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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “…the wireless receiver, the first light source, and the second light source are included in one or more adhesive labels that are attached to the medication delivery device“, subject matter of claim 2, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities: “steps associate with the instructions” should be corrected to “steps of the instructions” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 6 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 6 contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe wireless communication and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8-10, 13-18, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu (US 20160259913 A1).
Regarding claims 1, 6, and 8, Yu discloses a light-based medication delivery cueing system (abstract and [0055] and [0068]), comprising: a wireless receiver configured to receive a plurality of wireless communications from a computing device via a wireless communication protocol (“FIGS. 4A and 4B depict delivery device 10 in wireless communication with an external device 90 via one or more transmitters and/or a receivers, in accordance with additional embodiments of the present disclosure… One or more of external device 90, transponder 50, and/or cap 80 may include a transmitter, a receiver, and/or a processor for facilitating communication.”, [0077]; external device 90 may be a smart phone, watch, laptop, wearable, etc., [0079]);
a first light source that is activated based on a first wireless communication of the plurality of wireless communications (“Transponder 50 may include an indicator 56 configured to provide an output to a user indicative of the sensed parameter. Indicator 56 may include, e.g., a visual indicator, such as one or more lights, screens, displays, or other suitable devices.”, [0055]; “Processor 54 may be operatively connected to indicator 56, which may notify the user of one or more parameters in a number of different manners… indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; ” Further, to facilitate communication, raw and/or processed data generated by the sensors of transponder 50, cap 80… may be processed and/or stored in… external device 90.”, [0078]; raw data generated by sensor 52 and/or the sensor of cap 80 may be transmitted for processing to device 90; processed raw data determines functionality of indicator 56, see [0066] and [0068]; since device 90 processes the raw data, the processed raw data must necessarily be wirelessly communicated back to indicator 56 to facilitate indicator 56 function, [0068]; “LEDs may be arranged in any configuration that may clearly indicate to the user one or more parameter, such as injection start/stop/in-progress, or whether the medicament temperature is ready to start an injection.”, [0068]; for example, first light of the LEDs may be activated based on a first wireless communication from device 90 that a threshold pressure was exceeded, indicating a dose being initiated, that injection does not occur at a desired angle, that injection speed is too fast or slow, etc., see [0062] and [0067]),
wherein activating of the first light source is a first visual cue to perform a first step of a plurality of steps of instructions for use of a medication delivery device (“Pressure switches 55 may also function as a safety feature detecting, e.g., when a user applies a pressure to push rod 30 that exceeds a suitable threshold pressure, for example, when a dose is delivered too quickly. Pressure switches 55 may initiate any suitable visual, audible, and/or tactile output via processor 54 and/or indicator 56 to indicate a relationship of the detected parameter with one or more threshold pressures”, [0062]; “For example, the LEDs may illuminate when the user applies excessive pressure to actuator 70. A degree of brightness may indicate how excessive the pressure is being applied, such that a brighter LED may indicate a higher degree of error.”, [0072]; “In some embodiments, indicator 56 include one or more digital and/or analog screens that have colors, graphical, or pictorial indicators of parameters and/or fault alerts. In some embodiments, the screen may output raw data or words, such as “Ready” or “Error.” The screen may also provide a numerical output corresponding with the status of the drug or the progress of the injection. For example, the numerical output may be in form of a percentage or unit of measurement indicating the quantity of a dose remaining to be delivered or the quantity of a dose that has already been delivered. The numerical output may also be in the form of a clock indicating the estimated time remaining for the dosage delivery or an estimated completion time of the dosage delivery.”, [0071]; activation of the first LED may be a “Ready” output, indicating the device 10 is ready for use and injection may begin), and wherein the first light source is activated in correspondence with the first step being displayed by the computing device (“external device 90 may be used as an external indicator, instead of, or in addition to, indicator 56. External device 90 may notify the user of parameters and/or fault conditions with any visual, audible, and/or tactile output.”, [0079]); and
