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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 02/15/2023 and 06/16/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
“receptacle” (claims 6, 14)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) and/or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-4, 6-9, and 11 are objected to because of the following informalities:
In Claim 1, line 19 and Claim 6, lines 27-28, The language “predetermined operating voltage threshold” should be revised to “predetermined minimum operating voltage threshold”, because the latter term is introduced prior.
In Claim 11, lines 21-22, the language “first predetermined operating voltage threshold” should be revised to “first predetermined minimum operating voltage threshold”.
In Claim 11, lines 26-27, the language “second predetermined operating voltage threshold” should be revised to “second predetermined minimum operating voltage threshold”.
The language “first low battery voltage” should be revised to “first low battery voltage threshold” in the following claims, because the latter term is introduced prior.
Claim 2, line 3
Claim 3, line 2
Claim 4, lines 2-3
Claim 7, line 2
Claim 8, lines 2-3
Claim 9, lines 2-3
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, line 17 recites “the voltage sensor”. There is insufficient antecedent basis for this term in the claims.
Claims 7-10 are further rejected for their dependency on other rejected claims.
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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”) and Imran (US 4,488,555 A).
Regarding independent Claim 1, Guthrie discloses a method (flowchart of Fig. 2) for operating a medical device (“analyte data monitoring unit (DMU) 10”; Fig. 1A; ¶ [22-23]) comprising the following.
Guthrie further discloses activating (Fig. 2, step 202: “turn meter on”; ¶ [27]) a processor (“microcontroller 38”; Fig. 1B-1C; ¶ [24]: “38 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430”) in the medical device (10).
Guthrie further discloses the processor (38) receiving electrical power (“38” powered by “50” per ¶ [26]) from a battery (“primary battery 50”; Fig. 1C) electrically connected (via “battery connector” located on bottom surface of “circuit board 34”, but not shown in Fig. 1B; ¶ [23]) to the medical device (10).
Guthrie further discloses a housing (“housing 11”; Fig. 1A; ¶ [23]: “electronic components of monitor 10 can be disposed on a circuit board 34 which can be disposed in housing 11”) of the medical device (10).
Guthrie further discloses a first low battery voltage threshold (“first capacity threshold”; Fig. 2, step 204; ¶ [5]: “first threshold may be from about 80% of … a rated voltage … of the primary battery”).
Guthrie further discloses measuring, with a voltage sensor (part of “microprocessor”, i.e. “38”, per ¶ [4]) operatively connected to the processor (38), a first voltage level (¶ [3]: “measured capacity of the primary battery”; measured in step 204 of Fig. 2 per ¶ [27]; “voltage” per ¶ [27]) of the battery (50).
Guthrie further discloses commencing an operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24” per ¶ [27]) of the medical device (10) after measuring (Fig. 2, step 204) the first voltage level (“capacity of primary battery”) of the battery (50).
Guthrie further discloses generating, with the processor (“38” controls “display 14”; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”), an output (“flashing low battery icon” on “display 14”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) using an output device (“display 14”; Figs. 1A, 1C, 4G) in the medical device (10) indicating a low battery condition (Fig. 2, step 212: “annunciate low battery icon”; ¶ [27]).
Guthrie further discloses this output occurs in response to the first voltage level (“capacity of primary battery”; Fig. 2; “voltage” per ¶ [27]) of the battery (50) being less (“no” response to step 204; Fig. 2) than the first low battery voltage threshold (“first capacity threshold”; Fig. 2, step 204) and above (“yes” response to step 210; Fig. 2) a predetermined minimum operating voltage threshold (“second capacity threshold”; Fig. 2, step 210).
Guthrie further discloses the predetermined minimum operating voltage threshold (¶ [28]: “second threshold … about 2.5 volts”) being less than the first low battery voltage threshold (¶ [28]: “first threshold … about 2.6 volts”).
Guthrie does not disclose “measuring, with the processor, a temperature within a housing of the medical device; identifying, with the processor, a first low battery voltage threshold based on the temperature”.
Guthrie further does not disclose “generating, with a voltage comparator operatively connected to the processor, a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the battery during the operation sequence”.
Guthrie further does not disclose the output being in response to “at least one voltage comparison in the plurality of voltage comparisons indicating the voltage level of the battery is less than the reference voltage level during the operation sequence”. However, this limitation “b)” is optional due to the claim language “at least one of” (line 16) and “or” (line 20).
Carg teaches measuring, with the processor (“processor 16”; Fig. 1), a temperature (“ambient temperature”; ¶ [32]) within a housing (because “21” is an integrated circuit within “RFID tag 10”, the measured “ambient temperature” is the temperature within the housing of “10”) of the device (“RFID tag 10”).
Carg further teaches identifying, with the processor (16), a first low battery voltage threshold (see annotated Fig. 3, included infra; ¶ [24]: “curve 67 represents a threshold or limit curve”, “if the measured voltage is less than the threshold or limit value, then the battery 13 may have reached a low voltage condition”) based on the temperature (Fig. 3, x-axis: “temperature (°C)”).
NOTE: Though Carg’s teachings are with respect to a device, the device is not specifically a medical device. However, one of ordinary skill in the art understands that the device taught by Carg and the medical device taught by Guthrie are both electronic devices with housings, a processor, and an internal temperature. Thus, it would be obvious to one of ordinary skill in the art that Carg’s teachings would also be applicable to a medical device.
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Carg further teaches measuring the temperature in the housing as a basis for identifying the first low battery voltage threshold to more accurately model the low battery capacity across temperatures (¶ [2, 48]).
It would have been obvious to one of ordinary skill in the art to modify the method for operating the medical device disclosed by Guthrie to incorporate measuring the temperature in the housing as a basis for identifying the first low battery voltage threshold, as taught by Carg, threshold to more accurately model the low battery capacity across temperatures.
