DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22, 26, 31, and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 depends from claim 21 but recites in the preamble “[t]he wearable drug delivery system of claim 21,” whereas claim 21 recites in the preamble “[a] drug delivery system”. The change from “drug delivery system” to “wearable drug delivery system” renders the scope uncertain.
Claims 26 [and dependent claims 27-28] and 36 [and dependent claims 37-38] recite “smart accessor” but the preceding phrase is “smart accessory device.” The phrase “smart accessor” lacks clear antecedent basis and renders the scope unclear.
Independent claim 31 [and dependent claims 32-40] recites the doses of “the liquid drug” without previously reciting “a liquid drug.” Therefore, the phrase “the liquid drug” lacks antecedent basis.
Claim 35 depends from claim 31 and recites “wherein the glucose sensor is co-located with the controller” but claim 31 does not recite “a glucose sensor”. Therefore, the phrase “the glucose sensor” lacks antecedent basis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-25, 29-30, 31-35, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Roy (US 2018/0099092A) in view of Blomquist (US 2003/0163223A1) and Yudovsky et al. (US 2011/0105955A1).
In relation to independent claims 21 and 31, claim 21 recites a drug delivery system comprising a reservoir, pump mechanism, inertial measurement unit, and controller, wherein the controller receives a selection of an activity mode, receives a setting for the duration of that mode, modifies dose-calculation parameters based on an activity-level change exceeding thresholds, and exits the selected activity mode when the duration is exceeded. Claim 31 recites the corresponding controller implementation with a processor communicatively coupled to an inertial measurement unit and the same duration, activity-level-change, parameter-modification, and exit limitations.
A drug delivery system / controller for delivering a liquid drug.
Roy discloses an insulin infusion device, stating that “the infused fluid is insulin” and that the device is “suitable for infusing a fluid, a liquid, a gel, or other agent into the body of a user.” (Roy ¶ [0028].) Roy further discloses “fluid infusion devices including a motor that is operable to linearly displace a plunger (or stopper) of a reservoir provided within the fluid infusion device to deliver a dosage of fluid, such as insulin, to the body of a user.” (Roy ¶ [0022].)
A reservoir configured to store a liquid drug and a pump mechanism operable to expel doses of the liquid drug.
Roy discloses that “the illustrated embodiment of the fluid infusion device 200 includes a housing 202 adapted to receive a fluid-containing reservoir 205” and that “fluid communication from the interior of the reservoir 205 to the user is established via the tubing 221.” (Roy ¶ [0035].) Roy further discloses that “fluid is forced from the reservoir 205 via tubing 221 as the drive system 208 is operated to displace the slide 206 in the axial direction 218 toward the opening 220 in the housing 202.” (Roy ¶ [0037].) Roy also states that command signals operate the motor “to force fluid from the reservoir 205 along a fluid path ... thereby administering doses of the fluid contained in the reservoir 205 into the user's body.” (Roy ¶ [0041].)
An inertial measurement unit operable to detect an activity level of a user / processor communicatively coupled to an inertial measurement unit.
Roy discloses an acceleration sensor for activity/exercise detection, stating that “the illustrated infusion system 500 also includes an acceleration sensing arrangement 508 (or accelerometer) that may be worn on or otherwise associated with the user's body 501 to sense, detect, measure or otherwise quantify an acceleration of the user's body 501, which, in turn, may be indicative of exercise or some other condition in the body 501 that is likely to influence the user's insulin response.” (Roy ¶ [0047].) Roy also discloses auxiliary sensors “worn, carried, or otherwise associated with the body 501 of the user to measure characteristics or conditions of the user (or the user's activity) that may influence the user's glucose levels or insulin sensitivity.” (Roy ¶ [0046].) To the extent Roy does not expressly use the words “inertial measurement unit,” Yudovsky fills this terminology gap by disclosing that “accelerometers can be found in ... pedometers, and portable medical devices” and that “a medical device might utilize one accelerometer to measure physical activity levels of the user.” (Yudovsky ¶ [0002].)
