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 Objections
Claims 1, 2, 6, 7, 9, 10, 12, 13, 14, 15 and 16 is/are objected to due to the following informalities:
In claim 1, line 2, “a pre-selection means by means of which” should be corrected to “a pre-selection means by
In claim 1, line 5, “a medication” should be corrected to “the medication” since this term was previously introduced.
In claim 1, lines 9 and 13, “the drive” should be corrected to “the manually operable drive or the releasable motor drive” for claim language consistency.
In claim 1, line 15, “the duration” should be corrected to “the duration of time” for claim language consistency.
In claim 2, line 2, “the duration” should be corrected to “the duration of time” for claim language consistency.
In claim 6, line 2, “the control system” should be corrected to “the system controller” for claim language consistency.
In claim 7, line 2, “the control system” should be corrected to “the system controller” for claim language consistency.
In claim 9, lines 3-4, “the control system” should be corrected to “the system controller” for claim language consistency.
In claim 10, line 2, “an administration quantity” should be corrected to “the administration quantity” for claim language consistency.
In claim 12, lines 2, “the controller” should be corrected to “the control unit” for claim language consistency.
In claim 13, line 12, “the duration” should be corrected to “the duration of time” for claim language consistency.
In claim 14, lines 18, 19, 20 and 21, “the duration” should be corrected to “the duration of time” for each occurrence.
In claim 14, line 22, “the duration” should be corrected to “a duration” since this duration is different from “a duration of time” from claim 13.
In claim 15, line 5, “the container” should be corrected to “the medication container” for claim language consistency.
In claim 16, line 2, “a pre-selection means by means of which” should be corrected to “a pre-selection means by
In claim 16, line 10, “the drive” should be corrected to “the manually operable drive or the releasable motor drive” for claim language consistency.
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.
Claim(s) 14-15 is/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 14 contains the trademark/trade name QR code. 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 an out of band authentication and, accordingly, the identification/description is indefinite. Applicant is therefore suggested to amend claim 7 to overcome rejection.
Claim 15 is rejected by virtue of its dependency on claim 14.
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.
Claim(s) 1-4, 6, and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US 20220387722 A1, herein Mensinger) and further in view of Jepson et al. (US 20220152313 A1, herein Jepson).
Regarding claim 1, Mensinger discloses an administration device (medicine injection pen 20 in Fig. 2A) for parenteral administration (it can be interpreted that medicine injection pen 20 delivers parenterally due to being an injection device and not oral administration) of a medication (Medicine injection pen 20 is a reusable injection pen configured to removably receive a medicine cartridge, e.g., a cartridge of insulin [0036]), comprising:
a pre-selection means (dose setting mechanism 25 in Fig. 2A) by means of which a pre-selected quantity can be mechanically or electronically set and/or stored (dose setting mechanism 25 to enable the selection and/or setting of a dose of medicine to be dispensed [0041]);
a manually operable drive or a releasable motor drive (Dose dispensing mechanism 24 in Fig. 2A; dose dispensing mechanism 24 of pen 20 can include a manually powered mechanism (user powered and/or mechanically biased), a motorized mechanism, or an assisted mechanism (e.g., a mechanism that operates partly on manual power and partly on motorized power) [0046]) configured to move an output means (when a force is applied to drive screw 26c of dose dispensing mechanism 24, drive screw 26c turn provides a force to urge medicine from medicine cartridge 23 [0046]) relative to a container arranged in the administration device (medicine cartridge 23 in Fig. 2A) and containing a medication (Medicine injection pen 20 is a reusable injection pen configured to removably receive a medicine cartridge, e.g., a cartridge of insulin [0036]) to cause a discharge quantity to be discharged from the container (dose dispensing mechanism 24 to dispense (e.g., deliver) medicine contained in medicine cartridge 23 out of pen 20 [0041]) through a needle and/or a hollow cannula (needle 29 in Fig. 1B; dose dispensing mechanism 24 to dispense (e.g., deliver) medicine contained in medicine cartridge 23 out of pen 20 (e.g., through needle 29) [0041]), the discharge quantity corresponding to the pre-selected quantity (to dispense an amount of medicine from cartridge 23 through needle 29 into the user in accordance with the dose amount set by dose setting mechanism 25 [0042]);
an operating means (dose dispensing button 26b in Fig. 26b) configured to be manually actuated having a non-actuated state (it can be interpreted that the state of button 26b prior to being pressed is the non-actuated state) and an actuated state (when dispensing button 26b is actuated [0051]), the operating means configured to operate and/or release the drive in the actuated state (when dispensing button 26b is actuated, locking mechanism 26d is engaged to lock electronics unit 27 and dose knob 26a to one another such that electronics unit 27 and dose knob 26a rotate together as they translate into body 22 upon actuation of dose dispensing mechanism 24 to inject the selected dose [0051]); and
Mensinger further discloses a control unit (electronics unit 27 that can include a processor [0041]; electronics unit 27 in Fig. 1B) comprising a timer (the timestamp may be the current time or a time from a count-up timer [0045]), but fails to explicitly disclose wherein the timer is configured such that, when the operating means is actuated, the timer continuously measures a duration of time between when the output means is no longer moved by the drive and when the operating means is transferred to the non-actuated state, and wherein the control unit is configured to identify the discharge quantity as a priming quantity if the duration is shorter than a predefined duration threshold.
