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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, 30 and 38 recite “wherein the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device” without any direct support in the originally filed specification that there is no “data exchange with a device separate from the on-body drug delivery device”. In fact Claim 25 and paragraphs [0025-0026] teach that there may be communication with a ‘remote device’, which appears to imply the opposite, and that there may be data exchange with a device separate from the on-body drug device. As such there does not appear to be written description support for the claim limitation “wherein the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device” in the application as filed.
Claims 22-29, 31-37 and 39-40 are rejected due to their dependence on claims 21, 30 and 38.
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.
Claim 25 is 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 25 recites “wherein the controller, when generating the alert requesting confirmation of a change to drug delivery, is operable to: forward a message, via the communication interface, to a remote device”. However, claim 25 depends on claim 21 and claim 21 recites that “the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device”. It is unclear how the controller when generating an alert is communicating with a remote device, but the step afterwards of determining a response is done without a “remote device”. Currently claims 25 and 21 appears to state that in order to determine the response (as recited in the last clause of claim 21), first a message is forwarded through a remote device to a user, and then the indication from the user (“the received indication” as recited in claim 21) is based a response due to the result of a data exchange to a remote device (limitation of claim 25), therefore the “determine a response based on the received indication” would also be based on a ‘data exchange’ from the ‘remote device’. This appears to conflict with the recitation in independent claim 21 that there is no ‘data exchange’ with a ‘remote device’ in order for the controller to determine the response. (Also see 112a rejection above).
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.
Claim(s) 21-24, 26-32 and 34-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes et al. (US Patent Pub. 20160038675 hereinafter “Estes”) in view of Moberg et al. (US 20110028818 hereinafter “Moberg”).
Regarding Claim 21, Estes teaches an on-body drug delivery device (20), comprising:
a communication interface operable to communicate with a glucose sensor [0037];
an inertial measurement unit comprising at least one of an accelerometer (31, 231) or a gyroscope; and
a controller (23 and 43; see [0039] teaching how the controller 43 communicates with controller 23), at least a portion of which is implemented in circuitry (30, 46, 230) coupled to the communication interface and the inertial measurement unit (see [0067] teaching the control circuitry of controller device 200 receives input from the mobile device 40, and that the pump device 20 can receive and send communication from the NFC circuit 46 of the mobile device, based on this the examiner takes the position that the controllers are indirectly coupled to the communication interface and inertial measurement unit), wherein the controller is operable to:
determine that glucose measurements received from the communication interface are changing (see [0037] teaching that controller 43 determines the changes in glucose measurement and see [0039] teaching how the controller 43 communicates with controller 23 to send information of suggested dosage based on the changes of glucose measurements);
generate an alert requesting confirmation of a change to drug delivery (see [0029] "For example, in some embodiments, the user can engage the user interface 22 to confirm acceptance, decline acceptance, or modify a dosage of medicine suggested by the mobile device 40.");
receive from the user, via the inertial measurement unit, an indication responsive to the requested confirmation (see [0062]), wherein the received indication is a touch from the user (see [0062] “by requiring the user to physically bump the mobile device 40 against the pump assembly 20, the user's intentions for accepting the suggested bolus dosage can be confirmed with a greater level of confidence”, it is interpreted that the ‘touch from a user’ is the user bumping the mobile device to the pump assembly); and
determine a response based on the received indication received via the inertial measurement unit in response to the touch from the user (See [0069]; Estes also teaches in [0062] “ by requiring the user to physically bump the mobile device 40 against the pump assembly 20, the user's intentions for accepting the suggested bolus dosage can be confirmed with a greater level of confidence”. The user has to bump the mobile device to the pump assembly, which is detected by both accelerometers (Inertial measurement units). This detection by the accelerometer 231 of the device would allow for the data exchange to occur and confirm the user’s acceptance of the bolus drug.).
Estes does not teach the device wherein the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device.
Moberg teaches an infusion device comprising a processor (See [0030]) that determines a response of the device based on detected conditions of acceleration sensors (see [0031]) without a data exchange with a device separate from the device (see [0030-0031] teaching that the processor is within the pump and that the pump responds/alters operation based on the detected conditions).
