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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/4/2025. As directed by the amendment: claims 17-20, 24, 26, 28-29, and 31-35 has been amended. Thus, claims 17-35 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 11/4/2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to the independent claim(s), particularly those regarding presently amended subject matter of the manually operable syringe, pump volume displacement parameter, and the configuration of the user guidance device, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-35 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180333543 A, henceforth written as Diaz, in view of WO 2005072792 A1, henceforth written as Struys.
Regarding Claim 17,
Diaz discloses:
A user-guidance device for informing a required change to a pump volume displacement parameter of
(sensor flange 150; fig 6-10)
a syringe manually operable by applying a force to a plunger of the syringe by hand or with an inert, zero-order syringe pump, for use with manually-controlled infusion of at least one drug into a patient,
(manually actuated syringe of injection system 110; fig 6-10)
said user-guidance device comprising: at least one measurement component arranged to measure the volume displacement parameter; wherein the volume displacement parameter is a linear distance travelled by the plunger of the syringe or a rate of flow of the drug from the syringe measured by a flow meter and a computing device arranged to: calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter;
(paragraph 99-101+130-135; motion sensor 160 optically measures a distance travelled by plunger member 116 and uses a clock and processor 172 to determine when a full dose has been or has yet to be delivered by utilizing parameters such as rate of motion of the plunger member, therein both calculating a rate of infusion by determining the rate the plunger travels to dispense medicament and a rate of infusion by determining whether a scheduled dose is fully adhered to)
calculate with reference to said measured rate of infusion [and specific infused media characteristics] --derive user-guidance information based [calculations executed with measured rate of infusion data and specified infused media characteristics]; and output the user-guidance information,
(paragraph 60+96-97+108+110+135+140+145+150+171; output device 154 156 communicate information such as time for injection, missed dose, completed dose, injection too quick or slow, injectable substance reaching an adequate temperature, injection into atmosphere event, obstruction event, leak event, etc. to improve compliance with a therapeutic regiment for a user; fig 6-10; Diaz importantly notes in paragraph 150+171+173 that each injectable solution has known limits for an injection being too slow or too quick, therein known limits/range for adequate rate of infusion)
wherein the user-guidance device is not configured for making an automatic adjustment to a rate of infusion.
(paragraph 93+218; syringe of present embodiment are manually actuated by a user and not automatically by flange 150; fig 6-10)
Diaz discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model-simulated drug concentration in said patient; derive user-guidance information based on said model-simulated drug concentration; and output the user-guidance information
However, Struys teaches a method for controlling infusion to achieve a desired concentration in a patient:
calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model-simulated drug concentration in said patient; derive [injection]-guidance information based on said model-simulated drug concentration; and output the [injection]-guidance information
(Page 9 to 13; Controller 108 provides information to a medication delivery unit to deliver medicament at a desired rate/interval, therein a rate of infusion, to achieve a desired concentration of medication in the patient’s blood stream. The preferred/updated administration rate is determined based on a pharmacodynamic-pharmacokinetic model processing information -such as in vivo analyte concentration resulting from a previous administration rate infusing a set amount of medicament- to update a patient’s response profile. As Struys discusses, if a higher concentration is required, i.e. a previous infusion rate is inadequate for the desired effect, the controller may communicate that an infusion rate should be adjusted to achieve the desired effect, therein setting a desired rate of infusion based pharmacokinetic and pharmacodynamic model of a simulated desired drug concentration.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Struys’ teachings of a computational process of adjusting an infusion rate based on in vivo analyte data and previous infusion characteristics, such as infusion rate, which shape a patient’s drug response profile, to the user guidance invention of Diaz, such that Diaz’s invention utilizes Struys’ computational means of analyzing infusion parameter characteristics relative to in vivo analyte data acquired by Struys’ sensors to provide updated infusion guidance parameters to a user of Diaz’s syringe, in order to advantageously arrive at an invention which can communicate therapeutic regiment adjustments to a user administering a therapeutic regiment to more effectively and efficiently achieve a desired therapeutic effect in a patient, see page 9 to 12 of Struys.
