DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neta et al. (US 20130237955, henceforth Neta) in view of Yigal et al. (US 20200188608, henceforth Yigal).
Regarding claim 1, Neta discloses a drug delivery device (combination of patch unit 10, cradle 20, and remote control 40 as in fig. 4) comprising: a casing (housings 115 and 215, fig. 8, cradle 20, fig. 6a, and the outer shell of remote control unit 40, fig. 4); a drug infusion member (drug dispensing unit 10, fig. 5) disposed in the casing (see fig. 5, the contents of drug dispensing unit 10 are disposed within housings 115 and 215); an injection member (tip 300, fig. 6b) disposed in the casing (see fig. 6a, tip 300 is disposed at its proximal end inside of cradle 20) and connected to the drug infusion member (see [0137]); a sensing module (disclosed detectors of [0107]-[0112]) disposed in the casing (see [0107]-[0112], each of the described elements is within housings 115 and 215) and configured to sense statuses of the drug infusion member and the injection member (see [0107]-[0112], the detectors are used to sense statuses of various aspects of drug dispensing unit 10 and tip 300 as disclosed including flow rates through and presence of bubbles in unit 10 and tip 300); and a processing unit (processor of [0053]) disposed in the casing (see [0053], the processor is in the disclosed reusable part which is housed by housing 115 as in [0143]) and coupled to the sensing module (see at least [0053], [0094], and [0113]); wherein the processing unit determines that a medical fluid is filled in the drug infusion member in response to the sensing module (see [0151] and [0152]). Neta additionally discloses that the injection member can be inserted through different methods (see [0137], “A tip 300 can be inserted through well 25 and cradle passageway and can rigidly connect to the well 25 after insertion. Insertion can be done manually or automatically with an inserter device.”).
Neta does not disclose that the processing unit selectively controls the injection member to be exposed from the casing when the processing unit determines that the medical fluid is filled in the drug infusion member in response to the sensing module as claimed. Yigal teaches an injection member (injection needle 58, fig. 4) which is selectively controlled to be exposed from a casing into a patient (see [0022], needle 58 moves between a retracted position and an injection position where the injection position includes being exposed from housing 52) when a medical fluid is filled in a drug infusion unit (see [0026], Yigal teaches that the insertion of the injector onto the skin, which requires that the medical fluid to be infused is filled in a drug infusion unit since the assembly must be complete before skin application, includes moving the needle 58 from the retracted position to the injection position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the injection member of Neta with the selectively insertable injection member and needle shield assembly of Yigal for allowing for retraction of the injection member after use to prevent injury or physical harm to the patient as lack of retraction capability such as that of Neta can cause accidental needle prick injuries (see Yigal [0003]-[0005]) and because such a substitution would have yielded the same, predictable result of having a device with a patient-insertable injection member which can pierce skin to deliver medical fluids to the patient and can allow fluid communication from a reservoir to the patient.
{Examiner notes that all subsequent references are made to Neta unless otherwise noted.}
Regarding claim 2, Neta as modified by Yigal (henceforth Neta as modified) discloses the device of claim 1 wherein, when the processing unit determines that the medical fluid is exhausted from the drug infusion member in response to the sensing module (see at least [0116]-[0117], the delivered dose is computed by the processor as a result of flow detection, and once the total volume of the reservoir of fluid is delivered, the dose of fluid is considered to be exhausted from the infusion member as claimed), the processing unit controls the injection member to be hidden in the casing (see Yigal [0027] and [0028], once the total dose is delivered from Neta as in [0117] and [0160]-[0163], the alarm is provided to tell the patient to remove the device to replace the reservoir at which point the injection member is hidden in the casing by the needle shield of Yigal).
Regarding claim 3, Neta as modified discloses the device of claim 2 wherein the injection member is movably disposed in the casing (see Yigal [0026]-[0028]), and the processing unit controls the injection member to move with respect to the casing to be exposed from or hidden in the casing (see Yigal [0026]-[0028] and see the rejection of claim 2 above, the removal of the device 10 of Neta in the modified device includes the moving of the injection member with respect to the shield of Yigal as a result of the signaling from the processor that the reservoir is empty).
