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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
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 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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 1-20 are currently pending and being examined.
The 112 rejection from the previous office action is withdrawn.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (USPAP 2019/0336683) in view of Mandapaka (USPAP 2018/0110077).
In reference to independent claim 1, O’Connor teaches a drug delivery device (fig 1), comprising:
a processor (121); and
a memory (123) storing instructions (algorithm 129) that, when executed by the processor (121), configure the drug delivery device to:
receive an analyte measurement value from an analyte sensor (104) during a prior cycle time (715, fig 7B);
determine a present analyte measurement value has not been received during a present cycle time (para 0060 discloses “The processor may determine that a subsequent glucose measurement value has not been received within a next regular time interval (735)”),
in response to the determination, initiate an action to obtain the present analyte measurement value (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.”); and
based on an outcome of the initiated action, calculate a dosage of the drug using the present analyte measurement value (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”); and
output the calculated dosage of the drug (755, para 0060 discloses “The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”), however
O’Connor is silent to initiate an action to obtain the present analyte measurement value generated by the analyte sensor,
wherein the action comprises confirming a communication connection with the analyte sensor or confirming an absence thereof;
Mandapaka, , a similar system for monitoring glucose in the body, teaches initiate an action to obtain the present analyte measurement value generated by the analyte sensor (examiner is interpreting this to mean that the system attempts to requery the sensor to determine the sensed value, (para 0414 discloses “the process [700, fig 7A] may restart if exchanged messages fail or packets are dropped.” If messages drop it is a confirmation of an absence of communication between the sensor 708 and the display device 710, then at 705b top system requerys the sensor for new data);
wherein the action comprises confirming a communication connection with the analyte sensor (705b shows requesting communication with the analyte sensor 708 and then the sensor sends a signal back to the “master” granting the data connection, this action inherently confirms communication with the sensor; para 0072 specifically discloses “The method further includes the display device generating a confirmation for connection to the analyte sensor system based on a duration of the connection exceeding a pre-determined amount of time.”)
or confirming an absence thereof (if the “confirms communication” done above is not successful it inherently confirming an absence).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to independent claim 17, O’Connor teaches a drug delivery system (fig 1), comprising:
a controller including a processor (161), a communication device (164), and a memory (163), wherein the memory stores programming code and an automatic analyte control application (169, fig 1; fig 1 shows the memory 163 storing the algorithm 169);
a drug delivery device (102) including a drug delivery device processor (121), a drug delivery device memory (123), a drug delivery device communication device (126), a reservoir (126), and a pump mechanism (124); and
an analyte sensor (104) including an analyte sensor processor (141), an analyte sensor communication device (146), and a sensing/measuring device (144), the analyte sensor is configured to periodically obtain, via the sensing/measuring device, an analyte measurement value of an analyte from a user of the drug delivery system (para 0060 discloses “at 715, a processor, such as 121, 141, or 161, may receive a number of glucose measurement values from the sensor 104. In the example, each glucose measurement value of the number of glucose measurement values may be received at a regular time interval”),
wherein the drug delivery device processor (121) is operable to: receive an analyte measurement value from the analyte sensor (104) during a prior cycle time (this is when the system is operating correctly receiving sensor signals);
determine a present analyte measurement value has not been received during a present cycle time (para 0060 discloses “The processor may determine that a subsequent glucose measurement value has not been received within a next regular time interval (735)” 735, fig 7B);
in response to the determination, initiate an action to obtain the present analyte measure value (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.”);
based on an outcome of the initiated action, calculate a dosage of a drug using information related to the present analyte measurement value (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”); and
output the calculated dosage of the drug (755, para 0060 discloses “The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”).
