Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The following Office action in response to communications received December 12, 2025. Claim 1 has been amended. Therefore, claims 1-14 and 16-20 are pending and addressed below.
Applicant’s amendments to the claims are not sufficient to overcome the rejections set forth in the previous office action dated June 12, 2025.
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 1-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Patent No.: US 5873731 A to Prendergast in view of Pub. No.: US 20050235759 A1 to Sparks et al. further in view of Pub. No.: US 20050165559 A1 to Nelson et al.1 in view of Pub. No.: US 20120226447 A1 to Nelson et al.2.
As per claim 1, Prendergast teaches a method comprising:
-- coupling a fluid outlet of the secondary medication container to a medication port of a manually administrable medication device, wherein the manually administrable medication device includes a fluid flow stop disposed between the medication port and a fluid outlet configured to deliver the medication from the secondary medication container to a fluid line leading to a patient (see Prendergast Col 6 || 9-19; referring to FIG. 3, an example of an intravenous (IV) drug injection equipment 6 is shown comprising IV bag 60, port manifold 62, and IV line 63. Port manifold 62 is shown, by example only, as having three possible syringe port connections 64, 65, and 66. Each syringe 68, 69, and 70, partially shown as a cutaway of the end of the syringe, connects to three port openings 64, 65, and 66, respectively, which include manually actuated on and off valves 72, 73, and 74, one connected to each port opening 64, 65, and 66, with the manifold 63 being connected to the patients IV at 76.);
-- automatically receiving from an identification sensor, information for the secondary medication container including the secondary medication container identifier from the second information transfer element on the secondary medication container when the secondary medication container is coupled to or in the process of being coupled to the manually administrable medication device (see Prendergast Col 3 || 31-39; The present invention provides, for simulation and training purposes, an automatic drug recognition system to meet the training requirements that automatically reads a digitally encoded syringe that is manually attached by the trainee to an IV port manifold to obtain the drug type and concentration (e.g. identifiers), and also that may include measuring the amount of flow of liquid from the syringe into the port manifold to measure the amount of fluid transferred into each port in the manifold.);
-- transmitting, from the manually administrable medication device, the information for the secondary medication container to the remote data collection system (see Prendergast Fig 2 (e.g., remote computer 16/31), Figs 3-6 and Col 6 || 56-64; When the modified syringe 68 is placed onto the modified manifold 64, the computer 16 can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3, will each have a preprogrammed chip 84 in ID (e.g., identifier) discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.);
-- receiving, with at least one processor, data from or derived from a transmission from the manually administrable medication device that characterizes the secondary medication container including the secondary medication container identifier for the secondary medication container, the manually administrable medication device being one of a plurality of devices used within a clinical workflow (see Prendergast Fig 2 (e.g. remote computer 16/31), Figs 3-6 and Col 6 || 56-64; When the modified syringe 68 is placed onto the modified manifold 64, the computer 16 can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3 (e.g., plurality of devices), will each have a preprogrammed chip 84 in ID discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.);
-- generating, modifying, and/or appending, with at least one processor, the at least one data record, on the remote data collection system, with at least a portion of the received data using the secondary medication container identifier (see Prendergast Col 1 || 9-18, … recording actual drugs administered to a patient, and in particular to a patient and patient simulator drug recognition system that identifies the type, concentration, and amount of simulated drug being administered to the patient mannequin, or the type, concentration, and amount of actual drug being administered to the patient; see Prendergast Col 5 || 36-50, Computer 16 can be any suitable computer, such as personal computer 31, which provides for trainer 18 input and control, and other data logging (e.g. polling/generating) and/or analysis functions; see Prendergast Col 7 ||8-20, The computer 16 monitors the flow 96 of the fluid from each syringe 68, 69, and 70 and tracks the total amount of fluid transferred. The concentration and type of drug in the fluid is read (e.g. polling) from each syringe's memory chip 84, thus determining the total amount of drug injected. The drug flow information is passed to the patient physiological models 28 and drug models 26 in computer 16 for determining the proper real time mannequin response. As the injection flow 96 is terminated, the flow stops and computer 16, or personal computer 31, logs the drug injection (time, drug, concentration, and amount) for use in the physiological models and for later review by the instructor.);
-- receiving, with at least one processor, a request comprising the secondary medication identifier from a remote source (see Prendergast Fig 2 (e.g. remote computer 16), Figs 3-6 and Col 6 || 56-64; When the modified syringe 68 is placed onto the modified manifold 64, the computer 16 can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3, will each have a preprogrammed chip 84 in ID (e.g. identifier) discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.). Examiner interprets once 68 and 64 are connected, the medication content is identified via the ID disc/ID reader then transmitted per request to computer 16.;
-- transmitting, with at least one processor, data stored within the at least one data record associated with the secondary medication container to the remote source (see Prendergast Col 7 ||8-20, The computer 16 monitors the flow 96 of the fluid from each syringe 68, 69, and 70 and tracks the total amount of fluid transferred. The concentration and type of drug in the fluid is read from each syringe's memory chip 84, thus determining the total amount of drug injected. The drug flow information is passed to the patient physiological models 28 and drug models 26 in computer 16 for determining the proper real time mannequin response. As the injection flow 96 is terminated, the flow stops and computer 16, or personal computer 31, logs the drug injection (time, drug, concentration, and amount) for use in the physiological models and for later review by the instructor.);
-- coupling a primary medication container to a secondary medication container with a medication transfer device for medication transfer from the primary medication container to the secondary medication container including a syringe via a single fluid transfer channel of the medication transfer device, wherein the primary medication container includes a first information transfer element including a primary medication container identifier, wherein the medication transfer device includes a transfer device identification element including a transfer device identifier associated with the medication transfer device, and wherein the secondary medication container includes second information transfer element including a secondary medication container identifier, wherein the medication transfer device includes a housing with a shape and a size enabling the medication transfer device to be held by a first hand of a user while the user manually transfers a medication from the primary container to the secondary container with his or her second hand, and wherein the housing includes the single fluid transfer channel that extends between a fluid inlet at a first end of the housing and a fluid outlet at a second end of the housing opposite the first end of the housing (see Prendergast Col 7 || 48-52, 61-67 and Col 8 || 1-13; In an alternate embodiment, the present invention is utilized in an actual operating or emergency room to identify the type of drug, concentration, and quantity administered, and to log this data along with the time the drug was administered to a patient. Referring now to FIG. 7, an alternate method to identify drug type and concentration is to provide disc 110 (similar to disc 82 shown in FIG. 6a), on each syringe 112 to be used in the operating or emergency room (similar to syringe 68 in FIG. 6a with a hollow needle 114 attached at the lower end). Each disc 110, can contain an IC chip 116 (similar to IC chip 84) which is reprogrammable, such as EEPROM or RAM. When syringe 112 is inserted into a bottle 118 containing a desired drug 119, IC chip 116 on disc 110 will be reprogrammed, with the drug 119 type and concentration, by a mating programming disc 120 provided on each bottle 118 containing a drug 119. Programmer 122 can be electrically connected by conductors 124 to chip 116 when discs 120 and 110 are mated together. When drug 119 is administered, IC chip 116 will provide the drug type and concentration in a similar manner to that described herein above for administering simulated drugs. A flowmeter similar to that shown as 100 in FIG. 6a can be used to determine the quantity of drug administered.);