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 device of Estes such that the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device as taught by Moberg. Estes already includes all the elements (a controller and an accelerometer) within the device, therefore Estes would have the capabilities to have the controller do the determination without relying on the remote mobile device if it used the controller within the device similar to how Moberg uses just the processer within the device. One of ordinary skill in the art would recognize that this is an alternative form of controller that would result in a user not needing multiple devices and that this could simplify the amount of devices a user may need with them for the on-body drug delivery device to function.
Regarding Claim 22, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes further teaches the on-body drug delivery device wherein the inertial measurement unit (231) is further operable to detect an occurrence of one or more touches on the on-body drug delivery device, and the controller is further operable to determine whether the occurrence of the one or more touches on the on-body drug delivery device matches a pre- programmed sequence of touches (See [0063] teaching that accelerometer 231 can detect bumps or taps, it is interpreted that these taps/bumps are indirect touches by the user; also see [0064] teaching that the bumps or taps detected can be used to accept suggested bolus dosages).
Regarding Claim 23, the combination of Estes and Moberg teaches all elements of claim 22 as described above. Estes further teaches the on-body drug delivery device wherein the controller is further operable to: receive, from the inertial measurement unit (231), the detected occurrence of the one or more touches (See [0063] teaching that accelerometer 231 can detect bumps or taps, it is interpreted that these taps/bumps are indirect touches by the user; also see [0064] teaching that the bumps or taps detected can be used to accept suggested bolus dosages); and generate a notification confirming a bolus delivery has been or will be delivered (See [0056]).
Regarding Claim 24, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes further teaches the on-body drug delivery device wherein the controller is further operable to: determine that the received indication is confirmation that a meal has been ingested (See [0038] “the dosage calculator application 44 can determine a bolus dosage for the user in a manner that accounts for some of all of: the user's food intake,”; also see [0078-0079]).
Regarding Claim 26, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes further teaches the on-body drug delivery device wherein the controller, when determining the response based on the received indication, is further operable to: cause a change to drug delivery: and generate a notification that a change to drug delivery has been undertaken (See [0068] “In operation 520, the control circuitry optionally provides a prompt for the user to confirm a change in the operation of the medical device in response to input received from the mobile device. Such a prompt may be advantageously used to confirm the user's intent to change the operation of the medical device before the control circuitry actually implements the change.”).
Regarding Claim 27, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes further teaches the on-body drug delivery device wherein the controller, based on the determined response, is further operable to: cause a vibration to be emitted from the on-body drug delivery device indicating that a bolus injection is needed (See [0059] teaching that an alert such as a vibration is given to the user to indicate a suggest bolus dosage).
Regarding Claim 28, the combination of Estes and Moberg teaches all elements of claim 27 as described above. Estes further teaches the on-body drug delivery device wherein the controller is further operable to: receive, via the inertial measurement unit (231), a further indication confirming delivery of the bolus injection (See [0062-0063]).
Regarding Claim 29, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes further teaches the on-body drug delivery device wherein the alert requesting confirmation is an audible alert (See [0056] teaching the notification can be visual, audible, tactile or a combination; also see [0059] and [0068]).
Regarding Claim 30, Estes teaches an on-body drug delivery device, comprising: a drug reservoir (Fig 1, 27) operable to hold a liquid drug;
an inertial measurement unit (231) operable to detect taps or touches on the on-body drug delivery device (see [0062] teaching 'bumps' that are detected);
an output device operable to output alerts (223), and
a controller (23 and 43; see [0039] teaching how the controller 43 communicates with controller 23), wherein the controller is operable to:
generate, via the output device, and alert that a change to drug delivery is needed (See [0068]);
receive, via the inertial measurement, a signal regarding a sequence of one or more taps or touches to the on-body drug delivery device [0062-0063]; and
compare the sequence of one or more taps or touches to the on-body drug delivery device to one or more pre-programed sequences (see [0063-0065] teaching detection of bump to confirm bolus dosage); and
based on the comparison, carry out a change to drug delivery of the sequence of one or more taps or touches to the on-body drug delivery device matches a pre-programed sequence that corresponds to the change to drug delivery (See Fig 5; [0062] and [0065]).