A controller communicatively coupled to the pump mechanism and inertial measurement unit.
Roy discloses control electronics and pump control circuitry, stating that “the control electronics 224 generally represent the hardware, firmware, processing logic and/or software ... configured to control operation of the motor assembly 207 and/or drive system 208.” (Roy ¶ [0040].) Roy further discloses that the “pump control system 520 automatically adjusts or adapts one or more parameters or other control information used to generate commands for operating the motor 532 in a manner that is influenced by an exercise intensity level or other user behavior identified based on measurements output by the auxiliary sensing arrangement(s) 506, 508.” (Roy ¶ [0048].)
Receive a selection of an activity mode of operation.
Roy discloses exercise-affected operation and user-interface control, but Roy does not expressly disclose a user-selected activity mode named as such. Blomquist fills this gap by disclosing user-selectable exercise-named temporary basal programs: “the user can scroll through names such as Sick, Travel, Exercise, and the generic name Temp Rate X.” (Blomquist ¶ [0141].) Blomquist also discloses that “a user activates a temporary rate by selecting the Temporary Rate menu item from the main menu” and that the pump “lists the standard temporary rate delivery program ... and all of the custom temporary rate delivery programs ... [and] [t]he user scrolls to and selects the desired delivery program.” (Blomquist ¶ [0144].)
Receive a setting for a duration of the selected activity mode of operation.
Roy does not expressly disclose a user-set duration for a selected activity mode. Blomquist fills this gap by disclosing that “the user scrolls to and selects a duration for which they would like the temporary rate to be active once it begins.” (Blomquist ¶ [0142].) Blomquist also discloses, when executing the selected temporary basal program, that “the edit screen 379 has a duration field 378 that contains the duration for the temporary rate and a rate field 380 that contain data to set the temporary rate.” (Blomquist ¶ [0146].)
Based on a determined activity level change based on input from the inertial measurement unit exceeding activity-mode thresholds, modify parameters used in calculation of doses.
Roy discloses detecting and classifying exercise intensity from auxiliary measurements, stating that “measurements from one or more sensing arrangements, such as, for example, heart rate sensors, accelerometers, lactate sensors, ketone sensors, or the like, are monitored and analyzed to detect exercise by the user and characterize or otherwise classify intensity or level of the exercise based on the measurements.” (Roy ¶ [0024].) Roy further discloses that, based on exercise intensity, “control information may be adjusted to make the closed-loop control less aggressive or responsive or otherwise reduce insulin infusion while the user is exercising,” while for higher intensity exercise “the control information is adjusted to be more responsive or proactive.” (Roy ¶ [0024].) Roy discloses threshold/limit parameters used in generating dose commands because the pump control system “may generate or otherwise determine dosage commands configured to maintain the sensed glucose value below an upper glucose limit, above a lower glucose limit, or otherwise within a desired range of glucose values,” and the device may maintain “target value, upper and/or lower glucose limit(s), insulin delivery limit(s), and/or other glucose threshold value(s).” (Roy ¶ [0048].)
Exit the selected activity mode when the set duration is exceeded.
Roy does not expressly disclose exiting a user-selected activity mode after a user-set duration. Blomquist fills this gap by disclosing duration-bound temporary basal delivery and completion/reminder behavior: “[w]ithin the end-temporary-rate-reminder field 358, the user scrolls to and selects either a yes value or a no value. If the user selects the yes value, the pump 100 enables generation of the reminder upon completion of the temporary rate. The reminder is either an audible or vibratory reminder when delivery at the temporary rate is complete.” (Blomquist ¶ [0137].) Blomquist further discloses that the user sets “a duration for which they would like the temporary rate to be active once it begins.” (Blomquist ¶ [0142].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Roy with Blomquist and Yudovsky because Roy identifies the clinical problem of adapting insulin delivery to exercise/activity, stating that “a user's daily activities and experiences may cause that user's insulin response to vary throughout the course of a day” and that “it is desirable to account for the anticipated variations or fluctuations in the user's insulin response caused by the user's activities.” (Roy ¶ [0004].) Blomquist provides an established pump-interface mechanism for selecting an exercise temporary basal program and setting its duration. A person of ordinary skill in the art would have used Blomquist’s user-selectable, duration-limited temporary-basal program with Roy’s exercise-intensity control because both references address insulin pump operation and basal/dose adjustment in response to exercise-related glucose effects, and the combination would have predictably reduced user burden while limiting the time period of exercise-related dosing changes.