Regarding claim 4, Neta as modified discloses the device of claim 2 wherein the casing comprises a shielding member (see Yigal needle shield 10, fig. 3, which is included in the modified member with the substitution of the injection needle 58), the shielding member is movably disposed with respect to the injection member (see Yigal [0026]-[0028] and figs. 4-6), and the processing unit controls the shielding member to move with respect to the injection member (see Yigal [0026]-[0028] and see the rejection of claim 2 above, the removal of the device 10 of Neta in the modified device includes the moving of the shield with respect to the needle of Yigal as a result of the signaling from the processor that the reservoir is empty), such that the injection member is exposed from or hidden in the shielding member (see Yigal figs. 4-6).
Regarding claim 14, Neta as modified discloses the device of claim 1 further comprising a motor (motor 188, fig. 15a) disposed in the casing (see fig. 15a), coupled to the processing unit (see [0143]-[0145], the elements are functionally coupled together) and configured to infuse the medical fluid into the drug infusion member (see [0153], driving of the motor causes doses of medical fluid to be delivered), wherein the sensing module is configured to sense a current number of revolutions of the motor (see at least [0009], [0074], and [0108], the motor and sensing module include use of a rotary encoder); wherein, when the current number of revolutions is smaller than or equal to a first predetermined number of revolutions, the processing unit determines that the drug delivery device is in an injection-in-progress stage (see at least [0009], [0117], [0153], and [0155]-[0158], the number of motor pulses can be lower than the calculated number, which is the one more than the claimed predetermined number, during the delivery time); wherein, when the current number of revolutions is larger than the first predetermined number of revolutions, the processing unit determines that the drug delivery device is in a ready-to-stop stage (see at least [0009], [0117], [0153], and [0155]-[0158], once the motor has delivered the calculated number of pulses, the number of revolutions is determined to be complete and the claimed first number of revolutions has been passed, at which point the motor is turned off and the delivery is complete).
Regarding claim 15, Neta as modified discloses the device of claim 14 wherein, when the drug delivery device is in the injection-in-progress stage (see at least [0009], [0117], [0153], and [0155]-[0158]) and the sensing module senses that at least one air bubble exists in the drug infusion member (see at least [0118] and [0142]), the processing unit determines that the drug infusion member is leaking (see at least [01118], [0143], and [0216]).
Regarding claim 16, Neta as modified discloses the device of claim 15 further comprising an alarm unit (screen 41, fig. 4) disposed in the casing (see fig. 4) and coupled to the processing unit (see at least [0121], unit 40 is wirelessly connected to device 10 and thus is wirelessly coupled to the processing unit thereof), wherein, when the processing unit determines that the drug infusion member is leaking, the processing unit controls the alarm unit to send out an alarm (see [0096], leakages cause alarms).
Claim(s) 5-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neta et al. (US 20130237955, henceforth Neta) in view of Yigal et al. (US 20200188608, henceforth Yigal) as applied to claim 1 above, and further in view of Dechelette et al. (US 20190167895, henceforth Dechelette).
Regarding claim 5, Neta as modified discloses the device of claim 1. Neta as modified additionally discloses the device wherein the processor is configured to prime the drug infusion member and the injection member prior to use (see [0190]-[0192], air purging is set to occur during calibration before use).
Neta as modified does not disclose the device further comprising a safety detection member movably disposed in the casing, the sensing module being configured to sense a status of the safety detection member, wherein, when the processing unit determines that the safety detection member is hidden in the casing in response to the sensing module, the processing unit controls the medical fluid to be infused into the drug infusion member first and then controls the injection member to be exposed from the casing. Dechelette teaches a device (drug pump 10, fig. 1A) comprising a safety detection member (on-body sensor 24, fig. 1B) movably disposed in a casing (see [0051], sensor 24 can be displaced between an initial position and an actuated position), wherein a sensing module is configured to sense a status of the safety detection member (see [0051], power and control system 400 monitors the status of sensor 24), and wherein, when the safety detection member is sensed to be in the housing such that the device is properly attached to the patient, the processing unit controls a fully prepared injection member to be exposed from the casing and inserted into the patient (see [0053] and [0054], the ready to start status isn’t achieved until sensor 24 is activated as the device being on the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the on-body sensor functionality of Dechelette to the modified device of Neta for preventing premature activation of the device as in Dechelette ([0051]).
