DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 26, 2026 has been entered.
Status of Claims
The Amendment filed 01/26/2026 has been entered.
Claims 1-16, 18, 19, and 21 were previously canceled.
Claim 38 is currently cancelled.
Claims 17, 20, and 22-37 remain pending in the application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17, 20, 22-25, 28, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (U.S. Patent Pub. 20170300925), hereinafter Atkinson, in further view of Butler et al. (U.S. Patent Pub. 20150343152), in further view of Shah et al. (U.S. Patent Pub. 20110288388), hereinafter Shah.
Regarding claim 17, Atkinson discloses a label (electronic visual label, see [0132]) for an injection device (physical container, see [0132]; While Atkinson discloses a “medicine bottle, blister pack, vial, fluid bag/container)” as examples of a physical container, the Examiner is of the position that this is sufficient disclosure for teaching the label is fitting for an injection device.), the label comprising:
a flexible substrate configured for attachment to a body (“label 10 is intended for attachment to a good using an adhesive backing”, [0047]; “ In a preferred embodiment, the intelligent label comprises an integrated electro-optic display comprising a bistable electrophoretic layer and a permanently irreversible electrochromic layer (such as that described in patent application US20110096388A1 “Flexible and Printable Electro-optic Devices) and common electrodes.”, [0107]),
a first label area on the substrate provided with a durable first information content (See FIG. 1), the first information content comprising at least one visual sign or character (print information in [0053]) indicative at least one of the type and/or properties of a medicament located within the injection device (see product descriptions of medical equipment in [0133]),
a second label area on the substrate non-overlapping with the first label area, wherein the second label area comprises an electronic display configured to display a second information content (“message indicator 33 may be more complex and structured in a way that can build textual or numeric information”, [0057]), and
a processor connected to the electronic display and configured to modify at least the second information content (“In operation, electro-optic message indicator 33 would be transitioned according to rules set in the processor for the particular good that is being shipped. These rules would be implemented using processor 28, and when a rule is satisfied, the processor 28 would cause an appropriate electronic signal to transition the electro-optical material in the message indicator 33”, [0058]),
wherein the first label area comprises a first display type and wherein the second label area is of a second display type, and wherein the first display type and the second display type are different display types (“With the addition of one or more sensors, it is likely that the intelligent label 50 will need at least one more electro-optical message indicators 53. It will be appreciated that several electro-optical indicators and even of different types may be useful depending upon the number of sensors and sophistication of the rules for the good associated with intelligent label 50.”, [0065]), and wherein the first display type is one of an electroluminescent display and an electrophoretic display, and wherein the second display type is one of a liquid crystal display, or a light emitting diode display (“The display layer displays the message and may be any of different types including, but not limited to, electrophoretic, liquid crystal, plasma, OLED, and electrochromic.”, [0235]). However, Atkinson does not expressly state to display a varying second information content, different from the first information content, the second information content suitable to assist a user in a proper or intended handling of the injection device and/or dose of the medicament, and wherein the first label area comprises an electronic display of a first display type and wherein the electronic display of the second label area is an electronic display of a second display type.
Butler teaches a decoding system for use with a drug delivery device (Abstract) wherein the first label area comprises an electronic display (display 122) wherein the second information content represents at least one of a correct use and a correct handling of the medicament and/or of the injection device (“The display 122 may be configured to display information such as drug dose measurements and menu screens. The display electronics 210 may also show additional information, such as the actual time, the time of the last usage/injection, a remaining battery capacity, one or more warning signs, and/or the like.”, [0046]), and wherein the electronic display of the second label area is an electronic display (display 122; the Examiner notes Butler teaches the claimed invention except for a second display. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include a second display, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second label area of Atkinson to comprise electronic displays. Doing so provides menu screens configured to display information based on user input, as taught by Butler (see [0046]). However, Atkinson and Butler do not expressly state wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition.
Shah teaches a multiple-conductor electrical lead for use with medical device systems (Abstract) wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament (“, a processor determines a dynamic behavior of the physiological characteristic value and provides an observable indicator based upon the dynamic behavior of the physiological characteristic value so determined”, [0056]), instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition (“The label on, or associated with, the container indicates the preferred device use. The kit and/or device set may further include other materials desirable from a commercial and user standpoint, including elements or devices designed to facilitate the introduction of the device into an in vivo environment, other buffers, diluents, filters, needles, syringes, and package inserts with instructions for use.”, [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of Atkinson and Butler to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition. Doing so facilitates the introduction of the device into an in vivo environment with instructions for use for greater ease to the user, as taught by Shah (see [0056; 0069])
Regarding claim 20, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 18, and Atkinson further discloses wherein the first display type is an electrophoretic display and wherein the second display type is a light emitting diode display (“The display layer displays the message and may be any of different types including, but not limited to, electrophoretic, liquid crystal, plasma, OLED, and electrochromic.”, [0235]).