-- scanning, with a first sensor element disposed within the housing of the medication transfer device at the first end of the housing proximate the fluid inlet, the first information transfer element including the primary medication container identifier when the primary medication container is attached to the fluid inlet with the first information transfer element disposed between the primary medication container and an outer surface of the housing of the medication transfer device (see Prendergast Col 7 || 48-52, 61-67 and Col 8 || 1-13; In an alternate embodiment, the present invention is utilized in an actual operating or emergency room to identify the type of drug, concentration, and quantity administered, and to log this data along with the time the drug was administered to a patient. Referring now to FIG. 7, an alternate method to identify drug type and concentration is to provide disc 110 (similar to disc 82 shown in FIG. 6a), on each syringe 112 to be used in the operating or emergency room (similar to syringe 68 in FIG. 6a with a hollow needle 114 attached at the lower end) . Each disc 110, can contain an IC chip 116 (similar to IC chip 84) which is reprogrammable, such as EEPROM or RAM. When syringe 112 is inserted into a bottle 118 containing a desired drug 119, IC chip 116 on disc 110 will be reprogrammed, with the drug 119 type and concentration, by a mating programming disc 120 provided on each bottle 118 containing a drug 119. Programmer 122 can be electrically connected by conductors 124 to chip 116 when discs 120 and 110 are mated together. When drug 119 is administered, IC chip 116 will provide the drug type and concentration in a similar manner to that described herein above for administering simulated drugs. A flowmeter similar to that shown as 100 in FIG. 6a can be used to determine the quantity of drug administered.);
-- scanning, with a second sensor element disposed within the housing of the medication transfer device at the second end of the housing proximate the fluid outlet, the second information transfer element including the secondary medication container identifier when the secondary medication container is attached to the fluid outlet with the second information transfer element disposed between the secondary medication container and the outer surface of the housing of the medication transfer device (see Prendergast Col 7 || 48-52, 61-67 and Col 8 || 1-13; In an alternate embodiment, the present invention is utilized in an actual operating or emergency room to identify the type of drug, concentration, and quantity administered, and to log this data along with the time the drug was administered to a patient. Referring now to FIG. 7, an alternate method to identify drug type and concentration is to provide disc 110 (similar to disc 82 shown in FIG. 6a), on each syringe 112 to be used in the operating or emergency room (similar to syringe 68 in FIG. 6a with a hollow needle 114 attached at the lower end) . Each disc 110, can contain an IC chip 116 (similar to IC chip 84) which is reprogrammable, such as EEPROM or RAM. When syringe 112 is inserted into a bottle 118 containing a desired drug 119, IC chip 116 on disc 110 will be reprogrammed, with the drug 119 type and concentration, by a mating programming disc 120 provided on each bottle 118 containing a drug 119. Programmer 122 can be electrically connected by conductors 124 to chip 116 when discs 120 and 110 are mated together. When drug 119 is administered, IC chip 116 will provide the drug type and concentration in a similar manner to that described herein above for administering simulated drugs. A flowmeter similar to that shown as 100 in FIG. 6a can be used to determine the quantity of drug administered.);
-- with the primary medication container attached to the fluid inlet of the medication transfer device and the secondary medication container attached to the fluid outlet of the medication transfer device, transferring the medication from the primary medication container to the secondary medication container via the single fluid transfer channel of the medication transfer device by the user holding the medication transfer device in the first hand of the user and pulling on a plunger rod of the syringe with the second hand of the user to draw the medication from the primary medication container, through the single fluid transfer channel of the housing of medication transfer device, and into the secondary medication container including the syringe, wherein the medication transfer device further includes a flow sensor within the housing that measures a transfer time and a transfer amount associated with the medication transfer from the primary medication container to the secondary medication container (see Prendergast Col 7 || 48-52, 61-67 and Col 8 || 1-13; In an alternate embodiment, the present invention is utilized in an actual operating or emergency room to identify the type of drug, concentration, and quantity administered, and to log this data along with the time the drug was administered to a patient. Referring now to FIG. 7, an alternate method to identify drug type and concentration is to provide disc 110 (similar to disc 82 shown in FIG. 6a), on each syringe 112 to be used in the operating or emergency room (similar to syringe 68 in FIG. 6a with a hollow needle 114 attached at the lower end) . Each disc 110, can contain an IC chip 116 (similar to IC chip 84) which is reprogrammable, such as EEPROM or RAM. When syringe 112 is inserted into a bottle 118 containing a desired drug 119, IC chip 116 on disc 110 will be reprogrammed, with the drug 119 type and concentration, by a mating programming disc 120 provided on each bottle 118 containing a drug 119. Programmer 122 can be electrically connected by conductors 124 to chip 116 when discs 120 and 110 are mated together. When drug 119 is administered, IC chip 116 will provide the drug type and concentration in a similar manner to that described herein above for administering simulated drugs. A flowmeter similar to that shown as 100 in FIG. 6a can be used to determine the quantity of drug administered.).
Prendergast fails to teach:
-- optically scanning…..including an emitter and a detector;
-- transmitting, with a transmitter, to a remote data collection system, the primary container identifier associated with the primary medication container, the secondary medication identifier associated with the secondary medication container, the transfer device identifier associated with the medication transfer device, and a transfer time and a transfer amount associated with the medication transfer from the primary medication container to the secondary medication container,
-- receiving, with at least one processor, data from or derived from a transmission from the transmitter that characterizes the primary medication container including the primary medication container identifier, the secondary medication container including the secondary medication container identifier, the transfer device including the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- generating, modifying, and/or appending, with at least one processor, at least one data record, on the remote data collection system, with at least a portion of the received data using the primary medication container identifier, the secondary medication container identifier, the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- selectively causing, with the remote source, the fluid flow stop to transition between a first state that prevents fluid flow and a second state that permits fluid flow based on the data stored within the at least one data record associated with the secondary medication container;
-- wherein, during dispensing from an automated dispensing system, of the medication from the secondary medication container to the manually administrable medication device, accessing, with the at least one processor, in the at least one data record, information associated with the medication being dispensed being a controlled substance and including the transfer device identifier and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container, and in response to the medication dispensed being a controlled substance, creating, with the at least one processor, during the dispensing from the automated dispensing system, of the medication from the secondary medication container to the manually administrable medication device, a separate transaction record associated with a separate transaction record identifier on a waste collection system including an injection site configured for disposal of unused medication and joined to a waste container, wherein the separate transaction record identifier is added to the at least one data record and the separate transaction record is separately stored on the waste transaction system; and
-- wherein, in response to wasting of unused medication from the secondary medication container or the manually administrable medication device, adding, with at least one processor, a waste time, a waste witness identifier, and an amount of unused medication wasted, to the at least one data record associated with the medication container amount.
