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 2, 12, 13, 14, 15, 18, and 19 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 2 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Claim 2 recites "the external device." There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 2 depends, does not introduce an "external device." Appropriate correction is required.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 12 recites "the one or more components." There is insufficient antecedent basis for this limitation. Claim 12 depends from claim 1, which does not introduce "one or more components." It appears that claim 12 was intended to depend from claim 11, which introduces "one or more components of the module in addition to the control component." Appropriate correction is required.
Claim 13 and dependent claims 14-15 are rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 13 recites "an antenna coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device." The phrase "based on the injection device" is unclear and appears to be missing the word "data." It is believed the claim should read "based on the injection device data," consistent with claim 1. Appropriate correction is required.
Claims 18 and 19 are rejected under 35 U.S.C. § 112(b) as being indefinite. Claims 18 and 19 each recite "The medication injection system," whereas claim 16, from which they ultimately depend, introduces "A medicament injection system." The inconsistency between "medication" and "medicament" creates ambiguity as to whether the claims are properly referring back to the system of claim 16. Appropriate correction is required.
Claim 19 is further rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 19 recites "the injection device further comprise an integrated voltage regulator," which is grammatically incorrect. It should read "the injection device further comprises" or "the injection device further comprising." Appropriate correction is required.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683 A1; hereinafter “Feygin”) in view of Saint et al. (US 2016/0012205 A1; hereinafter “Saint”) and Pollack et al. (US 2011/0181399 A1; “Pollack”).
Independent claim 1 recites:
A module for attachment to an injection device, the module comprising:
a housing configured to be attached to a surface of the injection device;
one or more sensors attached to the housing, each sensor being configured to generate a respective sensor signal based on detecting at least one of an environmental condition, or a characteristic associated with the injection device or associated with a medicament contained within the injection device;
an energy harvester configured to harvest energy in response to receiving a trigger, the trigger including a priming operation of the injection device and an interrogation signal;
a control component connected to the one or more sensors, the control component being configured to process the respective one or more sensor signals and generate injection device data in response to receiving the harvested energy; and
an antenna coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device data.
In relation to independent claim 1, Feygin discloses a module for attachment to an injection device, the module comprising:
a housing configured to be attached to a surface of the injection device:
Feygin discloses "an adapter configured to be detachably coupled between an injection pen housing and its needle assembly and to deliver the medicament from the injection pen housing to the needle assembly" (para. [0012]). Feygin further describes a "needle adapter 18" that is removably coupled to the injection pen (para. [0041], [0042], and figure 1A).
one or more sensors attached to the housing, each sensor being configured to generate a respective sensor signal based on detecting at least one of an environmental condition, or a characteristic associated with the injection device or associated with a medicament contained within the injection device:
Feygin discloses "a sensor configured as a microchip provided in the adapter to sense at least one characteristic about the medicament or its delivery to the patient and generate sensor data" (para. [0012]). Feygin further teaches that the sensor can detect "temperature, contamination, drug manufacturer, compromised drugs (e.g., due to light exposure, improper handling, contaminated or faulty containers, tampering, temperature exposure, or expiry from actual drug deterioration)" (para. [0046]), and "drug identification, concentration, agglomeration, and degradation, and flow rate" (para. [0016]).
a control component connected to the one or more sensors, the control component being configured to process the respective one or more sensor signals and generate injection device data in response to receiving the harvested energy:
Feygin discloses that the portable device 22 includes "a processing device, memory, display, user interface and communications interface" (para. [0040]), and that the pen needle adapter 18 is "configured, for example, to detect or receive and process information relative to the medicament being delivered" (para. [0041]).
an antenna coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device data:
Feygin discloses "a device configured to wirelessly communicate with the sensor to obtain its sensor data" (para. [0012]). Feygin further teaches that the smart injection pen 2 has "RF (e.g., Bluetooth®) communication abilities" (para. [0054]). The wireless communication necessarily [inherently] requires an antenna.
