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.
Claims 1, 5, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”).
In relation to independent claim 1, Layman discloses an infusion-pump power management system having a rechargeable battery, charger control, battery temperature sensing, and runtime calculation. Layman states that “the present invention is directed to a power management system that automatically manages the power supplied to a biomedical device,” that “[t]he system includes a rechargeable battery,” and that the system “automatically controls battery charging and provides a display of time remaining for biomedical device battery operation based on the current power requirements of the biomedical device” (Layman; col. 2, lines 38-46). Layman further discloses that “the power management system 28 is incorporated in a biomedical device; i.e., a medical infusion pump 10” (Layman, col. 4, lines 12-14). Layman also teaches a battery-associated environmental condition because “[t]he power management system further comprises a temperature sensor for producing a temperature signal representative of the temperature of the battery and controls the charger in response to the temperature sensor so that the battery temperature remains within predetermined limits” (Layman, col. 3, lines 5-9). Layman does not expressly disclose switching an infusion-device operating mode to reduce power after a monitored battery-associated environmental value exceeds a threshold. Layman teaches battery temperature sensing and charger control, but not the claimed reduced-power mode switch. However, Gibson confirms that a drug delivery system may change operating state based on temperature of the drug or a temperature-sensitive component. It states that a drug delivery system includes a reservoir, drug delivery device, lock, temperature sensor, output device, and controller, and that the controller determines whether drug temperature exceeds an upper limit or is below a lower limit and then activates the output device and places the lock in the locked state (Gibson ¶ [0006]). Gibson further teaches that a temperature sensitive component may be a battery: “According to such an embodiment, at least one temperature-sensitive component 114 may be a battery.” (Gibson ¶ [0040].)
Lippert teaches the reduced-power mode itself, stating: “[i]f the battery discharge current exceeds a warning threshold current, the power consumption manager commands one or more selected information handling system components to enter a reduced power consumption mode so that current drawn from the battery remains at least a predetermined margin below maximum current discharge capacity of the battery.” (Lippert ¶ [0010].)
Aeschlimann further teaches infusion pump power-source threshold monitoring, stating that the voltage supervisor responds when processor supply voltage drops to “a predetermined response voltage level” (Aeschlimann ¶ [0007]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Layman’s infusion pump battery-temperature management with Gibson’s teaching of locking/limiting drug delivery based on drug or battery temperature, and Lippert’s reduced-power response. The references address predictable safety concerns in powered medical delivery systems: battery temperature, battery capacity, and continued safe delivery. Therefore, a person of ordinary skill would have been motivated to reduce power or limit operation when battery temperature or power conditions exceed safe thresholds to avoid unsafe operation, battery failure, or therapy interruption.
In relation to independent claim 11, as discussed above, Layman discloses a method and system for infusion pump power management, including battery temperature sensing and charger control. It states that the system “automatically manages the power supplied to a biomedical device,” includes “a rechargeable battery,” and includes “a temperature sensor for producing a temperature signal representative of the temperature of the battery” (Layman, col. 2, lines 38-46; col. 3, lines 5-7). Layman does not expressly disclose the method step of switching an operation mode to reduce power in response to threshold exceedance. However, Gibson discloses temperature-threshold-based operating control, including activating an output device and placing a lock in a locked state when temperature exceeds an upper limit or is below a lower limit (Gibson ¶¶ [0006], [0040]). Moreover, Lippert teaches the reduced power switching response when battery discharge exceeds a warning threshold (Lippert ¶ [0010]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement the method using the same combination for claim 1 because applying a reduced-power or locked mode after detecting unsafe battery or temperature conditions would have predictably protected an infusion device from unsafe power and temperature operation.
In relation to claims 5 and 14, as discussed above, Layman in view of Gibson, Lippert, and Aeschlimann teaches the limitations of independent claims 1 and 11. For the additional dependent limitations, Gibson also discloses temperature-threshold control of a drug delivery system. Gibson states that the system includes a reservoir, drug delivery device, lock, temperature sensor, output device, and controller; the controller determines whether the drug temperature exceeds an upper limit or is below a lower limit, activates the output device, and places the lock in the locked state (Gibson ¶ [0006]). Gibson also discloses operation based on temperature of a temperature-sensitive component, and states that “at least one temperature-sensitive component 114 may be a battery” (Gibson ¶ [0040]).