In relation to claims 22 and 32, these claims respectively depend from claims 21 and 31 and further recite that the set duration for the selected activity mode can be set between 30 minutes and several hours.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated into this rejection.
The set duration for the selected activity mode can be set between 30 minutes and several 014hours.
Roy does not expressly disclose this numerical duration range for a selected activity mode. Blomquist fills the gap by disclosing that, for a custom temporary rate, “the user scrolls to and selects a duration for which they would like the temporary rate to be active once it begins” and that “the user can scroll through rates in the range from 30 minutes to 72 hours.” (Blomquist ¶ [0142].) Blomquist also discloses execution editing where “the duration can be set in the range from 0 minutes to 72 hours.” (Blomquist ¶ [0146].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to apply Blomquist’s 30-minute-to-72-hour duration setting to Roy’s exercise-control mode because Roy’s adjustment is tied to the user’s exercise intensity, while Blomquist supplies a known pump mechanism for bounding temporary basal changes to a selected duration.
In relation to claims 23 and 33, claims 23 and 33 respectively depend from claims 21 and 31 and further recite generating an alert via a user interface requesting confirmation of initiation of the activity mode of operation.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated into this rejection.
Generate an alert via a user interface requesting confirmation of initiation of the activity mode.
Roy discloses UI notifications generally: the infusion system may include a display presenting “device status indicators, alert messages, or the like.” (Roy ¶ [0029].) Roy also discloses output UI elements “for providing notifications or other information to the user.” (Roy ¶ [0049].) To the extent Roy does not expressly request confirmation of initiating an activity mode, Blomquist fills the gap by disclosing a confirmation screen before delivering a temporary basal rate: “The user sets the duration, activates the Next function 200, sets the rate, activates the next function 200, and then the pump 100 indexes to a confirmation screen 382 that lists the set duration and rate ... The user then activates a Deliver function 384 ... and the pump 100 begins delivering insulin according to the operating parameters set in the temporary rate program.” (Blomquist ¶ [0148].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to include Blomquist’s confirmation screen in Roy’s exercise/activity dosing adjustment because confirmation of a temporary insulin-delivery change improves safety and reduces inadvertent activation of a dosing mode.
In relation to claims 24 and 34, claims 24 and 34 respectively depend from claims 21 and 31 and further recite a glucose sensor and basing the dose calculation further on glucose readings output from that glucose sensor.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated.
A glucose sensor and dose calculation based on glucose readings.
Roy discloses a glucose sensing arrangement, stating that “the sensing arrangement 504 [is] realized as a glucose sensing arrangement that senses, detects, measures or otherwise quantifies the user's glucose level.” (Roy ¶ [0044].) Roy further discloses that the glucose sensor “generate[s] or otherwise output[s] electrical signals ... indicative of the relative interstitial fluid glucose level.” (Roy ¶ [0045].) Roy also discloses dosing based on glucose readings: the pump control system “automatically generates or otherwise determines dosage commands for operating an actuation arrangement, such as a motor 532, to displace the plunger 517 and deliver insulin ... based on the difference between the sensed glucose value and the target glucose value.” (Roy ¶ [0048].)
Based on the above teachings, in view of the demonstrated conventionality of the enhancement(s), its implementation in the invention of this application would have been considered an obvious alternative in the design of the system.
In relation to claims 25 and 35, claims 25 and 35 recite that the glucose sensor is co-located with the controller.
Base rejection incorporated.
The rejections of claims 24 and 34 are incorporated.
The glucose sensor is co-located with the controller.
