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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 27, 2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 5, 7-8, 11-12, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) further in view of Lurvey et al. (US 20060224128).
Regarding claim 1, Toro discloses a pump cassette (cassette 100) for fluid delivery, the pump cassette comprising:
a housing (cassette body 110) dimensioned to engage with an infusion pump (infusion pump system 10; Figure 1A; “FIG. 1A illustrates an example of an infusion pump system. In accordance with certain embodiments, infusion pump system 10 may include one or more cassette recesses and disposable IV pump cassettes (e.g., cassette recesses 200, 400, 600 and cassettes 100, 300, and 500). For example, cassette recess 200 may be configured to receive cassette 100 and provide various mechanical couplings and operational interfaces (e.g., fittings, motor, gearing, driveshaft, sensors, etc.)” [0065]);
a fluid path within the housing (“membrane 117 can be a compliant material co-molded to the frame portion 116 and sealingly engaged with base portion 119 for defining a fluid pathway through cassette body 110 from inlet 112 to outlet 114.” [0086]), the fluid path configured to receive fluid from a fluid source and to deliver the fluid to tubing of an infusion line (“syringe or other fluid source 52 may be fluidly connected to inlet 112 of cassette 100, and outlet 114 of cassette 100 may be fluidly connected to a patient 54 as shown in the examples of FIGS. 1A and 1B.” [0067]); and
a flow stop valve (flow stop valve 164 controlled by slider 170) configured as a manual switch (Figure 1B, via slider 170) to stop the fluid from flowing from the pump cassette to the tubing of the infusion line (“When the slider 170 is positioned in the first position, the portion of interface-facing slider section 176 contacts and activates flow stop valve 164 such that fluid flow is occluded at that position of the fluid pathway proximal to outlet 114 cassette body 110.” [0111]), the flow stop valve being integrated with the housing the pump cassette (Figure 3A).
Toro fails to explicitly disclose a radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump.
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a fluid path (via flexible tube 21); a flow stop valve (pump activated pinch clamp 20) configurable to stop the fluid from flowing (“pump activated pinch clamp 20, 20' for allowing or preventing flow of a fluid in flexible tube 21” [0044]); and a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro to include a radio frequency identification tag attached to the flow stop valve based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Modified Toro in view of Zhang fails to explicitly disclose the radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump.
Kneip teaches a pump cassette (disposable set 30) comprising a radio frequency identification tag (RFID 210) embedded in a component of the pump cassette (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200.” [Col 8, lines 19-21]), the radio frequency identification tag being surrounded by molding material (“Referring to FIG. 4, an embodiment of RFID housing 200 having RFID tag 210 is illustrated. RFID housing 200, includes a body 202 and handle 204. Suitable materials for body 202 and handle 204 include plastic, such as injection molded ABS, Delrin.RTM., Noryl.RTM., polycarbonate or other suitable medical grade plastic.” [Col 7, lines 60-65]) of the component (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200. With RFID tag 210 embedded into RFID housing 200, housing 200 can be sterilized via steam or ethylene oxide ("EtO") gas sterilization, for example. Embedding RFID tag 210 into body 202 or otherwise encapsulating RFID tag 210 also helps to protect RFID tag 210.” [Col 8, lines 19-25]; Figure 4 showing the RFID tag 210 surrounded by the molding material of the body 202).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro in view of Zhang to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, is embedded in and surrounded by molding material of the flow stop valve of the pump cassette based on the teachings of Kneip to protect the radio frequency identification tag and allow the pump cassette to be steam or gas sterilized (Kneip [Col 8, lines 19-25]).
Modified Toro fails to explicitly teach the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump.
Lurvey teaches a pump cassette (infusion set 12) comprising: a housing (structure of infusion set 12) dimensioned to engage with an infusion pump (infusion device 14; “Infusion device 14 further includes a port 15 for receiving slide clamp 26.” [0056]; Figure 1); a fluid path (along infusate tube 24) within the housing (Figure 1), a flow stop valve (slide clamp 26), and a radio frequency identification tag (RFID tag 96) embedded in the flow stop valve (“The chipless RFID tag may include antennae printed on a surface of the slide clamp or embedded in the slide clamp interior.” [0099]; Figure 14), the radio frequency identification tag comprising an antenna (“RFID tag 96 may include an antenna, circuitry for processing RF signals, a microprocessor, memory, and, optionally, a power supply.” [0099]), wherein the antenna is configured to align with an antenna of a radio frequency identification reader (“the RF detector is an RF interrogator 102 as shown in FIG. 14. RF interrogator 102 typically includes an antenna, a transceiver for transmitting an interrogation signal to and receiving a response signal from the RFID tag, and a decoder for reading the encoded information in the signal from the RFID tag.” [0102]) when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump (“detection device 16 may be a component of infusion device 14 as shown in phantom in FIG. 1. In this arrangement, detection device 16 is preferably located proximate to port 15 and adapted to detect signaling component 38 when slide clamp 26 is secured in port 15” [0114]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the radio frequency identification tag, provided by Zhang, comprises an antenna that is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump based on the teachings of Lurvey to allow the radio frequency identification tag of the pump cassette to communicate with the infusion pump when the cassette is loaded into the infusion pump (Lurvey [0114], Figures 1 and 14).