Sparks et al. teaches the electronic means is operated to cause the flow controlling means to stop flow of the fluid from the fluid source after the prescribed dosage amount has been delivered to the patient based on the signal from the flow sensing means and the data contained by the memory means. According to a preferred aspect of the invention, the operation of the system 10 is preferably based on the specific type of medication contained in the fluid source 14 and to be administered to a patient. For this purpose, one or more suitable memory devices 24 are preferably integrated with the electronic circuitry 22 and store data specific to the particular medication, such as its identity, density, dosage amounts, dosage rates, etc. Depending on the manner in which the system 10 is intended for use, certain data (such as the identity and density/specific gravity of the medication) can be stored in permanent memory, while other data (such as the desired dosage and dosage rate for the medication) can be stored in programmable memory to permit a medical care giver to select a treatment appropriate for an individual patient. For this purpose, FIG. 1 shows the system 10 as also including a remote device 34 that is wired or wirelessly communicates with the circuitry 22. For example, the device 34 may be a desktop computer or a handheld unit for remote programming of the circuitry 22 and its memory 24. Alternatively, or in addition, the device 24 can serve to monitor and display information regarding the operation of the system 10. As discussed above, the preferred flow sensing device 20 produces density and flow rate outputs from which the electronic circuitry 22 (and/or an optional remote computer or unit 24) can calculate volumetric flow rate and dosage, either or both of which can be used to control the flow control device 18, e.g., open, close, or adjust to regulate fluid flow through the flow control device 18 (see paragraphs 8 and 20).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include systems/methods as taught by reference Sparks et al. within the system/methods as taught by reference Prendergast with the motivation of providing valves and flow sensors incorporated into infusion pump designs, thereby improving dosage accuracy and to control the flow of fluids through system (see Sparks et al. paragraph 3).
Prendergast and Sparks et al. fail to explicitly teach:
-- optically scanning…..including an emitter and a detector;
-- transmitting, with a transmitter, to a remote data collection system, the primary container identifier associated with the primary medication container, the secondary medication identifier associated with the secondary medication container, the transfer device identifier associated with the medication transfer device, and a transfer time and a transfer amount associated with the medication transfer from the primary medication container to the secondary medication container,
-- receiving, with at least one processor, data from or derived from a transmission from the transmitter that characterizes the primary medication container including the primary medication container identifier, the secondary medication container including the secondary medication container identifier, the transfer device including the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- generating, modifying, and/or appending, with at least one processor, at least one data record, on the remote data collection system, with at least a portion of the received data using the primary medication container identifier, the secondary medication container identifier, the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- wherein, during dispensing from an automated dispensing system, of the medication from the secondary medication container to the manually administrable medication device, accessing, with the at least one processor, in the at least one data record, information associated with the medication being dispensed being a controlled substance and including the transfer device identifier and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container, and in response to the medication dispensed being a controlled substance, creating, with the at least one processor, during the dispensing from the automated dispensing system, of the medication from the secondary medication container to the manually administrable medication device, a separate transaction record associated with a separate transaction record identifier on a waste collection system including an injection site configured for disposal of unused medication and joined to a waste container, wherein the separate transaction record identifier is added to the at least one data record and the separate transaction record is separately stored on the waste transaction system; and
-- wherein, in response to wasting of unused medication from the secondary medication container or the manually administrable medication device, adding, with at least one processor, a waste time, a waste witness identifier, and an amount of unused medication wasted, to the at least one data record associated with the medication container amount.
Nelson et al.1 teaches once the controlled substance is wasted, the process must be documented. Documentation consists of recording information such as the patient's name, the name of the controlled substance and its concentration, and the quantity (e.g., volume) that is wasted (see Nelson et al.1 paragraph 14).
In one broad respect, the present invention is directed to a method for disposing of controlled substances comprising the steps of: collecting a controlled substance from a depositor of said controlled substance; analyzing said controlled substance to verify at least a portion of said information; recording information about the chemical composition and concentration and amount of said controlled substance; and disposing of said controlled substance. In one narrow respect, the method further comprises the step of receiving information about the controlled substance from a depositor of the controlled substance, wherein the information received comprises chemical composition, concentration or amount or any combination thereof. In one narrow respect, the disposal step further comprises the step of rendering the controlled substance into a form unusable for human consumption. In another narrow respect, the step of collecting the substance comprises securing the controlled substance to prevent access by unauthorized persons. In another narrow respect, the step of obtaining information about said controlled substance comprises retrieving information from an automated injection system. In another narrow respect, the step of obtaining information about said controlled substance comprises the depositor entering information about said controlled substance including composition and amount. In another narrow respect, the step of analyzing said controlled substance comprises identifying the chemical composition, concentration, and volume of said controlled substance (see Nelson et al.1 paragraphs 17-18).
The information recorder 104 stores information about the deposited substance. In a preferred embodiment, the information is provided by the depositor of the substance. The depositor may provide information by using a keyboard 150, mouse, optical character recognition, barcode scanner, or any other technique that will provide accurate, legible information to the information recorder 104. In other embodiments, the information is acquired automatically from the secure substance container 102. Information may be provided by a combination of depositor information and secure substance container 102 information. For example, the controlled substance container 102 may be configured to automatically detect the quantity deposited in a container 102 and send that information to the information recorder 104. In other embodiments, the present invention is operatively coupled to an automated injection system. In these embodiments with an automated injection system, the information stored in the information recorder 104 may further be compared with information provided by the automated injection system (see Nelson et al.1 paragraphs 82-83).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include systems/methods as taught by reference Nelson et al.1 with the system/methods as taught by reference Prendergast and Sparks et al. with the motivation of providing a device as described by the present invention, thereby eliminating the potential for a person to substitute any other clear liquid for a controlled substance, eliminating the need for a second medical professional to witness the disposal event, reducing the time required to dispose of controlled substances, expediting the review and reconciliation of the controlled substance transaction, and eliminating the possibility for a person to illegally acquire medications that have been disposed (see Nelson et al.1 paragraph 101).
