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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/30/2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20-39 are rejected under 35 U.S.C. 103 as being unpatentable over Patent No.Us,: US 10,610,111 B1 to Tran, in view of Pub.No.: US 2021/0260284 A1 to Chase
Regarding claim 20, Tran discloses “a method of authenticating a user for using a drug delivery device” (at each viewer site , after a viewer specifies the correct URL to the client browser computer , a connection with the server 200 is established and user identity authenticated using suitable password or other security mechanisms [Col.33/lines 21-25]) “the method comprising: acquiring motion data of the user”(the system monitors motion patterns [Col.7/lines 23-25])
Tran does not explicitly disclose “comparing acquired motion data with stored motion data of a user-specific data record and generating a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data ; and enabling, disabling, triggering, or terminating an execution of a function of the drug delivery device based on the data matching index.”
However, Chase in an analogous art discloses “comparing acquired motion data with stored motion data of a user-specific data record and generating a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data”(controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]); “and enabling, disabling, triggering, or terminating an execution of a function of the drug delivery device based on the data matching index.”(if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tran’s smart watch system comprising a security system which monitors motions with Chase’s intelligent drug delivery system that utilizes a smart watch to also monitor motion in order to provide additional security. One of ordinary skill in the art would have been motivated to combine because Tran discloses a smart watch system with security measures to assist with monitoring the health of an individual, Chase also utilizes a smart watch to monitor the health and administer a drug system and both are from the same field of endeavor.
Regarding claim 21 in view of claim 20, the references combined disclose “wherein the motion data of the user is acquired by an electronic circuit comprising at least one of a communication interface and a sensor” (an insulin pump augmentation system may include a body , an accelerometer sensor , a gyroscopic pitch sensor , and a controller . The accelerometer sensor may be arranged on the body and configured to output motion data based on detected motion Chase [par.0011]).
Regarding claim 22 in view of claim 21, the references combined disclose “wherein at least a portion of the acquired motion data is acquired by the sensor” (an insulin pump augmentation system may include a body , an accelerometer sensor , a gyroscopic pitch sensor , and a controller Chase[par.0011])
Regarding claim 23 in view of claim 22, the references combined disclose
“wherein the sensor comprises at least one of an acceleration sensor, a rotation sensor, a position sensor, a distance sensor, and a physiologic data capturing sensor.”(accelerometer sensor, gyroscope pitch, and controller Chase[par.0011])
Regarding claim 24 in view of claim 21, the references combined disclose “wherein at least a portion of the acquired motion data is acquired by the communication interface through a wireless communication with at least one of: a satellite-based positioning system, an access point of a communication network, and a counterpart communication interface of at least one of: a supplementary device attachable to the drug delivery device, an electronic unit of the drug delivery device, and a mobile electronic device” (data output from these additional sensors is transmitted to an IPAS-equipped insulin pump (e.g. through wireless communication means), where the added data stream is combined with the data supplied from the pump's integral sensor(s), with both data streams subsequently being processed by an Artificial Intelligence sub-system within the insulin pump Chase [par.0050]).
Regarding claim 25 in view of claim 20, the references combined disclose “wherein the acquired motion data comprises at least one of: gesture data being indicative of characteristic gestures of the user, and a motion pattern being indicative of at least one of a position and a motion profile of the user at a specific point of time or during a specific time interval”(the controller may be configured to analyze the motion data and/or the orientation data on a time weighted basis. Further, the controller may be configured to utilize a data pattern matching algorithm to provide a determination of an occurrence of a lifestyle event of a user Chase [par.0013]).
Regarding claim 26 in view of claim 20, the references combined disclose “wherein the user-specific data record is obtained by at least one of: deriving and storing the stored motion data from previously acquired motion data of the user” (request user input [Fig.4/item 44], store user input Chase [Fig.4/item 46]) ; “and requesting and receiving at least one of a user-specific motion pattern and user-specific gesture data from a database”(monitor motion and orientation data Chase [Fig.5/item 32]).
Regarding claim 27 in view of claim 20, the references combined disclose “wherein the execution of the function of the drug delivery device is enabled or triggered when the data matching index is above an upper data matching threshold.”(controller may be configured to generate a signal when the sum of calories ingested by the user is greater than or equal to a predetermined caloric threshold Chase [par.0027]).