O’Connor is silent to initiate an action to obtain the present analyte measurement value generated by the analyte sensor,
wherein the action comprises confirming a communication connection with the analyte sensor or confirming an absence thereof;
Mandapaka, , a similar system for monitoring glucose in the body, teaches initiate an action to obtain the present analyte measurement value generated by the analyte sensor (examiner is interpreting this to mean that the system attempts to requery the sensor to determine the sensed value, (para 0414 discloses “the process [700, fig 7A] may restart if exchanged messages fail or packets are dropped.” If messages drop it is a confirmation of an absence of communication between the sensor 708 and the display device 710, then at 705b top system requerys the sensor for new data);
wherein the action comprises confirming a communication connection with the analyte sensor (705b shows requesting communication with the analyte sensor 708 and then the sensor sends a signal back to the “master” granting the data connection, this action inherently confirms communication with the sensor; para 0072 specifically discloses “The method further includes the display device generating a confirmation for connection to the analyte sensor system based on a duration of the connection exceeding a pre-determined amount of time.”)
or confirming an absence thereof (if the “confirms communication” done above is not successful it inherently confirming an absence)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 2, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, however
O’Connor is silent to the processor, when initiating the action to obtain the present analyte measure value, is further configured to: confirm a communication connection with the analyte sensor; upon confirmation of the communication connection with the analyte sensor, request the analyte sensor to send the present analyte measurement value; and receive the present analyte measurement value in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches the processor (para 0393 discloses “various tasks performed in connection with the procedure illustrated in FIG. 7A may be performed, for example, by a processor”), when initiating the action to obtain the present analyte measure value, is further configured to:
upon confirmation of the communication connection with the analyte sensor (done in 705b; para 0072 specifically discloses “The method further includes the display device generating a confirmation for connection to the analyte sensor system based on a duration of the connection exceeding a pre-determined amount of time.”), request the analyte sensor to send the present analyte measurement value (first part of 705d); and receive the present analyte measurement value in response to the request (second part of 705d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 3, O’Connor in view of Mandapaka teaches the drug delivery device of claim 2, O’Connor further discloses a device wherein the processor, when calculating the dosage of the drug using the present analyte measurement value, is further configured: extract the present analyte measurement value and information related to the present analyte measurement value (725, fig 7B discloses predicting more than one value, stating “Predict a number of future glucose measurement values using at least one of the number of received glucose measurement values” then using the “predicted number of future glucose measurement values” in step 745 to extrapolate one value,
the “number of future glucose measurement values”, discloses both the claimed “measurement value and information related to the present analyte measurement value”; as the “information related to the present analyte measurement value” is very broad and can be interpreted to be read on by the additional “number” of predicted values); and use the present analyte measurement value in an algorithm (129, fig 1) to determine the dosage of the drug (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values (745). The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”).
In reference to dependent claim 4, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, however
O’Connor is silent to wherein the processor, when initiating the action to obtain the present analyte measure value, is further configured to: upon confirmation of the absence of the communication connection with the analyte sensor, send signals to the analyte sensor to establish a new communication connection; and upon establishment of the new communication connection, request the analyte sensor to send the present analyte measurement value; and receive the present analyte measurement value in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches wherein the processor (para 0393 discloses “various tasks performed in connection with the procedure illustrated in FIG. 7A may be performed, for example, by a processor”), when initiating the action to obtain the present analyte measure value, is further configured to:
confirm an absence of a communication connection with the analyte sensor (para 0414 discloses “the process [700, fig 7A] may restart if exchanged messages fail or packets are dropped.” If messages drop it is a confirmation of an absence of communication between the sensor 708 and the display device 710); upon confirmation of the absence of the communication connection (“exchanged messages fail or packets are dropped”) with the analyte sensor (708),
send signals to the analyte sensor (708) to establish a new communication connection (top 705b); and
upon establishment of the new communication connection (bottom 705b),
request the analyte sensor to send the present analyte measurement value (top 705d); and
receive the present analyte measurement value in response to the request (bottom 705d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 5, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, however
O’Connor is silent to wherein the processor when initiating the action to obtain the present analyte measure value is further configured to: establish contact with a controller that is communicatively coupled to the analyte sensor; and request the present analyte measurement value from the controller; and receive the present analyte measurement value in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches wherein the processor (para 0393 discloses “various tasks performed in connection with the procedure illustrated in FIG. 7A may be performed, for example, by a processor”) when initiating the action to obtain the present analyte measure value is further configured to:
establish contact with a controller (710, fig 7A) that is communicatively coupled to the analyte sensor (708); and
request the present analyte measurement value from the controller (top 705d); and receive the present analyte measurement value in response to the request (bottom 705d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 6, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, O’Connor further discloses a drug delivery device wherein the processor when initiating actions to obtain the present analyte measure value (705, fig 7B) is further configured to: however
O’Connor is silent to wherein the processor when initiating actions to obtain the present analyte measure value is further configured to: upon confirmation of a communication connection with the analyte sensor, request the analyte sensor to send the present analyte measurement value; and receive an indication that the present analyte measurement value is not available in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches the processor (para 0393 discloses “various tasks performed in connection with the procedure illustrated in FIG. 7A may be performed, for example, by a processor”) when initiating actions to obtain the present analyte measure value is further configured to: confirm a communication connection with the analyte sensor (705b, fig 7A); upon confirmation of a communication connection with the analyte sensor (done in 705b), request the analyte sensor to send the present analyte measurement value (first part of 705d); and receive an indication that the present analyte measurement value is not available (para 0060, of O’Connor, discloses “The processor may determine that a subsequent glucose measurement value has not been received within a next regular time interval (735)”) in response to the request (request is provided by Mandapaka).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 7, O’Connor in view of Mandapaka teaches the drug delivery device of claim 6, O’Connor further discloses a drug delivery device wherein the processor when calculating the dosage of the drug use information related to the present analyte measurement value, is further configured to:
obtain an estimate of the present analyte measurement value (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.”), wherein the estimated present analyte measurement value (“values” determined in 725) is the information related to the present analyte measurement value (values in 725 are the “present analyte measurement value”); and use the estimated present analyte measurement value in an algorithm (129, fig 1) to determine the dosage of the drug (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”).
In reference to dependent claim 8, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, O’Connor further discloses a device wherein the processor when calculating the dosage of the drug using information related to the present analyte measurement value, is further configured to:
obtain an estimate of the present analyte measurement value (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.” The future glucose values predicted in 725 become the present values), wherein the estimated present analyte measurement value is the information related to the present analyte measurement value (they are related because present/future values are based on values from the past making them directly related); and use the estimated present analyte measurement value in an algorithm (129) to determine the dosage of the drug (par 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values. For example, each time the AP algorithm executing on the processor receives a value, a future glucose value to be received at a future time interval may be predicted”).
In reference to dependent claim 9, O’Connor in view of Mandapaka teaches the drug delivery device of claim 1, O’Connor discloses a device further comprising: a reservoir (125, fig 1) configured to store the drug (para 0027 discloses “a reservoir 125 for storing the drug (such as insulin)”); and a pump mechanism (124) operable to output the drug in response to command signals from the processor (para 0028 discloses “a processor 121 (or controller) for controlling the delivery of the medication”).
In reference to dependent claim 18, O’Connor in view of Mandapaka teaches the drug delivery system of claim 17, however
O’Connor is silent to wherein the initiating the action to obtain the present analyte measure value further comprises: upon confirmation of a communication connection with the analyte sensor, requesting the analyte sensor to send the present analyte measurement value; and receive the present analyte measurement value in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches initiating the action to obtain the present analyte measure value further comprises: upon confirmation of a communication connection with the analyte sensor (done in 705b; para 0072 specifically discloses “The method further includes the display device generating a confirmation for connection to the analyte sensor system based on a duration of the connection exceeding a pre-determined amount of time.”), requesting the analyte sensor to send the present analyte measurement value (first part of 705d); and receive the present analyte measurement value in response to the request (second part of 705d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
In reference to dependent claim 19, O’Connor in view of Mandapaka teaches the drug delivery system of claim 18, O’Connor further discloses a device wherein the calculating of the dosage of the drug using information related to the present analyte measurement value, comprises: extract the present analyte measurement value and information related to the present analyte measurement value (725, fig 7B discloses predicting more than one value, stating “Predict a number of future glucose measurement values using at least one of the number of received glucose measurement values” then using the “predicted number of future glucose measurement values” in step 745 to extrapolate one value,
the “number of future glucose measurement values”, discloses both the claimed “measurement value and information related to the present analyte measurement value”; as the “information related to the present analyte measurement value” is very broad and can be interpreted to be read on by the additional “number” of predicted values); and use the present analyte measurement value in an algorithm (129, fi g1) to determine the dosage of the drug (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values (745). The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”).