Feygin does not explicitly disclose an energy harvester configured to harvest energy in response to receiving a trigger, the trigger including a priming operation of the injection device and an interrogation signal. However, Feygin teaches that the sensor can be powered wirelessly: "the device is configured to obtain wireless transfer of the sensor data and to provide wireless power to the sensor" (para. [0014]), and "the device employs one of RFID and SAW for providing wireless power to the sensor" (para. [0015]). Feygin also teaches that "RFID or SAW are recommended for sensor powering. One of these techniques could have been used to provide enough power and signal amplification to allow the wireless transfer of information from the smart sensor 20 or 180 to the interrogator" (para. [0053]).
Saint teaches an injection pen device that detects and distinguishes priming operations from injection events. Saint discloses "a medicine injection device, in communication with a patient's companion device (e.g., smartphone), in which the injection device is able to detect and record dose sizes that are dispensed (e.g., primed or injected to the patient), and to distinguish between a prime dose and a therapy dose" (para. [0009]). Saint further teaches "determining a type of dispensing event as a priming event or an injection event for the dose data in the dose dispensing sequence" (para. [0006]). The priming operation involves displacement of a plunger: "the dose knob is translationally moveable to cause the shaft to drive the plunger to push against the cartridge to dispense the medicine from the cartridge" (para. [0005]).
Pollack teaches an RFID tag with energy harvesting capability that collects energy from an interrogation signal. Pollack discloses that "RFID tags may be provided with energy harvesting (EH) capability so that they may collect energy from the environment, either deliberately radiated (such as RF) or gathered from existing sources (i.e., motion, heat, etc.)" (Abstract). Pollack further teaches that "passive RFID tags, which have no power source (no battery) and require an electromagnetic field from an external source (such as the reader) to power the tag electronics and initiate a signal transmission" (para. [0006]).
Based on the above comments, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wirelessly powered sensor module of Feygin to incorporate the priming detection capability taught by Saint as a trigger for the module's operation, and to incorporate the explicit RF energy harvesting circuit taught by Pollack. The motivation to combine these references would have been to create a more power-efficient smart module for an injection device. Using the priming event as a trigger, as taught by Saint, would have allowed the module to remain in a low-power state until a relevant event occurred, thereby conserving energy. Incorporating the RF energy harvesting circuit of Pollack would have provided a well-established and reliable method for powering the device from an interrogation signal, as already suggested by Feygin's teaching of wireless power via RFID (para. [0015]).
Independent claim 13 recites:
An injection device comprising:
one or more sensors, each sensor being configured to generate a respective sensor signal based on detecting at least one of an environmental condition, or a characteristic associated with the injection device or associated with a medicament contained within the injection device;
an energy harvester configured to harvest energy in response to receiving a trigger, the trigger including a priming operation of the injection device and an interrogation signal;
a control component connected to the one or more sensors, the control component being configured to process the respective one or more sensor signals and generate injection device data in response to receiving the harvested energy; and
an antenna coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device.
In relation to independent claim 13, this claim recites an injection device comprising substantially the same elements as the system of claim 1. As discussed above, Feygin discloses a smart injection pen 2 that incorporates the smart adapter module (needle adapter 18 with smart sensor 20) (para. [0040], [0041]). The injection pen 2 with the integrated adapter constitutes an injection device.
one or more sensors:
Feygin discloses "a sensor configured as a microchip provided in the adapter to sense at least one characteristic about the medicament or its delivery to the patient and generate sensor data" (para. [0012]).
energy harvester:
Feygin does not explicitly disclose an energy harvester triggered by a priming operation and an interrogation signal. However, as set forth in the rejection of claim 1, Saint teaches detecting priming operations (para. [0006], [0009]), and Pollack teaches energy harvesting from RF signals (Abstract, para. [0030]).
control component:
Feygin discloses that the adapter includes a sensor configured as a microchip that processes information (para. [0012]).
antenna:
Feygin discloses wireless communication with the sensor (para. [0012], [0054]), which inherently requires an antenna.
The motivation to combine Feygin, Saint, and Pollack is the same as set forth in the rejection of claim 1: it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wirelessly powered sensor module of Feygin to incorporate the priming detection capability taught by Saint as a trigger for the module's operation, and to incorporate the explicit RF energy harvesting circuit taught by Pollack. The motivation to combine these references would have been to create a more power-efficient smart module for an injection device. Using the priming event as a trigger, as taught by Saint, would have allowed the module to remain in a low-power state until a relevant event occurs, thereby conserving energy. Incorporating the RF energy harvesting circuit of Pollack would provide a well-established and reliable method for powering the device from an interrogation signal, as already suggested by Feygin's teaching of wireless power via RFID (para. [0015]).