a second light source that is activated based on a second wireless communication of the plurality of wireless communications (“Transponder 50 may include an indicator 56 configured to provide an output to a user indicative of the sensed parameter. Indicator 56 may include, e.g., a visual indicator, such as one or more lights, screens, displays, or other suitable devices.”, [0055]; “Processor 54 may be operatively connected to indicator 56, which may notify the user of one or more parameters in a number of different manners… indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; ”Further, to facilitate communication, raw and/or processed data generated by the sensors of transponder 50, cap 80… may be processed and/or stored in… external device 90.”, [0078]; raw data generated by sensor 52 and/or the sensor of cap 80 may be transmitted for processing to device 90; processed raw data determines functionality of indicator 56, see [0066] and [0068]; since device 90 processes the raw data, the processed raw data must necessarily be wirelessly communicated back to indicator 56 to facilitate indicator 56 function, [0068]; “LEDs may be arranged in any configuration that may clearly indicate to the user one or more parameter, such as injection start/stop/in-progress, or whether the medicament temperature is ready to start an injection.”, [0068]; for example, a second light of the LEDs may be activated based on a second wireless communication from device 90 that a threshold pressure was exceeded, indicating an end of dose, that injection does not occur at a desired angle, that injection speed is too fast or slow, etc., see [0062] and [0067]), wherein activating of the second light source is a second visual cue to perform a second step of the plurality of steps associated with the instructions for use (“In some embodiments, indicator 56 include one or more digital and/or analog screens that have colors, graphical, or pictorial indicators of parameters and/or fault alerts. In some embodiments, the screen may output raw data or words, such as “Ready” or “Error.” The screen may also provide a numerical output corresponding with the status of the drug or the progress of the injection. For example, the numerical output may be in form of a percentage or unit of measurement indicating the quantity of a dose remaining to be delivered or the quantity of a dose that has already been delivered. The numerical output may also be in the form of a clock indicating the estimated time remaining for the dosage delivery or an estimated completion time of the dosage delivery.”, [0071]; activation of the second LED may be a visual cue indicating the remaining time for dosage delivery or that the dose has ended),
wherein the second light source is activated in correspondence with the second step being displayed by the computing device (“external device 90 may be used as an external indicator, instead of, or in addition to, indicator 56. External device 90 may notify the user of parameters and/or fault conditions with any visual, audible, and/or tactile output.”, [0079]), and
wherein the second wireless communication is transmitted based on user input to the computing device (“Processor 54 may also be configured to receive inputs pertaining to the desired treatment. To receive these inputs, processor 54 may be communicatively coupled with an external device, as discussed herein. The inputs may include, but are not limited to, scheduled treatments (e.g. time, date, and dosage amounts),”, [0066]; “External device 90 may be further configured to allow the user to input data to be communicated to transponder 50, cap 80… concerning the desired treatment. For example, external device 90 may be used to input or change threshold parameters... Exemplary applicable wireless technologies may include, e.g., RF and Bluetooth communication.”, [0079]; activation of the second LED is based on a wireless communication from device 90 that a time is remaining for dosage delivery or that a pressure threshold was met/exceeded indicating an end of dose, [0062]-[0063]; the treatment time and threshold parameters are based on a user input to device 90).
Yu further discloses that “external device 90 may store the parameter and/or fault condition received from transponder 50 and/or cap 80 on an internal or external hard drive or upload it onto a server. The information regarding the parameters may be displayed in a calendar of scheduled treatments, may link to specific directions pertaining to the injection of the medicament” ([0079]).
Regarding claim 2, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the wireless receiver, the first light source, and the second light source are included in one or more adhesive labels that are attached to the medication delivery device (transponder 50 including a receiver and indicator 56, [0058], [0062], and [0068] & Fig. 1A-2D and 4B; “indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; “Transponder 50 may be secured to push rod 30 and/or plunger 40 with an adhesive “, [0059]; therefore, transponder 50 may be interpreted as a structure that is attached to something, or a label).
Regarding claim 3, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the wireless receiver, the first light source, and the second light source are included within the medication delivery device (transponder 50 including a receiver and indicator 56, [0058], [0062], and [0068] & Fig. 1A-2D and 4B; “indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; transponder 50 included inside body 20 of device 10, [0053] & Fig. 1A-1B and 4B).
Regarding claim 4, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the medication delivery device is a medication injection device ([0074]).
Regarding claim 9, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the plurality of steps is performed in a designated sequence (a “Ready” output, indicating the device 10 is ready for use, and initiating an injection is necessarily performed before receiving an indication of the time remaining for dosage delivery or that injection has ended, [0062], [0067], and [0071]-[0072]).
Regarding claim 10, Yu discloses all the limitations of claim 9. Yu further discloses the light-based medication delivery cueing system wherein the second step immediately follows the first step in the designated sequence (receiving indication of a time remaining for dosage delivery would immediately follow the initiation of an injection, [0062], [0067], and [0071]-[0072]).