Gibson discloses locking or limiting drug delivery based on temperature but does not expressly disclose reducing power provided by the battery to a hardware component as the mode-switch
mechanism. However, Lippert discloses component-level reduced-power operation, stating that “[i]f the battery discharge current exceeds a warning threshold current, the power consumption manager commands one or more selected information handling System components to enter a reduced
power consumption mode” (Lippert ¶ [0010]) and Layman supplies infusion pump battery-temperature and charger-control context (Layman, col. 2, lines 38–46, col. 4, lines 12-14, and col. 3, lines 5-9).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement Gibson’s temperature-based lock/limited-delivery response by reducing or disconnecting battery power to selected hardware components, as taught by Lippert, because both techniques predictably reduce unsafe operation when a temperature-sensitive battery or device component is outside safe limits.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Eggers et al. (US 5713856; hereinafter “Eggers”).
In relation to claims 2 ands 12, as discussed above, the combination of Layman in view of Gibson, Lippert, and Aeschlimann teaches the limitations of independent claims 1 and 11. For the additional dependent limitation, Layman also discloses threshold-based battery and temperature management in an infusion pump. Layman explicitly states: “[w]hen the ambient temperature exceeds a predetermined threshold, a hot charge mode is used to fully charge the battery” (Layman, col. 2, lines 55-57). Layman does not expressly disclose determining the predetermined threshold based on a care area or a patient medical condition. However, Eggers teaches care-area/patient condition-based deployment of patient-care interface units, stating that “advanced interface units 100 may be assigned to areas in the hospital, such as intensive care units,” and that general wards may use basic interface units for patients “whose condition is no longer critical” (Eggers, col. 7, lines 46–48 and lines 51-54).
Aeschlimann teaches adaptive threshold selection because “[t]he response voltage level may be adaptive and be selected, for example, in dependence of the power source type, the temperature, and further factors.” (Aeschlimann ¶ [0029].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to include care area and patient condition among the “further factors” for setting an infusion-device threshold because Eggers teaches that device functionality and safety requirements differ between
intensive care and general care settings.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Zhu (US 20170252512A1).
In relation to claim 3, Layman does not expressly disclose the word “thermometer” and to the extent that term is construed as a particular type of temperature-measuring component, that implementation is not expressly named. However, Gibson discloses that “the temperature sensor comprises at least one of a resistance temperature detector, a thermocouple, an infrared thermopile, and an assembly comprising a thermally-sensitive label and an optical detector” (Gibson, claim 11). Zhu also discloses infusion-pump temperature sensing, stating that “a temperature sensor is included among the sensors 20” (Zhu ¶ [0045]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement Layman’s temperature sensor as a known thermometer/temperature-sensor structure, such as the RTD, thermocouple, or infrared thermopile taught by Gibson, because these are predictable temperature-sensing implementations in medical delivery systems.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Kamen et al. (CA3148154A1; hereinafter “Kamen”) and Zhu (US 20170252512A1).
In relation to claims 4 and 13, as discussed above, the combination of Layman in view of Gibson, Lippert, and Aeschlimann teaches the limitations of independent claims 1 and 11. For the additional dependent limitations, Kamen discloses an electronic patient-care system that interacts with an infusion pump, receives operating parameters, detects abnormalities, and responds by stopping or altering infusion and alerting caregivers. Kamen states on page 3, lines 5-10: “[i]n the case of an infusion pump, the first module or another connected module may provide the infusion pump with patient-treatment parameters, such as infusion settings including an infusion rate or infusion pressure, and receive from it various operating parameters, such for example, the presence of air in the infusion line, the amount of solution remaining in an IV bag to which it is connected, or the pressure of fluid in the infusion line.” Kamen further states on page 3, starting in line 10: “[i]f the operating parameters are found to be abnormal, the first module may be configured to respond by signaling the infusion pump to halt infusion, respond by signaling a mechanical occlude to occlude the IV line, alter the infusion rate, and/or alert a health care provider or others of the abnormality.” Kamen also discloses starting on page 113, last paragraph, fault threshold power response, stating that if current to a device connector “exceeds a predetermined threshold or is otherwise out of specification,” the safety processor signals circuitry “to disengage the power supplied from the primary battery 1462 to the device connector 1438.” Kamen does not expressly state that battery/environmental monitoring is performed specifically after the hardware error threshold is detected. Kamen teaches abnormal hardware/operating-parameter response and environmental sensors, but not the exact sequential relationship recited in the claims 4 and 13. However, Rodman discloses collecting operational data including “battery temperature,” “battery Voltage,” “battery capacity,” and “alarm threshold.” (Rodman ¶ [0031].) Additionally, Laymen discloses battery-temperature monitoring in an infusion pump using “a temperature sensor for producing a temperature signal representative of the temperature of the battery” (Laymen, col. 3, lines 5-7).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to monitor battery temperature, voltage, and capacity after abnormal infusion-pump operating parameters or power threshold faults are detected because battery or environmental conditions can cause or contribute to hardware errors. Combining Kamen’s fault response with Rodman’s battery parameter monitoring and Layman’s battery temperature sensing would have predictably improved fault diagnosis and safety.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Jacobson et al. (WO2015109252A1; hereinafter “Jacobson”) and Rodman et al. (US 20110073107A1; hereinafter “Rodman).
