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 one or more processing components, and the first 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 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, 3-7, 9-11, 15-16, 30, and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roe (US 20210046247 A1).
Regarding claims 1 and 9, Roe discloses a light-based medication delivery cueing system (abstract and [0182]), comprising: one or more force sensors (a force sensor, [0013]-[0014], [0126], [0143], [0158]-[0159], [0164], [0170], and [0174] & Fig. 10-11), wherein the one or more force sensors measure an applied force that is applied, in an insertion direction, to a movable component of a medication delivery device, wherein the movable component is moved, in the insertion direction, to result in an injection of a medication into a patient (“a sensor component and/or a deflection component comprises a force sensor that is configured or adapted to detect and/or measure one or more forces in one or more components of the subject drug delivery systems and devices. For example, in some embodiments, a force sensor is configured to measure the amount of force that is applied to a drug reservoir by an actuation component (e.g., the amount of force that is applied to a syringe stopper by a syringe stopper rod, or the amount of force that is applied to a thumb pad by a user). Force sensors in accordance with embodiments of the disclosure can be absolute or relative force sensors. “, [0126]; “a deflection component comprises a force sensor that is configured to measure one or more forces applied to a portion of a subject system or device by a user (e.g., to detect a force applied to a thumb pad during a delivery stroke).”, [0143]; “Aspects of the disclosure include actuation components that are configured to move, thereby causing a drug to be dispensed from the drug reservoir and injected into the patient.”, [0177]; “FIGS. 23-25 depict drug delivery devices in accordance with embodiments of the disclosure, comprising an actuation component in the form of a syringe stopper rod…”, [0180]), and
wherein the one or more force sensors further measure a resistive force that resists movement, in the insertion direction, of the movable component (“a delivery signature can comprise an injection force profile corresponding to an injection force applied to a portion of a subject device by a user. For example, in some embodiments, an injection force profile can comprise a break loose force, a glide force, an end of dose force… an injection force profile can comprise a time interval associated with… the end of dose force”, [0170] & Fig. 27; “…third time interval and/or force magnitude associate the end of dose force.”, [0014]; the force sensor measures a force magnitude at the end of dose, or a resistive force from the syringe stopper pressing against the rod at the end of injection, see [0014] and [0170] & Fig. 27);
one or more processing components (“a controller, a processor, and a computer readable medium that are configured or adapted to control or operate one or more components of the subject systems or devices.”, [0213]; also see [0121]-[0123]), wherein the one or more processing components determine when the applied force becomes greater than, or equal to, a threshold break force that is required to initiate movement of the movable component in the insertion direction, and wherein the one or more processing components further determine when the resistive force becomes greater than, or equal to, a threshold back force that stops the movement of the movable component in the insertion direction (the processor functions to determine the delivery signature, which determines the break loose force, the force required to initiate movement of the actuation element, and end of does force, the force that stops movement of the actuation element, [0014], [0028], [0030], [0114], [0120], [0135], and [0169]-[0170] & Fig. 27; “The graph shows a break loose force (spike located between 153 mm and 155 mm, with a maximum force value of approximately 5 Newtons), a glide force (plateau located between 155 mm and 173 mm, with a constant force value of approximately 2 Newtons) and an end of dose force (located between 173 mm and 176 mm, with a maximum force value of approximately 38 Newtons).”, [0174] & Fig. 27; the processor determines a break lose force, when the applied force reaches a threshold of approximately 5 Newtons (which is a force magnitude associated with the break loose force), and an end of dose force, when the applied force reaches a threshold of approximately 38 Newtons (which is a force magnitude associated with the end of dose force), [0014] and [0174] & Fig. 27);
a first light source, wherein a first lighting state change of the first light source is performed based on the applied force becoming greater than, or equal to, the threshold break force, and wherein a second lighting state change is performed based on the resistive force becoming greater than, or equal to, the threshold back force (“a visual indicator comprises a light-emitting component. Light emitting components in accordance with embodiments of the disclosure include, without limitation, light emitting diodes (LEDs) and organic light emitting diodes (OLEDs)… Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof. In some embodiments, an operational state of a subject system or device can be assigned a specific color“, [0182]; “the indicator component is configured to indicate a ready state to a user… an unready state to a user… a dose-in-progress state to a user. In some embodiments, the indicator component is configured to indicate a dose completed state to a user.”, [0017]; the visual indicator changes color when going from an unready state to a dose-in-progress state (which is determined based on the break loose force being measured), which is being interpreted as a first lighting state change; the visual indicator changes color when going from a dose-in-progress state to a dose complete state (which is determined based on the end of dose force being measured), which is being interpreted as a second lighting state change).