Examiner notes for clarity that in such a modification, Diaz’s flange 150 provides user guidance-information to a user involving Diaz’s plunger 116 being depressed too slowly/quickly relative to a particular infusion rate during an infusion, see Diaz paragraph 150+170-173. Note that in the modified invention this particular infusion rate which the modified invention guides the user to execute, is based on Struys’ computational processes which considers the user’s response to previous infusion rates and communicates an updated rate of infusion to achieve a desired drug concentration, where the desired drug concentration was simulated by an pharmacodynamic/kinetic model of Struys’ which considers a drug profile, patient drug response profile, and previous infusion parameters such as measured infusion rate.
Regarding claim 18, Diaz in view of Struys discloses:
A drug infusion system which includes a user-guidance device as claimed in claim 17 and a syringe.
Diaz: (system 110; fig 6-10)
Regarding claim 19, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 18 wherein the syringe is assemble to an inert, zero-order syringe pump.
Diaz: (paragraph 178; syringe of system 110 is a standard, therein inert, syringe having certain constant constraints such as area, dose, length, radius, etc. such that it can be considered zero order; fig 6-10)
Regarding claim 20, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 18 wherein the computing device is further arranged to calculate, with reference to the volume displacement parameter and the model, a rate of infusion required for achieving in said patient a drug concentration within a target concentration range.
Examiner notes that in light of the modification made in claims above, Diaz’s processor 172 performs the calculations and communication taught by Struys, including determining a rate of infusion to achieve a desired drug concentration, therein a concentration with an acceptable range, based on previous infusion parameters such as the previous infusion rate driven by a movement of Diaz’s plunger moving at a certain rate.
Regarding claim 21, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 20 wherein the computing device is arranged to compare the measured rate of infusion against the required infusion rate, thereby to establish a deviation of the measured infusion rate from the required infusion rate; and generate deviation notification data if said deviation breaches a definable threshold.
Diaz: (paragraph 36+60+170-173; alarm is communicated when rate of infusion is too quick/slow relative to a pre-determined range of a desirable infusion rate)
Regarding Claim 22,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
The drug infusion system as claimed in claim 18 wherein the computing device is arranged to generate deviation notification data if the model-simulated drug concentration breaches a definable threshold concentration.
However, Struys teaches in page 12-13+35 that its controller triggers alarms if dangerous situations, such as drug concentration being predictive to reach a maximum or minimum level or deviating outside of a desired effect range, are likely to occur.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys’ further computational teachings of warning of predictive dangerous situations to the modified invention, such that Diaz’s user guidance device may determine when a simulated drug concentration is predicted to reach a certain dangerous or undesirable threshold, in order to advantageously arrive at an invention which can generate data which may be utilized to protect a user from dangerous circumstances involving an over/under/inadequate drug concentration level, including worsening condition and death.
Regarding claim 23, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 21, which further includes at least one alerting component configured to trigger a user-discernible alert signal responsive to the generation of the deviation notification data.
Diaz: (output devices 154 156; fig 6-10)
Regarding claim 24, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 18 wherein the measurement component and the computing device are of a unitary construction configured for tool-free engagement with, and disengagement from, the syringe or an inert, zero-order syringe pump assembly.
Diaz: (flange 150, including its computational and sensor components which are unitary with it, is tool-free couplable/removable to syringe of system 110; fig 6-10)
Regarding Claim 25,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
The drug infusion system as claimed in claim 18 wherein the drug is selected from the group consisting of anaesthetic, hypnotic, analgesic, and neuromuscular blocking agents.
However, Struys teaches in page 1-3 the invention may distribute anesthesia, drugs with produce a sedative effect therein hypnotic, opiates therein analgesic drugs, muscle relaxants therein neuromuscular blocking agents, as well as other suitable drugs.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys’ teachings of types of injectable medicament to the medicament dispensed by the modified invention, in order to advantageously arrive at an invention which can provide a sedative effect on a patient, desirable in certain therapeutic regiments.
Regarding Claim 26,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
The drug infusion system as claimed in claim 18, which comprises a plurality of syringes for concurrently infusing a plurality of drugs, and a plurality of measurement components arranged in data communication with the computing device, wherein the computing device is arranged to calculate data relating to interactions between the drugs, and with reference to said data, a required change to a rate of infusion of at least one of the drugs
Notably, Struys details on page 3 that multiple drugs may be simultaneously administered to a patient with different desirable concentrations and subsequent interactions. Struys details on page 3+13-15+30-36 its computational method is configured to calculate drug concentration based on infusion parameters of a multitude of dispensed drugs, and adjust infusion parameters based on models simulating concentrations of drugs as they interact in the body.