However, Mensinger teaches where a pressure above the pressure threshold is not detected and/or other pressure metric(s) are not met prior to, during, for the duration of, at the conclusion of, and/or for a sufficient time during actuation of pen 20 to dispense medicine, the amount of medicine dispensed, as sensed by operations monitoring mechanism 28, can be flagged as a priming event [0061]. One of ordinary skill in the art may recognize that the timer of Mensinger may be programmed to measure the duration of actuation of pen 20.
Furthermore, Jepson teaches the distinguishing includes establishing one or more adjustable thresholds of a volume of a dispensed dose and/or a time between successive dispensed dosages, the adjustable thresholds being used to between a priming pen event and a therapeutic pen event, the adjustable thresholds being based at least in part on the previous dosing patterns of behavior of the user. In the above method, the previous dosing patterns of behavior of the user indicate that the user regularly dispenses a priming dose before dispensing a therapeutic dose and, based thereon, increasing the adjustable dispensed volume threshold and/or the adjustable time threshold [0011]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to incorporate the time threshold to distinguish between priming event and therapeutic event as taught by Jepson.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the administration device of Mensinger to include wherein the timer is configured such that, when the operating means is actuated, the timer continuously measures a duration of time between when the output means is no longer moved by the drive and when the operating means is transferred to the non-actuated state, and wherein the control unit is configured to identify the discharge quantity as a priming quantity if the duration is shorter than a predefined duration threshold as taught by Jepson since such a modification may enable the device of Mensinger to distinguish between priming and injection in order to track pen events [Jepson, 0016]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 2, Mensinger as modified by Jepson disclosed all limitations of claim 1. However, Mensinger failed to explicitly disclose wherein the control unit is configured to identify the discharge quantity as an administration quantity if the duration is equal to or greater than the predefined duration threshold.
However, Jepson teaches volume and/or time thresholds may be established that can be used to distinguish between priming and therapeutic doses. Dispensed doses that exceed those thresholds may be classified as therapeutic doses and dispensed doses that fall below those thresholds may be classified as priming doses [0184]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to incorporate the feature of Jepson to identify a dose discharged as administration if it exceeds the time threshold.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the administration device of Mensinger to include wherein the control unit is configured to identify the discharge quantity as an administration quantity if the duration is equal to or greater than the predefined duration threshold as taught by Jepson since such a modification may enable the device of Mensinger to distinguish between priming and injection in order to track pen events [Jepson, 0016]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 3, Mensinger as modified by Jepson disclosed all limitations of claim 2. Mensinger discloses a system controller (smartphone 30 in Fig. 1B) but failed to explicitly disclose wherein the predefined duration threshold ranges from 1 to 20 seconds, from 2 to 5 seconds, is 3 seconds, or is variably specified from the system controller.
However, Jepson teaches pen events historically classified as primes always occur between e.g., 20 and 40 seconds before a therapeutic dose [0190]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to incorporate a threshold of 20 seconds as taught by Jepson.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the administration device of Mensinger to include wherein the predefined duration threshold ranges from 1 to 20 seconds, from 2 to 5 seconds, is 3 seconds, or is variably specified from a system controller since such a modification may enable the device of Mensinger to use the time threshold to determine priming event. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 4, Mensinger as modified by Jepson disclosed all limitations of claim 3. Mensinger further discloses wherein the system controller is selected from the group consisting of: a remote control, a smartphone application, a blood glucose monitor, a continuous glucose monitor, a personal computer, a network, a cloud system, a host system, is implemented in the administration device, or a combination of two or more thereof (smartphone 30 of system 10 (FIG. 1A) including a data processing unit 31, a wireless communications unit 35, and a display unit 36. Data processing unit 31 includes a processor 32 to process data, a memory 33 in communication with the processor 32 to store data, and an input/output unit (I/O) 34 to interface processor 32 and/or memory 33 to other modules, units, and/or devices of smartphone 30 and/or external devices [0047]). One of ordinary skill in the art may recognize that the smartphone 30 of Mensinger may be configured to perform the functions of Jepson as required by claim 4.