Imran teaches generating, with a voltage comparator (“comparator 34”) operatively connected (via “SET” and “RESET” signals) to the control circuit (combination of “timing and control circuit 22” and “flip-flop 36”), a plurality of voltage comparisons (circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) between a reference voltage level (“VREF”, input to “34”) and a voltage level (“V”, output from “32”) delivered from the battery (“battery 32”) during the operation sequence (col. 1, lines 59-64: “during the operation of the medical implanted device and at fixed periodic time instances during automatic self-testing cycles”).
NOTE: Though Imran’s teachings are with respect to a control circuit, one of ordinary skill in the art would understand these teachings are also applicable to a processor, such as that taught by Guthrie. The processor taught by Guthrie is capable of controlling digital logic signals.
Imran further teaches generating, with the control circuit (22, 36), an output (col. 3, lines 40-44: “40 causes the system to generate audible sounds which can be heard by the patient thereby informing the patient of potential battery failure”) using an output device (“piezoelectric crystal 40”) in the medical device (“battery powered medical implant device”, per Abstract) indicating a low battery condition (col. 2, lines 29-30: “voltage falls below a certain predetermined level”).
Imran further teaches this output occurs in response to at least one voltage comparison in the plurality of voltage comparisons (col. 3, lines: 61-62: “if V falls below VREF, the audio alarm system is activated”) indicating the voltage level (“V”) of the battery (32) is less than the reference voltage level (“VREF”) during the operation sequence (“operation of the medical implanted device”).
Imran further teaches generating a plurality of voltage comparisons during the operation sequence to enable the continuous monitoring of the medical device’s battery voltage, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements (col. 2, lines 34-40).
It would have been obvious to one of ordinary skill in the art to modify the method, medical device, and processor disclosed by the combination of Guthrie and Carg to incorporate a voltage comparator to generate a plurality of voltage comparisons during the operation sequence, as taught by Imran, to enable the continuous monitoring of the medical device’s battery voltage during the operation sequence, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements.
Regarding Claim 5, the combination of Guthrie, Carg, and Imran teaches the method of claim 1.
Guthrie discloses the operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24”) further comprising a quality check process (see note included infra; per ¶ [22], the medical device “10” can perform many functions that may be considered a quality check, such as recording and/or displaying information including “general health condition and exercise levels of an individual”); a wait for fluid sample process (¶ [4]: “receives a physiological fluid”); and an analyte test sequence process (¶ [27]: “measuring the analyte level”).
NOTE: The “quality check” is broad language that can be interpreted to mean the checking quality of anything, not necessarily a check of the strip by applying “a series of electrical test signals to the test strip to ensure that the test strip has not been damaged”, as disclosed in ¶ [51] of the instant application. Thus, Guthrie is interpreted to disclose several possible quality checks during the operation sequence, including checks of user-input information. Further, the analyte test sequence may be considered a “quality check” of an analyte level.
The combination of Guthrie, Carg, and Imran further teaches the voltage comparator (incorporated from Imran: “comparator 34”) generates the plurality of voltage comparisons (from Imran: circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) during the entire operation sequence (Guthrie: “main/primary routine”; Imran equivalent: “operation of the medical implanted device”, during which voltage comparisons are continuously output by “32”).
Thus, the combination of Guthrie, Carg, and Imran teaches the voltage comparator (from Imran: “comparator 34”) generates the plurality of voltage comparisons (from Imran: output “SET” signal from “34” continuously generated through Guthrie’s operation sequence) during each of the quality check process (recording and/or displaying information including “general health condition and exercise levels of an individual” during Guthrie’s “main/primary routine”), the wait for fluid sample process (“receives a physiological fluid” during Guthrie’s “main/primary routine”), and the analyte test sequence process (“measuring the analyte level” during Guthrie’s “main/primary routine”).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”) Imran (US 4,488,555 A), and Osa (US 2014/0297707 A1).
Regarding Claims 2-4, the combination of Guthrie, Carg, and Imran teaches the method of claim 1.
The combination of Guthrie, Carg, and Imran teaches the identifying of the first low battery voltage threshold further comprising identifying, with the processor (Guthrie: “38”; modified to incorporate capabilities per Carg’s “16”), the first low battery voltage threshold (Guthrie: “first capacity threshold”; modified to be based on temperature per Carg) using a predetermined function (from Carg: “curve 67”).
The combination of Guthrie, Carg, and Imran further teaches a memory (Guthrie: “non-volatile memory 40” or “non-volatile memory” within “38” per ¶ [24]) of the medical device (Guthrie: “10”).
Guthrie is silent as to the details of how the predetermined function is implemented by the processor and stored in memory. Specifically, Guthrie does not disclose “identifying, with the processor, the first low battery voltage using a predetermined piecewise linear function stored in a memory” (claim 2).
Guthrie further does not disclose “the memory stores parameters of the piecewise linear function and the processor calculates the first low battery voltage using the parameters” (claim 3).
Guthrie further does not disclose “the memory stores parameters of the piecewise linear function and the processor calculates the first low battery voltage using the parameters” (claim 4).
However, these claimed approaches to approximating a nonlinear function (such as that of the first low battery voltage threshold, dependent on temperature) via stored parameters and/or a lookup table are well known in the art.
Osa teaches identifying, with the processor (“CPU 801”; Fig. 8; ¶ [60, 84]), the dependent value (variable “sapp” in the approximate function value “sapp(x)”; Fig. 3) using a predetermined piecewise linear function (“sapp(x)”; Fig. 3; “piecewise linear approximate function” per ¶ [15]; calculated in step S204 of Fig. 2) stored in a memory (“ROM 802”; Fig. 8; ¶ [60]: “non-volatile memory that stores programs”).