Regarding claim 5, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach wherein the radio frequency identification tag stores an identifier uniquely identifying the pump cassette.
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d), wherein the radio frequency identification tag stores an identifier uniquely identifying the pump cassette (“The pharmacist can provide the bar code or memory containing device with information about the patient and about the container that the tubing and the pump activated pinch clamp are connected to. The information may include drug name, dose, dose rate, name of patient, patient ID number, and other pharmacist notes…A reader mounted on the pump may be connected to read this information from the memory containing device…a microprocessor in the pump is connected to use the information received by the reader to automatically set pump parameters, including dose and dose rate.” [0072]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, stores an identifier uniquely identifying the pump cassette based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Regarding claim 7, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach wherein the radio frequency identification tag stores cassette usage information.
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d), wherein the radio frequency identification tag stores cassette usage information (“The pharmacist can provide the bar code or memory containing device with information about the patient and about the container that the tubing and the pump activated pinch clamp are connected to. The information may include drug name, dose, dose rate, name of patient, patient ID number, and other pharmacist notes…A reader mounted on the pump may be connected to read this information from the memory containing device…a microprocessor in the pump is connected to use the information received by the reader to automatically set pump parameters, including dose and dose rate.” [0072]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, stores cassette usage information based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Regarding claim 8, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach the radio frequency identification tag stores information identifying one or more pump cassette parameters.
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d), wherein the radio frequency identification tag stores information identifying one or more pump cassette parameters (“The pharmacist can provide the bar code or memory containing device with information about the patient and about the container that the tubing and the pump activated pinch clamp are connected to. The information may include drug name, dose, dose rate, name of patient, patient ID number, and other pharmacist notes…A reader mounted on the pump may be connected to read this information from the memory containing device…a microprocessor in the pump is connected to use the information received by the reader to automatically set pump parameters, including dose and dose rate.” [0072]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, stores information identifying one or more pump cassette parameters based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Regarding claim 11, modified Toro teaches the pump cassette of Claim 1, wherein the fluid path (“membrane 117 can be a compliant material co-molded to the frame portion 116 and sealingly engaged with base portion 119 for defining a fluid pathway through cassette body 110 from inlet 112 to outlet 114.” [0086]) is U-shaped (Figure 3A, U-shaped at least at middle of membrane 117 between upstream pressure dome 132 and downstream pressure dome 134).
Regarding claim 12, modified Toro teaches the pump cassette of Claim 1, wherein the pump cassette (cassette 100) is configured to deliver a set volume of the fluid with each pumping cycle (“piston 145 resides and moves within a rigid bore and allows a seal that permits fluid to be drawn into the pump chamber via pump chamber opening/access 125 on the fill cycle and expelled on the delivery cycle.” [0092]; “piston pump techniques can provide repeatedly precise positive displacement of fluid in the pump chamber.” [0097]).
Regarding claim 24, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach the radio frequency identification tag stores control information related to an infusion set that includes the pump cassette and the tubing of the infusion line.
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d), wherein the radio frequency identification tag stores control information related to an infusion set that includes the pump cassette and the tubing of the infusion line (“The pharmacist can provide the bar code or memory containing device with information about the patient and about the container that the tubing and the pump activated pinch clamp are connected to. The information may include drug name, dose, dose rate, name of patient, patient ID number, and other pharmacist notes…A reader mounted on the pump may be connected to read this information from the memory containing device…a microprocessor in the pump is connected to use the information received by the reader to automatically set pump parameters, including dose and dose rate.” [0072]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, stores control information related to an infusion set that includes the pump cassette and the tubing of the infusion line based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) further in view of Lurvey et al. (US 20060224128) as applied in claim 1 above, and further in view of Tieck et al. (US 20160015957).
Regarding claim 6, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach the radio frequency identification tag stores pairing information for wireless communication with a light set.
