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 § 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 21, 39 and 40 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 21 recites the limitation "the electronic module" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the electronic module of the drug delivery or of the supplemental device for the drug delivery device mentioned in line 1-2 or another electronic module. If it is referring to the electronic module of the drug delivery or of the supplemental device for the drug delivery device mentioned in line 1-2 then, it is recommended to amend to recite “the electronic module of the drug delivery or of the supplemental device for the drug delivery device …” appropriate correction is required.
Claim 21 recites the limitation "the electrical property" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the electrical property of the switch mentioned in line 7 or another electrical property. If it is referring to the electrical property of the switch mentioned in line 7 then, it is recommended to amend to recite “to the electrical property of the switch” appropriate correction is required.
Claim 39 recites the limitation "the electrical property" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the electrical property of the switch mentioned in line 7 or another electrical property. If it is referring to the electrical property of the switch mentioned in line 7 then, it is recommended to amend to recite “the electrical property of the switch …” appropriate correction is required.
Claim 40 recites the limitation "supplemental device" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the supplemental device of a drug delivery device mentioned in line 3 or another supplemental device. If it is referring to the supplemental device of a drug delivery device mentioned in line 3 then, it is recommended to amend to recite “the supplemental device of the drug delivery device …” appropriate correction is required.
Claim 40 recites the limitation "the electrical property" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the electrical property of the switch of the electronic module mentioned in lines 3-4 or another electrical property. If it is referring to the electrical property of the switch of the electronic module mentioned in line 3 then, it is recommended to amend to recite “the electrical property of the switch of the electronic module …” appropriate correction is required.
Claim 40 recites the limitation "the switch" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the switch of the electronic module mentioned in lines 3-4 or another switch. If it is referring to the switch of the electronic module mentioned in lines 3-4 then, it is recommended to amend to recite “the switch of the electronic module …” appropriate correction is required.
Claim 40 recites the limitation "the monitoring electronics" in line 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is referring to the monitoring electronics of the electronic module of the drug delivery device mentioned in line 1 or other monitoring electronics. If it is referring to the switch of the monitoring electronics of the electronic module of the drug delivery device mentioned in line 1, then, it is recommended to amend to recite “of the monitoring electronics of the electronic module of the drug delivery device …” appropriate correction is required.
Claims 22-38 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph for being dependent on claim 21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-24, 26-34, 39, 40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lemke; John et al. (US application #US 20120253262 A1; hereinafter Lemke).
Regarding claim 21, Lemke teaches
An electronic module (fig.1 #104 & #102; or fig.3 #300 & #302) of a drug delivery device (par.37 “a switch operated device, such as a drug delivery device (e.g. a drug delivery pump, electrotransport device or iontophoresis device).”) or of a supplemental device for a drug delivery device, the electronic module comprising:
a switch (fig.1 #102 or fig.3 #302) configured to detect an operation performed in relation to the drug delivery device or supplemental device and to provide a respective output signal (par.37 “a device switch configured to be operated by a user, which provides a switch signal to a switch input of a device controller when operated by a user;”); and
monitoring electronics (par.37 “a switch integrity test subcircuit”),
wherein the monitoring electronics are configured to:
measure an electrical property of the switch (par.76 “measuring the voltage at switch input 308”) to obtain at least one value corresponding to the electrical property (par.39 “the switch integrity test subcircuit is configured to test for and detect a voltage”); and
process the at least one value to detect a fault condition of the switch (par.12 “the switch integrity test subcircuit, which is configured to detect a fault or a precursor to a fault in the switch and provide a fault signal to the controller.”).
Regarding claim 22, Lemke teaches an electronic module according to claim 21, wherein the monitoring electronics are configured to measure the electrical property a predetermined period of time after determining that the switch has moved from a closed state to an open state (par.47 “During this period, which may be referred to as the debounce period, the controller can actively set certain circuit parameters (using the switch integrity test subcircuit), test voltages or changes in voltages at certain points and compare them to predetermined values that are indicative of what a normally operating circuit--i.e. a circuit that is not manifesting a fault or a precursor to a fault--would manifest.”; par.76 “other methods for measuring voltage can be implemented, such as the use of a set of comparator circuits in place of the ADC to measure the voltage level of the analog signal compared to a comparator threshold.”).
Regarding claim 23, Lemke teaches an electronic module according to claim 21, wherein the monitoring electronics are configured to measure the electrical property a predetermined period of time (par.73 “After predetermined time interval”) after determining that the switch has moved from an open state to a closed state (par.65 “When activation switch 302 is open, pull up resistor 304 pulls the voltage at switch input 308 to the level of the supply voltage V.sub.DD. When the activation switch 302 is closed, it pulls the voltage at switch input 308 down to ground.”).