Estes does not teach the device wherein the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device.
Moberg teaches an infusion device comprising a processor (See [0030]) that determines a response of the device based on detected conditions of acceleration sensors (see [0031]) without a data exchange with a device separate from the device (see [0030-0031] teaching that the processor is within the pump and that the pump responds/alters operation based on the detected conditions).
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 device of Estes such that the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device as taught by Moberg. Estes already includes all the elements (a controller and an accelerometer) within the device, therefore Estes would have the capabilities to have the controller do the determination without relying on the remote mobile device if it used the controller within the device similar to how Moberg uses just the processer within the device. One of ordinary skill in the art would recognize that this is an alternative form of controller that would result in a user not needing multiple devices and that this could simplify the amount of devices a user may need with them for the on-body drug delivery device to function.
Regarding Claim 31, the combination of Estes and Moberg teaches all elements of claim 30 as described above. Estes further teaches the on-body drug delivery device wherein the change to drug delivery is a bolus injection (830, 835; these steps are for a bolus injection).
Regarding Claim 32, the combination of Estes and Moberg teaches all elements of claim 30 as described above. Estes further teaches the on-body drug delivery device wherein the alert is an indication that a glucose level has risen (815) and the change to drug delivery is a bolus injection of the liquid drug (825; see [0028] teaching "the infusion pump assembly 20 can be used to deliver insulin or another medicinal fluid for purposes of regulating the user's blood glucose levels." ).
Regarding Claim 34, the combination of Estes and Moberg teaches all elements of claim 30 as described above. Estes further teaches the on-body drug delivery device wherein the output device comprises: a vibration device that is operable to output the generated alert as a tactile indicator (see [0059] and [0068] teaching a vibration alert).
Regarding Claim 35, the combination of Estes and Moberg teaches all elements of claim 30 as described above. Estes further teaches the on-body drug delivery device further comprising: a communication interface operable to receive communications via a wireless communication link (21), wherein the communication interface is coupled to the controller (See [0029]).
Regarding Claim 36, the combination of Estes and Moberg teaches all elements of claim 35 as described above. Estes further teaches the on-body drug delivery device wherein the communication interface is further operable to: provide the controller with glucose measurements received by the communication interface from a glucose monitor (see [0037] teaching that controller 43 determines the changes in glucose measurement and see [0039] teaching how the controller 43 communicates with controller 23 to send information of suggested dosage based on the changes of glucose measurements).
Regarding Claim 37, the combination of Estes and Moberg teaches all elements of claim 36 as described above. Estes further teaches the on-body drug delivery device wherein the controller is further operable to: receive the glucose measurements from the communication interface; and determine based on the received glucose measurements whether to generate the alert that a change to drug delivery is needed (see [0037] teaching that controller 43 determines the changes in glucose measurement and see [0039] teaching how the controller 43 communicates with controller 23 to send information of suggested dosage based on the changes of glucose measurements).
Claim(s) 25 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes in view of Moberg as applied to claims 21 and 30 above, and further in view of Kamen et al. (US Patent Pub. 20150011970 hereinafter “Kamen”).
Regarding Claim 25, the combination of Estes and Moberg teaches all elements of claim 21 as described above. Estes does not specify the on-body drug delivery device wherein the controller, when generating the alert requesting confirmation of a change to drug delivery, is operable to: forward a message, via the communication interface, to a remote device.
Kamen teaches [0523] a glucose delivery system when generating the alert is operable to: forward a message, via the communication interface, to a remote device (1800, 1900).
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 of Estes such that it is operable to: forward a message, via the communication interface, to a remote device as taught by Kamen. One of ordinary skill in the art would have been motivated to do so as it is an alternative visual alert for the user (Kamen [0080]).