Roy discloses alternative physical integration of sensing and control, stating that “the sensing arrangement 104 may be incorporated within the infusion device 102.” (Roy ¶ [0030].) Roy also discloses that “in other embodiments, the infusion device 102 may include all control functions, and may operate without the CCD 106 and/or the computer 108.” (Roy ¶ [0031].) Roy further discloses that “the sensing arrangement 104 and/or the infusion device 102 are cooperatively configured to utilize a closed-loop system for delivering fluid to the user.” (Roy ¶ [0033].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to co-locate the glucose sensor and controller in Roy’s infusion-device embodiment because Roy expressly presents integration of sensing arrangements and control functions in the infusion device as an alternative system architecture.
In relation to claims 29 and 39, claims 29 and 39 respectively depend from claims 21 and 31 and further recite that, in response to selecting a first activity mode, the controller sets a maximum insulin delivery to approximately 1 to 3 times an original basal rate of the user.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated into this rejection.
Setting a maximum insulin delivery to approximately 1 to 3 times an original basal rate.
Roy discloses adjusting insulin delivery limits based on exercise intensity, stating that “one or more insulin delivery limits may be adjusted to allow for the rate or amount of insulin delivery to be increased or decreased to account for the exercise intensity level,” and that “a maximum insulin infusion rate or other delivery limits could be increased in response to anaerobic exercise or other high intensity exercise ... but decreased in response to aerobic exercise or lower intensity exercise.” (Roy ¶ [0025].) Blomquist discloses numerical basal-rate scaling in temporary modes, stating that “the user scrolls to and selects a percentage to modify the basal rate” and that the user can select “percentages in the range from 0% to 250%.” (Blomquist ¶ [0142].) Blomquist also discloses execution values “from about 0% to about 400% if percent is the rate factor.” (Blomquist ¶ [0146].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement Roy’s adjustable maximum insulin delivery limits using Blomquist’s percentage-of-basal mechanism because both references use insulin-pump control parameters to vary insulin delivery in response to patient conditions and programmed temporary modes.
In relation to claims 30 and 40, claims 30 and 40 respectively depend from claims 21 and 31 and further recite that, in response to selecting a first activity mode, the controller sets a basal-rate input to an automated drug-delivery algorithm equal to approximately 50% to 90% of an original basal rate of the user.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated into this rejection.
Setting a basal-rate input to approximately 50% to 90% of an original basal rate.
Roy discloses reducing insulin infusion for aerobic/mild-to-moderate exercise: “in response to detecting mild or moderate intensity exercise, control information may be adjusted to make the closed-loop control less aggressive or responsive or otherwise reduce insulin infusion while the user is exercising.” (Roy ¶ [0024].) Blomquist discloses that a temporary rate can be a percentage modification of basal delivery: “[i]f the user selects the Percent value, the pump 100 sets the temporary rate delivery programs to increase and decrease the basal rate in terms of a percentage of the programmed basal rate.” (Blomquist ¶ [0135].) Blomquist also discloses “percentages in the range from 0% to 250%.” (Blomquist ¶ [0142].) The claimed 50%-90% range is within Blomquist’s disclosed range and implements Roy’s reduction of insulin infusion during exercise.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement Roy’s reduced insulin infusion during mild/moderate exercise as a 50%-90% basal-rate input using Blomquist’s temporary percentage-of-basal functionality because the combination uses known pump programming to achieve Roy’s stated exercise-safety objective of reducing insulin infusion while the user is exercising.
Claims 26, 27, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Roy (US 2018/0099092A) in view of Blomquist (US 2003/0163223A1) and Yudovsky et al. (US20110105955A1), as disclosed above, and in further view of Jiang (US 2016/0057268A1).
In relation to claims 26 and 36, claims 26 and 36 respectively depend from claims 21 and 31 and further recite a smart accessory device comprising a communication device, a processor, and a memory, wherein the controller receives the set duration of the selected activity from the smart accessory.
Base rejection incorporated.
The rejections of claims 21 and 31 are incorporated.
A smart accessory device comprising a communication device, processor, and memory.