Regarding claim 13, Yu discloses all the limitations of claim 1. Yu discloses the light-based medication delivery cueing system wherein the user input indicates that the first step has been performed (“external device 90 may alter the threshold parameters or the treatment schedule based on the information detected by transponder 50 and/or cap 80. This alteration… may be done manually… if a patient has skipped one or scheduled medicament dosage deliveries, or delivered an incomplete dose of medicament, subsequent treatments may be increased or decreased, to accommodate this change. The modification may be performed automatically (e.g., through a processor of external device 90), and/or manually... The modified treatment schedule may then be communicated (e.g., from external device 90 to transponder 50 and/or cap 80), to be implemented by delivery device 10. Thresholds of individual scheduled treatments may then be increased, reduced, added, and/or cancelled in order to promote proper administration of medicament and/or to monitor subsequent treatments, as discussed herein.”, [0080]; As manual inputs may be provided to device 90 by a user based on feedback from a first injection, this is indicative that a first injection (or step) has been performed as the input is in response to the first injection (or step)).
Regarding claim 14, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein activating of the second light source indicates that an injection is complete (activation of the second LED may be a visual cue indicating that the dose has ended, [0062], [0067]-[0068], [0071], and [0079]-[0080]).
Regarding claim 15, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the computing device displays an indication that an injection is complete (“external device 90 may be used as an external indicator, instead of, or in addition to, indicator 56. External device 90 may notify the user of parameters and/or fault conditions with any visual, audible, and/or tactile output.”, [0079]; external device 90 may indicate, in addition to indicator 56, an end of dose, [0060] and [0068]; also see [0010]).
Regarding claim 16, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the first light source is activated by at least one of causing the first light source to emit light, causing the first light source to flash, or causing the first light source to change color (activation of the first LED of indicator 56 comprises causing the LED to emit light, flash, or change color, see [0068]).
Regarding claim 17, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the second light source is activated by at least one of causing the second light source to emit light, causing the second light source to flash, or causing the second light source to change color (activation of the second LED of indicator 56 comprises causing the LED to emit light, flash, or change color, see [0068]).
Regarding claim 18, Yu discloses a light-based medication delivery cueing method (abstract and [0055] and [0068]), comprising: receiving, by a wireless receiver, from a computing device, via a wireless communication protocol, a first wireless communication (“FIGS. 4A and 4B depict delivery device 10 in wireless communication with an external device 90 via one or more transmitters and/or a receivers, in accordance with additional embodiments of the present disclosure… One or more of external device 90, transponder 50, and/or cap 80 may include a transmitter, a receiver, and/or a processor for facilitating communication.”, [0077]; ”Further, to facilitate communication, raw and/or processed data generated by the sensors of transponder 50, cap 80… may be processed and/or stored in… external device 90.”, [0078]; raw data generated by sensor 52 and/or the sensor of cap 80 may be transmitted for processing to device 90; processed raw data determines functionality of indicator 56, see [0066] and [0068]; since device 90 processes the raw data, the processed raw data must necessarily be wirelessly communicated back to indicator 56 to facilitate indicator 56 function, [0068]);
activating, based on the first wireless communication, a first light source (“Transponder 50 may include an indicator 56 configured to provide an output to a user indicative of the sensed parameter. Indicator 56 may include, e.g., a visual indicator, such as one or more lights, screens, displays, or other suitable devices.”, [0055]; “Processor 54 may be operatively connected to indicator 56, which may notify the user of one or more parameters in a number of different manners… indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; “LEDs may be arranged in any configuration that may clearly indicate to the user one or more parameter, such as injection start/stop/in-progress, or whether the medicament temperature is ready to start an injection.”, [0068]; for example, first light of the LEDs may be activated based on a first wireless communication from device 90 that a threshold pressure was exceeded, indicating a dose being initiated, that injection does not occur at a desired angle, that injection speed is too fast or slow, etc., see [0062] and [0067]), wherein activating of the first light source is a first visual cue to perform a first step of a plurality of steps of instructions for use of a medication delivery device (“Pressure switches 55 may also function as a safety feature detecting, e.g., when a user applies a pressure to push rod 30 that exceeds a suitable threshold pressure, for example, when a dose is delivered too quickly. Pressure switches 55 may initiate any suitable visual, audible, and/or tactile output via processor 54 and/or indicator 56 to indicate a relationship of the detected parameter with one or more threshold pressures”, [0062]; “For