Osa further teaches the memory (802) stores parameters (“parameters of s(x)” of step S203, Fig. 2; “coefficient holding unit 405” of Figs. 4-5) of the piecewise linear function (“sapp(x)”) and the processor (801) calculates the dependent value (“sapp”) using the parameters (“parameters of s(x)”).
Osa further teaches the memory (802) stores a lookup table (“LUT value” of step S203, Fig. 2; “LUT 403” of Figs. 4-5) corresponding to the piecewise linear function (“sapp(x)”) and the processor (801) identifies the dependent value (“sapp”) using the lookup table (403).
NOTE: Though Osa’s teachings are not explicitly with respect to identifying the “first low battery voltage threshold”, Osa a known technique that can be used to improve similar devices (processor, memory, and method for operating the medical device) in the same way. The following conclusion of obviousness is based on KSR rational (C). Reference MPEP § 2143.C. Osa teaches a technique for identifying a dependent value using a predetermined piecewise linear function. However, one of ordinary skill in the art understands the first low battery voltage threshold is a dependent value, such as that taught by Osa. Further, both Guthrie and Osa teach similar devices (processor, memory, dependent function). Thus, one of ordinary skill in the art would understand the teachings of Osa may also be applied to identifying the first low battery voltage threshold.
Osa further teaches the technique of identifying the dependent value (“sapp”) using a predetermined piecewise linear function (“sapp(x)”) stored in the memory via stored parameters and/or lookup table as a practical method of approximating a non-linear function that shortens the calculation times (¶ [23]).
It would have been obvious to one of ordinary skill in the art to modify the method, processor, and memory disclosed by the combination of Guthrie, Carg, and Imran to identify the first low battery voltage threshold using a predetermined piecewise linear function stored in the memory via stored parameters and/or lookup table, as taught by Osa, as a practical method of approximating the non-linear, temperature dependent first low battery voltage threshold that shortens the calculation times. This application of Osa’s technique improves the processor’s identification of the first low battery voltage threshold in the same way as the known technique taught by Carg to yield predictable results (practical, efficient calculations).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”) and Imran (US 4,488,555 A).
Regarding independent Claim 6, Guthrie discloses a medical device (“analyte data monitoring unit (DMU) 10”; Fig. 1A; ¶ [22-23]) comprising a housing (“housing 11”; Fig. 1A; ¶ [23]: “electronic components of monitor 10 can be disposed on a circuit board 34 which can be disposed in housing 11”) configured to hold the following features.
Guthrie further discloses a processor (“microcontroller 38”; Fig. 1B-1C; ¶ [24]: “38 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430”).
Guthrie further discloses a memory (“non-volatile memory 40”; Fig. 1B; alternatively, may be “volatile and non-volatile memory” within processor “38” per ¶ [24]) operatively connected (integrated within processor “38” per ¶ [24]) to the processor (38).
Guthrie further discloses an output device (“display 14”; Figs. 1A, 1C, 4G) operatively connected to the processor (38; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”).
Guthrie further discloses a receptacle (“battery connector”; per ¶ [23], located on bottom surface of “circuit board 34”, but not shown in Fig. 1B) configured to be electrically connected to a battery (“primary battery 50”; Fig. 1C).
Guthrie further discloses the receptacle (“battery connector”; used to connect “circuit board 34” to “50”) being operatively connected to the processor (“38” powered by “50” per ¶ [26]) and the memory (part of “38” per ¶ [24]).
Guthrie further discloses the processor (38) being configured to execute stored program instructions (¶ [31]: “various methods … may be embodied in any computer-readable medium that, when executed by a suitable microprocessor or computer”) in the memory (“40” or “non-volatile memory” within “38” per ¶ [24]) to perform the following actions.
Guthrie further discloses to activate to receive electrical power (“38” powered by “50” per ¶ [26]) from the battery (50).
Guthrie further discloses a first low battery voltage threshold (“first capacity threshold”; Fig. 2, step 204; ¶ [5]: “first threshold may be from about 80% of … a rated voltage … of the primary battery”).
Guthrie further discloses to measure, with the voltage sensor (part of “microprocessor”, i.e. “38”, per ¶ [4]), a first voltage level (¶ [3]: “measured capacity of the primary battery”; measured in step 204 of Fig. 2 per ¶ [27]) of the battery (50).
Guthrie further discloses to commence an operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24” per ¶ [27]) of the medical device (10) after the measurement (Fig. 2, step 204) of the first voltage level (“capacity of primary battery”) of the battery (50).
Guthrie further discloses to generate, with the output device (14), an output (“flashing low battery icon”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) indicating a low battery condition (Fig. 2, step 212: “annunciate low battery icon”; ¶ [27]).
Guthrie further discloses this output occurs in response to the first voltage level (“capacity of primary battery”; Fig. 2; “voltage” per ¶ [27]) of the battery (50) being less (“no” response to step 204; Fig. 2) than the first low battery voltage threshold (“first capacity threshold”; Fig. 2, step 204; ¶ [5]: “first threshold may be from about 80% of … a rated voltage … of the primary battery”) and above (“yes” response to step 210; Fig. 2) a predetermined minimum operating voltage threshold (“second capacity threshold”; Fig. 2, step 210; ¶ [5]: “second threshold may be any value of about 60% to about 79% of … rated voltage of the primary battery”).
Guthrie further discloses the predetermined minimum operating voltage threshold (“second threshold”) being less (¶ [5]) than the first low battery voltage threshold (“first threshold”).
Guthrie does not disclose “a voltage comparator operatively connected to the processor; a temperature sensor operatively connected to the processor”.
Guthrie further does not disclose the receptacle being operatively connected to “the voltage comparator”.
