counts and viral load are examples of surrogate markers in HIV infection.
BACKGROUND OF THE INVENTION
When a patient begins taking an agent or any medication for a length of time, a titration of the amount of agent taken by the patient is necessary in order to achieve the optimal benefit of the agent, and at the same time to prevent any undesirable side effects that taking too much of the agent could produce. Thus, there is a continuous balance between taking enough of the agent in order to gain the benefits from that agent, and at the same time not taking so much agent as to illicit a toxic event.
There is large inter-individual variability in the patient biological interactions and/or the patient pharmocodynamic and pharmacokinetic interactions of agents. What may be an appropriate agent dose for one individual, may be too much or too little for another. A physician was required to estimate the correct agent dosage for a patient and then to experiment with that dosage, usually by trial and error, until the correct dosage was achieved. Likewise, the FDA labeling of a agent suggests dosages based on epidemiological studies and again does not account for inter-individual variability. Non-linear least squares modeling methods involve the use of large amounts of data relating to a general population in order to calculate a best fit. Much like linear regression models, this method cannot take into account the variability between people with the same population characteristics.
Bayesian analysis is another method used to relate agent dose to efficacy. This method employs large-scale population parameters to stratify a population in order to better characterize the individuals. This method does not take into account the changes that can occur within a person over time, and as a result cannot reliably estimate dosages.
Pharmacokinetic compartment modeling has had success with some agents, but because the models are static and cannot adapt themselves to changes within a population or a patient, they are once again undesirable for dynamically determining agent dosages.
Expert systems have been developed using similar technology to predict specific drug dosages for specific immunosuppressant drugs (see, e.g., U.S. Pat. Nos. 5,365,948, 5,542,436 and 5,694,950). These algorithms, however, are not generic and only use immunosuppressant blood levels. Each algorithm is specific to an individual specific immunosuppressant drug. As it stands, these inventions cannot be applied to other agents and do not have a non-linear feedback loop mechanism.
Applicant's U.S. Pat. No. 6,267,116 discloses a major breakthrough in IDS™ technology, but can only accommodate one drug at a time.
It is a desideratum of the present invention to avoid the animadversions of conventional systems and techniques
SUMMARY OF THE INVENTION
The present invention provides in one embodiment thereof a method of calculating the next best dose for each agent of a multi-agent therapy which a patient may be using, comprising the steps of: accepting as first inputs the patient's current doses of a plurality of agents which the patient may be using; accepting as second inputs one or more numerical markers indicating one or more responses of the patient; and calculating new agent doses for said plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.
The present invention provides in a further embodiment thereof a storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a predetermined method, comprising: first means for accepting as first inputs a patient's current doses of a plurality of agents which the patient may be using; second means for accepting as second inputs one or more numerical markers indicating one or more responses of the patient; and third means for calculating new agent doses for said plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.
The present invention provides in another embodiment thereof an apparatus for calculating the next best dose for each agent of a multi-agent therapy which a patient may be using, comprising: first means for accepting as first inputs the patient's current doses of a plurality of agents which the patient may be using; second means for accepting as second inputs one or more numerical markers indicating one or more responses of the patient; and third means for calculating new agent doses for said plurality of agents as a function of said first inputs, said second inputs, and contributions which each agent makes to an overall effect to be achieved by said multi-agent therapy.
REFERENCES:
patent: 5365948 (1994-11-01), McMichael
patent: 5542436 (1996-08-01), McMichael
patent: 5694950 (1997-12-01), McMichael
patent: 6267116 (2001-07-01), McMichael
Gifford, Krass, Groh Sprinkle, Anderson & Citkowski, P.C.
Lacyk John P.
The RxFiles Corporation
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