example, the LEDs may illuminate when the user applies excessive pressure to actuator 70. A degree of brightness may indicate how excessive the pressure is being applied, such that a brighter LED may indicate a higher degree of error.”, [0072]; “In some embodiments, indicator 56 include one or more digital and/or analog screens that have colors, graphical, or pictorial indicators of parameters and/or fault alerts. In some embodiments, the screen may output raw data or words, such as “Ready” or “Error.” The screen may also provide a numerical output corresponding with the status of the drug or the progress of the injection. For example, the numerical output may be in form of a percentage or unit of measurement indicating the quantity of a dose remaining to be delivered or the quantity of a dose that has already been delivered. The numerical output may also be in the form of a clock indicating the estimated time remaining for the dosage delivery or an estimated completion time of the dosage delivery.”, [0071]; activation of the first LED may be a “Ready” output, indicating the device 10 is ready for use), and wherein the first light source is activated in correspondence with the first step being displayed by the computing device (“external device 90 may be used as an external indicator, instead of, or in addition to, indicator 56. External device 90 may notify the user of parameters and/or fault conditions with any visual, audible, and/or tactile output.”, [0079]);
receiving, by the wireless receiver, from the computing device, via the wireless communication protocol, a second wireless communication (“Transponder 50 may include an indicator 56 configured to provide an output to a user indicative of the sensed parameter. Indicator 56 may include, e.g., a visual indicator, such as one or more lights, screens, displays, or other suitable devices.”, [0055]; “Processor 54 may be operatively connected to indicator 56, which may notify the user of one or more parameters in a number of different manners… indicator 56 may include one or more light-emitting diodes (LEDs)”, [0068]; ”Further, to facilitate communication, raw and/or processed data generated by the sensors of transponder 50, cap 80… may be processed and/or stored in… external device 90.”, [0078]; raw data generated by sensor 52 and/or the sensor of cap 80 may be transmitted for processing to device 90; processed raw data determines functionality of indicator 56, see [0066] and [0068]; since device 90 processes the raw data, the processed raw data must necessarily be wirelessly communicated back to indicator 56 to facilitate indicator 56 function, [0068]; “LEDs may be arranged in any configuration that may clearly indicate to the user one or more parameter, such as injection start/stop/in-progress, or whether the medicament temperature is ready to start an injection.”, [0068]; for example, a second light of the LEDs may be activated based on a second wireless communication from device 90 that a threshold pressure was exceeded, indicating an end of dose, that injection does not occur at a desired angle, that injection speed is too fast or slow, etc., see [0062] and [0067]), wherein the second wireless communication is transmitted based on user input to the computing device (“Processor 54 may also be configured to receive inputs pertaining to the desired treatment. To receive these inputs, processor 54 may be communicatively coupled with an external device, as discussed herein. The inputs may include, but are not limited to, scheduled treatments (e.g. time, date, and dosage amounts),”, [0066]; “External device 90 may be further configured to allow the user to input data to be communicated to transponder 50, cap 80… concerning the desired treatment. For example, external device 90 may be used to input or change threshold parameters... Exemplary applicable wireless technologies may include, e.g., RF and Bluetooth communication.”, [0079]; activation of the second LED is based on a wireless communication from device 90 that a time is remaining for dosage delivery or that a pressure threshold was met/exceeded indicating an end of dose, [0062]-[0063]; the treatment time and threshold parameters are based on a user input to device 90); and
activating, based on the second wireless communication, a second light source, wherein activating of the second light source is a second visual cue to perform a second step of the plurality of steps associated with the instructions for use (“indicator 56 include one or more digital and/or analog screens that have colors, graphical, or pictorial indicators of parameters and/or fault alerts. In some embodiments, the screen may output raw data or words, such as “Ready” or “Error.” The screen may also provide a numerical output corresponding with the status of the drug or the progress of the injection. For example, the numerical output may be in form of a percentage or unit of measurement indicating the quantity of a dose remaining to be delivered or the quantity of a dose that has already been delivered. The numerical output may also be in the form of a clock indicating the estimated time remaining for the dosage delivery or an estimated completion time of the dosage delivery.”, [0071]; activation of the second LED may be a visual cue indicating the remaining time for dosage delivery or that the dose has ended), and
wherein the second light source is activated in correspondence with the second step being displayed by the computing device (“external device 90 may be used as an external indicator, instead of, or in addition to, indicator 56. External device 90 may notify the user of parameters and/or fault conditions with any visual, audible, and/or tactile output.”, [0079]).