Regarding claim 3, Roe discloses all the limitations of claim 1. Roe further discloses the light-based medication delivery cueing system wherein the one or more force sensors, the one or more processing components, and the first light source are included within the medication delivery device (the force sensor, processor, and visual indicator are included within the syringe, [0143], [0213], and [0185]-[0186]).
Regarding claim 4, Roe discloses all the limitations of claim 1. Roe further discloses the light-based medication delivery cueing system wherein the one or more processing components further determine when the applied force is greater than, or equal to, a threshold glide force that is required to continue the movement of the movable component in the insertion direction (“the injection force profile comprises a break loose force, a glide force, an end of dose force, or any combination thereof… the injection force profile further comprises… a second time interval and/or force magnitude associated with the glide force”, [0014] & Fig. 27; see [0169]-[0170] and [0172]).
Regarding claims 5-6, Roe discloses all the limitations of claim 4. Roe discloses the light-based medication delivery cueing system wherein a visual cue to continue the injection is provided based on the applied force being greater than, or equal to, the threshold glide force,
wherein the visual cue comprises a flashing on, and off, of the first light source (“a visual indicator component can be configured to flash a visual indicator on and off in a particular sequence (e.g., a series of three short flashes) or to remain constantly on to provide an indication of an operational state.”, [0182]; the visual indicator can flash on and off during the dose-in-progress state, which is determined based on the glide force being measured, [0014], [0017], [0170], and [0174]).
Regarding claim 7, Roe discloses all the limitations of claim 1. Roe discloses the light-based medication delivery cueing system wherein at least one of the one or more force sensors is contacted by a user during the injection (“a force sensor is configured to measure the amount of force that is applied to a drug reservoir by an actuation component (e.g., the amount of force that is applied to a syringe stopper by a syringe stopper rod, or the amount of force that is applied to a thumb pad by a user).”, [0126]; “a sensor component is mounted in a thumb pad that is attached to an actuation component”, [0140]; the force sensor mounted in the thumb is contacted by the user during injection).
Regarding claim 10, Roe discloses all the limitations of claim 1. Roe discloses the light-based medication delivery cueing system wherein the first lighting state change comprises at least one changing a color of the first light source or causing the first light source to start flashing (“Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof… an operational state of a subject system or device can be assigned a specific color. For example, in one embodiment, an unready operational state is assigned the color red, and when the system or device is in an unready state, a red color is displayed to a user using a visual indicator component… a visual indicator component can be configured to flash a visual indicator on and off in a particular sequence (e.g., a series of three short flashes) or to remain constantly on to provide an indication of an operational state.”, [0182]).
Regarding claim 11, Roe discloses all the limitations of claim 1. Roe discloses the light-based medication delivery cueing system wherein the second lighting state change comprises at least one of changing a color of the first light source or causing the first light source to stop flashing (“Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof… an operational state of a subject system or device can be assigned a specific color… a visual indicator component can be configured to flash a visual indicator on and off in a particular sequence (e.g., a series of three short flashes) or to remain constantly on to provide an indication of an operational state.”, [0182]).
Regarding claim 15, Roe discloses all the limitations of claim 1. Roe discloses the light-based medication delivery cueing system wherein the second lighting state change is a visual cue that a complete dosage of the medication has been delivered from the medication delivery device (the visual indicator is configured to indicate a dose completed state, [0017]; the visual indicator changes color when going from a dose-in-progress state to a dose complete state (which is determined based on the end of dose force being measured), which is being interpreted as the second lighting state change, [0182]).