Notably, MPEP 2144.04(VI)(B) provides that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The infusion of a plurality of drugs, is not new or unexpected in light of Struys page 3, and further a plurality of infusion pumps is not an unexpected manner of producing such an infusion.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the plurality of syringes monitored by Diaz’s modified user guidance device, and implement Struys analyses of interaction effects of simultaneous infusions on measured and simulated drug concentrations to consider adjusting infusion parameters, in order to arrive at an invention which advantageously can infuse a plurality of drugs to support a patient’s prescription and account for intervening effects of the plurality of drugs on their concentration in vivo by optimizing the respective drug’s infusion rate, see MPEP2144.04(VI(B) and page 3+13-15-30-36 of Struys.
Regarding claim 27, Diaz in view of Struys discloses:
The drug infusion system as claimed in claim 18 wherein the computing device includes a processing component and a memory configured to provide computer program instructions as software units to the processor to execute the calculations.
Examiner notes in light of the modification made in claims above, Diaz’s flange 150 includes circuitry for processing at processor 172, therein having software units for, and for storing relevant data in a memory module, see paragraph 106-107+110.
Regarding Claim 28,
Diaz discloses:
A computer implemented method for informing a required change to a volume displacement parameter of a syringe manually operable by applying a force to a plunger of the syringe by hand or with an inert, zero-order syringe pump, the method including:
(flange 150 provides information to a user to guide the time, duration, degree, and other characteristics of an infusion process driven by a user manually actuating a plunger 115 of the syringe of system 110)
monitoring at least one syringe having a volume displacement parameter;
(syringe of system 100, dispenses a volume when its plunger 116 is actuated by the user; fig 6-10)
measuring said volume displacement parameter, wherein the volume displacement parameter is a linear distance travelled by the plunger of the syringe or a rate of flow of the drug from the syringe measured by a flow meter; providing a computing device and operating it to: calculate a measured rate of infusion of a drug into a patient based on said volume displacement parameter;
(paragraph 99-101+130-135; motion sensor 160 optically measures a distance travelled by plunger member 116 and uses a clock and processor 172 to determine when a full dose has been or has yet to be delivered by utilizing parameters such as rate of motion of the plunger member, therein both calculating a rate of infusion by determining the rate the plunger travels to dispense medicament and a rate of infusion by determining whether a scheduled dose is fully adhered to)
calculate with reference to said measured rate of infusion [and specific infused media characteristics] --derive user-guidance information based [calculations executed with measured rate of infusion data and specified infused media characteristics]; and output the user-guidance information without making an automatic adjustment to a rate of infusion
(paragraph 60+96-97+108+110+135+140+145+150+171; output device 154 156 communicate information such as time for injection, missed dose, completed dose, injection too quick or slow, injectable substance reaching an adequate temperature, injection into atmosphere event, obstruction event, leak event, etc. to improve compliance with a therapeutic regiment for a user; fig 6-10; Diaz importantly notes in paragraph 150+171+173 that each injectable solution has known limits for an injection being too slow or too quick; (paragraph 93+218, syringe of present embodiment are manually actuated by a user and not automatically by flange 150)
Diaz discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model-simulated drug concentration in said patient; derive user-guidance information based on said model-simulated drug concentration; and output the user-guidance information
However, Struys teaches a method for controlling infusion to achieve a desired concentration in a patient:
calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model-simulated drug concentration in said patient; derive [injection]-guidance information based on said model-simulated drug concentration; and output the [injection]-guidance information
(Page 9 to 13; Controller 108 provides information to a medication delivery unit to deliver medicament at a desired rate/interval, therein a rate of infusion, to achieve a desired concentration of medication in the patient’s blood stream. The preferred/updated administration rate is determined based on a pharmacodynamic-pharmacokinetic model processing information -such as in vivo analyte concentration resulting from a previous administration rate infusing a set amount of medicament- to update a patient’s response profile. As Struys discusses, if a higher concentration is required, i.e. a previous infusion rate is inadequate for the desired effect, the controller may communicate that an infusion rate should be adjusted to achieve the desired effect, therein setting a desired rate of infusion based pharmacokinetic and pharmacodynamic model of a simulated desired drug concentration.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Struys’ teachings of a computational process of adjusting an infusion rate based on in vivo analyte data and previous infusion characteristics, such as infusion rate, which shape a patient’s drug response profile, to the user guidance invention of Diaz, such that Diaz’s invention utilizes Struys’ computational means of analyzing infusion parameter characteristics relative to in vivo analyte data acquired by Struys’ sensors to provide updated infusion guidance parameters to a user of Diaz’s syringe, in order to advantageously arrive at an invention which can communicate adjustments to a therapeutic regiment to a user administering a therapeutic regiment to more effectively and efficiently achieve a desired therapeutic effect in a patient, see page 9 to 12 of Struys.