In reference to dependent claim 20, O’Connor in view of Mandapaka teaches the drug delivery system of claim 17, however
O’Connor is silent to initiating the action to obtain the present analyte measure value further comprises: upon confirmation of the absence of the communication connection with the analyte sensor, sending signals to the analyte sensor to establish a new communication connection; and upon establishment of the new communication connection, request the analyte sensor to send the present analyte measurement value; and receive the present analyte measurement value in response to the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches initiating the action to obtain the present analyte measure value further comprises:
upon confirmation of the absence of the communication connection (“exchanged messages fail or packets are dropped”) with the analyte sensor (708), sending signals to the analyte sensor (708) to establish a new communication connection (top 705d); and upon establishment of the new communication connection (bottom 705b), request the analyte sensor to send the present analyte measurement value (top 705d); and receive the present analyte measurement value in response to the request (bottom 705d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Mandapaka “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
Claims 10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (USPAP 2019/0336683) in view of Badam (TW201635084).
In reference to independent claim 10, O’Connor teaches a method, O’Connor further comprising:
receiving, by a processor (121) of a drug delivery device (pump 102, fig 1), a series of analyte measurement values at predetermined intervals (715, fig 7B) from an analyte sensor (sensor 104, fig 1);
generating an estimate of a next analyte measurement value in continuation of the series based on each of the analyte measurement values in the series (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.”);
determining that the analyte sensor has not delivered the next analyte measurement value (para 0060 discloses “The processor may determine that a subsequent glucose measurement value has not been received within a next regular time interval (735)”);
after a predetermined period of time (the “regular time interval” in 735), determining an action to be taken related to delivery of a drug using the estimate of the next analyte measurement value (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”); and
generating a command signal based on the determination of the action (755, para 0060 discloses “The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”), however
O’Connor is silent to querying other devices to determine if the other devices received the next analyte measurement value from the analyte sensor.
Badam, a similar electronic device for use with sensors, teaches querying other devices to determine if the other devices received the next analyte measurement value from the analyte sensor (page 9, para 2 discloses “Upon request, the wearable cache 124 can be retrieved to obtain the expanded display data, and the mobile device 104 with the larger battery can use the full sensor log file to perform accurate sensor data analysis.” Badam discloses a wearable device (housing memory cache 124) communicating with the mobile device 104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the device data sharing feature taught in Badam in the system of O’Connor “to avoid loss of these sensor values (loss of these sensor values will result in incorrect analysis and can significantly reduce health applications)” page 9, para 2; Badam.
In reference to dependent claim 13, O’Connor in view of Badam teaches the method of claim 10, O’Connor further discloses a device wherein determining that the analyte sensor (104) has not delivered the next analyte measurement value, comprises:
monitoring a communication device (126) for receipt of the next analyte measurement value from the analyte sensor (para 0060 discloses “The processor may determine that a subsequent glucose measurement value has not been received within a next regular time interval (735)”); determining a preset period of time (in this case 1 hour) has passed since a deadline for receiving the next analyte measurement value was missed (done at 735); and generating a flag indicating the next analyte measurement value is missing (the table on pages 7 and 8 discloses notification of the user after 1 hour of missing points, concurrently para 0044 discloses sampling every hour, as a result O’Connor is capable of notifying a user every hour if a value is missed).
In reference to dependent claim 14, O’Connor in view of Badam teaches the method of claim 13, O’Connor further discloses a device wherein the preset period of time is several milliseconds, several seconds or one to three cycles (para 0044 discloses “Regular time intervals may be intervals, such as approximately every 5 minutes, 10 minutes, hourly, a particular time(s) of day, or the like.” In this case 1 hour can be a cycle), and a cycle includes time for receipt of an analyte measurement value (from 104, fig 1), determination of a dosage of a drug (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”) and delivery of a dosage of the drug (755, para 0060 discloses “The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”).