Prendergast, Sparks et al. and Nelson et al.1 fail to explicitly teach:
-- transmitting, with a transmitter, to a remote data collection system, the primary container identifier associated with the primary medication container, the secondary medication identifier associated with the secondary medication container, the transfer device identifier associated with the medication transfer device, and a transfer time and a transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- receiving, with at least one processor, data from or derived from a transmission from the transmitter that characterizes the primary medication container including the primary medication container identifier, the secondary medication container including the secondary medication container identifier, the transfer device including the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- generating, modifying, and/or appending, with at least one processor, at least one data record, on the remote data collection system, with at least a portion of the received data using the primary medication container identifier, the secondary medication container identifier, the transfer device identifier, and the transfer time and the transfer amount associated with the medication transfer from the primary medication container to the secondary medication container;
-- wherein, in response to wasting of unused medication from the secondary medication container or the manually administrable medication device, adding, with at least one processor, a waste time, a waste witness identifier, and an amount of unused medication wasted, to the at least one data record associated with the medication container amount.
Nelson et al.2 teaches a fluid tracking system which is configured to record and identify characteristic of a fluid in a computer-readable medium or electronic record, such as an electronic medical record (EMR) or a Pharmacy Information System. For example, the fluid tracking system may record the identity of the one or more drugs within the wasted fluid, a date and time of the wasting, an identity of the individual wasting the fluid, and other such information as may be useful for internal care center inventory (e.g., an amount of unused medication wasted). The recorded characteristics or information may be used for record-keeping purposes, patient billing purposes, inventory analysis purposes, identifying drug diversion and identifying unnecessary waste of drugs (or drug usage efficiency). For example, in some implementations a sensor of the fluid tracking system is able to detect a discrepancy in one or more characteristic of the wasted fluid. Where a discrepancy is detected, the fluid tracking system may provide an alert. In some instances, a fluid tracking system tracks and records a frequency and volume of a specific wasted fluid. This information is then made available to a pharmacy to assist the pharmacy in managing the inventory of the specific wasted fluid. In some configurations, the fluid tracking system may further record information on an electronic medication record system. The electronic medical record system may then create a log or record of fluid wasting generally, or create a record of wasting for a specific fluid prepared for a particular patient.
In some instances, the wasting fluid is monitored using a fluid tracking system 120. In some embodiments, fluid tracking system 120 comprises a waste disposal unit 50 operably connected to a processor unit 132. Fluid tracking system 120 may further include an electronic record, such as an electronic medical record (EMR) 148 operably connected to processor unit 132 via a network 38. When information is acquired by processor unit 132 from waste disposal unit 50, the information is transmitted to EMR 148 where the information is made accessible to other caregivers (see Nelson et al.2 paragraphs 6, 14, 41, 44 and 62-63).
With continued reference to FIGS. 3 and 4, in some embodiments port 52 further comprises a plurality of sensors 127 and sensor elements 129 positioned in fluid pathway 56, wherein each sensor element 129 is configured to detect at least one characteristic or identity of fluid 124. Port 52 may further include an adapter (not shown) which is configured to compatibly receive a surface of container 122. For example, in some embodiments an adapter is provided which includes electrical contacts or other circuitry whereby to establish communication between a sensor 126 of container 122 and processor unit 132 via port 52 and communication link 138. As such, processor unit 132 may collect, compare and verify fluid data from sensors 126 and 127 to determine proper and complete disposal (see Nelson et al.2 paragraphs 57, 62-63 and 67 [e.g., rfid chip]).
Accordingly, when fluid 124 is wasted via waste disposal unit 50 or 260, the fluid tracking system 120 can record one or more of the following pieces of information, including but not limited to the identity of any drugs within the fluid, the dose of any drugs, the concentration of any drugs, the identity of a diluent, the volume of the fluid wasted, the time and date of the wasting, patient information of the patient for whom the liquid was intended, the drug lot number, the drug maker, and the identity of the waster. This information can be recorded on a computer readable media electrically coupled to processor unit 132, including on an EMR 148 (see Nelson et al.2 paragraphs 57, 62-63 and 67 [e.g., rfid chip]).
Therefore it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include systems/methods as taught by reference Nelson et al.2 with the system/methods as taught by reference Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.21 with the motivation of using comparisons between the total medication prepared and the amount of medication administered and "wasted" by mapping of pharmaceutical usage efficiency, thereby this map will then be used provide and identify areas of improvement and cost savings (see Nelson et al.2 paragraph 70).
As per claim 2, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the manually administrable medication device comprises a device to characterize manual actions of one or more individuals involved in filling or preparing to fill medication into the secondary medication container, dispensing or preparing to dispense medication from the secondary medication container, and wasting or preparing to waste medication from the secondary medication container (see Prendergast Col 4 || 29-39 and Col 7 ||8-20; During the anesthesiology procedure or emergency room procedure, should an emergency situation arise, or as part of the correct medical procedure, the trainee will select a syringe containing a pre-identified drug that agrees or corresponds to the memory chip data and will manually inject the syringe nozzle into the input port which is connected to the IV tube adjacent the mannequin. The computer will then apply the administered drug, concentration, and quantity to affect the computer's model of the patient physiology as well as log the injection data for review purposes.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 3, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the remote source that generated the request is the manually administrable medication device that generated the received data (see Prendergast Col 4 || 29-39 and Col 7 ||8-20; During the anesthesiology procedure or emergency room procedure, should an emergency situation arise, or as part of the correct medical procedure, the trainee will select a syringe containing a pre-identified drug that agrees or corresponds to the memory chip data and will manually inject the syringe nozzle into the input port which is connected to the IV tube adjacent the mannequin. The computer will then apply the administered drug, concentration, and quantity to affect the computer's model of the patient physiology as well as log the injection data for review purposes.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 4, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the remote source that generated the request is one or more devices in the workflow other than the manually administrable medication device that generated the received data (see Prendergast Fig 2 (e.g. remote computer 16/31), Figs 3-6 and Col 6 || 47-64; When the modified syringe 68 is placed onto the modified manifold 64 (e.g. manually administrable medication device connection), the computer 16 (e.g. remote source) can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3 (e.g. plurality of devices), will each have a preprogrammed chip 84 in ID discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 5, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1 further comprising:
-- displaying, by the remote source, at least a portion of the transmitted data (see Sparks et al. paragraph 21; The safety of an infusion process performed with the fluid delivery system 10 described above is promoted by the ability to program the circuitry 22 (or, optionally, a remote computer or unit 24) for a specific drug (having a known specific gravity or density range) with a prescribed dose and dose rate. Should any one or more of these programmed values be exceeded, as sensed by the flow sensing device 20, the circuitry 22 (and/or remote device 24) can cause a visual and/or audible warning to be generated with a display panel, horn, etc., and operate the flow control device 18 to stop drug infusion.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 6, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1 further comprising:
-- providing audio and/or visual feedback, by the remote source, relating to at least a portion of the transmitted data (see Sparks et al. paragraph 21; The safety of an infusion process performed with the fluid delivery system 10 described above is promoted by the ability to program the circuitry 22 (or, optionally, a remote computer or unit 24) for a specific drug (having a known specific gravity or density range) with a prescribed dose and dose rate. Should any one or more of these programmed values be exceeded, as sensed by the flow sensing device 20, the circuitry 22 (and/or remote device 24) can cause a visual and/or audible warning to be generated with a display panel, horn, etc., and operate the flow control device 18 to stop drug infusion.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 7, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, further comprising:
-- applying at least one decision rule, by the remote source, using at least a portion of the transmitted data as input, the decision rule being used to determine how to provide care for a patient, characterize care given to the patient, and/or how to operate one or more medical devices within the clinical workflow (see Sparks et al. paragraph 21; The safety of an infusion process performed with the fluid delivery system 10 described above is promoted by the ability to program the circuitry 22 (or, optionally, a remote computer or unit 24) for a specific drug (having a known specific gravity or density range) with a prescribed dose and dose rate. Should any one or more of these programmed values be exceeded, as sensed by the flow sensing device 20, the circuitry 22 (and/or remote device 24) can cause a visual and/or audible warning to be generated with a display panel, horn, etc., and operate the flow control device 18 to stop drug infusion.). Examiner interpret the programmed values being exceed as a decision rule.