Regarding claim 6, Mensinger as modified by Jepson disclosed all limitations of claim 3. Mensinger further discloses wherein the control unit further comprises a transceiver (an electronics unit 27 that can include a processor, a memory, a transceiver, and a battery or other suitable power source [0041]) configured to establish a wireless connection to one or more of: the control system, a remote control, a smartphone application, a blood glucose meter, a continuous glucose monitor, a personal computer, a network, a cloud system, a host system, or a combination of two or more thereof (the transceiver of electronics unit 27 enables pen 20 to transmit the dose and related information to smartphone 30 [0044]; smartphone 30 of system 10 (FIG. 1A) including a data processing unit 31, a wireless communications unit 35 [0047]). One of ordinary skill in the art may interpret that the transceiver of electronics unit 27 and wireless communications unit 35 of smartphone 30 may establish a wireless connection.
Regarding claim 7, Mensinger as modified by Jepson disclosed all limitations of claim 6. Mensiger however failed to explicitly disclose wherein the control unit is configured to establish the wireless connection with the control system and to receive a default value from the control system for a next discharge over the wireless connection.
However, Mensinger teaches the transceiver of electronics unit 27 enables pen 20 to transmit the dose and related information to smartphone 30. In such aspects, once the dose is transmitted, the dose data and any related information associated with that particular transmitted dose is marked in the memory of electronics unit 27 of pen 20 as transmitted. If the dose is not yet transmitted to smartphone 30 such as, for example, because no connection between the pen 20 and smartphone 30 is available, then the dose and associated data can be saved and transmitted the next time a successful communication link between pen 20 and smartphone 30 is established [0044]. One of ordinary skill in the art may interpret that the processor of electronics unit 27 may be configured to save the information regarding dose to be discharged and transmit to wireless unit 35.
Regarding claim 8, Mensinger as modified by Jepson disclosed all limitations of claim 7. Mensinger further discloses wherein the administration device comprises a display means communicatively coupled to the control unit (display unit 36 in Fig. 1C), but fails to explicitly disclose wherein the control unit is configured to cause the display means to signal that a current pre-selected quantity set with the pre-selection means is at least one of: smaller than, equal to, somewhat greater than, or much greater than the default value.
However, Mensinger teaches display unit 36 of smartphone 30 can be configured to be in data communication with data processing unit 31, e.g., via I/O 34, to provide a visual display, an audio display, and/or other sensory display [0047]. One of ordinary skill in the art may interpret that the control unit of Mensinger may be configured to display the pre-selected dose information via display unit 36 when dose is selected using dose setting mechanism 25 in Fig. 2A.
Regarding claim 9, Mensinger as modified by Jepson disclosed all limitations of claim 8. However, Mensinger failed to explicitly disclose wherein the administration device comprises a scale configured to display the current pre-selected quantity from the pre-selection means, or wherein the current pre-selected quantity from the pre-selection means is caused to be displayed by the control system, or both.
However, Jepson teaches the integrated system can display information to the nurse, such as the host ID, sensor data received from the continuous glucose sensor, processed sensor data, medicament delivery data (e.g., data related to a medicament therapy to be delivered to the host), and the like [0109]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to use the display unit 36 of Mensinger to display medicament delivery data as taught by Jepson.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the administration device of Mensinger to include wherein the administration device comprises a scale configured to display the current pre-selected quantity from the pre-selection means, or wherein the current pre-selected quantity from the pre-selection means is caused to be displayed by the control system, or both as taught by Jepson since such a modification may enable the device to Mensinger to provide visual indication to user in regards to pre-selection of dosage. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 10, Mensinger as modified by Jepson disclosed all limitations of claim 2. Mensinger further discloses wherein the control unit further comprises a memory (electronics unit 27 that can include a processor, a memory, a transceiver, and a battery or other suitable power source [0041]) but fails to explicitly disclose the memory configured to store at least the discharge quantity as an administration quantity upon the discharge quantity not being identified as the priming quantity, and wherein at least one of the discharge quantity, the administration quantity, or the priming quantity is provided with at least one of: a time stamp, a date stamp, or at least one further characterization.