Guthrie further does not disclose to “measure, with the temperature sensor, a temperature within the housing; identify a first low battery voltage threshold based on the temperature”.
Guthrie further does not disclose to “generate, with the voltage comparator, a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the battery during the operation sequence”.
Guthrie further does not disclose the output being in response to “at least one voltage comparison in the plurality of voltage comparisons indicating the voltage level of the battery is less than the reference voltage level during the operation sequence”. However, this limitation “b)” is optional due to the claim language “at least one of” (line 24) and “or” (line 29).
Carg teaches a temperature sensor (“temperature sensor 21”; Fig. 1; ¶ [15]: “integrated circuit with an internal diode junction”) operatively connected to the processor (“processor 16”; Fig. 1).
Carg further teaches to measure, with the temperature sensor (21), a temperature (“ambient temperature”; ¶ [32]) within the housing (because “21” is an integrated circuit within “RFID tag 10”, the measured “ambient temperature” is the temperature within the housing of “10”).
Carg further teaches to identify a first low battery voltage threshold (see annotated Fig. 3, included supra; ¶ [24]: “curve 67 represents a threshold or limit curve”, “if the measured voltage is less than the threshold or limit value, then the battery 13 may have reached a low voltage condition”) based on the temperature (Fig. 3, x-axis: “temperature (°C)”).
Carg further teaches a temperature sensor to measure the temperature in the housing as a basis for identifying the first low battery voltage threshold to more accurately model the low battery capacity across temperatures (¶ [2, 48]).
It would have been obvious to one of ordinary skill in the art to modify the medical device disclosed by Guthrie to incorporate a temperature sensor to measure the temperature in the housing as a basis for identifying the first low battery voltage threshold, as taught by Carg, threshold to more accurately model the low battery capacity across temperatures.
Imran teaches a voltage comparator (“comparator 34”) operatively connected (via “SET” and “RESET” signals) to the control circuit (combination of “timing and control circuit 22” and “flip-flop 36”).
NOTE: Though Imran’s teachings are with respect to a control circuit one of ordinary skill in the art would understand these teachings are also applicable to a processor, such as that taught by Guthrie. The processor taught by Guthrie is capable of controlling digital logic signals.
Imran further teaches to generate, with the voltage comparator (34), a plurality of voltage comparisons (circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) between a reference voltage level (“VREF”, input to “34”) and a voltage level (“V”, output from “32”) delivered from the battery (“battery 32”) during the operation sequence (col. 1, lines 59-64: “during the operation of the medical implanted device and at fixed periodic time instances during automatic self-testing cycles”).
Imran further teaches to generate, with the output device (“piezoelectric crystal 40”), an output (col. 3, lines 40-44: “40 causes the system to generate audible sounds which can be heard by the patient thereby informing the patient of potential battery failure”) indicating a low battery condition (col. 2, lines 29-30: “voltage falls below a certain predetermined level”).
Imran further teaches this output occurs in response to at least one voltage comparison in the plurality of voltage comparisons (col. 3, lines: 61-62: “if V falls below VREF, the audio alarm system is activated”) indicating the voltage level (“V”) of the battery is less than the reference voltage level (“VREF”) during the operation sequence (“operation of the medical implanted device”).
Imran further teaches a voltage comparator to generate a plurality of voltage comparisons during the operation sequence to enable the continuous monitoring of the medical device’s battery voltage, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements (col. 2, lines 34-40).
It would have been obvious to one of ordinary skill in the art to modify the medical device and processor disclosed by the combination of Guthrie and Carg to incorporate a voltage comparator to generate a plurality of voltage comparisons during the operation sequence, as taught by Imran, to enable the continuous monitoring of the medical device’s battery voltage during the operation sequence, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements.
The combination of Guthrie, Carg, and Imran teaches the receptacle (Guthrie: “battery connector”) being operatively connected to the voltage comparator (incorporated “comparator 34” from Imran into the medical device of Guthrie; because Guthrie’s medical device connects to the battery “50” through the receptacle, the incorporated voltage comparator would also connect to the battery “50” through the receptacle; thus the receptacle would be operatively connected to the incorporated voltage comparator).
Regarding Claim 10, the combination of Guthrie, Carg, and Imran teaches the medical device of claim 6.
Guthrie discloses the operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24”) further comprising a quality check process (see note included infra; per ¶ [22], the medical device “10” can perform many functions that may be considered a quality check, such as recording and/or displaying information including “general health condition and exercise levels of an individual”); a wait for fluid sample process (¶ [4]: “receives a physiological fluid”); and an analyte test sequence process (¶ [27]: “measuring the analyte level”).
NOTE: The “quality check” is broad language that can be interpreted to mean the checking quality of anything, not necessarily a check of the strip by applying “a series of electrical test signals to the test strip to ensure that the test strip has not been damaged”, as disclosed in ¶ [51] of the instant application. Thus, Guthrie is interpreted to disclose several possible quality checks during the operation sequence, including checks of user-input information. Further, the analyte test sequence may be considered a “quality check” of an analyte level.
The combination of Guthrie, Carg, and Imran further teaches the voltage comparator (incorporated from Imran: “comparator 34”) generates the plurality of voltage comparisons (from Imran: circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) during the entire operation sequence (Guthrie: “main/primary routine”; Imran equivalent: “operation of the medical implanted device”, during which voltage comparisons are continuously output by “32”).
Thus, the combination of Guthrie, Carg, and Imran teaches the voltage comparator (from Imran: “comparator 34”) generates the plurality of voltage comparisons (from Imran: output “SET” signal from “34” continuously generated through Guthrie’s operation sequence) during each of the quality check process (recording and/or displaying information including “general health condition and exercise levels of an individual” during Guthrie’s “main/primary routine”), the wait for fluid sample process (“receives a physiological fluid” during Guthrie’s “main/primary routine”), and the analyte test sequence process (“measuring the analyte level” during Guthrie’s “main/primary routine”).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”) Imran (US 4,488,555 A), and Osa (US 2014/0297707 A1).