Independent claim 16 recites:
A medicament injection system comprising: an injection device comprising:
one or more sensors, each sensor being configured to generate a respective sensor signal based on detecting at least one of an environmental condition, or a characteristic associated with the injection device or associated with a medicament contained within the injection device,
an energy harvester configured to harvest energy in response to receiving a trigger, the trigger including a priming operation of the injection device and an interrogation signal,
a control component connected to the one or more sensors, the control component being configured to process the respective one or more sensor signals and generate injection device data in response to receiving the harvested energy, and
an antenna coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device; and
a computing device configured to receive the RF signal transmitted by the antenna.
In relation to independent claim 16, this claim recites an injection device comprising substantially the same elements as in the systems of claim 1 and claim 13; however, it further discloses a computing device configured to receive the RF signal.
injection device:
As set forth in the rejections of claim 1 and 13, the combination of Feygin, Saint, and Pollack teaches the claimed injection device.
computing device configured to receive the RF signal:
Feygin discloses a "portable device 22" that can be "a smartphone or tablet or other portable device such as a laptop or handheld personal data assistant (PDA)" (para. [0040]). Feygin teaches that the portable device wirelessly communicates with the sensor to obtain its sensor data (para. [0012]). Saint also discloses a "mobile communication device" (companion device 5) that wirelessly receives dose data from the injection pen (para. [0005], [0025]).
The motivation to combine Feygin, Saint, and Pollack is the same as set forth in the rejection of claims 1 and 13: it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wirelessly powered sensor module of Feygin to incorporate the priming detection capability taught by Saint as a trigger for the module's operation, and to incorporate the explicit RF energy harvesting circuit taught by Pollack. The motivation to combine these references would have been to create a more power-efficient smart module for an injection device. Using the priming event as a trigger, as taught by Saint, would have allowed the module to remain in a low-power state until a relevant event occurs, thereby conserving energy. Incorporating the RF energy harvesting circuit of Pollack would have provided a well-established and reliable method for powering the device from an interrogation signal, as already suggested by Feygin's teaching of wireless power via RFID (para. [0015]). Moreover, since the use of a computer device to receive an RF signal was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an obvious alternative in the design of the injection device and the overall system.
In relation to claim 2, Feygin discloses harvesting energy from a radio frequency signal and an electromagnetic field. Feygin teaches "providing wireless power inductively, through radio frequency energy transfer, or capacitively" (para. [0053]), and that "the device employs one of RFID and SAW for providing wireless power to the sensor" (para. [0015]). Pollack teaches harvesting energy from "deliberately radiated (such as RF) or gathered from existing sources (i.e., motion, heat, etc.)" (para. [0030]). Saint teaches detecting a priming operation (para. [0006], [0009]). The combination of these references teaches or suggests harvesting energy from at least one of the recited sources. Therefore, since the use of this enhancement(s) was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an obvious alternative in the design of the injection device and the overall system.
In relation to claim 3, Feygin discloses detecting the amount of administered medicament: "the sensor detects dose amount" (para. [0022]). Feygin also discloses detecting medicament temperature: the sensor can detect "temperature" (para. [0046]). Feygin further discloses associating a timestamp with the administration event: the pen or user interface can "interrogate the pen needle adapter 18 with smart sensor 20 periodically and/or after sensing an event such as dose dial-in or activation of insulin injection, and associate time stamp data with received sensor data" (para. [0057]). Since the claim requires only "at least one of" the listed characteristics, and Feygin teaches at least three of them, the limitation is met. Therefore, since the use of this enhancement(s) was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an 302obvious alternative in the design of the injection device and the overall system.
In relation to claim 4, Feygin discloses that the device wirelessly communicates with the sensor to both obtain data and provide wireless power (para. [0012], [0014]). This bidirectional wireless communication inherently requires a transceiver. Pollack also discloses an RFID tag comprising "a radio (active transmitter) 302 and associated antenna 304 for transmitting data" and a separate energy harvesting antenna 314 for receiving RF energy (para. [0138], describing FIG. 3). The RFID tag in Pollack can both receive energy/data from an energizing unit and transmit data to a receiver, which is the function of a transceiver. Therefore, it would have been obvious to include a transceiver in the module of Feygin to implement the bidirectional wireless communication already taught by Feygin.