However Mensinger teaches when the dose and associated information is communicated to health management application 40 running on smartphone 30, the timestamp and/or “time-since-dose” parameter (as determined by the count-up timer) is transmitted by pen 20 and received by smartphone 30 for storage in memory 33 of data processing unit 31 of the smartphone 30 (see FIG. 1C). Where a count-up timer is utilized, the time of the dose can be determined without pen 20 having to know the current time, which can simplify operation and setup of pen 20 [0045]. One of ordinary skill in the art may recognize that the control unit of Mensinger can be configured to record the discharge as time stamp in the memory.
Regarding claim 11, Mensinger as modified by Jepson disclosed all limitations of claim 1. Mensinger further discloses wherein the control unit is configured to determine a movement or an absence of movement of the output means (operations monitoring mechanism 28 of pen 20 senses movement of a rotating and/or translating driving component [0043]) based on one or more drive parameters or based on information received from one or more of: a limit switch, a sensor, a rotary encoder, or a linear encoder (Operations monitoring mechanism 28 may include one or more switches, sensors, and/or encoders for this purpose [0043]).
Regarding claim 12, Mensinger as modified by Jepson disclosed all limitations of claim 1. Mensinger further discloses wherein the control unit further comprises a sensor (operations monitoring mechanism 28 of pen 20 senses movement of a rotating and/or translating driving component (e.g., drive screw 26c (see also FIG. 2B)) of dose dispensing mechanism 24. Operations monitoring mechanism 28 may include one or more switches, sensors, and/or encoders for this purpose [0043]), and wherein the controller is configured to determine a quantity of medication based on a sensed movement of the output means (the encoder can be configured to sense the rotation of drive screw 26c (FIG. 2B) that, in turn, translates to dispense medicine; thus, by sensing rotation of drive screw 26c (FIG. 2B), the translational movement of drive screw 26c can be readily determined. Movement of the encoder may be detected as data processed by the processor of electronics unit 27 of pen 20, from which the amount of medicine dosed can be determined [0043]).
Regarding claim 13, Mensinger discloses a method of controlling (a method for medicine administration and tracking including tracking movement of an injection pen from a start location to a dispensing location [0005]) an administration device (medicine injection pen 20 in Fig. 2A) for administering a medication (Medicine injection pen 20 is a reusable injection pen configured to removably receive a medicine cartridge, e.g., a cartridge of insulin [0036]), comprising the steps of:
setting a pre-selected quantity on the administration device (dose setting mechanism 25 to enable the selection and/or setting of a dose of medicine to be dispensed [0041]);
determining actuation states (when dispensing button 26b in Fig. 26b is actuated, locking mechanism 26d is engaged to lock electronics unit 27 and dose knob 26a to one another such that electronics unit 27 and dose knob 26a rotate together as they translate into body 22 upon actuation of dose dispensing mechanism 24 to inject the selected dose [0051]; it can be interpreted that the state of button 26b prior to being pressed is the non-actuated state) of an operating means (dose dispensing button 26b in Fig. 26b), the operating means configured to release or operate a discharge of medication (actuation of dose dispensing mechanism 24 to inject the selected dose [0051]);
Mensinger disclosed a control system (smartphone 30 in Fig. 1B) but failed to explicitly disclose:
providing a default value for a discharge quantity and a predefined duration threshold on the control system;
transmitting, by the control system, the default value and the predefined duration threshold to the administration device;
measuring a duration of time between an end of the discharge and when the operating means is not actuated;
identifying the discharge quantity as a priming quantity if the duration is less than the predefined duration threshold.
However Jepson teaches user behavior patterns that may be identified from the historical data and resulting volume and time thresholds which may be established or adjusted (from e.g., default values) for distinguishing between priming doses and therapeutic doses [0187]. One of ordinary skill in the art may recognize that default value of volume and time threshold taught by Jepson may be incorporated into the method of Mensinger.
