DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because there is a lack of antecedent basis for “the patient’s body” in line 9-10 and “the start of execution of said target0controlled infusion protocol” in line 14-15. Appropriate correction is required.
Claim 5 is objected to because there is a lack of antecedent basis for “said drug concentration value within the patient” in line 6 as opposed to “said value of a drug concentration within the patient”. Appropriate correction is required.
Claim 14 is objected to because there is a lack of antecedent basis for “the patient’s body” in line 6 and “the start of execution of said target0controlled infusion protocol” in line 11. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8-11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickle et al. (USPN 7229430).
Regarding claim 1, Hickle discloses a system (drug delivery system 122) for controlling a target-controlled infusion for administering a drug to a patient (“This interface or translation algorithm 40 may be, among other things, a rate controlled infusion (RCI) algorithm, or a target controlled infusion (TCI) algorithm based on a pharmacokinetic model.” [Col 5, lines 25-28), comprising:
at least one infusion device (drug delivery device 119) for administering a drug to the patient;
a control device (controller 114) which is configured to control operation of the at least one infusion device in order to establish a drug concentration within the patient based on a target concentration (“As with the interface algorithm software 40, the drug state model software 38 can operate on the controller of drug delivery device 119, on controller 114 of an integrated system comprising drug delivery device 119 or an external computer.” [Col 7, lines 8-12]; see all of [Col 5, line 56 – Col 6, line 16]),
wherein the control device is configured to execute a target-controlled infusion protocol using a mathematical model modelling a drug distribution in the patient's body for controlling operation of the at least one infusion device (“An example of a TCI-based algorithm uses a pharmacokinetic model and a controller, preferably a proportional integral derivative ("PID") controller, for open loop, model-based control of the delivery system's pump. This PID controller may calculate a drug delivery rate error and use that error data to control the target drug levels. Based on the predictions of a pharmacokinetic model appropriately selected or modified from one or more of numerous available models, a TCI algorithm modulates the desired infusion rate requested of the delivery device in an effort to achieve a desired target concentration of a given drug at a given target or effect site within given times or time periods.” [Col 5, lines 54-67]);
wherein the control device (2) is configured to calculate, based on a user-specified induction dose (1), a value of a drug concentration within the patient (P) using said mathematical model and to consider said value of the drug concentration at the start of execution of said target-controlled infusion protocol (see at least: “FIG. 3 shows an example time plot of the actual rate of infusion of propofol for an 18 year-old, 90 kg, 140 cm tall female using an infusion pump with a 200 mg/min pumping limit set to reach a 2.0 .mu.g/ml ESC target at a 0.5 .mu.g/ml/min ramp-up of ESC according to one of these models. The software algorithm predicting the drug concentration at a target site and defining the rate of drug administration can employ many different pharmacokinetic models (for example, 2, 3, 4 or n compartments)” [Col 6, lines 18-26]).
Regarding claim 2, Hickle discloses the system according to claim 1, wherein the control device is configured to cause a display prompt requesting a user input to specify information concerning said induction dose administered to the patient prior to the display prompt or to be administered to the patient after the display prompt (“A drug delivery Example Run will now be described in order to illustrate certain embodiments of the drug state transitions that are possible according to the present invention…Initially, a clinician user enters the patient's demographic data such as, among others, weight, height, age, gender, and ethnicity via a UI of the system. The user then enters a conservative target ESC of propofol by pressing a "Propofol level" button or the like on the UI. At an ensuing prompt, the user presses the button labeled "2.0" and then the "OK" button to actually administer propofol.” [Col 17, lines 50-65]).
Regarding claim 8, Hickle discloses the system according to claim 1, wherein the control device (controller 114) is configured to assume a target concentration (CT) at the start of execution of the said target-controlled infusion protocol corresponding to said value of the drug concentration (see at least “TCI algorithm modulates the desired infusion rate requested of the delivery device in an effort to achieve a desired target concentration of a given drug at a given target or effect site within given times or time periods.” [Col 5, lines 64-67]).