Regarding Claim 33, the combination of Estes and Moberg teaches all elements of claim 30 as described above. Estes does not specify the on-body drug delivery device wherein the output device comprises: a speaker that is operable to output the generated alert as an audible alert.
Kamen teaches [0080] an audible alert generated on a speaker.
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 output device of Estes such that it comprises: a speaker that is operable to output the generated alert as an audible alert as taught by Kamen. One of ordinary skill in the art would have been motivated to do so as it is an alternative alert for the user (Kamen [0080]).
Claim(s) 38-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 20150011970 hereinafter “Kamen”) in view of Moberg (US 20110028818).
Regarding Claim 38, Kamen teaches a drug delivery system, comprising:
a glucose sensor (1802,1902,532, [0515]) including a sensing device and a communication device, wherein the sensing device is operable to measure glucose and the communication device is operable to transmit data indicative of the measured glucose; and
an on-body drug delivery device (100) including:
a drug reservoir operable to hold a liquid drug (see [0094]);
an inertial measurement unit operable to detect taps or touches on the on-body drug delivery device (See [0517] teaching a tap code and accelerometers); and
a controller (1800 or 1900), wherein the controller is operable to:
receive the data indicative of the measured glucose; based on the received data, generate a haptic or audible alert (See 0515-0516] teaching glucose monitoring and display indication; also see [0080] teaching alerts made with speakers or tactile elements) ;
receive, via the inertial measurement unit (see [0517] teaching an accelerometer), data indicative of a sequence of one or more taps or touches on the on-body drug delivery device (See [0517] teaching a tap code); and
generate a response based on the received data indicative of the sequence of one or more taps or touches on the on-body drug delivery device (See [0517] teaching how the remote interface is used to change therapy based on the tap code).
Kamen does not teach the device wherein the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device.
Moberg teaches an infusion device comprising a processor (See [0030]) that determines a response of the device based on detected conditions of acceleration sensors (see [0031]) without a data exchange with a device separate from the device (see [0030-0031] teaching that the processor is within the pump and that the pump responds/alters operation based on the detected conditions).
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 device of Kamen such that the controller determines the response without requiring data exchange with a device separate from the on-body drug delivery device as taught by Moberg. Kamen already includes a controller (see microprocessor 516 are within the device in Fig 5D) and an accelerometer (Kamen teaches in the last sentence of [0517] that the accelerometer may be placed in the device pump (1802, 1902) instead of the remote interface (1800, 1900)) within the device, therefore Kamen would have the capabilities to have the controller do the determination without relying on the remote mobile device if it used the controller within the device similar to how Moberg uses just the processer within the device. One of ordinary skill in the art would recognize that this is an alternative form of controller that would result in a user not needing multiple devices and that this could simplify the amount of devices a user may need with them for the on-body drug delivery device to function.
Regarding Claim 39, the combination of Kamen and Moberg teaches all elements of claim 38 as described above. Kamen further teaches the drug delivery system, the on-body drug delivery device further comprising: a speaker or a vibration device, wherein the speaker is operable to output the audible alert [0080], and the vibration device is operable to output the haptic alert [0080].
Regarding Claim 40, the combination of Kamen and Moberg teaches all elements of claim 38 as described above. Kamen further teaches the drug delivery system, wherein the alert is an indication that a glucose level has risen and the response is a bolus injection of the liquid drug ([0088] teaching bolus levels adjusted based on glucose meter/monitors).
Response to Arguments
Applicant’s arguments with respect to claim(s) 21, 30 and 38 have been considered but are moot because the new ground takes into consideration the amendments filed 12/3/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kamen et al. (US 20100185175) teaches accelerometer and gyroscope, and a speaker or a vibration motor. Additionally [1060] teaches there are some embodiments including a remote network operation center, which would imply there are some embodiments without the remote network operation center and the processor would be within the device itself.
Halbert (US 20120197196) teaches a gesture sensor with an accelerometer or gyroscope to sense a key press or a touch of a sensor. Halbert also teaches a speaker and a haptic speaker system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783 /WESLEY G HARRIS/Examiner, Art Unit 3783
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