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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. In this case, the original specification does not disclose that the processing device performs the functions specifically recited in claim 17, instead the specification discusses that the controller performs those functions.
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 9, 12 and 14 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.
Claims 12 and 14 contain the trademark/trade name “Bluetooth®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe conformance with a continuously changing communications protocol set forth by the BLUETOOTH® standard and, accordingly, the identification/description is indefinite. For examination purposes, the claim was construed to refer to any of the various BLUETOOTH® communication variants.
Similarly, claim 9 contains the trademark/trade name “iPad®”.
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 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 1-5 and 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Estes et al. (US 20190054236 A1, herein, Estes) in view of Ali et al. (US 20120277716 A1, herein, Ali).
Regarding claim 1, Estes discloses A fluid delivery device (infusion pump assembly 20 – Fig.2) comprising:
a reservoir (medicine reservoir 27 – Fig.1) that can contain a fluid to be delivered to a user (“to dispense the suggested dosage of medicine from the medicine reservoir 27”, see para [0031]);
a user output port (tubing 29 – Fig.1) configured to provide a fluid path between the reservoir and the user (“causes the medicine to be dispensed through tubing 29 of an infusion set”, see para [0032]);
a drive assembly (drive system 26 – Fig.1) configured to controllably drive fluid from the reservoir into the fluid path (“controller 23 can cause a drive system 26 of the pump assembly 20 to dispense the suggested dosage of medicine”, see para [0031]);
a communication interface (wireless communication device 21,41 – Fig,1) configured to send and receive signals on a communication path (“wireless communication device 21 is operable to send and receive data signals”, see para [0030]); and
a controller (controller 23 – Fig.1) connected to the drive assembly and the communication interface and configured to control the drive assembly to deliver a designated amount of fluid from the reservoir to the fluid path (“generates command signals for operating the various components of the pump assembly 20. For example, the controller 23 can cause a suggested dosage received by the wireless communication device 21 to be presented to the user”, see para [0031]);
generate a prompt for confirmation (“the controller prompts the user for confirmation of acceptance of the bolus dosage”, see para [0013]) a command, operate the drive assembly in accordance with the command when a reply to the prompt is received and comprises an input corresponding to an affirmative confirmation (“if the user accepts the recommended dosage, the controller 23 can generate control signals to cause the drive system 26 to dispense the suggested dosage”, see para [0040]), and ignore the command when the reply to the prompt is a negative confirmation chosen from an input corresponding to a negative confirmation (“if the user rejects the recommended dosage, the controller 23 can provide the user with an option to... reject any bolus dosage at the present time”, see para [0040]), and no reply being received within a designated time period after the prompt (“rejecting the change in operation… after lapse of a predetermined period of time in which no use confirmation is received”, see para [0010]).
Estes does not appear to expressly disclose wherein the controller is further configured to analyze the command to operate the drive assembly to determine when the command corresponds to an anomalous command.
Ali teaches a drug delivery device with a controller configured to analyze a command to operate the drive assembly to determine when the command corresponds to an anomalous command (under broadest reasonable interpretation, examiner interprets anomalous to mean outside of the standard or expected pattern, hence, any commands straying from the established delivery commands are considered anomalous (“indicate that the delivery of the agent to the patient according to the infusion schedule or bolus request has exceeded one or more threshold values, including, e.g., a maximum unit dose”, see para [0050]). Additionally, after determining whether a command is anomalous, Ali further teaches (“prevent delivering the therapeutic agent in a manner inconsistent with the therapy program (e.g., limiting the delivery according to safe delivery levels, or stopping the delivery altogether) and alert the clinician and/or patient 101 of any error conditions related to the delivery”, see para [0038])).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to analyze a command to determine the command to be an anomalous command as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Regarding claim 2, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, wherein the controller is further configured to operate the drive assembly in accordance with the command without the prompt for confirmation or the reply with an input corresponding to an affirmative confirmation when the command is not an anomalous command (“the controller device 200 may transmit a confirmation signal to the mobile device 40 to indicate that the suggested bolus dosage has been initiated”, see para [0040]).