In relation to claim 5, Saint discloses a dose setting and dispensing mechanism including "a dose knob, a shaft, and a piston assembly including a plunger, in which the dose knob is translationally moveable to cause the shaft to drive the plunger to push against the cartridge to dispense the medicine from the cartridge" (para. [0005]). The dose knob functions as a push button that is pressed to dispense medicine, and the plunger is displaced during this operation. Saint further teaches that "a force (e.g., either produced by the patient or by an electrically-powered motor) pushes on the plunger of the dose dispensing mechanism to in turn force a receiving plunger of the medicament vial or cartridge to deliver the specific amount of the medicament" (para. [0028]). The priming operation involves a displacement of the plunger rod. Therefore, the limitation is taught by Saint; since this enhancement(s) was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an obvious alternative in the design of the injection device and the overall system.
In relation to claim 6, Feygin does not explicitly disclose a boost converter. However, Pollack explicitly discloses that its energy harvesting circuitry includes "circuitry 212 associated with the EH device 210 for voltage rectification, boost, overvoltage protection and for charging of an energy storage capacitor 220" (para. [0122]-[0130]). Pollack further identifies the LTC3108 chip, stating: "The LTC3108 Power management chip is designed to operate on very low voltages, manage a storage capacitor and regulate its output with minimal power. The LTC3108 doesn't rectify, it just boosts a very low voltage DC input" (para. [0122]-[0130]). It would have been obvious to one of ordinary skill in the art to include a boost converter, such as the LTC3108 taught by Pollack, in the module of Feygin to increase the voltage level of the low-voltage energy harvested from RF signals to a level usable by the module's electronics.
In relation to claim 7, Feygin does not explicitly disclose a voltage regulator. However, Pollack discloses that the LTC3108 chip can "manage a storage capacitor and regulate its output with minimal power" (para. [0122]-[0130]). The LTC3108 integrates both boost and voltage regulation functions in a single chip, thereby constituting an integrated voltage regulator that regulates the voltage level generated by the boost converter. It would have been obvious to one of ordinary skill in the art to include an integrated voltage regulator, such as the LTC3108 taught by Pollack, in the module of Feygin to ensure a stable and regulated voltage output for the module's electronics.
In relation to claim 8, Feygin explicitly discloses the use of a temperature sensor. Feygin teaches that the sensor can detect "temperature" as one of the characteristics of drug administration (para. [0046]). Feygin further teaches that "[t]he sensor can also have temperature and/or light exposure history" (para. [0051]). Saint also discloses "a sensor to monitor temperature of the injection device" (para. [0022]). Since the claim requires only "at least one of" a temperature sensor, a humidity sensor, or a fill level sensor, and both Feygin and Saint teach a temperature sensor, the limitation is met; and moreover, since this enhancement(s) was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an obvious alternative in the design of the injection device and the overall system.
In relation to claim 9, Feygin does not explicitly disclose the power consumption of the sensor. However, Pollack, in the context of an energy-harvesting RFID tag, explicitly teaches "utilizing a ultra-low power temperature sensing circuit and memory" (para. [0045]). Pollack further teaches that the energy harvesting circuitry uses the LTC3108 chip, which "is designed to operate on very low voltages" (para. [0122]-[0130]). The entire disclosure of Pollack is directed towards minimizing power consumption to enable operation from harvested energy stored in a capacitor. Therefore, it would have been obvious to one of ordinary skill in the art to select sensors that operate in the nW or μW range when designing an energy-harvesting module, as taught by Pollack, because such ultra-low power operation is necessary to enable the device to function from the limited energy available through harvesting.
In relation to claim 10, Pollack teaches "utilizing a ultra-low power temperature sensing circuit" (para. [0045]) and that the power management chip (LTC3108) "is designed to operate on very low voltages, manage a storage capacitor and regulate its output with minimal power" (para. [0122]-[0130]). The specific range of about 50 nW to about 1 μW represents a design choice within the range of ultra-low power operation taught by Pollack. Therefore, it would have been obvious to one of ordinary skill in the art to select components operating within this power range, as it represents a routine optimization of the ultra-low power design principle taught by Pollack for energy-harvesting applications.