Tieck teaches a pump cassette (connection interface 40) comprising a radio frequency identification tag (element 42; “element 42 represents one or more RFID tags carried by the cap 4” [0598]) on a component (cap 4) of the pump cassette (Figure 1); wherein the radio frequency identification tag stores pairing information for wireless communication with a light set (“the RF detectable feature 42 includes a passive (or active) RFID chip or other RF detectable feature that is provided with a serial number or other code (unique or not unique among other reservoirs 1). In such embodiments, when the reservoir 1 (or base/reservoir/cap unit) is initially installed in the infusion pump device 30 (or other suitable delivery device), or at a particular time after installation, electronics (such as electronics 60 in FIG. 5) reads the serial number or code…the processing electronics may be configured to perform a predefined action in response to a determination that the serial number or code read from the reservoir 1 matches a pre-stored serial number or code (for a previously-used reservoir 1), including…providing an alarm or control signals” [0639]; “The alarm display device may include any suitable indicator such as, but is not limited to one or more of: a light emitting device, LED, LCD” [0505]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the radio frequency identification tag of the flow stop valve, as provided by Zhang, stores pairing information for wireless communication with a light set based on the teachings of Tieck to visually alert the user that cassette has been previously used (Tieck [0505], [0639]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) further in view of Lurvey et al. (US 20060224128) as applied to claim 1 above, and further in view of Pastrone et al. (USPN 5431627).
Regarding claim 9, modified Toro teaches the pump cassette of Claim 1, wherein the fluid path comprises a pumping chamber (“the pump chamber may be defined by a portion of the piston guide 143 or casing distal from the pump drive interface 142 that is adjacent to and fluidly coupled with a tract or section of the fluid pathway between inlet-side valve 122 and outlet-side valve 124.” [0092]).
Modified Toro fails to explicitly teach the fluid path comprises an air trap.
Pastrone teaches a pump cassette (cassette 30) for fluid delivery comprising a fluid path (Figure 2B) comprising an air trap (air trap 31).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the fluid path comprises an air trap based on the teachings of Pastrone to monitor and prevent air bubbles from entering the fluid outlet (Pastrone [Col 6, lines 45-68]; Figure 2).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) further in view of Lurvey et al. (US 20060224128) as applied in claim 1 above, and further in view of Day et al. (US 20160256622).
Regarding claim 10, modified Toro teaches the pump cassette of Claim 1.
Modified Toro fails to explicitly teach the pump cassette is configured to independently control pumping for a primary infusion and a secondary infusion.
Day teaches a pump cassette (“As seen in FIG. 6, the cassette kit includes a cassette” [0126]) for fluid delivery, wherein the pump cassette is configured to independently control pumping for a primary infusion (via primary line; “As seen in FIG. 6, the cassette kit includes a cassette connected to a convertible piercing pin with drip chamber via a primary line” [0126]) and a secondary infusion (via secondary line; “The cassette in FIG. 6 also includes a secondary inlet port at which a secondary line may be connected.” [0126]; “multi-channel infusion devices may include both a primary and a secondary line. A caregiver may program the infusion device to deliver a primary infusion via either the primary or the secondary line. When an infusion device has been programmed with a primary infusion, the caregiver may program the other line (either the primary line or the secondary line) to deliver a secondary infusion. The secondary infusion may be a concurrent infusion or a piggyback infusion. A concurrent infusion refers to simultaneous delivery from two delivery sources and independent infusion rates. Piggyback infusion refers to infusion that will stop infusion on one line, complete infusion on another line, and then restart infusion on the stopped line.” [0109]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro to be configured to independently control pumping for a primary infusion and a secondary infusion based on the teachings of Day to allow for the delivery of multiple fluids to the patient either simultaneously or sequentially in order to provide the necessary care (Day [0109]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991), Kneip et al. (USPN 8330579), Lurvey et al. (US 20060224128), and Pastrone et al. (USPN 5431627) as applied in claim 9 above, and further in view of Day et al. (US 20160256622).
Regarding claim 22, modified Toro teaches the pump cassette of Claim 9, wherein the fluid path (“membrane 117 can be a compliant material co-molded to the frame portion 116 and sealingly engaged with base portion 119 for defining a fluid pathway through cassette body 110 from inlet 112 to outlet 114.” [0086]) is U-shaped (Figure 3A, U-shaped at least at middle of membrane 117 between upstream pressure dome 132 and downstream pressure dome 134).
Modified Toro fails to explicitly teach a primary port and a secondary port, and wherein the pump cassette is configured to independently control pumping from the primary port and from secondary port.