Regarding claim 3, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, as recited above.
Estes does not appear to expressly disclose wherein the controller is configured to process a parameter in the command in accordance with at least one anomaly detection algorithm to compare the parameter with a value chosen from a threshold value and a selected range of values, and to determine the command to be an anomalous command if the parameter exceeds the threshold value or is outside the selected range of values and to be normal command if the parameter satisfies a threshold value or selected range of threshold values.
Ali teaches a drug delivery device with a controller configured to process a parameter in the command in accordance with at least one anomaly detection algorithm to compare the parameter with a value chosen from a threshold value and a selected range of values, and to determine the command to be an anomalous command if the parameter exceeds the threshold value or is outside the selected range of values and to be normal command if the parameter satisfies a threshold value or selected range of threshold values (under broadest reasonable interpretation, examiner interprets the anomalous to mean outside of the standard or expected pattern, hence, any commands straying from the established delivery commands is considered anomalous (“indicate that the delivery of the agent to the patient according to the infusion schedule or bolus request has exceeded one or more threshold values, including, e.g., a maximum unit dose”, see para [0050]). Additionally, after determining whether a command is anomalous, Ali further teaches (“prevent delivering the therapeutic agent in a manner inconsistent with the therapy program (e.g., limiting the delivery according to safe delivery levels, or stopping the delivery altogether) and alert the clinician and/or patient 101 of any error conditions related to the delivery”, see para [0038])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to determine the command to be an anomalous command if the parameter exceeds the threshold as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Regarding claim 4, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 3, as recited above.
Estes does not appear to expressly disclose wherein the parameter level or range is preset, or adapted over time in accordance with operation of the fluid delivery device.
Ali teaches wherein the parameter level or range is preset, or adapted over time in accordance with operation of the fluid delivery device (“threshold may be determined by processor 301 or the external computing device using parameters associated with a particular therapeutic agent, e.g., whether the agent has risks associated with over infusion, and/or parameters specific to patient 101, e.g., patient 101 weight, body composition, and the infusion history of patient 101”, see para [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to include a parameter level or range is preset, or adapted over time as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Regarding claim 5, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, as recited above.
Estes does not appear to expressly disclose wherein the controller is configured to process the command by analyzing variables chosen from historical commands to deliver the fluid to the patient and historical disease management data related to the patient to identify a fluid delivery device use pattern corresponding to one or more parameters related to amounts of fluid delivered, when the fluid is delivered, and patient physiological data affected by delivery of the fluid, and to detect when the command corresponds to an anomalous command because a parameter in the command is an outlier relative to one or more of the parameters of the use pattern.
Ali teaches a drug delivery device with a controller configured to process the command by analyzing variables chosen from historical commands to deliver the fluid to the patient and historical disease management data related to the patient to identify a fluid delivery device use pattern corresponding to one or more parameters related to amounts of fluid delivered, when the fluid is delivered, and patient physiological data affected by delivery of the fluid (“threshold may be determined... using parameters associated with a particular therapeutic agent, e.g., whether the agent has risks associated with over infusion, and/or parameters specific to patient 101, e.g., patient 101 weight, body composition, and the infusion history of patient 101”, see para [0090]), and to detect when the command corresponds to an anomalous command because a parameter in the command is an outlier relative to one or more of the parameters of the use pattern (“to stop delivering the agent to patient 101 after the one unit dose has been delivered, or when another condition is met, e.g., a delivery threshold is exceeded”, see para [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to process the command by analyzing variables chosen from historical commands as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Regarding claim 8, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, wherein the command is communicated to the fluid delivery device from an auxiliary device (“the mobile device 40 can wirelessly communicate… with the pump assembly 20 to facilitate remote control of the pump assembly 20 by a user operating the mobile device 40”, see para [0029]).
Regarding claim 9, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 8, wherein the auxiliary device is chosen from a smartphone, a computer, a laptop, an iPad, and a dedicated, portable remote controller configured to command the fluid delivery device (“the mobile device may be a smartphone device”, see para [0008]).