Regarding claim 24, Lemke teaches an electronic module according to claim 21, wherein the monitoring electronics are configured to measure the electrical property in response to determining that the switch has moved from an open state to a closed state and while the switch remains in the closed state (par.50 “the switch input is pulled up to V.sub.DD when the switch is open and the switch input is V.sub.SS when the switch is closed.”).
Regarding claim 26, Lemke teaches an electronic module according to claim 21, wherein the fault condition comprises at least one of a degradation condition, indicative that electrical contacts of the switch have degraded, and a leakage condition, indicative that an electrical leakage between the electrical contacts of the switch has occurred (par.12 “In some embodiments, the switch integrity test subcircuit is configured to test for and detect at least one fault or precursor to a fault such as contamination, short circuits, (including intermittent short circuits), compromised circuit components (including malfunctioning resistors, integrated circuit pins, and/or capacitors), etc.”).
Regarding claim 27, Lemke teaches an electronic module according to claim 21, wherein processing the at least one value to detect a fault condition of the switch comprises comparing the at least one value to a threshold value and detecting the fault condition of the switch based on the comparison (par.47 “During this period, which may be referred to as the debounce period, the controller can actively set certain circuit parameters (using the switch integrity test subcircuit), test voltages or changes in voltages at certain points and compare them to predetermined values that are indicative of what a normally operating circuit--i.e. a circuit that is not manifesting a fault or a precursor to a fault--would manifest.”; par.76 “other methods for measuring voltage can be implemented, such as the use of a set of comparator circuits in place of the ADC to measure the voltage level of the analog signal compared to a comparator threshold.”).
Regarding claim 28, Lemke teaches an electronic module according to claim 21, wherein the electrical property corresponds to a voltage across the switch (par.13 “detect a voltage”).
Regarding claim 29, Lemke teaches an electronic module according to claim 28,
wherein measuring the electrical property of the switch comprises obtaining a plurality of values corresponding to respective voltages across the switch (par.45 “measuring a change in voltage or current”) at different respective times (par.45 “between two selected time points”); and
wherein processing the at least one value to detect a fault condition (par.12) of the switch comprises:
determining a rate of change of voltage across the switch based on the plurality of values (par.13 “the controller is configured to measure a voltage or a rate of change of voltage at the switch input and execute the switch fault subroutine when the voltage or rate of change of voltage at the switch input fails to meet one or more predetermined parameters.”);
comparing the determined rate of change to a threshold rate of change (par.45 “Voltage and current rise times may also be characterized by measuring a change in voltage or current between two selected time points and comparing them to the change in voltage or current that would be expected for a normally operating circuit at the point and under the condition tested.”); and
detecting the fault condition of the switch based on the comparison (par.12 “detect at least one fault or precursor to a fault such as contamination, short circuits, (including intermittent short circuits), compromised circuit components (including malfunctioning resistors, integrated circuit pins, and/or capacitors), etc.”).
Regarding claim 30, Lemke teaches an electronic module according to claim 21, wherein the monitoring electronics comprise an analogue-to-digital convertor (par.76 “ADC” 1204) and a processor arrangement (par.58 “It can comprise a microprocessor”),
wherein the analogue-to-digital convertor is configured to convert the output signal into a digital signal corresponding to the electrical property and to provide the digital signal to the processor arrangement for determining the at least one fault condition (par.76 “In the depicted embodiment, the means for measuring voltage is analog to digital converter ("ADC") 1204, however other methods for measuring voltage can be implemented, such as the use of a set of comparator circuits in place of the ADC to measure the voltage level of the analog signal compared to a comparator threshold.”).
Regarding claim 31, Lemke teaches an electronic module according to claim 30, wherein the processor arrangement is configured to detect the fault condition by at least comparing the digital signal to a threshold (par.47 “compare them to predetermined values that are indicative of what a normally operating circuit--i.e. a circuit that is not manifesting a fault or a precursor to a fault--would manifest.”; fig.12 implicitly teaches comparing the digital signal to a threshold).
Regarding claim 32, Lemke teaches an electronic module according to claim 30, wherein the processor arrangement is configured to detect the fault condition by at least determining a rate of change of the digital signal (par.45 “Voltage and current rise times may also be characterized by measuring a change in voltage or current between two selected time points and comparing them to the change in voltage or current that would be expected for a normally operating circuit at the point and under the condition tested.”).
Regarding claim 33, Lemke teaches an electronic module according to claim 21, wherein the monitoring electronics are configured to generate an error signal based on the detection of a fault condition of the switch (par.44 “activating a user alert feature”).
Regarding claim 34, Lemke teaches an electronic module according to claim 21, wherein the electronic module is further configured to wake up one or components of the electronic module based on the output signal (implicitly taught in par.58 “Controller 104 can also comprise a power source, such as a battery,” and par.83 “the ADC circuitry could be powered off when not testing to save power.” Hints at a sleep mode).