Regarding Claims 7-9, the combination of Guthrie, Carg, and Imran teaches the medical device of claim 6.
The combination of Guthrie, Carg, and Imran teaches the processor (Guthrie: “38”; modified to incorporate capabilities per Carg’s “16”) being further configured to identify the first low battery voltage threshold (Guthrie: “first capacity threshold”; modified to be based on temperature per Carg) using a predetermined function (from Carg: “curve 67”).
Guthrie is silent as to the details of how the predetermined function is implemented by the processor and stored in memory. Specifically, Guthrie does not disclose “the processor being further configured to: identify the first low battery voltage using a predetermined piecewise linear function stored in the memory” (claim 7).
Guthrie further does not disclose “the memory stores parameters of the piecewise linear function and the processor calculates the first low battery voltage using the parameters” (claim 8).
Guthrie further does not disclose “the memory stores a lookup table corresponding to the piecewise linear function and the processor identifies the first low battery voltage using the lookup table” (claim 9).
However, these claimed approaches to approximating a nonlinear function (such as that of the first low battery voltage threshold, dependent on temperature) via stored parameters and/or a lookup table are well known in the art.
Osa teaches the processor (“CPU 801”; Fig. 8; ¶ [60, 84]) being further configured to identify the dependent value (variable “sapp” in the approximate function value “sapp(x)”; Fig. 3) using a predetermined piecewise linear function (“sapp(x)”; Fig. 3; “piecewise linear approximate function” per ¶ [15]; calculated in step S204 of Fig. 2) stored in the memory (“ROM 802”; Fig. 8; ¶ [60]: “non-volatile memory that stores programs”).
Osa further teaches the memory (802) stores parameters (“parameters of s(x)” of step S203, Fig. 2; “coefficient holding unit 405” of Figs. 4-5) of the piecewise linear function (“sapp(x)”) and the processor (801) calculates the dependent value (“sapp”) using the parameters (“parameters of s(x)”).
Osa further teaches the memory (802) stores a lookup table (“LUT value” of step S203, Fig. 2; “LUT 403” of Figs. 4-5) corresponding to the piecewise linear function (“sapp(x)”) and the processor (801) identifies the dependent value (“sapp”) using the lookup table (403).
NOTE: Though Osa’s teachings are not explicitly with respect to identifying the “first low battery voltage threshold”, Osa a known technique that can be used to improve similar devices (processor, memory) in the same way. The following conclusion of obviousness is based on KSR rational (C). Reference MPEP § 2143.C. Osa teaches a technique for identifying a dependent value using a predetermined piecewise linear function. However, one of ordinary skill in the art understands the first low battery voltage threshold is a dependent value, such as that taught by Osa. Further, both Guthrie and Osa teach similar devices (processor, memory, dependent function). Thus, one of ordinary skill in the art would understand the teachings of Osa may also be applied to identifying the first low battery voltage threshold.
Osa further teaches the technique of identifying the dependent value (“sapp”) using a predetermined piecewise linear function (“sapp(x)”) stored in the memory via stored parameters and/or lookup table as a practical method of approximating a non-linear function that shortens the calculation times (¶ [23]).
It would have been obvious to one of ordinary skill in the art to modify the processor and memory disclosed by the combination of Guthrie, Carg, and Imran to identify the first low battery voltage threshold using a predetermined piecewise linear function stored in the memory via stored parameters and/or lookup table, as taught by Osa, as a practical method of approximating the non-linear, temperature dependent first low battery voltage threshold that shortens the calculation times. This application of Osa’s technique improves the processor’s identification of the first low battery voltage threshold in the same way as the known technique taught by Carg to yield predictable results (practical, efficient calculations).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”).
Regarding independent Claim 11, Guthrie discloses a method (combo of flowcharts of Figs. 2-3) for operating a medical device (“analyte data monitoring unit (DMU) 10”; Fig. 1A; ¶ [22-23]) comprising the following.
Guthrie further discloses activating (Fig. 2, step 202: “turn meter on”; ¶ [27]) a processor (“microcontroller 38”; Fig. 1B-1C; ¶ [24]: “38 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430”) in the medical device (10).
Guthrie further discloses the processor (38) receiving electrical power (“38” powered by “50” per ¶ [26]) from a primary battery (“primary battery 50”; Fig. 1C) electrically connected (via “battery connector” located on bottom surface of “circuit board 34”, but not shown in Fig. 1B; ¶ [23]) to the medical device (10).
Guthrie further discloses activating (Fig. 3, step 302; ¶ [28]: occurs in response to user selecting the OK button on the monitor), with the processor (38; controls process steps of Figs. 2-3), at least one peripheral device (“backlight 60”; Fig. 1C) in the medical device (10), the at least one peripheral device (60) receiving electrical power (¶ [26]: “52 is utilized to power a backlight 60 of the display 14 via a back light circuit 54”) from a secondary battery (“secondary battery 52”; Fig. 1C) electrically connected to the medical device (10).
Guthrie further discloses a housing (“housing 11”; Fig. 1A; ¶ [23]: “electronic components of monitor 10 can be disposed on a circuit board 34 which can be disposed in housing 11”) of the medical device (10).
Guthrie further discloses measuring, with a voltage sensor (part of “microprocessor”, i.e. “38”, per ¶ [4]) operatively connected to the processor (38), a first voltage level (¶ [3]: “measured capacity of the primary battery”; measured in step 204 of Fig. 2 per ¶ [27]; “voltage” per ¶ [27]) of the primary battery (50).