Roy discloses portable external/control devices and transceiver communication: “one or more of the infusion device 102, the sensing arrangement 104, the CCD 106, and/or the computer 108 includes a transmitter, a receiver, and/or other transceiver electronics that allow for communication with other components of the infusion system 100.” (Roy ¶ [0029].) Roy further discloses that “the CCD 106 may be a portable electronic device” and that the CCD/computer may perform “processing, delivery routine storage, and ... control.” (Roy ¶ [0031].) To the extent Roy does not expressly call the accessory a smart accessory with processor/memory, Jiang fills the gap by disclosing a smartwatch main circuit with “CPU module ... storage module, short-distance wireless communication module, accelerometer sensor module.” (Jiang ¶ [0007].) Jiang further discloses that “Smart Watch can send information to the binding mobile phone,” including “accelerometer sensor information.” (Jiang ¶¶ [0015]-[0016].)
Controller receives the set duration of the selected activity from the smart accessory.
Roy discloses that target/threshold values “may be received from an external component (e.g., CCD 106 and/or computing device 108) or be input by a user via a user interface element 540 associated with the infusion device 502.” (Roy ¶ [0049].) Blomquist discloses that the selected temporary mode includes a duration field because “the user scrolls to and selects a duration for which they would like the temporary rate to be active once it begins.” (Blomquist ¶ [0142].) Combining Roy’s external component input and Jiang’s smartwatch communications with Blomquist’s activity-duration setting yields receipt of the set duration from the smart accessory.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to receive activity-duration settings through Jiang’s smartwatch accessory because Roy already allows external/portable components to communicate control information with the infusion system, while Blomquist supplies the user-set exercise/temporary-rate duration. The substitution of a smartwatch for Roy’s portable CCD/computing interface would have predictably improved convenience by letting a user configure activity-related therapy at a wrist-worn device.
In relation to claims 27 and 37, claims 27 and 37 respectively depend from claims 26 and 36 and further recite that the smart accessory device is a smartwatch.
Base rejection incorporated.
The rejections of claims 26 and 36 are incorporated into this rejection.
The smart accessory device is a smartwatch.
Jiang expressly discloses “[a] Smart Watch, comprising wristwatch strap, wristwatch body, dial-up button on wristwatch body,” and further recites the smart-watch main circuit including “CPU module ... storage module, short-distance wireless communication module, accelerometer sensor module.” (Jiang ¶ [0007].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement Roy’s portable communicating accessory as Jiang’s smartwatch for the same reasons provided above for claims 26 and 36.
Claims 28 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Roy (US 2018/0099092A) in view of Blomquist (US 2003/0163223A1), Yudovsky et al. (US20110105955A1) and Jiang (US 2016/0057268A1) as discussed above, and in further view of Oliver et al. (US 2015/0156567A1).
In relation to claims 28 and 38, claims 28 and 38 respectively depend from claims 26 and 36 and further recite that the smart accessory device is a wearable fitness device.
Base rejection incorporated.
The rejections of claims 26 and 36 are incorporated.
The smart accessory device is a wearable fitness device.
Roy discloses that an auxiliary activity sensor may be “worn, carried, or otherwise associated with the body 501 of the user to measure characteristics or conditions of the user (or the user's activity).” (Roy ¶ [0046].) Oliver discloses activity-reporting mobile/wearable sensor systems, stating that the system relates to “detecting and reporting human activity” and “remotely communicating the report, record or reward.” (Oliver ¶ [0002].) Oliver further discloses a mobile sensor system in which “Radio communication using ... Bluetooth Low Energy (Bluetooth 4) is used” and “movement ... [is] indicated by an accelerometer 118, gyroscope 119 ... or any other type of sensor.” (Oliver ¶ [0007].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use Oliver’s wearable/mobile activity-reporting device as the activity accessory in Roy’s insulin-delivery system because Roy already uses worn auxiliary sensors to detect activity affecting insulin response, and Oliver provides a known Bluetooth activity-reporting sensor architecture.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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