Yu further discloses that “external device 90 may store the parameter and/or fault condition received from transponder 50 and/or cap 80 on an internal or external hard drive or upload it onto a server. The information regarding the parameters may be displayed in a calendar of scheduled treatments, may link to specific directions pertaining to the injection of the medicament” ([0079]).
Regarding claim 30, Yu discloses all the limitations of claim 18. Yu further discloses the light-based medication delivery cueing method wherein the user input indicates that the first step has been performed (“external device 90 may alter the threshold parameters or the treatment schedule based on the information detected by transponder 50 and/or cap 80. This alteration… may be done manually… if a patient has skipped one or scheduled medicament dosage deliveries, or delivered an incomplete dose of medicament, subsequent treatments may be increased or decreased, to accommodate this change. The modification may be performed automatically (e.g., through a processor of external device 90), and/or manually... The modified treatment schedule may then be communicated (e.g., from external device 90 to transponder 50 and/or cap 80), to be implemented by delivery device 10. Thresholds of individual scheduled treatments may then be increased, reduced, added, and/or cancelled in order to promote proper administration of medicament and/or to monitor subsequent treatments, as discussed herein.”, [0080]; As manual inputs may be provided to device 90 by a user based on feedback from a first injection, this is indicative that a first injection (or step) has been performed as the input is in response to the first injection (or step)).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20160259913 A1) as applied to claim 1 above, and further in view of Biondi (US 20190321555 A1).
Regarding claim 5, Yu discloses all the limitations of claim 1. Yu further discloses the light-based medication delivery cueing system wherein the first light source is a light-emitting diode (LED) ([0068]) but fails to explicitly disclose the first light source is an organic light-emitting diode (OLED).
However, Biondi teaches a light-based medication delivery cueing system (abstract and [0182) wherein the first light source is an organic light-emitting diode (OLED) (“Light emitting components in accordance with embodiments of the invention include, without limitation, light emitting diodes (LEDs) and organic light emitting diodes (OLEDs).”, [0094]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first light source of Yu with Biondi to include the first light source being an organic light-emitting diode (OLED) since Roe teaches such to be an art effective visual indicator for an injection device and would yield the same predictable result of visual indication. Biondi teaches OLEDs to be an art effective equivalent to LEDs ([0010] and [0094] of Biondi).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20160259913 A1) as applied to claim 1 above, and further in view of Srinivasan US (20190134305 A1).
Regarding claim 7, Yu discloses all the limitations of claim 1. However, Yu fails to explicitly disclose the light-based medication delivery cueing system wherein the wireless communication protocol is Near-Field Communication (NFC) protocol.
However, Srinivasan teaches a light-based medication delivery cueing system (abstract and [0044]) wherein the wireless communication protocol is Near-Field Communication (NFC) protocol (“The communications interface is configured to connect the delivery device 102 to the other device 104 and can comprise… a wireless interface to communicate for example via Bluetooth™ or WiFi or near field communication (NFC) technology.”, [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the communication protocol of Yu with Srinivasan to include the wireless communication protocol being Near-Field Communication (NFC) protocol since Srinivasan teaches such to be an art effective wireless communication protocol for an injection device and an external device, such as a smartphone, and would yield the same predictable results pertaining to wireless connection. Srinivasan teaches NFC to be an art effective equivalent to Bluetooth (see [0037]-[0038] and [0040] of Srinivasan).
Claim(s) 11-12 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20160259913 A1) as applied to claims 1 and 18 above, and further in view of Song (US 20210151160 A1).
Regarding claim 11, Yu discloses all the limitations of claim 1. However, Yu fails to explicitly disclose the light-based medication delivery cueing system wherein the first step comprises removing a cap, to placing the medication delivery device on skin of a user, pushing down, keep pushing until a click is heard, or lifting the medication delivery device up.
However, Song teaches a light-based medication delivery cueing system ([0007] and [0111]) wherein the first step comprises to placing the medication delivery device on skin of a user or pushing down ([0132]-[0134] & Fig. 25a-27b; visual indication is provided cueing a user to perform a first step, which may be to “Push the injector towards your skin” (as seen in Fig. 25b) or “Hold injection in progress” (as seen in Fig. 26b-26c)).