In relation to claims 6 and 15, As discussed above, the combination of Layman in view of Gibson, Lippert, and Aeschlimann teaches the limitations of independent claims 1 and 11. For the additional dependent limitations, Jacobson discloses battery-capacity assessment for programmed infusion. Jacobson discloses that “the infusion pump controller performs a battery capacity assessment,” calculates an anticipated power capacity requirement, calculates remaining power capacity, compares them, and determines whether the pump is able to “fully execute the programmed infusion based only on the remaining power capacity” (Jacobson ¶ [0061]). Jacobson does not expressly disclose adjusting a hardware operating parameter to reduce power load and then recalculating sufficiency. However, Lippert discloses reducing power load by changing operating parameters, including “lower clock Speeds or reduced brightness for illumination of displays” (Lippert ¶ [0012]). Layman discloses runtime based on current power requirements (Layman; Abstract). Rodman further teaches collecting battery capacity and controlling device parameters, including “battery temperature,” “battery Voltage,” “battery
capacity,” and “data to change at least one parameter controlling” device operation (Rodman ¶¶ [0031], [0041]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to reduce nonessential operating parameters after determining insufficient battery capacity because the combination predictably extends runtime and allows therapy completion.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Eggers et al. (US5713856; hereinafter “Eggers”), Kamen et al. (CA3148154A1; hereinafter “Kamen”) and Jacobson et al. (WO 2015109252A1; hereinafter “Jacobson”).
In relation to claims 7 and 16, as discussed above, the rejection of claims 5 and 14 incorporates the rejection of independent claims 1 and 11. For the additional limitations, Eggers discloses a modular patient-care system with a central interface unit and multiple functional units. Eggers states that the
invention relates to “a method and apparatus for centrally interfacing with a plurality of individually controlled functional units which provide patient monitoring and therapies” (Eggers, col. 1, lines 6-9). Eggers further states that connectors “provide power and internal communication connections between the advanced interface unit and the functional units” (Eggers, col. 4, lines 31-33). Eggers also teaches
remaining battery capacity/runtime estimation: “[p]ower manager 254 … monitors the remaining capacity of internal power source 262, monitors system power consumption under battery operation, and uses system power consumption and remaining battery capacity to estimate remaining system runtime” (Eggers, col. 6, ll. 49–55). Eggers does not expressly disclose determining insufficiency based on a temperature threshold during programmed therapy and disabling at least one functional unit in response. However, Kamen discloses modular infusion-pump systems [functional units], stating that “modular infusion pumps 2906, 2908, 2910 are shown as docked into the device dock 2904” (Kamen, page 118, lines 6-7) and that a tablet or user can select specific modular infusion pumps for control (Kamen, page 118, lines 10-17). Jacobson discloses the programmed-infusion battery sufficiency determination. (Jacobson ¶ [0067].) Layman supplies battery-temperature monitoring (Layman, col. 3, ll. 5–10). Lippert discloses component-level reduction/power-off (Lippert ¶ [0020]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to disable or power down at least one functional unit in a modular infusion system when battery-temperature and programmed-therapy capacity calculations show insufficient power. The combination
predictably preserves essential therapy and reduces unsafe battery load.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Jacobson et al. (WO2015109252A1; hereinafter “Jacobson”).
In relation to claims 8 and 17, as discussed above, the rejection of claims 5 and 14 incorporates the rejection of independent claims 1 and 11. For the additional dependent limitations, Jacobson discloses programmed infusion execution and battery management during therapy. Jacobson states that “the programmed infusion may be executed via the infusion pump 100 and infusion is started” (Jacobson ¶ [0061]). Jacobson further states that recharge may occur “before or during the executed programmed infusion” (Jacobson ¶ [0068]). Jacobson does not disclose that the monitored value is a battery-associated environmental condition, such as battery temperature. However, as explained in detail in the previous rejections, Layman discloses battery temperature monitoring (Layman, col. 3, lines 5-10). Gibson discloses that a temperature-sensitive component may be a battery and that delivery is locked when the component temperature is outside limits (Gibson ¶ [0040]). Aeschlimann discloses battery testing “during normal operation” (Aeschlimann ¶ [0081]). Based on the above teachings, it would have been obvious to monitor battery temperature during or after programmed therapy because battery conditions can change during therapy and affect safe delivery.