In relation to claim 11, Feygin does not explicitly disclose this energy management feature. However, Pollack discloses an RFID tag comprising "an energy storage device ('CAP'), such as a capacitor (other means for storing electrical energy harvested from the EH device, such as a supercap and a non-chemical battery may be employed)" (para. [0068]). Pollack further teaches that harvested energy is stored in a capacitor and used to power the device: "[t]he energy received by the bolus may be used to charge a storage capacitor (including supercap) or solid state battery and this stored energy can be used to power circuitry to independently... enable taking temperature or other sensor readings periodically" (para. [0111]). Pollack also discloses a "voltage sensor (140) to sense the voltage across capacitor CS" (para. [0022]), which is used to determine whether sufficient energy is available. The combination of energy storage in a capacitor and voltage sensing to manage power constitutes determining whether harvested energy is sufficient and retrieving supplemental energy from a capacitor when needed. Therefore, it would have been obvious to incorporate this energy management system from Pollack into the module of Feygin to ensure reliable operation even when the harvested energy is intermittent or insufficient.
In relation to claim 12, Pollack discloses that "harvested energy may enable powering microcontroller and sensor circuits in the bolus that measure temperature or other parameters" (para. [0036]). Pollack further discloses that the RFID tag comprises "sensors 208 for temperature or other conditions" and "a radio (active transmitter) 202 and associated antenna 204 for transmitting data" (para. [0122], all of which are powered by the harvested energy. The sensors and the antenna/transmitter are the primary components that are activated by the harvested energy. Therefore, the limitation that the "one or more components" includes the sensor and/or the antenna is taught by Pollack. Therefore, since this enhancement(s) was well-known in the art at the time of filing, the implementation of such enhancement in the invention would have been considered an obvious alternative in the design of the injection device and the overall system.
In relation to claim 14, this claim adds the same energy management limitation as claim 11. As set forth in the rejection of claim 11, Pollack discloses an energy storage device such as a capacitor (para. [0068]), storing harvested energy in a capacitor for later use (para. [0111]), and a voltage sensor to sense the voltage across the capacitor (para. [0022]). The combination of these features teaches determining whether harvested energy is sufficient and retrieving supplemental energy from a capacitor. The motivation to combine is the same as set forth in the rejection of claim 11.
In relation to claim 15, this claim adds the same boost converter limitation as claim 6. As set forth in the rejection of claim 6, Pollack discloses "circuitry 212 associated with the EH device 210 for voltage rectification, boost, overvoltage protection" (para. [0122]-[0130]). Pollack further identifies the LTC3108 chip, which "boosts a very low voltage DC input" (para. [0122]-[0130]). The motivation to combine is the same as set forth in the rejection of claim 6.
In relation to claim 17, this claim adds the same energy management limitation as claims 11 and 14. As set forth in the rejection of claim 11, Pollack discloses an energy storage device such as a capacitor (para. [0068]), storing harvested energy in a capacitor for later use (para. [0111]), and a voltage sensor to sense the voltage across the capacitor (para. [0022]). The combination of these features teaches determining whether harvested energy is sufficient and retrieving supplemental energy from a capacitor. The motivation to combine is the same as set forth in the rejection of claim 11.
In relation to claim 18, this claim adds the same boost converter limitation as claims 6 and 15. As set forth in the rejection of claim 6, Pollack discloses "circuitry 212 associated with the EH device 210 for voltage rectification, boost, overvoltage protection" (para. [0122]-[0130]). Pollack further identifies the LTC3108 chip, which "boosts a very low voltage DC input" (para. [0122]-[0130]). The motivation to combine is the same as set forth in the rejection of claim 6.
In relation to claim 19, this claim adds the same voltage regulator limitation as claim 7. As set forth in the rejection of claim 7, Pollack discloses that the LTC3108 chip can "manage a storage capacitor and regulate its output with minimal power" (para. [0122]-[0130]). The LTC3108 integrates both boost and voltage regulation functions, constituting an integrated voltage regulator. The motivation to combine is the same as set forth in the rejection of claim 7.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783