Jepson further teaches the processor continually calculates a deliverable medicament dose that can be transmitted to a hand-held medicament injection pen within range of the communication module [0159]. One of ordinary skill in the art may interpret that the processor of Jepson which is capable of transmitting medicament dose information to the injection device can be configured to also transmit duration threshold, and therefore may be incorporated into the method of Mensinger.
Furthermore, Jepson teaches volume and/or time thresholds may be established that can be used to distinguish between priming and therapeutic doses. Dispensed doses that exceed those thresholds may be classified as therapeutic doses and dispensed doses that fall below those thresholds may be classified as priming doses [0184]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to incorporate the feature of Jepson to identify a dose discharged as administration if it exceeds the time threshold.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Mensinger to include providing a default value for a discharge quantity and a predefined duration threshold on a control system; transmitting, by the control system, the default value and the predefined duration threshold to the administration device; measuring a duration of time between an end of the discharge and when the operating means is not actuated; identifying the discharge quantity as a priming quantity if the duration is less than the predefined duration threshold as taught by Jepson since such a modification may enable the method of Mensinger to distinguish between priming and injection in order to track pen events [Jepson, 0016]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 14, Mensinger as modified by Jepson disclosed all limitations of claim 13. Mensinger further discloses further comprising one or more of the following steps:
signaling a relation of the pre-selected quantity to the default value by the administration device, comprising signaling that the pre-selected quantity is identical to the default value, or signaling that the administration device is ready for an administration, or both;
generating a wireless authenticated pairing of the administration device and the control system, comprising pairing by an “out of band” method using a QR code on the administration device or a medication container insertable therein;
generating a cryptographically secured wireless connection between the administration device and the control system;
comparing stored discharge quantities, characterizations, default values, statuses, parameters, real-time clocks, geographical coordinates between the administration device and the control system;
signaling that a currently set pre-selected quantity is smaller than the default value;
signaling that the currently set pre-selected quantity is equal to the default value;
signaling that the currently set pre-selected quantity is greater than the default value;
signaling the end of the discharge upon the currently set pre-selected quantity or the discharge quantity is discharged;
signaling that the duration does not reach the predefined duration threshold;
signaling that the duration reaches or exceeds the predefined duration threshold;
signaling that the duration does not reach a specified dwell time;
signaling that the duration reaches or exceeds the specified dwell time;
determining the duration from the end of the discharge until the operating means is not actuated as a holding duration;
providing the discharge quantity with one or more of a time stamp, a medication designation, a concentration, a lot number, a carpule number, a temperature, a geographical location, or a spatial orientation (the processor of electronics unit 27 of pen 20 can store the dose along with a timestamp for that dose and/or any other information associated with the dose [0044]);
identifying the discharge quantity as an administration quantity if the duration is greater than or equal to the predefined threshold duration;
identifying the discharge quantity as a compliant administration quantity if the duration is greater than or equal to the specified dwell time;
deleting the default value in the administration device if the administration quantity is equal to or greater than the default value;
storing the administration quantity in the administration device;
storing the priming quantity in the administration device;
transmitting the administration quantity from the administration device to the system controller;
transmitting the priming quantity from the administration device to the system controller; or retrieving a confirmation on the system controller for verifying a last administration quantity and/or the priming quantity.
Regarding claim 15, Mensinger as modified by Jepson disclosed all limitations of claim 14. However, Mensinger failed to explicitly disclose further comprising one or more of the following steps:
decreasing the default value by the administration quantity in the administration device;
transmitting the decreased default value from the administration device to the system controller;
requesting by the system controller to change the container in the administration device; or
requesting by the system controller to perform a priming on the administration device.