Claims 9, 10, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Layman et al. (US 5712795; hereinafter “Layman”) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Lippert et al. (US20040236969A1; hereinafter “Lippert”), and Aeschlimann et al. (US20110060281A1; hereinafter “Aeschlimann”), as discussed above, and in further view of Kamen et al. (CA3148154A1; hereinafter “Kamen”) and Zhu (US 20170252512A1).
In relation to claims 9 and 18, the combination of Layman in view of Gibson, Lippert, and Aeschlimann does not disclose an “amount of light” or the requirement that the alert must be acknowledge before administration resumes. Kamen discloses acknowledgement and infusion-pump alert/control context. Kamen discloses that warnings may be avoided after “the warning has been acknowledged by the user … through an input signal from the user interface” (Kamen, page 2, lines 21-24). Kamen also teaches infusion-pump control, including halting infusion, altering infusion rate, and alerting caregivers when operating parameters are abnormal (Kamen, page 3, starting in line 10). Kamen further discloses environment sensors including “a temperature sensor” and “an ambient light sensor” (Kamen, page 112, lines 6-7). Zhu discloses infusion-pump temperature threshold disablement, stating that “if the ambient temperature is less than 15° C. or greater than 38° C., the infusion pump is disabled” (Zhu ¶ [0045]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to combine Gibson’s temperature-based drug-delivery lock with Kamen’s infusion-pump alert acknowledgement and environmental-sensor teachings because both references address safe administration of medication and prevention of unsafe delivery. A person of ordinary skill would have been motivated to require acknowledgement before resuming administration so that a clinician is made aware that the drug/fluid was exposed to unsafe environmental conditions.
In relation to claims 10 and 19, the combination of Layman in view of Gibson, Lippert, and Aeschlimann does not disclose algorithmic pump-speed adjustment to maintain flow-rate accuracy. However, Zhu discloses software/controller-based pump-speed or pulse-frequency adjustment. Zhu states: “[t]he flow rate and the specified type of administration set are used to calculate a pulse rate
for the pumping device,” and gives the pulse-frequency formula (Zhu ¶ [0027]. Zhu also states: “[t]he pulse frequency is adjusted by the compensation factor such that a new pulse frequency is set according to the equation.” (Zhu¶ [0032].) Zhu explains acceptable error, stating that “an unacceptable level may be determined to be an error of 5%,” and that “the pulse rate of the pump should be adjusted to maintain acceptable accuracy for long-duration pumping” (Zhu ¶ [0030]). Kamen also discloses altering infusion rate in response to abnormal parameters (Kamen, page 115, last line). Based on the above teachings, it would have been obvious to adjust pump speed while responding to a temperature threshold because Gibson teaches temperature-controlled delivery safety and Zhu teaches known controller algorithms for maintaining flow accuracy. The combination would predictably maintain safe and accurate infusion under changed environmental operating conditions.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 20170252512A1) in view of Gibson et al. (WO 2015061389A1; hereinafter “Gibson”), Layman et al. (US 5712795; hereinafter “Layman”), and Lippert et al. (US20040236969A1; hereinafter “Lippert”).
Zhu discloses a controller, memory, processor, and executable instructions in an infusion pump. It states that “the memory 16 stores at least instructions which, when executed, facilitate control of the pumping device 12,” and that “[t]he processor 18 is preferably a microprocessor or other central processing unit capable of executing the instructions stored in the memory 16” (Zhu ¶ [0019]). Zhu does not expressly disclose battery-associated environmental-condition monitoring and reduced power
switching stored as instructions. However, Gibson discloses programmed/controller-based temperature threshold determinations for a drug or temperature-sensitive component, including a battery (Gibson ¶ [0040]). Layman discloses battery temperature monitoring in an infusion pump. (Layman, col. 3, lines 5-10). Lippert discloses reduced-power mode switching when a battery threshold is exceeded (Lippert ¶ [0010]). Based on the above teachings, it would have been obvious to embody battery-temperature monitoring and threshold-triggered reduced-power switching in processor-executed instructions because, as explained above, Zhu already implements infusion-pump control through stored instructions executed by a processor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
Prosecution Insights