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 .
Election/Restrictions
Applicant’s election with traverse of claims 1-9 in the reply filed on April
30, 2025 is acknowledged. The traversal to the restriction between the inventive groups is on the ground(s) that if the Examiner finds the invention of claims 1-9, there is more than likely a disclosure of a method of using the apparatus as described in the invention of claims 10-12. This is not found persuasive because the apparatus of claims 1-9 can be used in a materially different process of using that product.
The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable by Kamen et al. (WO 2014100658 A1) in view of Barts Health Education Academy (https://www.youtube.com/watch?v=sokeIbE-EdA).
Regarding claim 1, Kamen et al. discloses an infusion device (Fig. 1, system 1) comprising:
a pump (Fig. 86, pump 50200) configured to be connected to a container (Fig. 86, syringe of pump 50200), and to deliver a fluid from the container (para. 00656) during at least a therapy delivery mode (para. 00545, pump infusing VTBI into a patient) and a stand-by delivery mode (para. 00545, pump in a keep-vein-open mode);
an audible alarm (Fig. 83, para. 00600, the audio server process 4370) and a plurality of visible indicators (Fig. 86, para. 00635, the indicator light 50260 contains a plurality of embedded LED lights); and
a pump controller (Fig. 83, user interface processor 3600 and real time processor 3500) coupled to the pump, the audible alarm, and the plurality of visible indicators (Fig. 83, para. 00463, para. 00638),
the pump controller configured to operate the pump in the therapy delivery mode or the stand-by delivery mode (Fig. 83, para. 00618), and to actuate the audible alarm and the plurality of visible indicators (Fig. 83, para. 00463, para. 00638),
wherein the pump controller is configured to actuate the first set of visible indicators in the therapy delivery mode and the stand-by delivery mode (para. 00545, para. 00635), and to actuate the second set of visible indicators and the audible alarm at an end of the therapy delivery mode and at intervals during the stand-by delivery mode (para. 00545, para. 00635).
Kamen et. al does not explicitly state the plurality of visible indicators comprising at least a first set of visible indicators, a second set of visible indicators, and a third set of visible indicators.
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Kamen et al. discloses the claimed invention except for the three sets of visible indicators. It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to duplicate the lights within the visible indicator (Fig. 86, para. 00635, indicator light 50260 comprises a plurality of LED lights) to include a first set of visible indicators (a first set of lights within the plurality of LED lights of the indicator light 50260), a second of visible indicators (a second set of lights within the plurality of LED lights of the indicator light 50260), and a third set of visible indicators (a third set of lights within the plurality of LED lights of the indicator light 50260), since it has been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motivated to duplicate the LED lights of Kamen et al. for the purpose of providing relief lights in the case that another light within the set fails to illuminate.
Kamen et al. does not explicitly state wherein the pump controller is configured to and to actuate the third set of visible indicators during the stand-by delivery mode when the second set of visible indicators is deactivated (para. 00635).
However, Barts Health Education Academy teaches an infusion device (Fresenius Kabi Agilia SP Syringe Pump, 0:13-0:21) containing a first set of visible indicators (see Fig. 1 below, 9:47-10:45), a second set of visible indicators (see Fig. 2 below, 9:47-10:45), and a third set of visible indicators (see Fig. 3 below, 9:47-10:45). The device is in a stand-by delivery mode when the pump is not delivering the volume-to-be-infused (VTBI, see 8:37-9:46).The third set of visible indicators is actuated during the stand-by delivery mode when the second set of visible indicators is deactivated (see Fig. 3 below, 9:47-10:45).
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Fig. 1: infusion device with first set of visible indicators actuated
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Fig. 2: infusion device with second set of visible indicators actuated
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Fig. 3: infusion device with third set of visible indicators actuated
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pump controller of Kamen et al. to be configured to actuate the third set of visible indicators during the stand-by delivery mode when the second set of visible indicators is deactivated, as taught by Barts Health Education Academy, in order to notify the user that the infusion session is near its end (10:40-10:45).
Regarding claim 2, Kamen et al. discloses the infusion device according to claim 1,
further comprising an input device (Fig. 84, para. 00633, silence button 50710) coupled to the pump controller (para. 00463), wherein the pump controller is configured to deactivate the audible alarm when the input device is actuated and for an interval of time thereafter (see para. 00463, para. 00633, para. 00619).
Kamen et al. does not explicitly state wherein the pump controller is configured to deactivate the second set of visible indicators when the input device is actuated and for an interval of time thereafter.