Regarding claim 22, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 17, and Atkinson further teaches wherein the electronic display of the second label area comprises an organic light emitting diode display (“The display layer displays the message and may be any of different types including, but not limited to, electrophoretic, liquid crystal, plasma, OLED, and electrochromic”, [0235]).
Regarding claim 23, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 17, and Atkinson further teaches wherein the electronic display of the second label area comprises a color display configured to visualize at least one of the second information content or an information background in at least two different colors (“electro-optic material may be specifically formulated and activated in a way that it has two color or transparency states”, [0056]).
Regarding claim 24, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 17, and Atkinson further teaches comprising at least one of a device sensor or an ambient sensor, wherein the device sensor is configured to determine at least one of a position or orientation of at least one of a dose tracker or a piston rod of the injection device relative to a housing or body of the injection device and wherein the ambient sensor is configured to determine at least one of an ambient brightness, an acceleration, a temperature, or a variation of ambient air pressure (“intelligent label 50 has a sensor 55…sensor 55 could be a temperature sensor, a humidity sensor, and altitude sensor, a pressure sensor, an optical sensor, a vibration sensor (including a shock sensor), a humidity sensor, biological or a chemical sensor (including a gas sensor, a pH sensor), a magnetic sensor, and a smoke sensor, etc.”, [0063]).
Regarding claim 25, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 24, and Atkinson further teaches wherein the processor is operable to modify at least one of the first information content or the second information content depending on an electric signal received from at least one of the device sensor or the ambient sensor (see [0063-0065]; “processor can then cause state detector 62 to confirm that the electro-optic material has changed states. This can be done, for example, using electrical measurements across the electro-optic indicator, or using optical sensors”, [0066]).
Regarding claim 28, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 17, and Atkinson further teaches wherein the processor comprises a power management operable to switch on and/or to switch off the electronic display (“Actuation, or initiation of the electronics also may be via a variety of means including a remote signal (e.g. RF, optical or electrical) a mechanical, electro-mechanical or electrical switch.”, [0048]; “Electronics includes a processor 28”, [0054]).
Regarding claim 29, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 28, and Atkinson further teaches wherein the power management is configured to switch on, switch off, and/or dim the electronic display dependent on varying ambient conditions (“a display may be monitored for the effect of temperature, vibration, shock, electrical failure, material fatigue, damage or other conditions that could cause the contrast ratio of the display to diminish”, [0083]).
Regarding claim 37, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 17, and Shah further teaches wherein the dynamically- modified second information content is indicative of at least one of a point of time at which a next use of the device or an injection is due, an amount or a size of the dose to be set and/or to be dispensed by the injection device, a current state or configuration of the injection device or user instructions being indicative of the correct handling of the injection device for the purpose of setting and/or expelling or dispensing a dose of the medicament (“The label on, or associated with, the container indicates the preferred device use. The kit and/or device set may further include other materials desirable from a commercial and user standpoint, including elements or devices designed to facilitate the introduction of the device into an in vivo environment, other buffers, diluents, filters, needles, syringes, and package inserts with instructions for use.”, [0069]).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (U.S. Patent Pub. 20170300925), hereinafter Atkinson, in further view of Butler et al. (U.S. Patent Pub. 20150343152), hereinafter Butler, in further view of Shah et al. (U.S. Patent Pub. 20110288388), hereinafter Shah, in further view of Kim et al. (U.S. Patent No. 20060221045), hereinafter Kim.
Regarding claim 26, Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 24, however, Atkinson in view of Butler in view of Shah does not expressly state wherein the device sensor comprises an electrode structure on the substrate configured to measure at least one of an electric capacitance, an electric field, or a magnetic field (the Examiner notes Atkinson does disclose a magnetic sensor 55 on the label, see [0063]; “an electrophoretic display forms images by rearranging charged pigment particles (pixels) with an applied electric field”, [0059]; “Typically, the pixels on the display will be activated using an electrode or electrode set to provide an electric stimulation or signal to each individual pixel. It will be understood that the process for activating pixels with electrodes is well understood.”, [0074]).