Regarding claim 9, Hickle discloses the system according to claim 8, wherein the control device is configured vary the target concentration (CT) after the start of execution of the said target-controlled infusion protocol (“The interface algorithm 40 controlling the rate of change of the drug concentration can produce different time profiles of the target drug concentration at different effect sites. The time profiles can be a linear ramp from target concentration A to B or a nonlinear increase or waveform. Nonlinear drug level increases can be controlled by several variables including the starting point (target concentration A) and the initial patient response during the initiation of a drug level change.” [Col 6, lines 35-42]).
Regarding claim 10, Hickle discloses the system according to claim 9, wherein the control device is configured to linearly increase the target concentration (CT) within a specified time span after the start of execution of the said target-controlled infusion protocol (“The interface algorithm 40 controlling the rate of change of the drug concentration can produce different time profiles of the target drug concentration at different effect sites. The time profiles can be a linear ramp from target concentration A to B or a nonlinear increase or waveform.” [Col 6, lines 35-38]).
Regarding claim 11, Hickle discloses the system according to claim 1, wherein the control device is configured to control operation of the at least one infusion device (31-33) in order to establish a drug concentration at an effect site or at a plasma site within the patient (P) based on the target concentration (“An example of a TCI-based algorithm uses a pharmacokinetic model and a controller, preferably a proportional integral derivative ("PID") controller, for open loop, model-based control of the delivery system's pump. This PID controller may calculate a drug delivery rate error and use that error data to control the target drug levels. Based on the predictions of a pharmacokinetic model appropriately selected or modified from one or more of numerous available models, a TCI algorithm modulates the desired infusion rate requested of the delivery device in an effort to achieve a desired target concentration of a given drug at a given target or effect site within given times or time periods. A TCI software algorithm, as one embodiment of an interface or translation layer, can operate effectively on the drug delivery device computer directly or on an external computer.” [Col 5, line 56 – Col 6, line 3]).
Regarding claim 13, Hickle discloses the system according to claim 1, wherein the mathematical model models a drug concentration in a multiplicity of compartments of the patient (P) during execution of the target-controlled infusion protocol (“The software algorithm predicting the drug concentration at a target site and defining the rate of drug administration can employ many different pharmacokinetic models (for example, 2, 3, 4 or n compartments) now known or yet to be developed. Target and/or monitoring sites include the blood plasma, brain, central nervous system, neuromuscular junction, alveolar space, kidney, liver, pancreas, hypothalamus, heart tissue, baroreceptors and any other drug receptor laden sites or spaces in or on the body.” [Col 6, lines 21-30]).
Regarding claim 14, Hickle discloses a method for controlling a target-controlled infusion for administering a drug to a patient (via drug delivery system 122; “This interface or translation algorithm 40 may be, among other things, a rate controlled infusion (RCI) algorithm, or a target controlled infusion (TCI) algorithm based on a pharmacokinetic model.” [Col 5, lines 25-28), comprising:
controlling, using a control device (controller 114), operation of at least one infusion device (drug delivery device 119) in order to establish a drug concentration within the patient (P) based on a target concentration by executing a target-controlled infusion protocol using a mathematical model modelling a drug distribution in the patient's body for controlling operation of the at least one infusion device (“As with the interface algorithm software 40, the drug state model software 38 can operate on the controller of drug delivery device 119, on controller 114 of an integrated system comprising drug delivery device 119 or an external computer.” [Col 7, lines 8-12]; “An example of a TCI-based algorithm uses a pharmacokinetic model and a controller, preferably a proportional integral derivative ("PID") controller, for open loop, model-based control of the delivery system's pump. This PID controller may calculate a drug delivery rate error and use that error data to control the target drug levels. Based on the predictions of a pharmacokinetic model appropriately selected or modified from one or more of numerous available models, a TCI algorithm modulates the desired infusion rate requested of the delivery device in an effort to achieve a desired target concentration of a given drug at a given target or effect site within given times or time periods.” [Col 5, lines 54-67]; see all of [Col 5, line 56 – Col 6, line 16]); and
calculating, by the control device and based on a user- specified induction dose, a value of a drug concentration within the patient (P) using said mathematical model and considering said value of the drug concentration at the start of execution of the said target-controlled infusion protocol (see at least: “FIG. 3 shows an example time plot of the actual rate of infusion of propofol for an 18 year-old, 90 kg, 140 cm tall female using an infusion pump with a 200 mg/min pumping limit set to reach a 2.0 .mu.g/ml ESC target at a 0.5 .mu.g/ml/min ramp-up of ESC according to one of these models. The software algorithm predicting the drug concentration at a target site and defining the rate of drug administration can employ many different pharmacokinetic models (for example, 2, 3, 4 or n compartments)” [Col 6, lines 18-26]).