Regarding claim 29 in view of claim 27, the references combined disclose “wherein the execution of the function of the drug delivery device is disabled or terminated when the data matching index is below a lower data matching threshold.” (i.e. if low “suspend insulin delivery [Fig.5/item 68], check level threshold [Fig.5/item 66] if high reduce rate, if low level insulin delivery rate Chase [Fig.5])
Regarding claim 30 in view of claim 29, the references combined disclose “further comprising: entering into a dialogue with the user; generating and outputting a user request when the data matching index is below the upper data matching threshold and above the lower data matching threshold” (i.e. if low “suspend insulin delivery [Fig.5/item 68], check level threshold [Fig.5/item 66] if high reduce rate, if low level insulin delivery rate Chase [Fig.5]); and enabling or triggering the function of the drug delivery device in response to the dialogue with the user or in response to a reaction of the user to the user request” (i.e. if low “suspend insulin delivery [Fig.5/item 68], check level threshold [Fig.5/item 66] if high reduce rate, if low level insulin delivery rate Chase [Fig.5])
Regarding claim 30, Tran discloses “an authentication system for authenticating a user for using a drug delivery device(at each viewer site , after a viewer specifies the correct URL to the client browser computer , a connection with the server 200 is established and user identity authenticated using suitable password or other security mechanisms [Col.33/lines 21-25]), the authentication system comprising: an electronic circuit integrated into or attachable to the drug delivery device(the system monitors motion patterns [Col.7/lines 23-25]).
Tran does not explicitly disclose “electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device;
at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record; and
at least one processor operable to compare acquired motion data to stored motion data
and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data, wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device.
However, Chase in an analogous art discloses “electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device; at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record; and at least one processor operable to compare acquired motion data to stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data”(controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]) ; “wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device”(if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tran’s smart watch system comprising a security system which monitors motions with Chase’s intelligent drug delivery system that utilizes a smart watch to also monitor motion in order to provide additional security. One of ordinary skill in the art would have been motivated to combine because Tran discloses a smart watch system with security measures to assist with monitoring the health of an individual, Chase also utilizes a smart watch to monitor the health and administer a drug system and both are from the same field of endeavor.
Regarding claim 31 in view of claim 31, the references combined disclose “wherein the electronic circuit is part of a supplementary device attachable to the drug delivery device, or wherein the electronic circuit is part of an electronic unit integrated into the drug delivery device”(Chase [Fig.1]).
Regarding claim 32 in view of claim 30, the references combined disclose “further comprising a mobile electronic device comprising at least one of the sensor and the communication interface for acquiring at least a portion of the motion data of the user.” (data output from these additional sensors is transmitted to an IPAS-equipped insulin pump (e.g. through wireless communication means), where the added data stream is combined with the data supplied from the pump's integral sensor(s), with both data streams subsequently being processed by an Artificial Intelligence sub-system within the insulin pump Chase [par.0050]).
Regarding claim 33 in view of claim 32, the references combined disclose “wherein the electronic circuit comprises a circuit communication interface configured to wirelessly communicate with the communication interface of the mobile electronic device”(data output from these additional sensors is transmitted to an IPAS-equipped insulin pump (e.g. through wireless communication means), where the added data stream is combined with the data supplied from the pump's integral sensor(s), with both data streams subsequently being processed by an Artificial Intelligence sub-system within the insulin pump Chase [par.0050]).
Regarding claim 34 in view of claim 33, the references combined disclose “wherein the circuit communication interface is operable to receive at least the portion of the motion data acquired by the mobile electronic device” (data output from these additional sensors is transmitted to an IPAS-equipped insulin pump (e.g. through wireless communication means), where the added data stream is combined with the data supplied from the pump's integral sensor(s), with both data streams subsequently being processed by an Artificial Intelligence sub-system within the insulin pump Chase [par.0050]).
Regarding claim 35 in view of claim 30 the references combined disclose “wherein the mobile electronic device comprises at least one of an external electronic device, a wearable electronic device, and a wireless tag” (In one embodiment, medicine for the patient is tracked using radio frequency identification (RFID) tags Tran [Col.34/lines 51-54]).
Regarding claim 36 in view of claim 30 the references combined disclose “wherein the at least one processor is operable to enable, disable, trigger, or terminate the execution of the function of the drug delivery device depending on the data matching index”(controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]).