However, Jepson teaches If the historical data indicates that a given user dispenses low total daily therapeutic doses, the dispensed volume threshold can be reduced, thereby reducing the risk of misclassification of therapeutic doses as priming doses [0197]. One of ordinary skill in the art may recognize that the reducing of dispensed volume threshold by Jepson can be incorporated into the method of Mensinger to mimic the decreasing of default value by administration quantity as required by claim 15.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Mensinger to include further comprising one or more of the following steps: decreasing the default value by the administration quantity in the administration device; transmitting the decreased default value from the administration device to the system controller; requesting by the system controller to change the container in the administration device; or requesting by the system controller to perform a priming on the administration device as taught by Jepson since such a modification may enable the method of Mensinger to reduce the risk of misclassification of therapeutic doses as priming doses [0197]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 16, Mensinger as modified by Jepson disclosed all limitations of claim 13. Mensinger further discloses wherein the administration device comprises:
a pre-selection means (dose setting mechanism 25 in Fig. 2A) by means of which a pre-selected quantity can be mechanically or electronically set and/or stored (dose setting mechanism 25 to enable the selection and/or setting of a dose of medicine to be dispensed [0041]);
a manually operable drive or a releasable motor drive (Dose dispensing mechanism 24 in Fig. 2A; dose dispensing mechanism 24 of pen 20 can include a manually powered mechanism (user powered and/or mechanically biased), a motorized mechanism, or an assisted mechanism (e.g., a mechanism that operates partly on manual power and partly on motorized power) [0046]) configured to move an output means (when a force is applied to drive screw 26c of dose dispensing mechanism 24, drive screw 26c turn provides a force to urge medicine from medicine cartridge 23 [0046]) relative to a container arranged in the administration device (medicine cartridge 23 in Fig. 2A) and containing a medication (Medicine injection pen 20 is a reusable injection pen configured to removably receive a medicine cartridge, e.g., a cartridge of insulin [0036]) to cause a discharge quantity to be discharged from the container (dose dispensing mechanism 24 to dispense (e.g., deliver) medicine contained in medicine cartridge 23 out of pen 20 [0041]) through a needle and/or a hollow cannula (needle 29 in Fig. 1B; dose dispensing mechanism 24 to dispense (e.g., deliver) medicine contained in medicine cartridge 23 out of pen 20 (e.g., through needle 29) [0041]), the discharge quantity corresponding to the pre-selected quantity (to dispense an amount of medicine from cartridge 23 through needle 29 into the user in accordance with the dose amount set by dose setting mechanism 25 [0042]); and
wherein the operating means is configured to be manually actuated having a non-actuated state (it can be interpreted that the state of button 26b prior to being pressed is the non-actuated state) and an actuated state (when dispensing button 26b is actuated [0051]), the operating means configured to operate and/or release the drive in the actuated state (when dispensing button 26b is actuated, locking mechanism 26d is engaged to lock electronics unit 27 and dose knob 26a to one another such that electronics unit 27 and dose knob 26a rotate together as they translate into body 22 upon actuation of dose dispensing mechanism 24 to inject the selected dose [0051]).
Mensinger further discloses a control unit (electronics unit 27 that can include a processor [0041]; electronics unit 27 in Fig. 1B) but failed to explicitly disclose the control unit is configured to identify the discharge quantity as the priming quantity.
However Jepson teaches in the medicament injection pen described herein a dose distinguisher or dose identification component or module may be provided to process dose dispensing data and determine and distinguish between a priming dose and a therapy dose that is dispensed from the pen [0180].
Jepson further teaches the dose distinguisher may incorporate a processor module (e.g., processor module 112 in FIG. 13), which may be located in the medicament injection pen itself [0181]. One of ordinary skill in the art may recognize that the device of Mensinger may be configured to include a dose distinguisher as part of the control unit to identify priming dose.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the device of Mensinger to include the control unit is configured to identify the discharge quantity as the priming quantity as taught by Jepson since such a modification may enable the device of Mensinger to determine priming events. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US 20220387722 A1, herein Mensinger) and further in view of Jepson et al. (US 20220152313 A1, herein Jepson) and Mirov et al. (US 20170312455 A1, herein Mirov).
Regarding claim 5, Mensinger as modified by Jepson disclosed all limitations of claim 3. However, Mensinger as modified by Jepson failed to explicitly disclose wherein the control unit further comprises a real-time clock configured to be synchronized with a clock of the system controller.
However, Mirov teaches plunger head 22 may also include a crystal oscillator 32 configured to keep a real time clock (RTC) so that the date and time of each injection may be accurately recorded and stored in memory of controller 26 [0065]. One of ordinary skill in the art may recognize that the device of Mensinger as modified by Jepson may be configured to have a real time clock as taught by Mirov to perform the functions as required by claim 5.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the administration device of Mensinger as modified by Jepson to include wherein the control unit further comprises a real-time clock configured to be synchronized with a clock of the system controller as taught by Mirov since such a modification may enable the device of Mensinger to accurately record and timestamp priming or injection events. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20150126963 A1 (Despa): related to an injection device with medicament priming procedure.
US 20150126963 A1 (Andrews): related to an injection device that can determine injection event and priming event.
WO 2009083600 A1 (Jespersen): related to an injection device that can detect priming conditions.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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