Guthrie further discloses measuring, with the voltage sensor (part of “38” per ¶ [4]) operatively connected to the processor (38), a second voltage level (¶ [3]: “measured capacity of the secondary battery”; measured in step 304 of Fig. 3 per ¶ [28]) of the secondary battery (52).
Guthrie further discloses generating, with the processor (“38” controls “display 14”; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”), an output (“flashing low battery icon” on “display 14”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) using an output device (“display 14”; Figs. 1A, 1C, 4G) in the medical device (10) indicating a low battery condition (Fig. 2, step 212: “annunciate low battery icon”; ¶ [27]).
Guthrie further discloses this output occurs in response to the first voltage level (“capacity of primary battery”; Fig. 2; “voltage” per ¶ [27]) of the primary battery (50) being less (“no” response to step 204; Fig. 2) than the first low battery voltage threshold (“first capacity threshold”; Fig. 2, step 204) and above (“yes” response to step 210; Fig. 2) a first predetermined minimum operating voltage threshold (“second capacity threshold”; Fig. 2, step 210) of the primary battery (50).
Guthrie further discloses the first predetermined minimum operating voltage threshold (¶ [28]: “second threshold … about 2.5 volts”) being less than the first low battery voltage threshold (¶ [28]: “first threshold … about 2.6 volts”).
Though not required by the claim language, Guthrie further discloses the output (Fig. 3, step 318: “annunciate low secondary battery capacity”) occurs in response to the second voltage level (“capacity of secondary battery”; Fig. 3) of the secondary battery (52) being less (“no” response to step 314; Fig. 3) than the second low battery voltage threshold (“fourth capacity threshold”; Fig. 3, step 314) and above (“yes” response to step 306; Fig. 3) a second predetermined minimum operating voltage threshold (“third capacity threshold”; Fig. 3, step 306) of the secondary battery (52).
Guthrie further discloses the second predetermined minimum operating voltage threshold (¶ [28]: “third threshold … about 2.0 volts”) being less than the second low battery voltage threshold (¶ [28]: “fourth threshold … about 2.1 volts”).
Guthrie does not disclose “measuring, with the processor, a temperature within a housing of the medical device; identifying, with the processor, a first low battery voltage threshold based on the temperature; identifying, with the processor, a second low battery voltage threshold based on the temperature”.
Carg teaches measuring, with the processor (“processor 16”; Fig. 1), a temperature (“ambient temperature”; ¶ [32]) within a housing (because “21” is an integrated circuit within “RFID tag 10”, the measured “ambient temperature” is the temperature within the housing of “10”) of the device (“RFID tag 10”).
NOTE: Though Carg’s teachings are with respect to a device, the device is not specifically a medical device. However, one of ordinary skill in the art understands that the device taught by Carg and the medical device taught by Guthrie are both electronic devices with housings, a processor, and an internal temperature. Thus, it would be obvious to one of ordinary skill in the art that Carg’s teachings would also be applicable to a medical device.
Carg further teaches identifying, with the processor (16), a low battery voltage threshold (see annotated Fig. 3, included supra; ¶ [24]: “curve 67 represents a threshold or limit curve”, “if the measured voltage is less than the threshold or limit value, then the battery 13 may have reached a low voltage condition”) based on the temperature (Fig. 3, x-axis: “temperature (°C)”).
Carg further teaches the technique of measuring the temperature in the housing as a basis for identifying a low battery voltage threshold to more accurately model the low battery capacity across temperatures (¶ [2, 48]).
NOTE: Though Carg’s teachings are not explicitly with respect to a “first low battery voltage threshold” and a “second low battery voltage threshold”, Carg teaches a known technique that can be used to improve similar low battery voltage thresholds, such as the first/second low battery voltage thresholds disclosed by Guthrie, in the same way. The following conclusion of obviousness is based on KSR rational (C). Reference MPEP § 2143.C.
It would have been obvious to one of ordinary skill in the art to modify the method for operating the medical device and processor disclosed by Guthrie to incorporate measuring the temperature in the housing as a basis for identifying both the first low battery voltage threshold and the second low battery voltage threshold, as taught by Carg, to more accurately model the low battery capacities of the primary battery and secondary battery across temperatures. This application of Carg’s technique improves both the first/second low battery voltage thresholds in the same way as the known technique taught by Carg to yield predictable results (temperature dependent values for low battery voltage thresholds).
Thus, the combination of Guthrie and Carg teaches identifying, with the processor (Guthrie: “38”; modified per teachings of Carg), a first low battery voltage threshold (Guthrie: “first capacity threshold”; modified to be based on temperature per the technique taught by Carg) based on the temperature.
The combination of Guthrie and Carg further teaches identifying, with the processor (Guthrie: “38”; modified per teachings of Carg), a second low battery voltage threshold (Guthrie “fourth capacity threshold”; modified to be based on temperature per the technique taught by Carg) based on the temperature.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Cargonja et al. (US 2006/0267554 A1; hereinafter “Carg”) and Imran (US 4,488,555 A).
Regarding Claim 12, the combination of Guthrie and Carg teaches the method of claim 11 further comprising the following.
Guthrie further discloses commencing an operation sequence (“main routine” of Fig. 3, step 312; Fig. 3; ¶ [28]: “main routine for measurements of analytes with the biosensor 24”) of the medical device (10) after measuring the first voltage level (step 204: “capacity of primary battery”) of the primary battery (50) and the second voltage level (step 304: “secondary battery capacity”) of the secondary battery (52).
Guthrie further discloses generating, with the processor (“38” controls “display 14”; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”), the output (“flashing low battery icon” on “display 14”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) using the output device (14) in the medical device (10) indicating the low battery condition (Fig. 2, step 212 and Fig. 3, step 318).