Regarding claim 16, Roe discloses a light-based medication delivery cueing method (abstract and [0182]) comprising: measuring, by one or more force sensors, an applied force that is applied, in an insertion direction, to a movable component of a medication delivery device, wherein the movable component is moved, in the insertion direction, to result in an injection of a medication into a patient (“a sensor component and/or a deflection component comprises a force sensor that is configured or adapted to detect and/or measure one or more forces in one or more components of the subject drug delivery systems and devices. For example, in some embodiments, a force sensor is configured to measure the amount of force that is applied to a drug reservoir by an actuation component (e.g., the amount of force that is applied to a syringe stopper by a syringe stopper rod, or the amount of force that is applied to a thumb pad by a user). Force sensors in accordance with embodiments of the disclosure can be absolute or relative force sensors. “, [0126]; “a deflection component comprises a force sensor that is configured to measure one or more forces applied to a portion of a subject system or device by a user (e.g., to detect a force applied to a thumb pad during a delivery stroke).”, [0143]; “Aspects of the disclosure include actuation components that are configured to move, thereby causing a drug to be dispensed from the drug reservoir and injected into the patient.”, [0177]; “FIGS. 23-25 depict drug delivery devices in accordance with embodiments of the disclosure, comprising an actuation component in the form of a syringe stopper rod…”, [0180]);
measuring, by the one or more force sensors, a resistive force that resists movement, in the insertion direction, of the movable component (“a delivery signature can comprise an injection force profile corresponding to an injection force applied to a portion of a subject device by a user. For example, in some embodiments, an injection force profile can comprise a break loose force, a glide force, an end of dose force… an injection force profile can comprise a time interval associated with… the end of dose force”, [0170] & Fig. 27; “…third time interval and/or force magnitude associate the end of dose force.”, [0014]; the force sensor measures a force magnitude at the end of dose, or a resistive force from the syringe stopper pressing against the rod at the end of injection, see [0014] and [0170] & Fig. 27); determining when the applied force becomes greater than, or equal to, a threshold break force that is required to initiate movement of the movable component in the insertion direction (the processor functions to determine the delivery signature, which determines a break loose force, the force required to initiate movement of the actuation element, [0014], [0028], [0030], [0114], [0120], [0135], and [0169]-[0170] & Fig. 27; “The graph shows a break loose force (spike located between 153 mm and 155 mm, with a maximum force value of approximately 5 Newtons)”, [0174] & Fig. 27; the processor determines a break lose force, when the applied force reaches a threshold of approximately 5 Newtons (which is a force magnitude associated with the break loose force, [0014] and [0174] & Fig. 27);
performing a first lighting state change of a first light source based on the applied force becoming greater than, or equal to, the threshold break force (“a visual indicator comprises a light-emitting component. Light emitting components in accordance with embodiments of the disclosure include, without limitation, light emitting diodes (LEDs) and organic light emitting diodes (OLEDs)… Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof. In some embodiments, an operational state of a subject system or device can be assigned a specific color“, [0182]; “the indicator component is configured to indicate a ready state to a user… an unready state to a user… a dose-in-progress state to a user. In some embodiments, the indicator component is configured to indicate a dose completed state to a user.”, [0017]; the visual indicator changes color when going from an unready state to a dose-in-progress state (which is determined based on the break loose force being measured), which is being interpreted as a first lighting state change);
determining when the resistive force becomes greater than, or equal to, a threshold back force that stops the movement of the movable component in the insertion direction (the processor functions to determine the delivery signature, which determines an end of does force, the force that stops movement of the actuation element, [0014], [0028], [0030], [0114], [0120], [0135], and [0169]-[0170] & Fig. 27; “The graph shows… an end of dose force (located between 173 mm and 176 mm, with a maximum force value of approximately 38 Newtons).”, [0174] & Fig. 27; the processor determines an end of dose force, when the applied force reaches a threshold of approximately 38 Newtons (which is a force magnitude associated with the end of dose force), [0014] and [0174] & Fig. 27); and performing a second lighting state change based on the resistive force becoming greater than, or equal to, the threshold back force (“a visual indicator comprises a light-emitting component. Light emitting components in accordance with embodiments of the disclosure include, without limitation, light emitting diodes (LEDs) and organic light emitting diodes (OLEDs)… Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof. In some embodiments, an operational state of a subject system or device can be assigned a specific color“, [0182]; “the indicator component is configured to indicate a ready state to a user… an unready state to a user… a dose-in-progress state to a user. In some embodiments, the indicator component is configured to indicate a dose completed state to a user.”, [0017]; the visual indicator changes color when going from a dose-in-progress state to a dose complete state (which is determined based on the end of dose force being measured), which is being interpreted as a second lighting state change).