Examiner notes for clarity that in such a modification, Diaz’s flange 150 provides user guidance-information to a user involving Diaz’s plunger 116 being depressed too slowly/quickly relative to a particular infusion rate during an infusion, see Diaz paragraph 150+170-173. Note that in the modified invention this particular infusion rate which the modified invention guides the user to execute, is based on Struys’ computational processes which considers the user’s response to previous infusion rates and communicates an updated rate of infusion to achieve a desired drug concentration, where the desired drug concentration was simulated by an appropriate model which considers a drug profile, patient drug response profile, and previous infusion parameters such as measured infusion rate.
Regarding Claim 29,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method as claimed in claim 28, which includes generating deviation notification data if either or both of the following conditions are met: (b) a deviation of the measured rate of infusion from a required infusion rate occurs, said required infusion rate being a rate of infusion required for achieving, in said patient, a drug concentration within a target concentration range, and said deviation of the measured rate of infusion therefrom being established by performance of the following steps: calculating, with reference to the volume displacement parameter and the model, the required infusion rate; and comparing the measured rate of infusion against the required infusion rate, thereby to establish the deviation of the measured rate of infusion from the required infusion rate.
Examiner notes that in light of the modification made in claims above, when Diaz’s flange 150 makes the notification described in paragraph 60+150+171+173, where a user is informed that a rate of infusion is too fast or slow and should be corrected, this rate of infusion has been updated by the teachings of Struys’ such that the rate of infusion is intended to achieve a desired drug concentration.
However, Diaz is silent regarding:
The method as claimed in claim 28, which includes generating deviation notification data if either or both of the following conditions are met:(a) the model-simulated drug concentration breaches a definable threshold concentration;
However, Struys teaches in page 12-13+35 that its controller triggers alarms if dangerous situations, such as drug concentration being predictive to reach a maximum or minimum level or deviating outside of a desired effect range, are likely to occur.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys’ further computational teachings of warning of predictive dangerous situations to the modified invention, such that Diaz’s user guidance device may determine when a simulated drug concentration is predicted to reach a certain dangerous or undesirable threshold and informing a user to take desired action such as increasing dose frequency or change dose level, in order to advantageously arrive at an invention which can generate data which may be utilized to protect a user from dangerous circumstances involving an over/under/inadequate drug concentration level, including worsening condition and death.
Regarding claim 30, Diaz in view of Struys discloses:
The method as claimed in claim 29, which further includes generating deviation notification data if the model-simulated drug concentration breaches a definable threshold concentration.
Examiner notes that in light of the modification made in claims above, the modified invention generates data to protect a user if the modified invention predicts a over/under/inadequate drug concentration level and action must be taken.
Regarding Claim 31,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
The method as claimed in claim 19, which includes monitoring infusion of a plurality of drugs from a plurality of syringes; measuring respective volumes of the drugs dispensed from the respective syringe; operating the computing device to calculate information relating to interactions between said drugs, based on the measured volumes dispensed; and outputting said information.
Notably, Struys details on page 3 that multiple drugs may be simultaneously administered to a patient with different desirable concentrations and subsequent interactions. Struys details on page 3+13-15+30-36 its computational method is configured to calculate drug concentration based on infusion parameters of a multitude of dispensed drugs, and adjust infusion parameters based on models simulating concentrations of drugs as they interact in the body.
Notably, MPEP 2144.04(VI)(B) provides that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The infusion of a plurality of drugs, is not new or unexpected in light of Struys page 3, and further a plurality of infusion pumps is not an unexpected manner of producing such an infusion.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the plurality of syringes monitored by Diaz’s modified user guidance device, and implement Struys analyses of interaction effects of simultaneous infusions on measured and simulated drug concentrations to consider adjusting infusion parameters, in order to arrive at an invention which advantageously can infuse a plurality of drugs to support a patient’s prescription and account for intervening effects of the plurality of drugs on their concentration in vivo by optimizing the respective drug’s infusion rate, see MPEP2144.04(VI(B) and page 3+13-15-30-36 of Struys.