Further, it would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Neta to have followed the same sequencing and activation as in Dechelette to have yielded the full safety benefits of the added on-body sensor of Dechelette, such as configuring the processor to not allow for the needle of Neta as modified to have been inserted until the on-body sensor of Dechelette has been sensed to have been fully inserted into the housing such that the device is assembled onto the skin of the patient, as this is what allows for the on-body sensor of Dechelette to provide its safety benefit.
Regarding claim 6, Neta as modified by Yigal and Dechelette (henceforth Neta as modified) discloses the device of claim 5 wherein, when the processing unit determines that the safety detection member is exposed from the casing in response to the sensing module (this is a state where the on-body sensor of Dechelette has not been actuated as shown in Dechelette fig. 1B), the processing unit controls the injection member to be hidden in the casing (see the modification made above in claim 5).
Regarding claim 7, Neta as modified discloses the device of claim 5 wherein, when the casing is placed on an object (see fig. 6A, the object is the skin of the patient P) and the safety detection member faces the object (see Dechelette fig. 1B, the on-body sensor 24 is arranged such that it is on the skin-facing surface of the device 10, and thus it faces the skin which is the object from Neta), the object forces the safety detection member to be hidden in the casing (see at least Dechelette [0051] and [0054], on-body sensor is pressed in to allow for its activation in the embodiment where it is a mechanical switch, which is the chosen embodiment; this inward pressing is a hiding of at least a portion of sensor 24 to be hidden in the casing as claimed).
Regarding claim 8, Neta as modified discloses the device of claim 7 wherein, when the casing moves away from the object (this is the state shown in Dechelette fig. 1B, the device is moved away from the object and sensor 24 is exposed), the safety detection member is automatically exposed from the casing (see Dechelette fig. 1B; this is the same arrangement of the modified device of Neta).
Regarding claim 9, Neta as modified discloses the device of claim 5 wherein the safety detection member surrounds the injection member (see Yigal fig. 6).
Regarding claim 10, Neta as modified discloses the device of claim 9 wherein, when the casing moves away from the object (this is the state shown in Dechelette fig. 1B, the device is moved away from the object and sensor 24 is exposed), the safety detection member is automatically exposed from the casing (see Dechelette fig. 1B; this is the same arrangement of the modified device of Neta) and self-locked (see [0051], the sensor 24 is part of a mechanical lock and is thus considered to be self-locked as claimed).
Regarding claim 11, Neta as modified discloses the device of claim 5 wherein the sensing module comprises at least one optical sensor (optical rotary encoder as in [0108]) configured to sense an amount of light related to at least one of the drug infusion member (see [0108] and see [0143], since the optical rotary encoder is to measure the revolutions of the motor of drug dispensing unit 10 which is the drug infusion member, the optical sensor is configured as claimed), the injection member and the safety detection member.
Regarding claim 12, Neta as modified discloses the device of claim 5 wherein the sensing module comprises an optical sensor (optical rotary encoder as in [0108]), and the drug infusion member, the safety detection member and the injection member are arranged along an optical axis of the optical sensor (see fig. 8, the optical axis of the encoder extends in a line between 132a and 132b through the middle of reusable part 100; in the modified device, the replaced needle of Yigal is still maintained on the disposable part 200, and thus it is capable of being aligned along the optical axis when the two parts are separated as shown in fig. 9a; in the modified device, the safety detection member is integrated into the case, and thus when it is retracted into the case due to being pressed against the patient, it is considered to be arranged along and aligned with the optical axis since it extends along the same plane that the axis lies in, and should the member be arranged on the disposable side, which would be the more obvious choice of the two options for one of ordinary skill in the art since it would be directly tied to the injection member which is on the disposable side, it could also be arranged directly along the axis when the parts are separated as in fig. 9a).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neta et al. (US 20130237955, henceforth Neta) in view of Yigal et al. (US 20200188608, henceforth Yigal) and Dechelette et al. (US 20190167895, henceforth Dechelette) as applied to claim 5 above, and further in view of Argersinger et al. (US 20210338931, henceforth Argersinger).