Day teaches a pump cassette (“As seen in FIG. 6, the cassette kit includes a cassette” [0126]) for fluid delivery, wherein the pump cassette comprises a primary port (via primary line; “As seen in FIG. 6, the cassette kit includes a cassette connected to a convertible piercing pin with drip chamber via a primary line” [0126]) and a secondary port (“The cassette in FIG. 6 also includes a secondary inlet port at which a secondary line may be connected.” [0126]), and wherein the pump cassette is configured to independently control pumping from the primary port and from the secondary port (“multi-channel infusion devices may include both a primary and a secondary line. A caregiver may program the infusion device to deliver a primary infusion via either the primary or the secondary line. When an infusion device has been programmed with a primary infusion, the caregiver may program the other line (either the primary line or the secondary line) to deliver a secondary infusion. The secondary infusion may be a concurrent infusion or a piggyback infusion. A concurrent infusion refers to simultaneous delivery from two delivery sources and independent infusion rates. Piggyback infusion refers to infusion that will stop infusion on one line, complete infusion on another line, and then restart infusion on the stopped line.” [0109]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro include a primary port and a secondary port, and wherein the pump cassette is configured to independently control pumping from the primary port and from the secondary port based on the teachings of Day to allow for the delivery of multiple fluids to the patient either simultaneously or sequentially in order to provide the necessary care (Day [0109]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Pastrone et al. (USPN 5431627) in further view of Day et al. (US 20160256622) in further view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) and in further in view of Lurvey et al. (US 20060224128).
Regarding claim 23, Toro discloses a pump cassette (cassette 100) for fluid delivery, the pump cassette comprising:
a housing (cassette body 110) dimensioned to engage with an infusion pump (infusion pump system 10; Figure 1A; “FIG. 1A illustrates an example of an infusion pump system. In accordance with certain embodiments, infusion pump system 10 may include one or more cassette recesses and disposable IV pump cassettes (e.g., cassette recesses 200, 400, 600 and cassettes 100, 300, and 500). For example, cassette recess 200 may be configured to receive cassette 100 and provide various mechanical couplings and operational interfaces (e.g., fittings, motor, gearing, driveshaft, sensors, etc.)” [0065]);
a fluid path within the housing (“membrane 117 can be a compliant material co-molded to the frame portion 116 and sealingly engaged with base portion 119 for defining a fluid pathway through cassette body 110 from inlet 112 to outlet 114.” [0086]), the fluid path comprising a pumping chamber (“the pump chamber may be defined by a portion of the piston guide 143 or casing distal from the pump drive interface 142 that is adjacent to and fluidly coupled with a tract or section of the fluid pathway between inlet-side valve 122 and outlet-side valve 124.” [0092]), the fluid path being U-shaped (Figure 3A, U-shaped at least at middle of membrane 117 between upstream pressure dome 132 and downstream pressure dome 134), the fluid path configured to receive fluid from a fluid source and to deliver the fluid to tubing of an infusion line (“syringe or other fluid source 52 may be fluidly connected to inlet 112 of cassette 100, and outlet 114 of cassette 100 may be fluidly connected to a patient 54 as shown in the examples of FIGS. 1A and 1B.” [0067]); and
a flow stop valve (flow stop valve 164 controlled by slider 170) configurable to stop the fluid from flowing from the pump cassette to the tubing of the infusion line (“When the slider 170 is positioned in the first position, the portion of interface-facing slider section 176 contacts and activates flow stop valve 164 such that fluid flow is occluded at that position of the fluid pathway proximal to outlet 114 cassette body 110.” [0111]).
Toro fails to explicitly disclose the fluid path comprising an air trap; the pump cassette comprising a primary port and a secondary port, and wherein the pump cassette is configured to independently control pumping from the primary port and from secondary port; and a radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, wherein an antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump.
Pastrone teaches a pump cassette (cassette 30) for fluid delivery comprising a fluid path (Figure 2B) comprising an air trap (air trap 31).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro to include that the fluid path comprises an air trap based on the teachings of Pastrone to monitor and prevent air bubbles from entering the fluid outlet (Pastrone [Col 6, lines 45-68]; Figure 2).
Toro fails to explicitly disclose the pump cassette comprising a primary port and a secondary port, and wherein the pump cassette is configured to independently control pumping from the primary port and from secondary port; a radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, wherein an antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump.