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 8, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the remote source comprises one or more systems selected from a group consisting of:
-- pharmacy information systems, medication administration record systems, blood bank information systems, patient admissions record systems, electronic medical record systems, medical record documentation systems, anesthesia information management systems, operating room information systems, patient scheduling systems, barcode medication administration systems, barcode verification systems, clinical information systems, infusion pumps, patient-controlled analgesia systems, patient monitoring devices, automated medication dispensing systems, medication dispensing carts, automated supply cabinets, medication container filling units, medication compounding units, fluid composition sensors, medication preparation and transfer units, medication injection sites, medication waste and data collection systems, clinical procedure process tracking systems, inventory control systems, logistical tracking systems, drug diversion prevention systems, quality control measurement systems, statistical analysis systems, billing systems, and compliance verification systems (see Prendergast Col 8 || 34-40, The computer 16 monitors the patient's physiological status in a similar manner to that shown in FIGS. 1, 2a, and 2b, except the sensors are actual sensors monitoring a real patient. The computer monitors the patient's condition, and using programmed physiological models, determines the appropriate drug, concentration, and amount to administer; see Prendergast Col 9 || 4-8, FIG. 11 shows an infusion pump 178 and attached ID disc 190, similar in operation to disc 82. Disc 190 would be read by an ID reader disc similar in operation to disc 94 described herein above, and utilized with an actual or simulated patient.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 9, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the plurality of devices comprise one or more devices selected from a group consisting of:
-- a medication container filling unit, a medication compounding unit, a fluid composition sensor, an automated medication dispensing station, a medication dispensing cart, an infusion pump, a patient-controlled analgesia system, a medication preparation and transfer unit, a barcode medication administration system, a medication injection site, and a medication waste collection system (see Prendergast Col 9 || 4-8, FIG. 11 shows an infusion pump 178 and attached ID disc 190, similar in operation to disc 82. Disc 190 would be read by an ID reader disc similar in operation to disc 94 described herein above, and utilized with an actual or simulated patient.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 10, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the received data comprises data selected from a group consisting of:
-- a type of medication contained within the secondary medication container, the concentration of medication contained within the secondary medication container, a type of medication container, a maximum volume capacity of the secondary medication container, a volume of medication contained within the secondary medication container, a volume of medication extracted from the secondary medication container, a volume of medication and/or diluents added to the secondary medication container, a volume of medication manually administered from the secondary medication container, a patient identifier, a caregiver identifier, a pharmacist identifier, a care area identifier, a pharmacy identifier, a device and/or system identifier, a medical order identifier, a primary container identifier, a secondary container identifier, a controlled substance identifier, at least one time stamp identifying the timing of an event within the clinical workflow, at least one medical procedure associated with the workflow, a medication expiration date, a dosage form of the medication, dose instructions for the medication, specific-patient administration instructions for a medication, a medication formulation, medication manufacturer information, a re-packager of the medication, a distributor of the medication, a medication package form, a medication package size, a medication container serial number, a medication lot number, a blood type of a patient, an NDC code (National Drug Code), an RxNorm code, a segment of an NDC code identifying a corresponding medication product, a segment of an NDC code identifying a corresponding medication package, a unique identifier code, a serialized NDC (sNDC) code, a drug classification, a human readable alphanumeric string, and a machine readable code (Prendergast Col 3 || 31-44; The present invention provides, an automatic drug recognition system that automatically reads a digitally encoded syringe that is manually attached to an IV port manifold to obtain the drug type and concentration, and also that may include measuring the amount of flow of liquid from the syringe into the port manifold to measure the amount of fluid transferred into each port in the manifold.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 11, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the remote source comprises a second manually administrable medication device and the request is transmitted by such manually administrable medication device automatically upon reading of a medication container information transfer element (see Prendergast Fig 2 (e.g. remote computer 16/31), Figs 3-6 and Col 6 || 47-64; When the modified syringe 68 is placed onto the modified manifold 64 (e.g. manually administrable medication device connection), the computer 16 (e.g. remote source) can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3 (e.g. plurality of devices), will each have a preprogrammed chip 84 in ID discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.).