Regarding claim 13, Neta as modified discloses the device of claim 5 wherein the sensing module comprises an optical sensor (optical rotary encoder as in [0108]) where the drug infusion member is arranged along an optical axis of the optical sensor (see fig. 8, the optical axis of the encoder extends in a line between 132a and 132b through the middle of reusable part 100 and thus the elements are arranged as claimed). Neta as modified additionally discloses the use of an electronic sensing system for the on-body sensor of Dechelette (see Dechelette at [0051], the sensor can be an electromechanical sensor which combines mechanical movement and electric sensing).
Neta as modified does not disclose the device comprising a second optical sensor, and where the safety detection member and the injection member are arranged along an optical axis of the second optical sensor. Argersinger teaches using an optical sensor as an element detector (see [0061], light is reflected off of a reflected surface thus providing a determination of whether or not the element is present in the needed position) and for detecting bubbles flowing along an infusion fluid flow path ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an optical sensor for bubble detection at the downstream most point of the fluidic path as in Argersinger for the benefit of allowing for additional confirmations of initial bubble findings, detect speed, detect bubble volume, and confirm bubble volume as in Argersinger ([0047]).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the reflective surface of the optical sensor of Argersinger (see reflective surface 802 of fig. 8 and see [0061]) to be located on the safety detection member of Neta as modified such as to allow for the light to be reflected – and thus to allow for the sensor to work only when the device is activated as a result of the safety detection member being activated – within the optical sensor only when the safety detection member has been properly activated since Dechelette teaches the safety detection member to be obvious to arrange in electromechanical sensors involving both moving parts and electrical sensing arrangements (see Dechelette [0051]).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neta et al. (US 20130237955, henceforth Neta) in view of Yigal et al. (US 20200188608, henceforth Yigal) as applied to claim 14 above, and further in view of Argersinger et al. (US 20210338931, henceforth Argersinger).
Regarding claim 17, Neta as modified discloses the device of claim 14 wherein, when the drug delivery device is in the ready-to-stop stage (see rejection of claim 14), the sensing module is configured to sense that at least one air bubble exists in the drug infusion member (see [0160] and [0161], flow detection, which includes detection of air bubbles, continues after a dose has been delivered).
Neta as modified does not disclose the device wherein, when the drug delivery device is in the ready-to-stop stage and the sensing module is senses that at least one air bubble exists in the drug infusion member, the processing unit determines whether a percentage of the at least one air bubble to the medical fluid within a time period is larger than a threshold; wherein, when the percentage of the at least one air bubble to the medical fluid within the time period is larger than the threshold, the processing unit determines that an injection process of the drug delivery device has been completed and controls the motor to stop. Argersinger teaches detection of air bubbles in a fluid delivery path including once the pump has reached a set amount of motor turns for the prescribed dose (see [0028]-[0030]) and to determine if a bubble is expected due to a relative proportion between the amount of fluid delivered and the amount of the bubble, as Argersinger teaches that the presence of a bubble while the amount of fluid is not equal to the total dose of fluid to be delivered (or too high of a percentage of bubble-to-fluid) is indicative of a dangerous bubble, while an elongated bubble with a fully delivered dose of fluid (or a percentage below the danger threshold) is indicative of an empty reservoir and a completed dose such that the motor can stop turning (see Argersinger [0028]-[0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the bubble detection logic of Argersinger in the modified device of Neta for automatically determining if the reservoir is empty and if the bubble requires an immediate alarm or a completion of a delivered dose as this allows for automation of monitoring of the reservoir as opposed to the patient being required to observe the status of the reservoir (see Argersinger [0027]-[0030]).