Guthrie does not disclose “generating, with a voltage comparator operatively connected to the processor, a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the primary battery during the operation sequence”.
Guthrie further does not disclose the output being in response to “at least one voltage comparison in the plurality of voltage comparisons indicating the voltage level of the battery is less than the reference voltage level during the operation sequence”.
Imran teaches generating, with a voltage comparator (“comparator 34”) operatively connected (via “SET” and “RESET” signals) to the control circuit (combination of “timing and control circuit 22” and “flip-flop 36”), a plurality of voltage comparisons (circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) between a reference voltage level (“VREF”, input to “34”) and a voltage level (“V”, output from “32”) delivered from the primary battery (“battery 32”) during the operation sequence (col. 1, lines 59-64: “during the operation of the medical implanted device and at fixed periodic time instances during automatic self-testing cycles”).
NOTE: Though Imran’s teachings are with respect to a control circuit, one of ordinary skill in the art would understand these teachings are also applicable to a processor, such as that taught by Guthrie. The processor taught by Guthrie is capable of controlling digital logic signals.
Imran further teaches generating, with the control circuit (22, 36), the output (col. 3, lines 40-44: “40 causes the system to generate audible sounds which can be heard by the patient thereby informing the patient of potential battery failure”) using the output device (“piezoelectric crystal 40”) in the medical device (“battery powered medical implant device”, per Abstract) indicating the low battery condition (col. 2, lines 29-30: “voltage falls below a certain predetermined level”).
Imran further teaches this output occurs in response to at least one voltage comparison in the plurality of voltage comparisons (col. 3, lines: 61-62: “if V falls below VREF, the audio alarm system is activated”) indicating the voltage level (“V”) of the primary battery (32) is less than the reference voltage level (“VREF”) during the operation sequence (“operation of the medical implanted device”).
Imran further teaches generating a plurality of voltage comparisons during the operation sequence to enable the continuous monitoring of the medical device’s battery voltage, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements (col. 2, lines 34-40).
It would have been obvious to one of ordinary skill in the art to modify the method, medical device, and processor disclosed by the combination of Guthrie and Carg to incorporate a voltage comparator to generate a plurality of voltage comparisons during the operation sequence, as taught by Imran, to enable the continuous monitoring of the medical device’s primary battery voltage during the operation sequence, which enables the medical device to notify the user to replace the primary battery and reduces unnecessary battery replacements.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Imran (US 4,488,555 A).
Regarding independent Claim 13, Guthrie discloses a method (flowchart of Fig. 2) for operating a medical device (“analyte data monitoring unit (DMU) 10”; Fig. 1A; ¶ [22-23]) comprising the following.
Guthrie further discloses activating (Fig. 2, step 202: “turn meter on”; ¶ [27]) a processor (“microcontroller 38”; Fig. 1B-1C; ¶ [24]: “38 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430”) in the medical device (10).
Guthrie further discloses the processor (38) receiving electrical power (“38” powered by “50” per ¶ [26]) from a battery (“primary battery 50”; Fig. 1C) electrically connected (via “battery connector” located on bottom surface of “circuit board 34”, but not shown in Fig. 1B; ¶ [23]) to the medical device (10).
Guthrie further discloses commencing an operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24”) of the medical device (10)
Guthrie further discloses generating, with the processor (“38” controls “display 14”; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”), an output (“flashing low battery icon” on “display 14”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) using an output device (“display 14”; Figs. 1A, 1C, 4G) in the medical device (10) indicating a low battery condition (Fig. 2, step 212: “annunciate low battery icon”; ¶ [27]).
Guthrie does not disclose “generating, with a voltage comparator operatively connected to the processor, a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the battery during the operation sequence”.
Guthrie further does not disclose the output being in response to “at least one voltage comparison in the plurality of voltage comparisons indicating the voltage level of the battery is less than the reference voltage level during the operation sequence”.
Imran teaches generating, with a voltage comparator (“comparator 34”) operatively connected (via “SET” and “RESET” signals) to the control circuit (combination of “timing and control circuit 22” and “flip-flop 36”), a plurality of voltage comparisons (circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) between a reference voltage level (“VREF”, input to “34”) and a voltage level (“V”, output from “32”) delivered from the battery (“battery 32”) during the operation sequence (col. 1, lines 59-64: “during the operation of the medical implanted device and at fixed periodic time instances during automatic self-testing cycles”).
NOTE: Though Imran’s teachings are with respect to a control circuit, one of ordinary skill in the art would understand these teachings are also applicable to a processor, such as that taught by Guthrie. The processor taught by Guthrie is capable of controlling digital logic signals.
Imran further teaches generating, with the control circuit (22, 36), an output (col. 3, lines 40-44: “40 causes the system to generate audible sounds which can be heard by the patient thereby informing the patient of potential battery failure”) using an output device (“piezoelectric crystal 40”) in the medical device (“battery powered medical implant device”, per Abstract) indicating a low battery condition (col. 2, lines 29-30: “voltage falls below a certain predetermined level”).
Imran further teaches this output occurs in response to at least one voltage comparison in the plurality of voltage comparisons (col. 3, lines: 61-62: “if V falls below VREF, the audio alarm system is activated”) indicating the voltage level (“V”) of the battery is less than the reference voltage level (“VREF”) during the operation sequence (“operation of the medical implanted device”).
Imran further teaches generating a plurality of voltage comparisons during the operation sequence to enable the continuous monitoring of the medical device’s battery voltage, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements (col. 2, lines 34-40).