Regarding claim 15, Hickle discloses the method according to claim 14, further comprising prompting a user, prior to said calculating, in a display prompt to specify information concerning said induction dose administered to the patient prior to the prompting or to be administered to the patient after the prompting (“A drug delivery Example Run will now be described in order to illustrate certain embodiments of the drug state transitions that are possible according to the present invention…Initially, a clinician user enters the patient's demographic data such as, among others, weight, height, age, gender, and ethnicity via a UI of the system. The user then enters a conservative target ESC of propofol by pressing a "Propofol level" button or the like on the UI. At an ensuing prompt, the user presses the button labeled "2.0" and then the "OK" button to actually administer propofol.” [Col 17, lines 50-65]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hickle et al. (USPN 7229430) in view of Johnson et al. (USPN 5522798).
Regarding claim 3, Hickle discloses the system according to claim 2.
Hickle fails to explicitly disclose wherein said information includes a dose information and a time information to specify a time of administration.
Johnson teaches a system (Figure 1 using host controller 10 and PK model 100) for controlling a target-controlled infusion for administering a drug to a patient (“In the PK model controlled delivery mode, a desired setpoint is automatically achieved by controlling the multi-channel drug delivery system to attain the desired setpoint based upon a predicted drug concentration within the patient produced by the model.” [Col 6, lines 21-26]), comprising a control device (host controller 10) configured to cause a display prompt requesting a user input to specify information concerning said induction dose administered to the patient prior to the display prompt or to be administered to the patient after the display prompt, wherein said information includes a dose information and a time information to specify a time of administration (“A typical control for a drug delivery system includes a keypad or other user interface enabling a medical practitioner to enter the rate of drug delivery, duration, and volume of a drug or medicinal fluid to be infused into a patient. Drug delivery is normally either programmed to occur as a continuous infusion or as a single bolus dose.” [Col 1, lines 15-21]; “On the touch screen, a user enters the age, weight, gender, and other patient specific parameters or drug parameters (if not stored in the memory of controller 32) that a PK model may require for predicting the drug concentration and selectively controlling the rate at which each drug is delivered to the patient.” [Col 6, lines 50-55]; “Turning first to FIG. 5, the steps involved in predicting the drug concentration begin with a start block 120. A block 122 provides for input by the user of patient information, including as required, the patient's weight, age, and gender. Input of these data start the PK prediction model running. In addition, the user enters the (initial) desired drug concentration setpoint, either for blood plasma drug concentration or effect compartment drug concentration. Then, the user scans the drug vial, so that controller 32 (FIG. 1) can identify the drug being delivered to the patient. Identification of the drug is important, since, as noted in a block 124, the controller must fetch the drug PK data that are stored in memory in order to properly determine the PK model parameters that will be used.” [Col 15, lines 26-39]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Hickle to include that the information includes a dose information and a time information to specify a time of administration based on the teachings of Johnson to provide the controller with the necessary information to accurately calculate a value of a drug concentration within the patient (Johnson [Col 6, lines 50-67]).
Regarding claim 4, Hickle discloses the system according to claim 2.
Hickle fails to explicitly disclose said information includes a combination of at least two of a dose information, a duration information specifying a duration of administration and a flow rate information.