Regarding claim 18, Neta as modified by Yigal and Argersinger discloses the device of claim 17 wherein, when the percentage of the at least one air bubble to the medical fluid within the time period is smaller than or equal to the threshold (see Argersinger [0028]-[0029], this is the scenario of a bubble not related to an end of dose), the motor continues to operate until the current number of revolutions reaches a second predetermined number of revolutions (see Argersinger [0028]-[0030], this is disclosed in the modified device where the motor is configured to adjust for the missed revolutions because of the bubble, see also Argersinger [0051]); the second predetermined number of revolutions is larger than the first predetermined number of revolutions (the second number of revolutions is higher than the first number of revolutions by the amount of revolutions which did not deliver fluid as a result of the bubble, see at least Argersinger [0051]).
Regarding claim 19, Neta as modified discloses the device of claim 14 wherein the sensing module comprises an optical sensor (optical rotary encoder as in [0108]) wherein a rotating portion of the motor (rotating pinion 133, fig. 8) is arranged along an optical axis of the optical sensor (see fig. 8, the optical axis stretches between 132a and 132b and pinion 133 is located along the axis between these elements as claimed).
Neta as modified does not disclose the device comprising a second optical sensor where the drug infusion member is arranged along an optical axis the second optical sensor. Argersinger teaches using an optical sensor for detecting bubbles flowing along an infusion fluid flow path ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an optical sensor for bubble detection at the downstream most point of the fluidic path as in Argersinger for the benefit of allowing for additional confirmations of initial bubble findings, detect speed, detect bubble volume, and confirm bubble volume as in Argersinger ([0047]).
Claim(s) 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neta et al. (US 20130237955, henceforth Neta) in view of Argersinger et al. (US 20210338931, henceforth Argersinger).
Regarding claim 20, Neta discloses a drug delivery device (combination of patch unit 10, cradle 20, and remote control 40 as in fig. 4) comprising: a casing (housings 115 and 215, fig. 8, cradle 20, fig. 6a, and the outer shell of remote control unit 40, fig. 4); a drug infusion member (drug dispensing unit 10, fig. 5) disposed in the casing (see fig. 5, the contents of drug dispensing unit 10 are disposed within housings 115 and 215); a motor (motor 188, fig. 15a) disposed in the casing (see fig. 15a) and configured to infuse a medical fluid into the drug infusion member (see [0153], driving of the motor causes doses of medical fluid to be delivered); a sensing module (disclosed detectors of [0107]-[0112]) disposed in the casing (see [0107]-[0112], each of the described elements is within housings 115 and 215) and configured to sense a status of the drug infusion member (see [0107]-[0112], the detectors are used to sense statuses of various aspects of drug dispensing unit 10 as disclosed including flow rates through and presence of bubbles in unit 10) and sense a current number of revolutions of the motor (see at least [0009], [0074], and [0108], the motor and sensing module include use of a rotary encoder); and a processing unit (processor of [0053]) disposed in the casing (see [0053], the processor is in the disclosed reusable part which is housed by housing 115 as in [0143]) and coupled to the motor (see [0143]-[0145], the elements are functionally coupled together) and the sensing module (see at least [0053], [0094], and [0113], the elements are functionally coupled); wherein, when the current number of revolutions is larger than a first predetermined number of revolutions, the processing unit determines that the drug delivery device is in a ready-to-stop stage (see at least [0009], [0117], [0153], and [0155]-[0158], once the motor has delivered the calculated number of pulses, the number of revolutions is determined to be complete and the claimed first number of revolutions, which is one less than the calculated number of revolutions, has been passed, at which point the motor is turned off and the delivery is complete); wherein, when the drug delivery device is in the ready-to-stop stage (see rejection of claim 14), the sensing module is configured to sense that at least one air bubble exists in the drug infusion member (see [0160] and [0161], flow detection, which includes detection of air bubbles, continues after a dose has been delivered).