Regarding Claim 32,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
A method of operating a user-guidance device as claimed in claim 17 to compile statistical information for a study selected from the group consisting of pharmacokinetic and pharmacodynamic studies; said method including steps of monitoring infusion of a drug into a cohort of patients conducted by a applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly, said pump assembly having a pump volume displacement parameter; for each patient within said cohort of patients: operating the measurement component of the user-guidance device to measure the pump volume displacement parameter of the pump assembly; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured pump volume displacement parameter, and recording data pertaining to the measured rate of infusion; thereby to provide statistical information relating to measured rates of infusion pertinent to the patients in the cohort.
However, Struys teaches a method comprising:
compile statistical information for a study selected from the group consisting of pharmacokinetic and pharmacodynamic studies; said method including steps of monitoring infusion of a drug into a cohort of patients conducted by a applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly, said pump assembly having a pump volume displacement parameter; for each patient within said cohort of patients: operating the measurement component of the user-guidance device to measure the pump volume displacement parameter of the pump assembly; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured pump volume displacement parameter, and recording data pertaining to the measured rate of infusion; thereby to provide statistical information relating to measured rates of infusion pertinent to the patients in the cohort.
(page 8-9+10-27; population, therein cohort study, derived patient response profiles, therein statistics relating to rates of infusion and concentration, are acquired/produced by the invention using population pharmacokinetic and pharmacodynamic modeling)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys teachings of cohort study derived patient response profiles based on infusions statistics and pharmaco-dyanmic/kinetic modeling to the modified invention of Diaz in view of Struys in order to advantageously arrive at an invention which can improve its efficacy at achieving a target drug concentration by leveraging data for multiple persons and their unique drug response profiles.
Regarding Claim 33,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
A method of operating a user-guidance device as claimed in claim 17 to construct a model selected from the group consisting of pharmacokinetic and pharmcodynamic models; said method including steps of monitoring infusion of a drug into a cohort of patients conducted by a applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly, said syringe having a volume displacement parameter; for each patient within said cohort of patients: operating the measurement component of the user-guidance device to measure the volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter; recording data pertaining to the measured rate of infusion; measuring and recording a time of infusion of the drug into the patient; and measuring and recording a concentration of the drug in the patient; thereby to provide statistical information relating to measured rates of infusion, times of infusion and drug concentrations pertinent to the patients in the cohort; and mathematically manipulating the statistical information using a pre-defined algorithm adapted to cross-reference parameters selected from the group consisting of the measured rates of infusion, the times of infusion and the drug concentrations for the patients in the cohort, thereby to construct the model.
However, Struys teaches a method comprising:
construct a model selected from the group consisting of pharmacokinetic and pharmcodynamic models; said method including steps of monitoring infusion of a drug into a cohort of patients conducted by a applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly, said syringe having a volume displacement parameter; for each patient within said cohort of patients: operating the measurement component of the user-guidance device to measure the volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter; recording data pertaining to the measured rate of infusion; measuring and recording a time of infusion of the drug into the patient; and measuring and recording a concentration of the drug in the patient; thereby to provide statistical information relating to measured rates of infusion, times of infusion and drug concentrations pertinent to the patients in the cohort; and mathematically manipulating the statistical information using a pre-defined algorithm adapted to cross-reference parameters selected from the group consisting of the measured rates of infusion, the times of infusion and the drug concentrations for the patients in the cohort, thereby to construct the model.
(page 8-9+10-27; population, therein cohort study, derived patient response profiles, therein statistics relating to rates of infusion and concentration, are acquired/produced by the invention using population pharmacokinetic and pharmacodynamic modeling)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys teachings of cohort study derived patient response profiles based on infusions statistics and pharmaco-dyanmic/kinetic modeling to the modified invention of Diaz in view of Struys in order to advantageously arrive at an invention which can improve its efficacy at achieving a target drug concentration by leveraging data for multiple persons and their unique drug response profiles.