Johnson teaches a system (Figure 1 using host controller 10 and PK model 100) for controlling a target-controlled infusion for administering a drug to a patient (“In the PK model controlled delivery mode, a desired setpoint is automatically achieved by controlling the multi-channel drug delivery system to attain the desired setpoint based upon a predicted drug concentration within the patient produced by the model.” [Col 6, lines 21-26]), comprising a control device (host controller 10) configured to cause a display prompt requesting a user input to specify information concerning said induction dose administered to the patient prior to the display prompt or to be administered to the patient after the display prompt, said information includes a combination of at least two of a dose information, a duration information specifying a duration of administration and a flow rate information (“A typical control for a drug delivery system includes a keypad or other user interface enabling a medical practitioner to enter the rate of drug delivery, duration, and volume of a drug or medicinal fluid to be infused into a patient. Drug delivery is normally either programmed to occur as a continuous infusion or as a single bolus dose.” [Col 1, lines 15-21]; “On the touch screen, a user enters the age, weight, gender, and other patient specific parameters or drug parameters (if not stored in the memory of controller 32) that a PK model may require for predicting the drug concentration and selectively controlling the rate at which each drug is delivered to the patient.” [Col 6, lines 50-55]; “Turning first to FIG. 5, the steps involved in predicting the drug concentration begin with a start block 120. A block 122 provides for input by the user of patient information, including as required, the patient's weight, age, and gender. Input of these data start the PK prediction model running. In addition, the user enters the (initial) desired drug concentration setpoint, either for blood plasma drug concentration or effect compartment drug concentration. Then, the user scans the drug vial, so that controller 32 (FIG. 1) can identify the drug being delivered to the patient. Identification of the drug is important, since, as noted in a block 124, the controller must fetch the drug PK data that are stored in memory in order to properly determine the PK model parameters that will be used.” [Col 15, lines 26-39])..
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Hickle to include that the information includes a combination of at least two of a dose information, a duration information specifying a duration of administration and a flow rate information based on the teachings of Johnson to provide the controller with the necessary information to accurately calculate a value of a drug concentration within the patient (Johnson [Col 6, lines 50-67]).
Regarding claims 5-6, Hickle discloses the system according to claim 1.
Hickle fails to explicitly disclose the control device is configured to control operation of the at least one infusion device selectively in a manual induction mode and in an automatic induction mode, wherein in the manual induction mode the control device is configured to calculate, based on said user-specified induction dose, said drug concentration value within the patient using said mathematical model and to consider said drug concentration at the start of execution of the said target-controlled infusion protocol, and in the automatic induction mode to assume a zero drug concentration in the patient at the start of execution of the said target-controlled infusion protocol, as required by claim 5; and
wherein the control device is configured to cause a display prompt requesting a user input to select one of the manual induction mode and the automatic induction mode, as required by claim 6.
Johnson teaches a system (Figure 1 using host controller 10 and PK model 100) for controlling a target-controlled infusion for administering a drug to a patient (“In the PK model controlled delivery mode, a desired setpoint is automatically achieved by controlling the multi-channel drug delivery system to attain the desired setpoint based upon a predicted drug concentration within the patient produced by the model.” [Col 6, lines 21-26]), comprising a control device (host controller 10) configured to control operation of at least one infusion device (cassette pumps 20) selectively in a manual induction mode and in an automatic induction mode (“The user input determines the control mode of the host controller for each drug channel. Two modes of drug delivery are provided, including a manual mode…and a PK model controlled delivery mode. In the PK model controlled delivery mode, a desired setpoint is automatically achieved by controlling the multi-channel drug delivery system to attain the desired setpoint based upon a predicted drug concentration within the patient produced by the model.” [Col 6, lines 16-26]), wherein in the manual induction mode the control device is configured to calculate, based on said user-specified induction dose, said drug concentration value within the patient using said mathematical model and to consider said drug concentration at the start of execution of the said target-controlled infusion protocol (“when the user selectively operates the multi-channel drug delivery system under manual control, the PK simulation uses the drug rate delivery information to continue to track and predict the drug concentration (either or both blood plasma and effect compartment), even though it is not controlling that rate. This feature enables the predicted rate and historical rate to be displayed to the user for each drug administered, at any time, including during manual control of drug delivery and after the delivery of a drug is interrupted or even terminated.” [Col 9, lines 37-46]), and in the automatic induction mode to assume a zero drug concentration in the patient at the start of execution of the said target-controlled infusion protocol (“As noted in the above mathematical discussion of the PK model, it is assumed that the model begins with zero drug concentration in each of the central and peripheral compartments, and in the effect compartment.” [Col 16, lines 3-6]), as required by claim 5; and
wherein the control device is configured to cause a display prompt requesting a user input to select one of the manual induction mode and the automatic induction mode (“The user interface includes a mode switch enabling the user to select between a manual mode and a PK model control mode for controlling the delivery of any of the plurality of drugs by the multi-channel drug delivery system” [Col 3, lines 39-42]), as required by claim 6.