Regarding claim 30, Roe discloses a light-based medication delivery cueing system (abstract and [0182]), comprising: one or more proximal sensors that detect a first interaction of a movable component of a medication delivery device with the one or more proximal sensors (plurality of trigger switches, [0143]-[0144] and [0153] & Fig. 1-4, with the proximal most trigger switch being interpreted as the proximal sensor; trigger switch detects an interaction of the syringe stopper rod as the rod travels through the syringe barrel, [0157]; the Examiner notes that the drawings and the majority of the disclosure disclose the trigger switches disposed on the stopper rod, however, paragraph [0157] discloses that “the locations of components on the syringe barrel and stopper rod may be reversed”), wherein the movable component is moved, in an insertion direction, to result in an injection of a medication into a patient, (“actuation components that are configured to move, thereby causing a drug to be dispensed from the drug reservoir and injected into the patient. “, [0177]; “FIGS. 23-25 depict drug delivery devices in accordance with embodiments of the disclosure, comprising an actuation component in the form of a syringe stopper rod”, [0180])
one or more distal sensors that detect a second interaction of the movable component with the one or more distal sensors, wherein, when being moved in the insertion direction to result in the injection, the movable component interacts with the one or more distal sensors after interacting with the one or more proximal sensors (the distal most trigger switch is being interpreted as the distal sensor; trigger switch detects an interaction of the syringe stopper rod as the rod travels through the syringe barrel, past the proximal trigger switch, [0157]); and a first light source, wherein a first lighting state change of the first light source is performed based on the first interaction, and wherein a second lighting state change is performed based on the second interaction (“a visual indicator comprises a light-emitting component. Light emitting components in accordance with embodiments of the disclosure include, without limitation, light emitting diodes (LEDs) and organic light emitting diodes (OLEDs)… Visual indicator components in accordance with embodiments of the disclosure can be configured or adapted to generate visual signals having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof. In some embodiments, an operational state of a subject system or device can be assigned a specific color“, [0182]; “the indicator component is configured to indicate a ready state to a user… an unready state to a user… a dose-in-progress state to a user. In some embodiments, the indicator component is configured to indicate a dose completed state to a user.”, [0017]; the visual indicator changes color when going from an unready state to a dose-in-progress state (which is determined based on the proximal most trigger switch being deflected, see [0169]), which is being interpreted as a first lighting state change, to a dose complete state (which is determined based on the distal most trigger switch being deflected, see [0169), which is being interpreted as a second lighting state change).
Regarding claim 33, Roe discloses all the limitations of claim 30. Roe discloses the light-based medication delivery cueing system wherein the one or more proximal sensors comprise at least one of a tactile sensor or a force sensor, and wherein the first interaction comprises contacting of the one or more proximal sensors by the movable component (“the locations of components on the syringe barrel and stopper rod may be reversed or located elsewhere. For example, the trigger switch or switches may be located on the barrel along with other electrical components. In these embodiments, the switch(es) may be deflected outward by features of the stopper rod as it travels through the barrel.”, [0157]).
Regarding claim 34, Roe discloses all the limitations of claim 30. Roe discloses the light-based medication delivery cueing system wherein the one or more distal sensors comprise at least one of a tactile sensor or a force sensor, and wherein the second interaction comprises contacting of the one or more distal sensors by the movable component (the locations of components on the syringe barrel and stopper rod may be reversed or located elsewhere. For example, the trigger switch or switches may be located on the barrel along with other electrical components. In these embodiments, the switch(es) may be deflected outward by features of the stopper rod as it travels through the barrel.”, [0157]).
Claim(s) 30 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu (US 20160259913 A1 ).
Regarding claims 30 and 35, Yu discloses a light-based medication delivery cueing system (abstract and [0055]), comprising: one or more proximal sensors, wherein the one or more proximal sensors comprise a light sensor, that detect a first interaction of a movable component of a medication delivery device with the one or more proximal sensors (detectors 852, configured to receive a wavelength of energy from emitters 851, which may include one or more of a laser or diode, [0099] & Fig. 10A-10B; proximal most detector 852 may be interpreted as a proximal sensor, which detects an interruption of a wavelength of energy from emitter 851, caused by plunger 840 moving distally, [0099]), wherein the movable component is moved, in an insertion direction, to result in an injection of a medication into a patient (plunger 840 is moved in an insertion direction to inject medication, [0098]-[0099] & Fig. 10A-10B),
one or more distal sensors that detect a second interaction of the movable component with the one or more distal sensors, wherein, when being moved in the insertion direction to result in the injection, the movable component interacts with the one or more distal sensors after interacting with the one or more proximal sensors (detectors 852, configured to receive a wavelength of energy from emitters 851, which may include one or more of a laser or diode, [0099] & Fig. 10A-10B; distal most detector 852 may be interpreted as a distal sensor, which detects an interruption of a wavelength of energy from emitter 851, caused by plunger 840 moving distally, [0099]; “One of the emitters 851 may be positioned immediately proximal of plunger 840 when it is in the distal-most position within body 820 to indicate that reservoir 825 is empty.”, [0099]); and
a first light source (indicator 856, [0098]-[0099] & Fig. 10A; indicator may include a visual indicator, [0055], one or more LEDs, [0068]), wherein a first lighting state change of the first light source is performed based on the first interaction, and wherein a second lighting state change is performed based on the second interaction (“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…. The LEDs may emit a white or colored light or may change colors to output information. The LEDs may turn on/off to indicate a desirable parameter and then may change to indicate a threshold has been detected.”, [0068]; “one of the indicators 856 may signal to the user that a dose was delivered or that a certain amount of a dose has been delivered.”, [0099]; indicator 856 changes colors to output that an injection has started (which is determined based on proximal detector 852 and emitter 851 being interrupted), which is being interpreted as a first lighting state change; indicator 856 changes colors to output that an injection has ended (which is determined based on distal detector 852 and emitter 851 being interrupted), which is being interpreted as a second lighting state change, [0068] and [0098]-[0099] & Fig. 10A-10B), and wherein the first interaction comprises a reduction in light detection due to covering of the light sensor by the movable component (plunger 840 moving distally interrupts the connection between emitter 851 and detector 852, which comprises a reduction in light detection, [0098]-[0099 & Fig. 10B).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roe (US 20210046247 A1) as applied to claim 1 above, and further in view of Yu (US 20160259913 A1).