Song also teaches that “The APP is designed to work with the internal logic to receive information or data from the eAdaptor to process, calculate and manipulate same.” ([0111]) and that “Preferably, the data calculation and manipulation are conducted on smart phone 250, since these smart devices would have a more robust processor and free up memory space on the eAdaptor” ([0135]). The eAdaptor includes a digital screen 16 and may have one or more color LED lights 70 to “to communicate information to the patients, such as battery status, injection status” ([0109]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first step of Yu with Song to include the first step comprises placing the medication delivery device on skin of a user or pushing down since such a modification would include additional visual cues to aid a user in performing an injection correctly and would yield predictable results pertaining to step-by-step injection guidance ([0111] and [0132]-[0134], and [0145] of Song).
As modified, the external device 90 of Yu may include the first step being an indication to place the medication delivery device on skin of a user or to push down, as in Song. Device 90 of Yu would remain in control of indicator 56, wirelessly communicating activation of indicator 56 to provide a first visual cue to perform the first step.
Regarding claim 12, Yu discloses all the limitations of claim 1. However, Yu fails to explicitly disclose the light-based medication delivery cueing system wherein the second step comprises removing a cap, to placing the medication delivery device on skin of a user, pushing down, keep pushing until a click is heard, or lifting the medication delivery device up.
However, Song teaches a light-based medication delivery cueing system ([0007] and [0111]) wherein the second step comprises pushing down or lifting the medication delivery device up ([0132]-[0134] & Fig. 25a-27b; visual indication is provided cueing a user to perform a second step, which may be to “Hold injection in progress” (as seen in Fig. 26b-26c) or “Please remove the injector from your skin” (as seen in Fig. 27b)).
Song also teaches that “The APP is designed to work with the internal logic to receive information or data from the eAdaptor to process, calculate and manipulate same.” ([0111]) and that “Preferably, the data calculation and manipulation are conducted on smart phone 250, since these smart devices would have a more robust processor and free up memory space on the eAdaptor” ([0135]). The eAdaptor includes a digital screen 16 and may have one or more color LED lights 70 to “to communicate information to the patients, such as battery status, injection status” ([0109]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the second step of Yu with Song to include the second step comprises pushing down or lifting the medication delivery device up since such a modification would include additional visual cues to aid a user in performing an injection correctly and would yield predictable results pertaining to step-by-step injection guidance ([0111] and [0132]-[0134], and [0145] of Song).
As modified, the external device 90 of Yu may include the second step being an indication to push down or lift the medication delivery device up, as in Song. Device 90 of Yu would remain in control of indicator 56, wirelessly communicating activation of indicator 56 to provide a second visual cue to perform the second step.
Regarding claim 28, Yu discloses all the limitations of claim 18. However, Yu fails to explicitly disclose the light-based medication delivery cueing method wherein the first step comprises removing a cap, to placing the medication delivery device on skin of a user, pushing down, keep pushing until a click is heard, or lifting the medication delivery device up.
However, Song teaches a light-based medication delivery cueing method (abstract, [0007], [0039], and [0111]) wherein the first step comprises to placing the medication delivery device on skin of a user or pushing down ([0132]-[0134] & Fig. 25a-27b; visual indication is provided cueing a user to perform a first step, which may be to “Push the injector towards your skin” (as seen in Fig. 25b) or “Hold injection in progress” (as seen in Fig. 26b-26c)).
Song also teaches that “The APP is designed to work with the internal logic to receive information or data from the eAdaptor to process, calculate and manipulate same.” ([0111]) and that “Preferably, the data calculation and manipulation are conducted on smart phone 250, since these smart devices would have a more robust processor and free up memory space on the eAdaptor” ([0135]). The eAdaptor includes a digital screen 16 and may have one or more color LED lights 70 to “to communicate information to the patients, such as battery status, injection status” ([0109]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first step of Yu with Song to include the first step comprises placing the medication delivery device on skin of a user or pushing down since such a modification would include additional visual cues to aid a user in performing an injection correctly and would yield predictable results pertaining to step-by-step injection guidance ([0111] and [0132]-[0134], and [0145] of Song).
As modified, the external device 90 of Yu may include the first step being an indication to place the medication delivery device on skin of a user or to push down, as in Song. Device 90 of Yu would remain in control of indicator 56, wirelessly communicating activation of indicator 56 to provide a first visual cue to perform the first step.
Conclusion
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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