Regarding claim 39, Lemke teaches
A drug delivery device (par.37 “a switch operated device, such as a drug delivery device (e.g. a drug delivery pump, electrotransport device or iontophoresis device).”) or a supplemental device attachable to a drug delivery device, comprising an electronic module (fig.1 #104 & #102; or fig.3 #300 & #302), comprising
a switch (fig.1 #102 or fig.3 #302) configured to detect an operation performed in relation to the drug delivery device or supplemental device and to provide a respective output signal (par.37 “a device switch configured to be operated by a user, which provides a switch signal to a switch input of a device controller when operated by a user;”); and
monitoring electronics (par.37 “a switch integrity test subcircuit”),
wherein the monitoring electronics are configured to:
measure an electrical property of the switch (par.39 “the switch integrity test subcircuit is configured to test for and detect a voltage”) to obtain at least one value corresponding to the electrical property (par.39); and
process the at least one value to detect a fault condition of the switch (par.12 “the switch integrity test subcircuit, which is configured to detect a fault or a precursor to a fault in the switch and provide a fault signal to the controller.”).
Regarding claim 40, Lemke teaches
A method (abstract), comprising:
measuring, by monitoring electronics of an electronic module (fig.1 #104 & #102; or fig.3 #300 & #302) of a drug delivery device (par.37 “a switch operated device, such as a drug delivery device (e.g. a drug delivery pump, electrotransport device or iontophoresis device).”) or of a supplemental device for a drug delivery device, an electrical property (par.76 “measuring the voltage at switch input 308”) of a switch of the electronic module (fig.1 #102 or fig.3 #302) to obtain at least one value corresponding to the electrical property, wherein the switch is configured to detect an operation performed in relation to the drug delivery device (par.9 “a means for detecting one or more faults and/or precursors to faults during device operation”) or supplemental device and to provide a respective output signal (par.88); and
processing, by the monitoring electronics, the at least one value to detect a fault condition of the switch (par.12 “the switch integrity test subcircuit, which is configured to detect a fault or a precursor to a fault in the switch and provide a fault signal to the controller.”).
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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Lemke in view of Macaulay; Rob (US application #US 20080062017 A1; hereinafter Macaulay).
Regarding claim 25, Lemke teaches an electronic module according to claim 21, but fails to teach further comprising a debounce capacitor coupled across the switch.
Macaulay does teach further comprising a debounce capacitor coupled across the switch (fig.3).
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Lemke to include the teachings of Macaulay; which would provide an improved debouncing circuit that successfully removes high frequency chatter from the switch signal as disclosed by Macaulay (par.11).
Claim(s) 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lemke in view of LEMKE; John et al. (US application# US 20140288526 A1; hereinafter Lemke II).
Regarding claim 35, Lemke teaches the electronic module according to claim 21, but fails to teach wherein: the operation performed in relation to the drug delivery device or supplemental device comprises a dose dialing operation, and the electronic module is configured to determine a dialed dose based on the output signal.
Lemke II does teach wherein:
the operation performed in relation to the drug delivery device or supplemental device comprises a dose dialing operation (fig.18 A-B), and the electronic module is configured to determine a dialled dose based on the output signal (par.118-120).
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Lemke to include the teachings of Lemke II; which would provide a switch validation circuit that validates the integrity of a dose switch circuit and signal characteristics prior to initiating a dose as disclosed by Lemke II (par.7).
Regarding claim 36, Lemke teaches the electronic module according to claim 21, but fails to teach wherein: the operation performed in relation to the drug delivery device or supplemental device comprises a dose dispensing operation, and the electronic module is configured to determine a dispensed dose based on the output signal.
Lemke II does teach wherein:
the operation performed in relation to the drug delivery device or supplemental device comprises a dose dispensing operation (fig.18 A-B), and the electronic module is configured to determine a dispensed dose based on the output signal (par.118-120).
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Lemke to include the teachings of Lemke II; which would provide a switch validation circuit that validates the integrity of a dose switch circuit and signal characteristics prior to initiating a dose as disclosed by Lemke II (par.7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US 20090212975 A1; Ausman; Marc et al. is an embodiment for In-Circuit Testing For Integrity Of Solid-State Switches.
US 20160238658 A1; Edwards; William E. et al. is an embodiment for Wetting Current Diagnostics.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARL F.R. TCHATCHOUANG whose telephone number is (571)272-3991. The examiner can normally be reached Monday - Friday 8:00am -5:00am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Huy Phan can be reached at 571-272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARL F.R. TCHATCHOUANG/Examiner, Art Unit 2858
/HUY Q PHAN/Supervisory Patent Examiner, Art Unit 2858
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