Regarding claim 2, Roe discloses all the limitations of claim 1. However, Roe fails to explicitly disclose the light-based medication delivery cueing system wherein the one or more force sensors, the one or more processing components, and the first light source are included in one or more adhesive labels that are attached to the medication delivery device.
However, Yu teaches a light-based medication delivery cueing system (abstract and [0055]) wherein the one or more force sensors, the one or more processing components, and the first light source are included in one or more adhesive labels that are attached to the medication delivery device (transponder 50 including a pressure sensor 52/55, processor 54, and indicator 56, [0058], [0062], and [0068] & Fig. 1A-2D; “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).
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 system of Roe with Yu to include the one or more force sensors, the one or more processing components, and the first light source included in one or more adhesive labels that are attached to the medication delivery device, since such a modification would provide structure to connect the force sensor, processor, and light source to the syringe stopper rod and would yield the same predictable results pertaining to force measurement, accompanied by visual indication, during injection ([0062] and [0068] of Yu).
Claim(s) 8 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roe (US 20210046247 A1) as applied to claim 1 above, and further in view of Schauderna (US 20210038833 A1).
Regarding claim 8, Roe discloses all the limitations of claim 1. However, Roe fails to explicitly disclose the light-based medication delivery cueing system wherein at least one of the one or more force sensors is not contacted by a user during the injection.
However, Schauderna teaches a light-based medication delivery cueing system (abstract and [0085]) wherein at least one of the one or more force sensors is not contacted by a user during the injection (“a force sensor is disposed in or around a cartridge being acting upon by a plunger rod of the drug delivery device, or in the plunger rod itself”, [0004] and [0024]; “the pressure or force sensor 341 is remote from the electronics assembly and is for example, located between the stopper 200 and the plunger rod 106 or in any other suitable location to measure the force applied by the plunger rod 106 to the stopper 200 or to the medicament 40.”, [0089] & Fig. 3).
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 position of the force sensor of Roe with Schauderna to include the force sensor located in a cartridge being acted upon by a plunger rod since Schauderna teaches such to be an art effective configuration for a force sensor configured to measure force applied by a plunder rod and would yield the same predictable results pertaining to force measurement throughout an injection cycle (abstract, [0022]-[0024], [0069], and [0089] of Schauderna).
Regarding claims 12-14, Roe discloses all the limitations of claim 1. However, Roe fails to explicitly disclose the light-based medication delivery cueing system further comprising a second light source wherein the second lighting state change comprises at least one of causing the second light source to start emitting light, changing a color of the second light source, or causing the second light source to start flashing, and wherein the first light source has a different color than the second light source.
However, Schauderna teaches a light-based medication delivery cueing system (abstract and [0085) further comprising a second light source (a display or series of LED lights, [0085]), wherein the second lighting state change comprises at least one of causing the second light source to start emitting light or changing a color of the second light source, and wherein the first light source has a different color than the second light source (“a representative alert mechanism could be a display or series or LED lights arranged to illuminate a different color to a user based on the sensed pressure or force signal and a determined indication of the quality of a drug delivery operation. For instances, a blue light could indicate that the device is ready to use, an orange light could be illuminated while the drug delivery device is conducting the drug delivery operation, and then a green or red light could come on at the sensed completion of the drug delivery operation to indicate a successful or failed delivery operation”, [0085]; a first LED light of the series of LED lights can display one color while a second LED light of the series of LED lights can display another color).
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 system of Roe with Schauderna to include a second light source, wherein the second lighting state change comprises at least one of causing the second light source to start emitting light or changing a color of the second light source, wherein the first light source has a different color than the second light source, since such a modification would provide a lighting arrangement capable of distinguishing between operational states while allowing for multiple signals to be displayed and yield the same predictable results pertaining to the visual indication of steps of an injection cycle ([0085] of Schauderna).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Maréchal (US 20230233774 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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