Regarding claim 10, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 8, wherein the auxiliary device is connected to the fluid delivery device by a communication modality chosen from WiFi, Bluetooth®, near field communication (NFC), cellular communication, and wired communication, and is configured to remotely control the fluid delivery device by sending commands via the communication modality (“the mobile device 40 can wirelessly communicate (e.g., via near field communication (NFC), Bluetooth connectivity, or another short-range wireless connection, or via radio frequency (RF) or Wi-Fi connectivity, or another wireless connection) with the pump assembly 20 to facilitate remote control of the pump assembly 20”, see para [0029]).
Regarding claim 11, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 8, wherein the auxiliary device is connected to the fluid delivery device by a communication modality, and the command and the prompt are both transmitted using the communication modality (“the mobile device 40 can wirelessly communicate... with the pump assembly 20 to facilitate remote control of the pump assembly 20”, see para [0029]).
Regarding claim 12, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 11, wherein the communication modality is chosen from WiFi, near field communication (NFC) and Bluetooth® (“the mobile device 40 can wirelessly communicate (e.g., via near field communication (NFC), Bluetooth connectivity, or another short-range wireless connection, or via radio frequency (RF) or Wi-Fi connectivity, or another wireless connection) with the pump assembly 20”, see para [0029]).
Regarding claim 13, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 8, wherein the prompt is transmitted using a second communication modality that is different from a first communication modality used to send the command (“the mobile device 40 can wirelessly communicate (e.g., via... Bluetooth connectivity, or... Wi-Fi connectivity, or another wireless connection… the pump assembly 20 may further include a NFC circuit 30 responsive to an optional NFC circuit 46 incorporated in the mobile device 40”, see para [0029]-[0033]).
Regarding claim 14, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 13, wherein the first communication modality is chosen from WiFi and Bluetooth® (“the mobile device 40 can wirelessly communicate (e.g., via... Bluetooth connectivity, or... Wi-Fi connectivity, or another wireless connection”, see para [0029]), and the second communication modality is chosen from near field communication (NFC), a magnet and Hall Effect sensor (“the pump assembly 20 may further include a NFC circuit 30 responsive to an optional NFC circuit 46 incorporated in the mobile device 40”, see para [0033]) provided to respective ones of the fluid delivery device and an auxiliary device that sends the command to the fluid delivery device, an accelerometer sensor (“the pump assembly 20 can detect a bump with the mobile device 40 via the NFC circuit 230 and/or the accelerometer 231... (e.g., directly or indirectly such that both devices undergo a detectable bump impact) ”, see para [0063]) configured to detect a movement of an auxiliary device relative to the fluid delivery device, and a switch (“user may press one or more of the buttons 224 to shuffle through a number of menus or program screens”, see para [0052]) on the fluid delivery device.
Regarding claim 15, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, wherein the controller comprises a communication processor device ("the controller device 200 of the pump assembly 20 also includes a wireless communication device 221”, see para [0054]) and a safety processor device (processor 25 – Fig.1), wherein the communication processor device establishes secure messaging with an auxiliary device connected to the fluid delivery before passing a message signal comprising the command from the auxiliary device to the fluid delivery device (“secure communications protocol... in wireless communications between the controller device 200 and the mobile device 40”, see para [0055]), and the safety processor device performs anomaly detection of the command.
Estes does not appear to expressly disclose performing anomaly detection of the command.
Ali teaches a drug delivery device with a controller that performs anomaly detection of the command (under broadest reasonable interpretation, examiner interprets the anomalous to mean outside of the standard or expected pattern, hence, any commands straying from the established delivery commands is considered anomalous (“indicate that the delivery of the agent to the patient according to the infusion schedule or bolus request has exceeded one or more threshold values, including, e.g., a maximum unit dose”, see para [0050])).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to include a safety processor device that performs anomaly detection of the command as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Regarding claim 16, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 16, wherein the communication processor device and the safety processor device are both provided within the fluid delivery device (“the controller device 200 of the pump assembly 20 also includes a wireless communication device 221”, see para [0054] and Fig.1).