In reference to dependent claim 15, O’Connor in view of Badam teaches the method of claim 10, O’Connor further discloses a device wherein the next analyte measurement value includes information related to the next analyte measurement value (725, fig 7B discloses predicting more than one value, stating “Predict a number of future glucose measurement values using at least one of the number of received glucose measurement values” then using the “predicted number of future glucose measurement values” in step 745 to extrapolate one value,
the “number of future glucose measurement values”, discloses both the claimed “measurement value and information related to the present analyte measurement value”; as the “information related to the present analyte measurement value” is very broad and can be interpreted to be read on by the additional “number” of predicted values) as well as information related to previously-sent analyte measurement values (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.” The previously sent values are used to determine future values).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (USPAP 2019/0336683) in view of Badam (TW201635084) further in view Vanslyke (USPAP 2015/0351672).
In reference to dependent claim 11, O’Connor in view of Badam teaches the method of claim 10, O’Connor further discloses wherein the generating the estimate of the next analyte measurement value in the series based on the analyte measurement values in the series (par 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values. For example, each time the AP algorithm executing on the processor receives a value, a future glucose value to be received at a future time interval may be predicted”), comprises:
estimating, based on the timestamp (combined below from Vanslyke) associated with each analyte measurement value and the analyte measurement value, a next analyte measurement value that corresponds to a time later than a latest timestamp associated with a latest respective analyte measurement value (para 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values.”); and storing the estimated analyte measurement value in a memory (memory 123, 725 shows using values from the memory to determine values), however
O’Connor, and Badam are silent to obtaining a timestamp associated with each analyte measurement value of the analyte measurement values.
Vanslyke, a similar system for handling medical data, teaches obtaining a timestamp associated with each analyte measurement value of the analyte measurement values (para 0232 discloses “timestamps of data may be used in certain analyses, e.g., to detect certain time-based patterns”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the timestamp acquisition taught in Vanslyke in the system of O’Connor in view of Badam because “raw sensor data indicating a potentially faulty situation because of an abnormally high signal value may at first appear to indicate a fault, but may also be caused by the user eating a regular meal. The determination that the user has eaten a regular meal may be by way of timestamp data, as well as machine learning (or other technique) in which a pattern may be established. Similarly, a spike in the data at a consistent time of day may be indicative of a water related error, such as related to a daily shower. Similarly, other types of faults may be more likely to occur at night, such as compression artifacts.” Para 0232; Vanslyke.
In reference to dependent claim 12, O’Connor in view of Badam, and Vanslyke teaches the method of claim 11, O’Connor further disclose a device wherein determining the action to be taken related to delivery of the drug using the generated estimate of the next analyte measurement value (par 0060 discloses “The processor may use at least one of the number of received glucose measurement values, at 725, to predict future glucose values. For example, each time the AP algorithm executing on the processor receives a value, a future glucose value to be received at a future time interval may be predicted” then in step 755, fig 7B, and in para 0060, the system determines how much drug to give), comprises:
in response to receiving an indication that the next analyte measurement value is not available (735, fig 7B), retrieving the estimate of the next analyte measurement value (725) from the memory (123); determining a next dosage of a drug to be delivered based on the retrieved estimate of the next analyte measurement value (para 0060 discloses “in response to the determination that the subsequent glucose measurement value has not arrived, a total daily insulin-based basal delivery rate may be adjusted to be provided by a medical device based on at least one of the predicted number of future glucose measurement values”); and indicating output of the determined next dosage of the drug as the determination of the action (755, para 0060 discloses “The processor may issue instructions to the medical device, such as 102 of FIG. 2, so insulin, at 755, may be delivered via the medical device 102 according to the adjusted total daily insulin-based basal delivery rate.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (USPAP 2019/0336683) in view of Badam (TW201635084).