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Hickle to include the control device is configured to control operation of the at least one infusion device selectively in a manual induction mode and in an automatic induction mode, wherein in the manual induction mode the control device is configured to calculate, based on said user-specified induction dose, said drug concentration value within the patient using said mathematical model and to consider said drug concentration at the start of execution of the said target-controlled infusion protocol, and in the automatic induction mode to assume a zero drug concentration in the patient at the start of execution of the said target-controlled infusion protocol, and wherein the control device is configured to cause a display prompt requesting a user input to select one of the manual induction mode and the automatic induction mode based on the teachings of Johnson to allow the user to easily switch between various control modes, such as to accommodate for delivery of bolus dosages, in a manner that allows the controller to maintain a history of and accurate future predictions of the drug concentration in the patient (Johnson [Col 2, lines 46-67]).
Regarding claim 7, Hickle discloses the system according to claim 1.
Hickle fails to explicitly disclose the control device is configured to cause a display prompt displaying said value of the drug concentration at the start of execution of the said target-controlled infusion protocol.
Johnson teaches a system (Figure 1 using host controller 10 and PK model 100) for controlling a target-controlled infusion for administering a drug to a patient (“In the PK model controlled delivery mode, a desired setpoint is automatically achieved by controlling the multi-channel drug delivery system to attain the desired setpoint based upon a predicted drug concentration within the patient produced by the model.” [Col 6, lines 21-26]), wherein a control device (host controller 10) is configured to cause a display prompt displaying said value of the drug concentration at the start of execution of the said target-controlled infusion protocol (“The user can also selectively determine the information that is displayed on EL display 36 for any drug administered during a patient case, including the prior drug concentration at any past time, the current drug concentration, and a predicted drug concentration at a specified future time.” [Col 6, lines 55-60]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Hickle to include the control device is configured to cause a display prompt displaying said value of the drug concentration at the start of execution of the said target-controlled infusion protocol based on the teachings of Johnson to alert the user to the current drug concentration during execution of the target-controlled infusion protocol and allow the user to evaluate If the target concentration needs to be adjusted (Johnson [Col 6, lines 55-60], [Col 17, lines 44-51]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hickle et al. (USPN 7229430) in view of Becker (US 20160074582).
Regarding claim 12, Hickle discloses the system according to claim 1, wherein the mathematical model is a pharmacokinetic model (“TCI algorithms use a pharmacokinetic (PK) model to predict target or effect site concentrations of a given drug at a given site in a patient with given demographic data such as weight, height, age and gender.” [Col 2, lines 12-15]).
Hickle fails to explicitly disclose wherein the mathematical model is a pharmacokinetic/ pharmacodynamic model.
Becker discloses a system for controller a target-controlled infusion for administering a drug to a patient (see all of [0026]), comprising a control device (control device 2) configured to execute a target-controlled infusion protocol using a mathematical model modeling a drug distribution in the patient’s body for controlling operation of at least one infusion device (infusion devices 31, 32, 33), wherein the mathematical model is a pharmacokinetic/ pharmacodynamic model (“The control device 2 serves to control the infusion operation of one or multiple of the infusion devices 31, 32, 33 during the anaesthesia procedure such that infusion devices 31, 32, 33 inject anaesthetic drugs to the patient P in a controlled fashion to obtain a desired anaesthetic effect.” [0080]; “The control device 2 uses, to control the infusion operation of one or multiple infusion devices 31, 32, 33, a pharmacokinetic-pharmacodynamic (PK/PD) model” [0088]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the mathematical model of Hickle to be a pharmacokinetic/pharmacodynamic model based on the teachings of Becker to model and account for both processes action on the drug within the patient’s body and also effects of the drug in the body (Becker [0088]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