Day teaches a pump cassette (“As seen in FIG. 6, the cassette kit includes a cassette” [0126]) for fluid delivery, wherein the pump cassette comprises a primary port (via primary line; “As seen in FIG. 6, the cassette kit includes a cassette connected to a convertible piercing pin with drip chamber via a primary line” [0126]) and a secondary port (“The cassette in FIG. 6 also includes a secondary inlet port at which a secondary line may be connected.” [0126]), and wherein the pump cassette is configured to independently control pumping from the primary port and from the secondary port (“multi-channel infusion devices may include both a primary and a secondary line. A caregiver may program the infusion device to deliver a primary infusion via either the primary or the secondary line. When an infusion device has been programmed with a primary infusion, the caregiver may program the other line (either the primary line or the secondary line) to deliver a secondary infusion. The secondary infusion may be a concurrent infusion or a piggyback infusion. A concurrent infusion refers to simultaneous delivery from two delivery sources and independent infusion rates. Piggyback infusion refers to infusion that will stop infusion on one line, complete infusion on another line, and then restart infusion on the stopped line.” [0109]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro include a primary port and a secondary port, and wherein the pump cassette is configured to independently control pumping from the primary port and from the secondary port based on the teachings of Day to allow for the delivery of multiple fluids to the patient either simultaneously or sequentially in order to provide the necessary care (Day [0109]).
Zhang discloses a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a fluid path (via flexible tube 21); a flow stop valve (pump activated pinch clamp 20) configurable to stop the fluid from flowing (“pump activated pinch clamp 20, 20' for allowing or preventing flow of a fluid in flexible tube 21” [0044]); and a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro to include a radio frequency identification tag attached to the flow stop valve based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Modified Toro in view of Zhang fails to explicitly disclose the radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, wherein an antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump.
Kneip teaches a pump cassette (disposable set 30) comprising a radio frequency identification tag (RFID 210) embedded in a component of the pump cassette (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200.” [Col 8, lines 19-21]), the radio frequency identification tag being surrounded by molding material (“Referring to FIG. 4, an embodiment of RFID housing 200 having RFID tag 210 is illustrated. RFID housing 200, includes a body 202 and handle 204. Suitable materials for body 202 and handle 204 include plastic, such as injection molded ABS, Delrin.RTM., Noryl.RTM., polycarbonate or other suitable medical grade plastic.” [Col 7, lines 60-65]) of the component (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200. With RFID tag 210 embedded into RFID housing 200, housing 200 can be sterilized via steam or ethylene oxide ("EtO") gas sterilization, for example. Embedding RFID tag 210 into body 202 or otherwise encapsulating RFID tag 210 also helps to protect RFID tag 210.” [Col 8, lines 19-25]; Figure 4 showing the RFID tag 210 surrounded by the molding material of the body 202).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro in view of Zhang to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, is embedded in and surrounded by molding material of the flow stop valve of the pump cassette based on the teachings of Kneip to protect the radio frequency identification tag and allow the pump cassette to be steam or gas sterilized (Kneip [Col 8, lines 19-25]).
Modified Toro fails to explicitly teach wherein an antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump.
Lurvey teaches a pump cassette (infusion set 12) comprising: a fluid path (along infusate tube 24), a flow stop valve (slide clamp 26), and a radio frequency identification tag (RFID tag 96) embedded in the flow stop valve (“The chipless RFID tag may include antennae printed on a surface of the slide clamp or embedded in the slide clamp interior.” [0099]; Figure 14), radio frequency identification tag comprising an antenna (“RFID tag 96 may include an antenna, circuitry for processing RF signals, a microprocessor, memory, and, optionally, a power supply.” [0099]) configured to align with an antenna of a radio frequency identification reader (“the RF detector is an RF interrogator 102 as shown in FIG. 14. RF interrogator 102 typically includes an antenna, a transceiver for transmitting an interrogation signal to and receiving a response signal from the RFID tag, and a decoder for reading the encoded information in the signal from the RFID tag.” [0102]) when the pump cassette is loaded in the infusion pump (“detection device 16 may be a component of infusion device 14 as shown in phantom in FIG. 1. In this arrangement, detection device 16 is preferably located proximate to port 15 and adapted to detect signaling component 38 when slide clamp 26 is secured in port 15” [0114]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include an antenna of the radio frequency identification tag, provided by Zhang, is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump based on the teachings of Lurvey to allow the radio frequency identification tag of the pump cassette to communicate with the infusion pump when the cassette is loaded into the infusion pump (Lurvey [0114], Figures 1 and 14).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Toro et al. (US 20160151561) in view of Zhang et al. (US 20120238991) in further view of Kneip et al. (USPN 8330579) further in view of Lurvey et al. (US 20060224128), and further in view of Day et al. (US 20160256622).