However, Barts Health Education Academy teaches an infusion device (Fresenius Kabi Agilia SP Syringe Pump, 0:13-0:21) containing a first set of visible indicators (see Fig. 1 above, 9:47-10:45), a second set of visible indicators (see Fig. 2 above, 9:47-10:45), and a third set of visible indicators (see Fig. 3 above, 9:47-10:45). When a user presses on the input device (silence alarm button, see Fig. 4 below, 9:47-10:45), the second set of visible indicators is deactivated (15:30-16:45).
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Fig. 4: infusion device with “silence alarm” button circled
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pump controller of Kamen et al. to be configured to deactivate the second set of visible indicators when the input device is actuated and for an interval of time thereafter, as taught by Barts Health Education Academy, in order to silence the visual alarm (15:30-16:45).
Regarding claim 3, the modified device of Kamen et al. in view of Barts Health Education Academy discloses the infusion device according to claim 1,
wherein the plurality of visible indicators comprises a plurality of light emitting diodes (LED) (Kamen et al., para. 00635), and the first set of visible indicators are green LEDs (Kamen et al., para. 00635), the second set of visible indicators are red LEDs (Kamen et al., para. 00635), and the third set of visible indicators are yellow LEDs (Kamen et al., para. 00635).
Regarding claim 4, the modified device of Kamen et al. in view of Barts Health Education Academy discloses the infusion device according to claim 1,
wherein pump controller actuates the second set of visible indicators to flash on and off at the end of the therapy delivery mode and at intervals during the stand-by delivery mode (Kamen et al., para. 00545, para. 00635).
Regarding claim 5, Kamen et al. fails to teach wherein the plurality of visible indicators comprises a linear array of visible indicators including the first, second, and third sets of visible indicators.
However, Barts Health Education Academy teaches an infusion device (Fresenius Kabi Agilia SP Syringe Pump, 0:13-0:21) containing a first set of visible indicators (see Fig. 1 above, 9:47-10:45), a second set of visible indicators (see Fig. 2 above, 9:47-10:45), and a third set of visible indicators (see Fig. 3 above, 9:47-10:45) all configured in a linear array (see Figs. 1-3 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the visible indicators of Kamen et al. to be arranged in a linear array, as taught by Barts Health Education Academy in order to operate the visible indicators in a traffic light system to alert the user of the pump status (9:47-10:45).
Regarding claim 6, the modified device of Kamen et al. in view of Barts Health Education Academy teaches the infusion device according to claim 5,
further comprising a display screen (Kamen et al., Fig. 86, touchscreen 50240), the linear array of visible indicators being disposed adjacent the display screen (Kamen et al., Fig. 86).
Regarding claim 7, the modified device of Kamen et al. in view of Barts Health Education Academy discloses the infusion device according to claim 1,
wherein the pump comprises a syringe pump (Kamen et al., Fig. 86, pump 50200).
Regarding claim 8, the modified device of Kamen et al. in view of Barts Heath Education Academy discloses the infusion device according to claim 7,
wherein the container comprises a syringe if the pump comprises a syringe pump (Kamen et al., Fig. 86, syringe of pump 50200).
Regarding claim 9, Kamen et al. discloses an infusion device (Fig. 1, system 1) comprising:
a pump (Fig. 86, pump 50200) configured to be connected to a container (Fig. 86, syringe of pump 50200) and to deliver a fluid from the container (para. 00656) in at least a therapy delivery mode (para. 00545, pump infusing VTBI into a patient) and a stand-by delivery mode (para. 00545, pump in a keep-vein-open mode);
an audible alarm (Fig. 83, para. 00600, the audio server process 4370) and a plurality of visible indicators (Fig. 86, para. 00635, the indicator light 50260 contains a plurality of embedded LED lights); and
a pump controller (Fig. 83, user interface processor 3600 and real time processor 3500) coupled to the pump, the audible alarm, and the plurality of visible indicators (Fig. 83, para. 00463, para. 00638), and configured to:
operate the pump in a therapy delivery mode to deliver fluid from the container (Fig. 83, para. 00545, para. 00618, pump infusing VTBI into a patient),
end the therapy delivery mode and actuate the audible alarm (para. 00545), and
operate the pump in a stand-by delivery mode to deliver fluid from the container (para. 00545, pump in a keep-vein-open mode).
Kamen et. al does not explicitly state the plurality of visible indicators comprising at least a first set of visible indicators, a second set of visible indicators, and a third set of visible indicators.
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Kamen et al. discloses the claimed invention except for the three sets of visible indicators. It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to duplicate the lights within the visible indicator (Fig. 86, para. 00635, indicator light 50260 comprises a plurality of LED lights) to include a first set of visible indicators (a first set of lights within the plurality of LED lights of the indicator light 50260), a second of visible indicators (a second set of lights within the plurality of LED lights of the indicator light 50260), and a third set of visible indicators (a third set of lights within the plurality of LED lights of the indicator light 50260), since it has been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motivated to duplicate the LED lights of Kamen et al. for the purpose of providing relief lights in the case that another light within the set fails to illuminate.