Regarding claim 37 in view of claim 30 the references combined disclose “wherein at least a portion of the acquired motion data is acquired by the sensor, and wherein the sensor comprises at least one of an acceleration sensor, a rotation sensor, a position sensor, a distance sensor, and a physiologic data capturing sensor” (accelerometer sensor, gyroscope pitch, and controller Chase[par.0011])
Regarding claim 38, Tran discloses “a computer program that is executable by at least one processor of an authentication system for authenticating a user for using a drug delivery device(at each viewer site , after a viewer specifies the correct URL to the client browser computer , a connection with the server 200 is established and user identity authenticated using suitable password or other security mechanisms [Col.33/lines 21-25]), wherein the authentication system comprises: an electronic circuit integrated into or attachable to the drug delivery device (smart watch [Fig.6a]).
Tran does not explicitly disclose “the electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device; at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record; and at least one processor operable to compare acquired motion data with stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data, wherein the data matching index is; configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device; and wherein the computer program product comprises computer readable instructions that, when the computer program product is executed by the at least one processor of the authentication system, causes the at least one processor to: acquire the motion data of the user; compare the acquired motion data to the stored motion data of the user-specific data record; generate the data matching index ; and enable, disable, trigger, or terminate the execution of the function of the drug delivery device based on the data matching index.
However, Chase in an analogous art discloses “the electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device” (if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]); “at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record” an insulin pump augmentation system may include a body , an accelerometer sensor , a gyroscopic pitch sensor , and a controller . The accelerometer sensor may be arranged on the body and configured to output motion data based on detected motion Chase [par.0011]); and at least one processor operable to compare acquired motion data with stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data” (controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]); “wherein the data matching index is; configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device” (if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]); “and wherein the computer program product comprises computer readable instructions that, when the computer program product is executed by the at least one processor of the authentication system, causes the at least one processor to: acquire the motion data of the user; compare the acquired motion data to the stored motion data of the user-specific data record; generate the data matching index ; and enable, disable, trigger, or terminate the execution of the function of the drug delivery device based on the data matching index” (controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tran’s smart watch system comprising a security system which monitors motions with Chase’s intelligent drug delivery system that utilizes a smart watch to also monitor motion in order to provide additional security. One of ordinary skill in the art would have been motivated to combine because Tran discloses a smart watch system with security measures to assist with monitoring the health of an individual, Chase also utilizes a smart watch to monitor the health and administer a drug system and both are from the same field of endeavor.
Regarding claim 39, Tran discloses “a set configured for use with or in an authentication system, the authentication system comprising: an electronic circuit integrated into or attachable to the drug delivery device(if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]), “the electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device; at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record an insulin pump augmentation system may include a body , an accelerometer sensor , a gyroscopic pitch sensor , and a controller . The accelerometer sensor may be arranged on the body and configured to output motion data based on detected motion Chase [par.0011]).
Tran does not explicitly disclose “and at least one processor operable to compare acquired motion data to stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data ; wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device; the set comprising one or more of: the drug delivery device, wherein the drug delivery device is provided with the electronic circuit of the authentication system, a supplementary device attachable to the drug delivery device and provided with the electronic circuit of the authentication system, and a mobile electronic device comprising at least one of the sensor and the communication interface of the authentication system.”
However, Chase in an analogous art discloses “and at least one processor operable to compare acquired motion data to stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data” (controller may be configured to utilize a data pattern matching algorithm to compare the motion data with one or more predetermined motion data patterns stored in the pump augmentation system Chase [par.0018]); “wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device” (if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]); “the set comprising one or more of: the drug delivery device, wherein the drug delivery device is provided with the electronic circuit of the authentication system” (if high, reduce insulin Chase [Fig.5/item 74]) , if low increase (Chase [Fig.5/item 72]), “a supplementary device attachable to the drug delivery device and provided with the electronic circuit of the authentication system, and a mobile electronic device comprising at least one of the sensor and the communication interface of the authentication system” (data output from these additional sensors is transmitted to an IPAS-equipped insulin pump (e.g. through wireless communication means), where the added data stream is combined with the data supplied from the pump's integral sensor(s), with both data streams subsequently being processed by an Artificial Intelligence sub-system within the insulin pump Chase [par.0050]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tran’s smart watch system comprising a security system which monitors motions with Chase’s intelligent drug delivery system that utilizes a smart watch to also monitor motion in order to provide additional security. One of ordinary skill in the art would have been motivated to combine because Tran discloses a smart watch system with security measures to assist with monitoring the health of an individual, Chase also utilizes a smart watch to monitor the health and administer a drug system and both are from the same field of endeavor.
Conclusion
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/MICHAEL D ANDERSON/Examiner, Art Unit 2433
/JEFFREY C PWU/Supervisory Patent Examiner, Art Unit 2433