It would have been obvious to one of ordinary skill in the art to modify the method, medical device, and processor disclosed by Guthrie to incorporate a voltage comparator to generate a plurality of voltage comparisons during the operation sequence, as taught by Imran, to enable the continuous monitoring of the medical device’s battery voltage during the operation sequence, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Guthrie et al. (US 2014/0059360 A1) in view of Imran (US 4,488,555 A).
Regarding independent Claim 14, Guthrie discloses a medical device (“analyte data monitoring unit (DMU) 10”; Fig. 1A; ¶ [22-23]) comprising the following features.
Guthrie further discloses a processor (“microcontroller 38”; Fig. 1B-1C; ¶ [24]: “38 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430”).
Guthrie further discloses a memory (“non-volatile memory 40”; Fig. 1B; alternatively, may be “volatile and non-volatile memory” within processor “38” per ¶ [24]) operatively connected (integrated within processor “38” per ¶ [24]) to the processor (38).
Guthrie further discloses an output device (“display 14”; Figs. 1A, 1C, 4G) operatively connected to the processor (38; Fig. 1C shows electrical connection between “14” and “38”; ¶ [23]: “38 can be electrically connected to … display 14”).
Guthrie further discloses a receptacle (“battery connector”; per ¶ [23], located on bottom surface of “circuit board 34”, but not shown in Fig. 1B) configured to be electrically connected to a battery (“primary battery 50”; Fig. 1C).
Guthrie further discloses a receptacle (“battery connector”; per ¶ [23], located on bottom surface of “circuit board 34”, but not shown in Fig. 1B) configured to be electrically connected to a battery (“primary battery 50”; Fig. 1C).
Guthrie further discloses the receptacle (“battery connector”; used to connect “circuit board 34” to “50”) being operatively connected to the processor (“38” powered by “50” per ¶ [26]) and the memory (part of “38” per ¶ [24]).
Guthrie further discloses the processor (38) being configured to execute stored program instructions (¶ [31]: “various methods … may be embodied in any computer-readable medium that, when executed by a suitable microprocessor or computer”) in the memory (“40” or “non-volatile memory” within “38” per ¶ [24]) to perform the following actions.
Guthrie further discloses to activate to receive electrical power (“38” powered by “50” per ¶ [26]) from the battery (50).
Guthrie further discloses to commence an operation sequence (“primary routine” of steps 206 and 224; Fig. 2; also referred to as “main routine … for measuring the analyte level of the biosensor 24”) of the medical device (10).
Guthrie further discloses to generate, with the output device (14), an output (“flashing low battery icon”; ¶ [27]; Figs. 4A, 4D, 4E, 4F) indicating a low battery condition (Fig. 2, step 212: “annunciate low battery icon”; ¶ [27]).
Guthrie does not disclose “a voltage comparator operatively connected to the processor”.
Guthrie further does not disclose the receptacle being operatively connected to “the voltage comparator”.
Guthrie further does not disclose to “generate, with the voltage comparator, a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the battery during the operation sequence”.
Guthrie further does not disclose the output being in response to “at least one voltage comparison in the plurality of voltage comparisons indicating the voltage level of the battery is less than the reference voltage level during the operation sequence”.
Imran teaches a voltage comparator (“comparator 34”) operatively connected (via “SET” and “RESET” signals) to the control circuit (combination of “timing and control circuit 22” and “flip-flop 36”).
NOTE: Though Imran’s teachings are with respect to a control circuit one of ordinary skill in the art would understand these teachings are also applicable to a processor, such as that taught by Guthrie. The processor taught by Guthrie is capable of controlling digital logic signals.
Imran further teaches to generate, with the voltage comparator (34), a plurality of voltage comparisons (circuit topology causes “SET” signal to be continuously updated; thus, a plurality of comparisons between “VREF” and voltage “V” from “32” are made) between a reference voltage level (“VREF”, input to “34”) and a voltage level (“V”, output from “32”) delivered from the battery (“battery 32”) during the operation sequence (col. 1, lines 59-64: “during the operation of the medical implanted device and at fixed periodic time instances during automatic self-testing cycles”).
Imran further teaches to generate, with the output device (“piezoelectric crystal 40”), an output (col. 3, lines 40-44: “40 causes the system to generate audible sounds which can be heard by the patient thereby informing the patient of potential battery failure”) indicating a low battery condition (col. 2, lines 29-30: “voltage falls below a certain predetermined level”).
Imran further teaches this output occurs in response to at least one voltage comparison in the plurality of voltage comparisons (col. 3, lines: 61-62: “if V falls below VREF, the audio alarm system is activated”) indicating the voltage level (“V”) of the battery is less than the reference voltage level (“VREF”) during the operation sequence (“operation of the medical implanted device”).
Imran further teaches a voltage comparator to generate a plurality of voltage comparisons during the operation sequence to enable the continuous monitoring of the medical device’s battery voltage, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements (col. 2, lines 34-40).
It would have been obvious to one of ordinary skill in the art to modify the medical device and processor disclosed by Guthrie to incorporate a voltage comparator to generate a plurality of voltage comparisons during the operation sequence, as taught by Imran, to enable the continuous monitoring of the medical device’s battery voltage during the operation sequence, which enables the medical device to notify the user to replace the battery and reduces unnecessary battery replacements.
The combination of Guthrie and Imran teaches the receptacle (Guthrie: “battery connector”) being operatively connected to the voltage comparator (incorporated “comparator 34” from Imran into the medical device of Guthrie; because Guthrie’s medical device connects to the battery “50” through the receptacle, the incorporated voltage comparator would also connect to the battery “50” through the receptacle; thus the receptacle would be operatively connected to the incorporated voltage comparator).
Conclusion
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/DANIEL P MCFARLAND/ Examiner, Art Unit 2859
/DREW A DUNN/ Supervisory Patent Examiner, Art Unit 2859
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