Kamen et al. does not explicitly state that the pump controller is configured to:
operate the pump in a therapy delivery mode to deliver fluid from the container and actuate the first set of visible indicators,
end the therapy delivery mode and actuate the audible alarm and the first and second sets of visible indicators,
operate the pump in a stand-by delivery mode to deliver fluid from the container and actuate the first and third sets of visible indicators, and
at intervals during operation of the pump in the stand-by delivery mode, deactivate the third set of visible indicators and actuate the audible alarm and the second set of visible indicators.
However, Barts Health Education Academy teaches an infusion device (Fresenius Kabi Agilia SP Syringe Pump, 0:13-0:21) containing a first set of visible indicators (see Fig. 1 above, 9:47-10:45), a second set of visible indicators (see Fig. 2 above, 9:47-10:45), and a third set of visible indicators (see Fig. 3 above, 9:47-10:45). The first set of visible indicators are actuated during the therapy delivery mode (green lights are on while delivering the bolus, 8:37-9:45), the first and second sets of visible indicators are actuated at the end of the therapy delivery mode (green and yellow lights are actuated during “Near end of infusion” alarm, 9:47-10:45), the first and third sets of visible indicators are actuated during the stand-by delivery mode (green and yellow lights are actuated during “Drug X” delivery mode, 9:47-10:45), and at intervals during operation of the pump in the stand-by delivery mode, deactivate the third set of visible indicators and actuate the audible alarm and the second set of visible indicators (the red lights and the audible alarm are actuated when the “End in” timer on the display reaches zero during the “Drug X” delivery mode, 9:47-10:45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pump controller of Kamen et al. to be configured to actuate the sets of visible indicators at specific time intervals during the therapy delivery mode and stand-by delivery mode, as taught by Barts Health Education Academy, in order to alert the user of changes in pressure, battery life, or pump status (9:47-10:45).
Response to Amendment
Applicant has amended claims 4, 6 and 9 which were previously objected to; Examiner accordingly withdraws the objections of claims 4, 6 and 9.
Applicant has amended Fig. 4 which was previously objected to; Examiner accordingly withdraws the drawing objection of Fig. 4.
Response to Arguments
Applicant’s argument filed on 04/30/2025 have been fully considered but they are not found persuasive.
Applicant has argued that Kamen does not teach the device as claimed since Kamen does not actuate a first set of visible indicators in a therapy delivery mode and a stand-by delivery mode, and a second set of visible indicators and audible alarm at end of the therapy mode and at intervals during the stand-by delivery mode. Examiner respectfully disagrees. Kamen teaches in Para. [00635] indicator light 50260 may blink or maybe a specific color (e.g., red, blue, green, yellow, etc.) when the pump 50200 is running and may be continuously on when the pump 50200 is not running or is in a standby state. Kamen further teach a visible indicator associated with the standby/KVO mode. See Para. [00549], which recites: “syringe pump 500 may be configured issue a "VTBI ZERO ALERT" and drop the infusion rate to a KVO rate after completing the intermittent infusion.” Applicant’s specification, at Para. [0014] and [0015] indicates that a keep vein open mode (KVO) corresponds to a standby mode, thus Para. [00545] of Kamen teaches KVO/standby mode. In Para. [00545] it is disclosed that the “VTBI ZERO ALERT” may be in the form of a message on GUI 3300 which uses screen 3204 as a visual display, as further disclosed in Para. [00506]. Kamen also teaches that the message on GUI 3300 may be accompanied by flashing lights and audible noises such as beeps in Para. [00545]. Further, Barts Health Education Academy (youtube video) taught three sets of visible indicators as seen in annotated Fig. 1-4 above. It is noted that Barts Health Education Academy also teaches audible alarm noises accompanying with the display of the visible indicators in the video. Examiner maintains the indicator light 50260 and GUI 3300 with screen 3204 of Kamen, and the three visible indicators taught by Barts Health Education Academy satisfy the first set, second set and third set of visible indicators as required by claim 1 and 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Laurence et al. (WO 2017093803 A1) is considered relevant prior art with regards to using similar audible alarms and/or light indicators as status indicators.
Agard et al. (US 9814832 B2) is considered relevant prior art with regards to using status indication features such as piezo alarms and/or light indicators to provide feedback to user before, during and after drug delivery.
Mazlish et al. (US 20170199985 A1) is considered relevant prior art with regards to using a plurality of LED indicators adapted to inform the user of certain conditions.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday - Friday 8 am - 5 pm, EST.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783