Neta does not disclose the device wherein, when the drug delivery device is in the ready-to-stop stage and the sensing module is senses that at least one air bubble exists in the drug infusion member, the processing unit determines whether a percentage of the at least one air bubble to the medical fluid within a time period is larger than a threshold; wherein, when the percentage of the at least one air bubble to the medical fluid within the time period is larger than the threshold, the processing unit determines that an injection process of the drug delivery device has been completed and controls the motor to stop. Argersinger teaches detection of air bubbles in a fluid delivery path including once the pump has reached a set amount of motor turns for the prescribed dose (see [0028]-[0030]) and to determine if a bubble is expected due to a relative proportion between the amount of fluid delivered and the amount of the bubble, as Argersinger teaches that the presence of a bubble while the amount of fluid is not equal to the total dose of fluid to be delivered (or too high of a percentage of bubble-to-fluid) is indicative of a dangerous bubble, while an elongated bubble with a fully delivered dose of fluid (or a percentage below the danger threshold) is indicative of an empty reservoir and a completed dose such that the motor can stop turning (see Argersinger [0028]-[0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the bubble detection logic of Argersinger in the modified device of Neta for automatically determining if the reservoir is empty and if the bubble requires an immediate alarm or a completion of a delivered dose as this allows for automation of monitoring of the reservoir as opposed to the patient being required to observe the status of the reservoir (see Argersinger [0027]-[0030]).
Regarding claim 21, Neta as modified by Argersinger (henceforth Neta as modified) discloses the device of claim 20 wherein, when the percentage of the at least one air bubble to the medical fluid within the time period is smaller than or equal to the threshold (see Argersinger [0028]-[0029], this is the scenario of a bubble not related to an end of dose), the motor continues to operate until the current number of revolutions reaches a second predetermined number of revolutions (see Argersinger [0028]-[0030], this is disclosed in the modified device where the motor is configured to adjust for the missed revolutions because of the bubble, see also Argersinger [0051]); the second predetermined number of revolutions is larger than the first predetermined number of revolutions (the second number of revolutions is higher than the first number of revolutions by the amount of revolutions which did not deliver fluid as a result of the bubble, see at least Argersinger [0051]).
Regarding claim 22, Neta as modified discloses the device of claim 20 wherein, when the current number of revolutions is smaller than or equal to the first predetermined number of revolutions, the processing unit determines that the drug delivery device is in an injection-in-progress stage (see at least [0009], [0117], [0153], and [0155]-[0158], the number of motor pulses can be lower than the calculated number, which is the one more than the claimed predetermined number, during the delivery time); wherein, when the drug delivery device is in the injection-in-progress stage (see at least [0009], [0117], [0153], and [0155]-[0158]) and the sensing module senses that the at least one air bubble exists in the drug infusion member (see at least [0118] and [0142]), the processing unit determines that the drug infusion member is leaking (see at least [01118], [0143], and [0216]).
Regarding claim 23, Neta as modified discloses the device of claim 20 further comprising an alarm unit (screen 41, fig. 4) disposed in the casing (see fig. 4) and coupled to the processing unit (see at least [0121], unit 40 is wirelessly connected to device 10 and thus is wirelessly coupled to the processing unit thereof), wherein, when the processing unit determines that the drug infusion member is leaking, the processing unit controls the alarm unit to send out an alarm (see [0096], leakages cause alarms).
Regarding claim 24, Neta as modified discloses the device of claim 20 wherein the sensing module comprises an optical sensor (optical rotary encoder as in [0108]) wherein a rotating portion of the motor (rotating pinion 133, fig. 8) is arranged along an optical axis of the optical sensor (see fig. 8, the optical axis stretches between 132a and 132b and pinion 133 is located along the axis between these elements as claimed).
Neta as modified does not disclose the device comprising a second optical sensor where the drug infusion member is arranged along an optical axis the second optical sensor. Argersinger teaches using an optical sensor for detecting bubbles flowing along an infusion fluid flow path ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an optical sensor for bubble detection at the downstream most point of the fluidic path as in Argersinger for the benefit of allowing for additional confirmations of initial bubble findings, detect speed, detect bubble volume, and confirm bubble volume as in Argersinger ([0047]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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