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The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 12, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1 further comprising:
-- automatically transmitting, by the remote source, the request upon reading of the information for the secondary medication container (see Prendergast Fig 2 (e.g. remote computer 16/31), Figs 3-6 and Col 6 || 47-64; When the modified syringe 68 is placed onto the modified manifold 64 (e.g. manually administrable medication device connection), the computer 16 (e.g. automatically transmitting data to remote source 16) can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3 (e.g. plurality of devices), will each have a preprogrammed chip 84 in ID discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 13, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, wherein the secondary medication container identifier is one or more of:
-- a unique number, a unique alphanumeric string, a unique symbol, or a uniform resource locator (URL) (see Prendergast Figs 2-6 (e.g. remote computer 16/31); Col 3 || 40-45, The present invention is comprised generally of a donut-shaped, rigid, non-conductive body or housing that has embedded therein a memory chip that is preprogrammed to provide digital information to a computer that would be recognized as identifying a specific drug (e.g. a unique alphanumeric string such as a human readable string such as a name as taught in Applicant specification paragraph 31) or other type of information as desired; and Col 6 || 47-64, When the modified syringe 68 is placed onto the modified manifold 64 (e.g. manually administrable medication device connection), the computer 16 (e.g. automatically transmitting data to remote source 16) can read the contents of the memory chip 84 (preprogrammed) which contains the type of the drug simulated in the syringe 68 and the drug's concentration. Remaining syringes 69, 70, in FIG. 3 (e.g. plurality of devices), will each have a preprogrammed chip 84 in ID discs 82' and 82", read by ID reader disc 94' and 94", respectively, to simulate different drugs and different concentrations which will be monitored by computer 16.). Examiner interprets when identifying anything there will be numbers, letters or symbols, therefore identifying a specific drug at least covers all items in claim except URL.
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 16, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 1, further comprising:
-- polling, with at least one processor, at least one data source for complementary data associated with at least one of the medication container and medication contained within the secondary medication container; and generating, modifying, and/or appending, with at least one processor, the at least one data record with complementary data received from the polling (see Prendergast Col 1 || 9-18, … recording actual drugs administered to a patient, and in particular to a patient and patient simulator drug recognition system that identifies the type, concentration, and amount of simulated drug being administered to the patient mannequin, or the type, concentration, and amount of actual drug being administered to the patient; see Prendergast Col 5 || 36-50, Computer 16 can be any suitable computer, such as personal computer 31, which provides for trainer 18 input and control, and other data logging (e.g. polling/ generating, modifying, and/or appending) and/or analysis functions; see Prendergast Col 7 ||8-20, The computer 16 monitors the flow 96 of the fluid from each syringe 68, 69, and 70 and tracks the total amount of fluid transferred. The concentration and type of drug in the fluid is read (e.g. polling and providing complementary data) from each syringe's memory chip 84, thus determining the total amount of drug injected. The drug flow information is passed to the patient physiological models 28 and drug models 26 in computer 16 for determining the proper real time mannequin response. As the injection flow 96 is terminated, the flow stops and computer 16, or personal computer 31, logs the drug injection (time, drug, concentration, and amount) for use in the physiological models and for later review by the instructor.).
Examiner interprets system provides polling information such as concentration of medication as taught in Applicant specification paragraph 31 || 7.
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 17, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method as in claim 16, wherein the complementary data comprises data selected from a group consisting of:
-- fluid information, patient-specific information, medical order information, clinical guideline information, environmental factors, and historical patient information, a type of medication contained within the secondary medication container, the concentration of medication contained within the secondary medication container, a type of medication container, a maximum volume capacity of the secondary medication container, a volume of medication contained within the secondary medication container, a volume of medication extracted from the secondary medication container, a volume of medication and/or diluents added to the secondary medication container, a volume of medication manually administered from the secondary medication container, a patient identifier, a caregiver identifier, a pharmacist identifier, a care area identifier, a pharmacy identifier, a device and/or system identifier, a medical order identifier, a primary container identifier, a secondary container identifier, a controlled substance identifier, at least one time stamp identifying the timing of an event within the clinical workflow, at least one medical procedure associated with the workflow, a medication expiration date, a dosage form of the medication, dose instructions for the medication, specific-patient administration instructions for a medication, a medication formulation, medication manufacturer information, a re-packager of the medication, a distributor of the medication, a medication package form, a medication package size, a medication container serial number, a medication lot number, a blood type of a patient, an NDC code (National Drug Code), an RxNorm code, a segment of an NDC code identifying a corresponding medication product, a segment of an NDC code identifying a corresponding medication package, a unique identifier code, a serialized NDC (sNDC) code, a drug classification, a human readable alphanumeric string, and a machine readable code (see Prendergast Col 1 || 9-18, … recording actual drugs administered to a patient, and in particular to a patient and patient simulator drug recognition system that identifies the type, concentration, and amount of simulated drug being administered to the patient mannequin, or the type, concentration, and amount of actual drug being administered to the patient; see Prendergast Col 5 || 36-50, Computer 16 can be any suitable computer, such as personal computer 31, which provides for trainer 18 input and control, and other data logging (e.g. polling/ generating, modifying, and/or appending) and/or analysis functions; see Prendergast Col 7 ||8-20, The computer 16 monitors the flow 96 of the fluid from each syringe 68, 69, and 70 and tracks the total amount of fluid transferred. The concentration and type of drug in the fluid is read (e.g. polling and providing complementary data) from each syringe's memory chip 84, thus determining the total amount of drug injected. The drug flow information is passed to the patient physiological models 28 and drug models 26 in computer 16 for determining the proper real time mannequin response. As the injection flow 96 is terminated, the flow stops and computer 16, or personal computer 31, logs the drug injection (time, drug, concentration, and amount) for use in the physiological models and for later review by the instructor.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 18, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method of claim 1, wherein coupling the primary medication container to the secondary medication container with the medication transfer device further comprises coupling the primary medication container to the medication transfer device by at least one of a vial adapter, a needle, a blunt tip cannula, and a needle-less lure adapter with a spike (see Nelson et al.2 paragraphs 38 and 49-50; container 122 (e.g. a syringe, and IV bag, an ampoule, a vial, an auto-injector container, or another such container which is needed to administer fluid). In some embodiments, waste disposal unit 50 comprises a receptacle having a lid 51 including one or more ports 52 configured to receive container 122 holding liquid 124 for disposal. In some embodiments, a first port 52 is provided to receive a first type of container 122, and a second port 52 is provided to receive a second type of container. In other embodiments, lid 51 comprises a plurality of ports having a variety of interfaces for receiving various types of containers. Disposal unit 50 further comprises a sensor 127 coupled to a portion of port 52 and in a fluid pathway of disposal unit 50. In some embodiments, sensor 127 is positioned within port 52 so as to be in a fluid pathway 56 of port 52, as shown in FIG. 4. As such, fluid being wasted from container 122 into disposal unit 50 flows over sensor 127 thereby providing sensing measurements to processor unit 132. In some embodiments, sensor 127 further comprises a sensor element 129 which is configured to detect a specific characteristic or parameter of fluid 124 as it is being wasted into disposal unit 50.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 19, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method of claim 1, wherein coupling the primary medication container to the secondary medication container with the medication transfer device further comprises coupling the secondary medication container to the medication transfer device by at least one of a vial adapter, a needle, a blunt tip cannula, and a needle-less lure adapter with a spike (see Nelson et al.2 paragraphs 38 and 49-50; container 122 (e.g. a syringe, and IV bag, an ampoule, a vial, an auto-injector container, or another such container which is needed to administer fluid). In some embodiments, waste disposal unit 50 comprises a receptacle having a lid 51 including one or more ports 52 configured to receive container 122 holding liquid 124 for disposal. In some embodiments, a first port 52 is provided to receive a first type of container 122, and a second port 52 is provided to receive a second type of container. In other embodiments, lid 51 comprises a plurality of ports having a variety of interfaces for receiving various types of containers. Disposal unit 50 further comprises a sensor 127 coupled to a portion of port 52 and in a fluid pathway of disposal unit 50. In some embodiments, sensor 127 is positioned within port 52 so as to be in a fluid pathway 56 of port 52, as shown in FIG. 4. As such, fluid being wasted from container 122 into disposal unit 50 flows over sensor 127 thereby providing sensing measurements to processor unit 132. In some embodiments, sensor 127 further comprises a sensor element 129 which is configured to detect a specific characteristic or parameter of fluid 124 as it is being wasted into disposal unit 50.).