Regarding Claim 34,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
A method of operating a user-guidance device as claimed in claim 17 for assessing accuracy of first and second models selected from the group consisting of pharmacokinetic and pharmacodynamic models; said method including steps of monitoring infusion of a drug into a patient conducted by applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly to achieve a target drug concentration in the patient calculated by interrogation of the first model, said syringe having a volume displacement parameter; operating the measurement component of the user-guidance device to measure the volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter;and calculate with reference to said measured rate of infusion and to the second model, a model- simulated drug concentration in said patient; measuring and recording a concentration of the drug in the patient; comparing the measured concentration of the drug in said patient with the target drug concentration and the model-simulated drug concentration; thereby to provide comparative information relating to the first and second models; and outputting the comparative information to support assessment of the relative accuracy of the first and second models in relation to the measured concentration.
However, Struys teaches a method comprising:
A method of operating a user-guidance device as claimed in claim 17 for assessing accuracy of first and second models selected from the group consisting of pharmacokinetic and pharmacodynamic models; said method including steps of monitoring infusion of a drug into a patient conducted by applying a force to a plunger of a syringe by hand or with an inert, zero-order syringe pump assembly to achieve a target drug concentration in the patient calculated by interrogation of the first model, said syringe having a volume displacement parameter; operating the measurement component of the user-guidance device to measure the volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter;and calculate with reference to said measured rate of infusion and to the second model, a model- simulated drug concentration in said patient; measuring and recording a concentration of the drug in the patient; comparing the measured concentration of the drug in said patient with the target drug concentration and the model-simulated drug concentration; thereby to provide comparative information relating to the first and second models; and outputting the comparative information to support assessment of the relative accuracy of the first and second models in relation to the measured concentration.
(page 8-9+10-27; patient response profiles, therein statistics relating to rates and duration of infusion and drug concentration, are acquired/produced by the invention using population pharmacokinetic and pharmacodynamic modeling; measured points of concentration are compared to those outputted by the model to evaluate and output the accuracy/variance of said models, providing an opportunity to bias an infusion rate to achieve a desired concentration in a patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys teachings of determining the accuracy of multiple patient response profiles based on infusions statistics and pharmaco-dynamic/kinetic modeling to the modified invention of Diaz in view of Struys in order to advantageously arrive at an invention which can improve its accuracy and efficacy at achieving a target drug concentration by leveraging data for multiple persons and their unique drug response profiles.
Regarding Claim 35,
Diaz in view of Struys discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Diaz in view of Struys is silent regarding:
A method of operating a user-guidance device as claimed in claim 17 for validation of operational accuracy of an automated target-controlled infusion pump configured to drive a syringe for infusing a drug into a patient to achieve a target drug concentration; said method including steps of monitoring the infusion of the drug into the patient by operating the measurement component of the user-guidance device to measure a volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter; calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model- simulated drug concentration in said patient; comparing the target drug concentration against the model-simulated drug concentration calculated by the user-guidance device, thereby to determine a deviation of the target concentration from the model-simulated concentration and provide a metric of the operational accuracy of said target-controlled infusion pump; and outputting said metric to support the validation of the operational accuracy of said target- controlled infusion pump.
However, Struys teaches a method comprising:
validation of operational accuracy of an automated target-controlled infusion pump configured to drive a syringe for infusing a drug into a patient to achieve a target drug concentration; said method including steps of monitoring the infusion of the drug into the patient by operating the measurement component of the user-guidance device to measure a volume displacement parameter of the syringe; operating the computing device of the user-guidance device to calculate a measured rate of infusion of the drug into the patient based on the measured volume displacement parameter; calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model- simulated drug concentration in said patient; comparing the target drug concentration against the model-simulated drug concentration calculated by the user-guidance device, thereby to determine a deviation of the target concentration from the model-simulated concentration and provide a metric of the operational accuracy of said target-controlled infusion pump; and outputting said metric to support the validation of the operational accuracy of said target- controlled infusion pump.
(page 8-9+10-27; patient response profiles, therein statistics relating to rates and duration of infusion and drug concentration, are acquired/produced by the invention using population pharmacokinetic and pharmacodynamic modeling; measured points of concentration are compared to those outputted by the model to evaluate and output the accuracy/variance of said models, providing an opportunity to bias an infusion rate to achieve a desired concentration in a patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Struys teachings of determining the accuracy of multiple patient response profiles based on infusions statistics and pharmaco-dynamic/kinetic modeling to the modified invention of Diaz in view of Struys in order to advantageously arrive at an invention which can improve its accuracy and efficacy at achieving a target drug concentration by leveraging data for multiple persons and their unique drug response profiles.
Conclusion
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/FORREST B DIPERT/Examiner, Art Unit 3783
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