Regarding claim 25, Toro discloses an infusion set (cassette 100 with attached lines from fluid source 52 and to patient 54; Figure 1A) comprising: a primary line (fluid source 52 line attached to inlet 112; Figure 1A); a patient line (patient 54 line attached to outlet 114; Figure 1A); a pump cassette (cassette 100) comprising:
a housing (cassette body 110) dimensioned to engage with an infusion pump (infusion pump system 10; Figure 1A; “FIG. 1A illustrates an example of an infusion pump system…infusion pump system 10 may include one or more cassette recesses and disposable IV pump cassettes (e.g., cassette recesses 200, 400, 600 and cassettes 100, 300, and 500). For example, cassette recess 200 may be configured to receive cassette 100 and provide various mechanical couplings and operational interfaces (e.g., fittings, motor, gearing, driveshaft, sensors, etc.)” [0065]);
a fluid path within the housing (“membrane 117 can be a compliant material co-molded to the frame portion 116 and sealingly engaged with base portion 119 for defining a fluid pathway through cassette body 110 from inlet 112 to outlet 114.” [0086]), the fluid path configured to receive fluid from the primary line and to deliver the fluid to the patient line (“syringe or other fluid source 52 may be fluidly connected to inlet 112 of cassette 100, and outlet 114 of cassette 100 may be fluidly connected to a patient 54 as shown in the examples of FIGS. 1A and 1B.” [0067]);
a flow stop valve (flow stop valve 164 controlled by slider 170) configured as a manual switch (Figure 1B, via slider 170) to stop the fluid from flowing from the pump cassette to the patient line (“When the slider 170 is positioned in the first position, the portion of interface-facing slider section 176 contacts and activates flow stop valve 164 such that fluid flow is occluded at that position of the fluid pathway proximal to outlet 114 cassette body 110.” [0111]).
Toro fails to explicitly disclose a radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump; and a slide clamp movable along the primary line, wherein the slide clamp is separate from the pump cassette.
Zhang discloses an infusion set comprising a pump cassette for fluid delivery (Figure 1c), the pump cassette comprising a fluid path (via flexible tube 21); a flow stop valve (pump activated pinch clamp 20) configured to stop the fluid from flowing (“pump activated pinch clamp 20, 20' for allowing or preventing flow of a fluid in flexible tube 21” [0044]); and a radio frequency identification tag (information containing structure 246; “information containing structure 246, such as a bar code or a memory containing device, such as an RFID tag or a USB device, is attached to the pump activated pinch clamp” [0072]) attached to the flow stop valve (Figure 1d).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump cassette of the infusion set of Toro to include a radio frequency identification tag attached to the flow stop valve based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Modified Toro in view of Zhang fails to explicitly disclose the radio frequency identification tag embedded in the flow stop valve, the radio frequency identification tag being surrounded by molding material of the flow stop valve, the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump; and a slide clamp movable along the primary line, wherein the slide clamp is separate from the pump cassette.
Kneip teaches a pump cassette (disposable set 30) comprising a radio frequency identification tag (RFID 210) embedded in a component of the pump cassette (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200.” [Col 8, lines 19-21]), the radio frequency identification tag being surrounded by molding material (“Referring to FIG. 4, an embodiment of RFID housing 200 having RFID tag 210 is illustrated. RFID housing 200, includes a body 202 and handle 204. Suitable materials for body 202 and handle 204 include plastic, such as injection molded ABS, Delrin.RTM., Noryl.RTM., polycarbonate or other suitable medical grade plastic.” [Col 7, lines 60-65]) of the component (“RFID tag 210 could be… embedded into handle 204 or other desirable portion of RFID housing 200. With RFID tag 210 embedded into RFID housing 200, housing 200 can be sterilized via steam or ethylene oxide ("EtO") gas sterilization, for example. Embedding RFID tag 210 into body 202 or otherwise encapsulating RFID tag 210 also helps to protect RFID tag 210.” [Col 8, lines 19-25]; Figure 4 showing the RFID tag 210 surrounded by the molding material of the body 202).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of the infusion set of Toro in view of Zhang to include the radio frequency identification tag of the flow stop valve, as provided by Zhang, is embedded in and surrounded by molding material of the flow stop valve of the pump cassette based on the teachings of Kneip to protect the radio frequency identification tag and allow the pump cassette to be steam or gas sterilized (Kneip [Col 8, lines 19-25]).