The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
As per claim 20, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 teach the method of claim 1, wherein the medication transfer device and the identification element for an identified transfer device, wherein the identified transfer device can be separable allowing a first portion to remain with the primary medication container, and a second portion to remain attached to the secondary medication container (see Nelson et al.2 paragraphs 38 and 49-50; container 122 (e.g. a syringe, and IV bag, an ampoule, a vial, an auto-injector container, or another such container which is needed to administer fluid). In some embodiments, waste disposal unit 50 comprises a receptacle having a lid 51 including one or more ports 52 configured to receive container 122 holding liquid 124 for disposal. In some embodiments, a first port 52 is provided to receive a first type of container 122, and a second port 52 is provided to receive a second type of container. In other embodiments, lid 51 comprises a plurality of ports having a variety of interfaces for receiving various types of containers. Disposal unit 50 further comprises a sensor 127 coupled to a portion of port 52 and in a fluid pathway of disposal unit 50. In some embodiments, sensor 127 is positioned within port 52 so as to be in a fluid pathway 56 of port 52, as shown in FIG. 4. As such, fluid being wasted from container 122 into disposal unit 50 flows over sensor 127 thereby providing sensing measurements to processor unit 132. In some embodiments, sensor 127 further comprises a sensor element 129 which is configured to detect a specific characteristic or parameter of fluid 124 as it is being wasted into disposal unit 50.).
It’s obvious to one skilled in the art would observe or know that 122 is or can be attached and reattached to lid 51 as shown in Figure 3. The obviousness of combining the teachings of Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 are discussed in the rejection of claim 1, and incorporated herein.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 as applied to claims 1-13 and 15-20 above, and further in view of Pub. No.: US 20050055242 A1 to Bello et al.
As per claim 14, Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 fail to teach the method as in claim 1, wherein the secondary medication container identifier is linked to a secondary unique identifier, and wherein the secondary unique identifier includes a uniform resource locator (URL) configured to access the data stored in the at least one data record.
Bello et al. teaches infusion system 210 can include an additional block (not shown) where the central computer accepts a second medication identifier. The clinician 116 at the remote location can enter the second medication identifier. The second medication identifier can be a revised first medication identifier. For example, the second medication identifier can be part of the prescription or electronic physician order entry that is the source for the first patient ID and the operating parameters. The infusion system 210 can then confirm the first and second medication IDs are equivalent prior to sending the operating parameters to the medical device. The second medication ID can be replaced by a revised first medication ID between the time the prescription is entered and the time the medication 124 arrives at the treatment location 106. The infusion system 210 will then sound an alarm if the second medication identifier is not equivalent to the first medication identifier that was included in the medication label 124a (see Bello et al. paragraph 377).
Bello et al. further teaches a patient identifier (e.g., wristband ID), the medication identifier (e.g., bag ID), a completion URL, and a cancellation URL. The completion URL is a network address used if a prescription match is found. The cancellation URL is a network address used if a prescription match is not found (see Bello et al. paragraph 520).
Therefore it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include systems/methods as taught by reference Bello et al. with the systems/methods as taught by reference Prendergast, Sparks et al., Nelson et al.1 and Nelson et al.2 with the motivation of providing a safety net of support for clinicians as they deliver patient care under increasing time and cost pressures supplied through a wireless network that supplies data, thereby improving clinician workflow, making delivery of care easier (see Bello et al. paragraph 244).
Response to Arguments
Applicant’s arguments filed December 12, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
(1) Claims 1-13 and 16-20 are rejected under 35 U.S.C. § 103 as being unpatentable over United States Patent No. 5,873,731 to Prendergast (hereafter "Prendergast) in view of United States Patent Application Publication No. 2005/0235759 to Sparks et al. (hereafter "Sparks") further in view of United States Patent Application Publication No. 2005/0165559 to Nelson et al. (hereinafter "Nelson 1") in view of United States Patent Application Publication No. 2012/0226447 to Nelson et al. (hereinafter "Nelson 2"). Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable over Prendergast, Sparks, Nelson 1, and Nelson 2 as applied to claims 1-13 and 15-20 above, and further in view of United States Patent Application Publication No. 2005/0055242 to Bello et al. (hereafter "Bello").
The art cited by the Office Action fails to disclose or suggest,
"-optically scanning, with a first sensor element including an emitter and a detector disposed within the housing of the medication transfer device at the first end of the housing proximate the fluid inlet, the first information transfer element including the primary medication container identifier when the primary medication container is attached to the fluid inlet with the first information transfer element disposed between the primary medication container and an outer surface of the housing of the medication transfer device;
-optically scanning, with a second sensor element including an emitter and a detector disposed within the housing of the medication transfer device at the second end of the housing proximate the fluid outlet, the second information transfer element including the secondary medication container identifier when the secondary medication container is attached to the fluid outlet with the second information transfer element disposed between the secondary medication container and the outer surface of the housing of the medication transfer device;
-with the primary medication container attached to the fluid inlet of the medication transfer device and the secondary medication container attached to the fluid outlet of the medication transfer device, transferring the medication from the primary medication container to the secondary medication container via the single fluid transfer channel of the medication transfer device by the user holding the medication transfer device in the first hand of the user and pulling on a plunger rod of the syringe with the second hand of the user to draw the medication from the primary medication container, through the single fluid transfer channel of the housing of medication transfer device, and into the secondary medication container including the syringe, wherein the medication transfer device further includes a flow sensor within the housing that measures a transfer time and a transfer amount associated with the medication transfer from the primary medication container to the secondary medication container", as expressly recited by amended independent claim 1. (Emphasis added).