In reference to dependent claim 16, O’Connor in view of Mandapaka and Badam teach the method of claim 10, O’Connor further discloses querying other devices to determine if the other devices received the next analyte measurement value (O’Connor is silent to other devices but Badam, combined above, discloses checking other devices) from the analyte sensor (104), comprises:
in response to a flag (notification in the table on pages 7 and 8) indicating the next analyte measurement value is missing (after 1 hour), however
O’Connor, and Badam are silent to establishing a wireless communication link with a controller; sending a request via the established wireless communication link to the controller, wherein the request is for the next analyte measurement value; and starting a clock to measure an amount of time since sending the request.
Mandapaka, a similar system for monitoring glucose in the body, teaches establishing a wireless communication link with a controller (705b, fig 7A); sending a request via the established wireless communication link to the controller (top 705d, fig 7A), wherein the request is for the next analyte measurement value (the value is “data”); and
starting a clock to measure an amount of time since sending the request (735, fig 7B of O’Connor discloses a “time interval”, after combination, in order to measure the time interval a clock must be started from the time when the request is sent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection features of Mandapaka in the drug delivery device of O’Connor in view of Badam “improving performance with respect to reliability, speed, accuracy of wireless communications and connection protocols” para 0187; Mandapaka.
Response to Arguments
In response to applicant’s argument that “Mandapaka's system architecture requires terminating failed sessions and establishing an entirely new communication session through the complete sequence of operations if any failed packet occurs This is fundamentally different from confirming a communication connection status or absence as an action to retrieve a missed measurement value” examiner respectfully disagrees. Mandapaka specifically discloses in para 0467 that “in some cases, even if enough ping messages are missed such that slave latency is triggered, supervision timeout may be used to effectively override the consequences (e.g., disconnection of analyte sensor system 708 and display device 710, etc.). As with other connection parameters, the supervision timeout parameter may be proposed/counter-proposed in conjunction with connection establishment at operation 795b as a value and/or range of values, and may in some cases be defined according to a set of rules”. Mandapaka is clearly interested in missed communications as well as dropped connections, previously in para 0465 Mandapaka discloses “slave latency can be employed such that, for example, even if a certain number of packets or ping messages are missed/dropped”. This cite shows how Mandapaka broadly is concerned with accurate communication of sensor data including missed connections.
In response to applicant’s argument that “Applying Mandapaka's connection-restart methodology to O'Connor would fundamentally transform O'Connor's prediction-based operational principle into a connection-troubleshooting principle, thereby changing the basic character of O'Connor's invention. Such a modification would require abandoning O'Connor's core predictive algorithm approach in favor of a communication session management approach, which constitutes an improper change of principle of operation that renders the combination improper under 35 U.S.C. § 103” examiner respectfully disagrees. Applicant is interpreting Mandapaka too narrowly, the title of Mandapaka is “SYSTEM AND METHOD FOR COMMUNICATION OF ANALYTE DATA”. Mandapaka’s specification discloses in the “technical field” as “The present disclosure relates generally to the monitoring of analyte values received from a sensor. More particularly, the present disclosure is directed to systems, methods, apparatuses, and devices, for the communication of analyte (e.g., glucose) data.”. Therefore the it is completely within one of ordinary skill in the art to modify O’Connor with a small feature of Mandapaka which clearly is analogous art as they both involve analyte sensor communication.
In response to applicant’s argument that “the retrieval operation described in Badam occurs upon request from the mobile device seeking to access previously stored historical data from the wearable cache, not in response to detecting that a present analyte measurement value was not received from the analyte sensor during the current operational cycle. Furthermore, Badam's wearable cache 124 is not described as receiving analyte measurement values directly from an analyte sensor. Rather, it stores display data and sensor log files that have already been processed, transmitted, and logged. Accordingly, Badam does not cure the deficiency of O'Connor”, examiner respectfully disagrees. Examiner is not relying on Badam for “detecting that a present analyte measurement value was not received from the analyte sensor during the current operational cycle”, just for “querying other devices to determine if the other devices received the next analyte measurement value from the analyte sensor”. Applicant is reminded, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES W NICHOLS/Examiner, Art Unit 3783
Prosecution Insights