Modified Toro fails to explicitly disclose the radio frequency identification tag comprising an antenna, wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump; and a slide clamp movable along the primary line, wherein the slide clamp is separate from the pump cassette.
Lurvey teaches a pump cassette (infusion set 12) comprising: a housing (structure of infusion set 12) dimensioned to engage with an infusion pump (infusion device 14; “Infusion device 14 further includes a port 15 for receiving slide clamp 26.” [0056]; Figure 1); a fluid path (along infusate tube 24) within the housing (Figure 1), a flow stop valve (slide clamp 26), and a radio frequency identification tag (RFID tag 96) embedded in the flow stop valve (“The chipless RFID tag may include antennae printed on a surface of the slide clamp or embedded in the slide clamp interior.” [0099]; Figure 14), the radio frequency identification tag comprising an antenna (“RFID tag 96 may include an antenna, circuitry for processing RF signals, a microprocessor, memory, and, optionally, a power supply.” [0099]), wherein the antenna of the radio frequency identification tag is configured to align with an antenna of a radio frequency identification reader (“the RF detector is an RF interrogator 102 as shown in FIG. 14. RF interrogator 102 typically includes an antenna, a transceiver for transmitting an interrogation signal to and receiving a response signal from the RFID tag, and a decoder for reading the encoded information in the signal from the RFID tag.” [0102]) when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump (“detection device 16 may be a component of infusion device 14 as shown in phantom in FIG. 1. In this arrangement, detection device 16 is preferably located proximate to port 15 and adapted to detect signaling component 38 when slide clamp 26 is secured in port 15” [0114]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the radio frequency identification tag, provided by Zhang, comprises an antenna that is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump based on the teachings of Lurvey to allow the radio frequency identification tag of the pump cassette to communicate with the infusion pump when the cassette is loaded into the infusion pump (Lurvey [0114], Figures 1 and 14).
Modified Toro fails to explicitly disclose a slide clamp movable along the primary line, wherein the slide clamp is separate from the pump cassette.
Day teaches an infusion set (Figure 6; “cassette kit” [0126]) comprising a primary line (“PRIMARY LINE” - Figure 6); a patient line (“DISTAL (PATIENT) LINE” – Figure 6); a pump cassette (“As seen in FIG. 6, the cassette kit includes a cassette” [0126]; “CASSETTE” – Figure 6); and a slide clamp (“SLIDE CLAMP” – Figure 6) movable along the primary line, wherein the slide clamp is separate from the pump cassette (Figure 6).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the infusion set of Toro to include a slide clamp movable along the primary line, wherein the slide clamp is separate from the pump cassette based on the teachings of Day to manually control fluid flow into the infusion set from an infusion source to allow for the delivery of multiple fluids to the patient either simultaneously or sequentially in order to provide the necessary care (Day [0109]; Figure 6).
Response to Arguments
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Regarding the argument that “one of ordinary skill in the art would have avoided modifying the proposed combination of Toro and Zhang to have included an RFID tag embedded in a flow stop valve in view of paragraph [0072] of Zhang” because it “would make the proposed combination unsatisfactory for Zhang’s express purpose of having a pharmacist attach a bar code or memory containing device to a pump activated pinch clamp” (Remarks, page 9), the examiner respectfully disagrees. The intended purpose of having an RFID, or more generally an information containing structure, on the flow stop valve of Zhang is to provide information about the pump cassette, including dosage and patient information, to the infusion pump in order to automatically set pump parameters ([0072]). Zhang does not disclose that this intended purpose is due to the process by which the RFID is secured to the flow stop valve. Though Zhang discloses that the RFID can be attached to the valve by the pharmacist, the RFID could instead by embedded in the flow stop valve (as taught by Kneip et al. (USPN 8330579) and Lurvey et al. (US 20060224128) as detailed in the rejections above) while still maintaining the intended purpose of providing information about the pump cassette to the infusion pump.