Prendergast does not, in the first place, disclose or suggest optical scanning of an information transfer element. In Prendergast, identification is performed via the IC chips 84, 116 of disks 82, 94, 110, 120. Specifically, Prendergast discloses that: "[e]ach disc 110, can contain an IC chip 116 (similar to IC chip 84) which is reprogrammable, such as EEPROM or RAM. When syringe 112 is inserted into a bottle 118 containing a desired drug 119, IC chip 116 on disc 110 will be reprogrammed, with the drug 119 type and concentration, by a mating programming disc 120 provided on each bottle 118 containing a drug 119" and that "[w]hen drug 119 is administered, IC chip 116 will provide the drug type and concentration in a similar manner to that described herein above for administering simulated drugs.". See col. 7, 1. 61 through col. 8, 1. 14. The other cited references do not cure this deficiency of Prendergast.
Further, Prendergast does not disclose or suggest using a medication transfer device, in which each of the first sensor, the second sensor, the flow sensor, and the single fluid transfer channel are disposed in the same housing, to scan an information transfer element, let alone that, when the scanning is performed, the information transfer element is disposed between the medication container and an outer surface of the housing of the medication transfer device. These specific structural and positional relationships of the claimed elements, which are expressly required to perform the claimed method, are absent and would not result from simply substituting an optical reader for the IC-disk reader of Prendergast. The other cited references again fail to cure these deficiencies.
Independent claim 1 is accordingly believed to be patentable over the cited art.
Claims 2-14 and 16-20, each of which depend from claim 1, are believed to be patentable over the cited art for at least the same reasons as claim 1.
Withdrawal of the rejections under 35 U.S.C. § 103 is requested.
In response to argument (1), Examiner respectfully disagrees.
As cited, in previous office action, information recorder 104 stores information about the deposited substance. In a preferred embodiment, the information is provided by the depositor of the substance. The depositor may provide information by using a keyboard 150, mouse, optical character recognition, barcode scanner, or any other technique that will provide accurate, legible information to the information recorder 104. In other embodiments, the information is acquired automatically from the secure substance container 102. Information may be provided by a combination of depositor information and secure substance container 102 information. For example, the controlled substance container 102 may be configured to automatically detect the quantity deposited in a container 102 and send that information to the information recorder 104. In other embodiments, the present invention is operatively coupled to an automated injection system. In these embodiments with an automated injection system, the information stored in the information recorder 104 may further be compared with information provided by the automated injection system (see Nelson et al.1 paragraphs 82-83).
In addition, as also cited, in previous office action, referring now to FIG. 6, a fluid tracking system 320 is shown. Fluid tracking system 320 includes various input devices coupled thereto configured to provide information to processor unit 132. Through these and other input devices, processor unit 132 receives data relating to the identity of fluid 124 stored in container 122 and a previously determined identity of a fluid 124. Processor unit 132 may further receive information regarding the identity of a patient for whom the fluid was prescribed or intended, the identity of the individual wasting the fluid, the original volume of the fluid placed in container 122, the drug lot number, the drug maker, and other such information. In some embodiments, system 320 comprises a plurality of input devices, such as a manual input device 340 (i.e. a keypad, a mouse, or a touchpad electronically coupled to processor unit 132 for manually entering information), a card reader 342, an RFID reader 343 and a barcode reader 346. Input devices of the present invention may be used to acquire additional information related to the individual wasting the fluid. For example, an input device may be used to acquire the identification of the person wasting the fluid.
Another input device that may be connected to the processor unit 132 is a reader unit for reading information from a container's label. The type of reader unit may be selected based on the nature of a label 310 selected for container 122. For example, a reader unit may include an RFID reader 343 to read information from RFID chips 316 on the label 310, or a barcode reader 346, which can read information from a barcode 312 on the label 310. Accordingly, a label 310 may include various structures configured so that they can be affixed to or printed on container 122. In some instances, label 310 includes text. Label 310 may further include various types of information such as the identity and characteristics of fluid 124 in container 122, the initial volume of fluid 124, a drug lot number, a drug manufacturer, the identity of the pharmacist who prepared the drug, the identity of a drug manufacturer, a drug catalog number, an expiration date of the fluid, and the identity of a patient for whom the fluid 124 is intended. In the various embodiments, some or all of this information may be received by the processor unit 132 and used to identity a fluid being wasted, as explained herein.
For example, when a physician prescribes a fluid for a patient, the physician may enter the identity, concentration, dose or other parameters or characteristics of the fluid as may be necessary to enable preparation of the fluid by a pharmacist or other technician. In some embodiments, this information is stored in an electronic medical record. In other embodiments, this information is printed onto a label which is applied to the container holding the fluid. Further still, in some embodiments this information is printed onto a label which is adhered to an outer surface of a container, or embedded within the wall of a container holding the fluid. As previously discussed, a label may include a barcode, an RFID chip, or some other form of machine recognizable code that may be scanned or accessed by a processor unit operably coupled to a sensor of the fluid wasting system or the container. For example, an RFID chip may be embedded into the wall of a container, such as a syringe (see Nelson et al.2 paragraphs 63-64 and 67).
As taught in Applicant specification in at least paragraphs 80-81, an Injection site can have detection and scanning sensor element 33 (emitter/detector) to identify identification element 60. As interpreted by at least Fig. 6, the optical element is a barcode, on the syringe. Both Nelson1 and Nelson2 teach reading a barcode or the interior or exterior of the medication container.
Although a great portion of arguments are based on structure, Examiner believes that Prendergast, Sparks et al., Nelson et al.1, Nelson et al.2 and Bello et al. teach each and every method limitation in claims. Thus, the rejection of the previous Office Action is maintained.
Examiner suggest amending claims to directed to or encompassing a human organism. Section 33(a) of the America Invents Act reads as being directed to or encompassing a human organism. Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Conclusion
Pub. No.: US 20100280486 A1 to Khair et al.; A method of delivering medication to a patient utilizing a medication delivery system is provided. A first medication to be delivered to the patient is supplied. The patient's identity is verified. The first medication is selected on a user interface to be delivered to the patient. The volume of the medication the patient will receive is entered. The first medication is injected into the patient through a flow sensor assembly. The flow rate and the volume of the first medication delivered to the patient are monitored by the flow sensor assembly while the injection occurs. A visual display provides information related to the injection. The method updates the patient's electronic medical administration record to capture the information regarding the injection of the first medication.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683