Regarding claim 17, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, further comprising a processing device separate from and coupled to the controller;
wherein the controller is configured to generate the prompt for confirmation (“the controller prompts the user for confirmation of acceptance of the bolus dosage”, see para [0013]) of the command, operate the drive assembly in accordance with the command when a reply to the prompt is received and comprises an input corresponding to an affirmative confirmation (“if the user accepts the recommended dosage, the controller 23 can generate control signals to cause the drive system 26 to dispense the suggested dosage”, see para [0040]), and ignore the command when the reply to the prompt is a negative confirmation chosen from an input corresponding to a negative confirmation (“if the user rejects the recommended dosage, the controller 23 can provide the user with an option to... reject any bolus dosage at the present time”, see para [0040]), and no reply being received within a designated time period after the prompt (“rejecting the change in operation… after lapse of a predetermined period of time in which no use confirmation is received”, see para [0010]).
Estes does not appear to expressly disclose wherein the processing device is configured to analyze the command to operate the drive assembly to determine when the command corresponds to an anomalous command, and to provide an indication to the controller when the command is determined to correspond to an anomalous command.
Ali teaches a drug delivery device with a controller configured to analyze a command to operate the drive assembly to determine when the command corresponds to an anomalous command (under broadest reasonable interpretation, examiner interprets the anomalous to mean outside of the standard or expected pattern, hence, any commands straying from the established delivery commands is considered anomalous (“indicate that the delivery of the agent to the patient according to the infusion schedule or bolus request has exceeded one or more threshold values, including, e.g., a maximum unit dose”, see para [0050]). Additionally, after determining whether a command is anomalous, Ali further teaches (“prevent delivering the therapeutic agent in a manner inconsistent with the therapy program (e.g., limiting the delivery according to safe delivery levels, or stopping the delivery altogether) and alert the clinician and/or patient 101 of any error conditions related to the delivery”, see para [0038])).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to analyze a command to determine the command to be an anomalous command as taught by Ali to further ensure that “the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced” (Ali see abstract).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Estes in view of Jiang et al. (US 20200098465 A1, herein, Jiang).
Regarding claim 6, Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 1, as recited above.
Estes does not appear to expressly disclose wherein the controller determines when the command corresponds to an anomalous command by using at least one anomaly detection algorithm.
Jiang teaches a drug delivery device wherein the controller determines when the command corresponds to an anomalous command by using at least one anomaly detection algorithm (“the current physiological condition of the patient, and/or other activities engaged in by the patient in comparison to the patient's activity plan and generates or otherwise provides user notifications in response to deviations from the patient's activity plan”, see para [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to determine an anomalous command by using at least one anomaly detection algorithm as taught by Jiang to further help “facilitate improved glucose control that reduces patient workload” (Jiang para [0004]).
Regarding claim 7, Estes discloses the Estes discloses the fluid delivery device (infusion pump assembly 20 – Fig.2) of claim 6, as recited above.
Estes does not appear to expressly disclose wherein the at least one anomaly detection algorithm employs anomaly detection techniques chosen from local outlier factor, histogram- based outlier score, one-class support vector machine, robust covariance, k-nearest neighbor, isolation forests, supervised machine-learning model, unsupervised machine-learning model, and hybrid approach using a semi-supervised machine-learning model.
Jiang teaches a drug delivery device wherein the at least one anomaly detection algorithm employs anomaly detection techniques chosen from local outlier factor, histogram- based outlier score, one-class support vector machine, robust covariance, k-nearest neighbor, isolation forests, supervised machine-learning model, unsupervised machine-learning model, and hybrid approach using a semi-supervised machine-learning model (“a nearest neighbor algorithm or similar machine learning technique may be performed to identify substantially similar historical situations multidimensionally” and “a k-nearest neighbor algorithm may be utilized to utilized to map a patient”, see para [0125] and [0128] respectively).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller disclosed by Estes to include one anomaly detection algorithm using machine learning as taught by Jiang to further help “facilitate improved glucose control that reduces patient workload” (Jiang para [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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/T.M.A./Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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