Regarding the argument that Zhang’s teachings are unrelated to ‘a flow stop valve configurable configured as a manual switch to stop the fluid from flowing from the pump cassette to the tubing of the infusion line, the flow stop valve being integrated with the housing of the pump cassette’ and “Zhang provides no apparent reason to have modified Toro to meet claim 1” (Remarks, page 9), the examiner respectfully disagrees. As detailed above, both Toro and Zhang disclose a pump cassette with a flow stop valve. Though Zhang discloses “a pinch clap 20” rather than explicitly disclosing a “flow stop valve” as claimed, Zhang also disclose that this pinch clamp is part of a pump cassette and functions as a flow stop valve that is configured to stop fluid from flowing from the pump cassette to tubing of the infusion line (“pump activated pinch clamp 20, 20' for allowing or preventing flow of a fluid in flexible tube 21” [0044]). Toro discloses a flow stop valve (164 and 170) configured as a manual switch (Figure 1B, via slider 170) and integrated with the housing the pump cassette (Figure 3A). Zhang discloses a flow stop valve (20) configurable to stop the fluid from flowing ([0044]); and a radio frequency identification tag (246; [0072]) attached to the flow stop valve (Figure 1d). It is maintained that it would have been obvious to one having ordinary skill in the art to modify the pump cassette of Toro to include a radio frequency identification tag attached to the flow stop valve based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]).
Regarding the argument that “the slide clamp 26 of Lurvey…does not include an embedded radio frequency identification tag” and “fails to provide any apparent reason to have modified Toro (Remarks, page 9), the examiner respectfully disagrees. As detailed above, Lurvey teaches a flow stop valve (26) and a radio frequency identification tag (RFID tag 96) embedded in the flow stop valve (“The chipless RFID tag may include antennae printed on a surface of the slide clamp or embedded in the slide clamp interior.” [0099]; Figure 14). It is maintained that it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the radio frequency identification tag, provided by Zhang, comprises an antenna that is configured to align with an antenna of a radio frequency identification reader when the pump cassette is loaded in the infusion pump and the housing of the pump cassette is engaged with the infusion pump based on the teachings of Lurvey to allow the radio frequency identification tag of the pump cassette to communicate with the infusion pump when the cassette is loaded into the infusion pump (Lurvey [0114], Figures 1 and 14).
Regarding the argument “General teachings of Kneip would not have motivated one of ordinary skill in the art to have modified Toro to embed a radio frequency identification tag in a flow stop valve” (Remarks, page 10), the examiner respectfully disagrees. As detailed above, Kneip teaches a pump cassette (30) comprising a radiofrequency identification tag (210) embedded in a component of the pump cassette ([Col 8, lines 19-21]), the radio frequency identification tag being surrounded by molding material of the component ([Col 7, lines 60-65]; [Col 8, lines 19-25]; Figure 4). It is acknowledged that Kneip does not explicitly disclose that the component that the RFID tag is embedded in is a flow stop valve. However, Zhang already discloses that an RFID tag can be attached to a flow stop valve, and Kneip discloses that it is beneficial to have the RFID tag embedded to protect the RFID tag. Based on these disclosures, one having ordinary skill in the art would have found it obvious to further modify the pump cassette of Toro in view of Zhang to include the radio frequency identification tag, as provided by Zhang, is embedded in and surrounded by molding material of the flow stop valve of the pump cassette based on the teachings of Kneip to protect the radiofrequency identification tag and allow the pump cassette to be steam or gas sterilized (Kneip [Col 8, lines 19-25]).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks page 10), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (see at least “the cited references…provide no reason or advantage for embedding an RFID tag in a flow stop valve” (Remarks, page 10)), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the reason and motivation for embedding an RFID tag in a flow stop valve as required by the independent claims was found in the references themselves, as detailed in the rejections above.
Regarding the argument that “neither Zhang nor Lurve teaches or suggests any reason to have applied features related to a pump activated pinch clamp or a slide clamp, respectively, to a flow stop valve of a pump cassette that incudes features of claim 23” (Remarks, page 11-12), the examiner respectfully disagrees. As detailed in the response above, Toro, Zhang, and Lurvey each disclose a pump cassette having a fluid path and flow stop valve. It would have been obvious to one having ordinary skill in the art to modify the flow stop valve of Toro to include a RFID tag based on the teachings of Zhang to provide an identifier specific for the pump cassette that allows the infusion pump to automatically set pump parameters, such as dosage and dosage rate, based on the specific pump cassette attached (Zhang [0072]); and further, it would have been obvious to one having ordinary skill in the art to further modify the pump cassette of Toro to include that the radio frequency identification tag, provided by Zhang, comprises an antenna based on the teachings of Lurvey to allow the radio frequency identification tag of the pump cassette to communicate with the infusion pump when the cassette is loaded into the infusion pump (Lurvey [0114], Figures 1 and 14). Neither Zhang nor Lurvey were relied upon for a teachings of the fluid path being U-shaped, an air trap, or a primary and second part as required by claim 23. These features were found in the disclosures of Toro et al. (US 20160151561) in view of Pastrone et al. (USPN 5431627) in further view of Day et al. (US 20160256622) as detailed above.
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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