Kim teaches a backlight unit and a liquid crystal display device (Abstract) wherein the device sensor comprises an electrode structure on the substrate (“second electrodes 220 are arranged on the inner surface of the second substrate 200”, [0025]) configured to measure at least one of an electric capacitance, an electric field, or a magnetic field (“second electrodes 220 are electrically coupled with a voltage applying unit. Here, the first electrode 130 is grounded. When applying a discharge voltage that exceeds a minimum discharge voltage to the second electrodes 220, a discharge is generated between the first electrode 130 and the second electrodes 220”, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Atkinson in view of Butler in view of Shah to include the device sensor with an electrode structure on the substrate configured to measure at least one of an electric capacitance, an electric field, or a magnetic field. Doing so would decrease the amount of heat and electromagnetic interference (EMI) that affects the display panel, as taught by Kim (see [0010]).
Regarding claim 27, Atkinson in view of Butler in view of Shah in view of Kim teaches the claimed invention as discussed above concerning the rejection of claim 26, and Kim further teaches wherein the electronic display comprises at least one electrically conductive grid electrode (“The first electrode 130 may be formed as a single film, or it may be formed in various patterns… such as a grid.”, [0024]) at least partially spatially overlapping with the electrode structure of the device sensor (second electrodes 220), and wherein the at least one electrically conductive grid electrode provides an electromagnetic shield for the electrode structure of the device sensor (“shield discharge and electromagnetic waves”, [0024]).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Usami et al. (U.S. Patent Pub. 20180090106), hereinafter Usami, in further view of Atkinson et al. (U.S. Patent Pub. 20170300925), hereinafter Atkinson, in further view of Butler et al. (U.S. Patent Pub. 20150343152), hereinafter Butler, in further view of Shah et al. (U.S. Patent Pub. 20110288388), hereinafter Shah.
Regarding claim 30, Usami discloses an injection device (syringe 16b; see FIG. 4) for setting and injecting of a dose of a medicament (see [0028], the injection device comprising:
a housing configured to accommodate a medicament container (see FIG. 4);
a drive mechanism configured to withdraw or to expel the dose of the medicament from the medicament container and configured to inject the dose of the medicament into biological tissue (“a liquid medicine is injected into the patient”, [0074]); and a label (tag 12) attached to the housing. However, Usami does not expressly state wherein the label comprises: a flexible substrate configured for attachment to the housing of the injection device, a first label area on the substrate provided with a durable first information content, the first information content comprising at least one visual sign or character indicative at least one of the type and/or properties of a medicament located within the injection device, a second label area on the substrate non-overlapping with the first label area, wherein the second label area comprises an electronic display configured to display a second information content, different from the first information content, and a processor connected to the electronic display and configured to modify at least the second information content.
Akinson teaches an intelligent display device (claim 23) a flexible substrate configured for attachment to the housing of the injection device (“label 10 is intended for attachment to a good using an adhesive backing”, [0047]; “ In a preferred embodiment, the intelligent label comprises an integrated electro-optic display comprising a bistable electrophoretic layer and a permanently irreversible electrochromic layer (such as that described in patent application US20110096388A1 “Flexible and Printable Electro-optic Devices) and common electrodes.”, [0107]),
a first label area on the substrate provided with a first durable information content (See FIG. 1), the first information content comprising at least one visual sign or character (print information in [0053]) indicative at least one of the type and/or properties of a medicament located within the injection device (“The memory 38 stores the image display information corresponding to the information included in the data code 22… in which the information of the data code 22 is a medicine name, the memory 38 stores, as the image display information”, [0069]).
a second label area on the substrate non-overlapping with the first label area, wherein the second label area comprises an electronic display configured to display a second information content , different from the first information content (“message indicator 33 may be more complex and structured in a way that can build textual or numeric information”, [0057]), and
a processor connected to the electronic display and configured to modify at least the second information content (“In operation, electro-optic message indicator 33 would be transitioned according to rules set in the processor for the particular good that is being shipped. These rules would be implemented using processor 28, and when a rule is satisfied, the processor 28 would cause an appropriate electronic signal to transition the electro-optical material in the message indicator 33”, [0058]),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the label of Usami to include a flexible substrate configured for attachment to the housing of the injection device, a first label area and second label, wherein the second label area comprises an electronic display, both labels configured to display information content, and a processor connected to the display to modify the second information content. Doing so would provide a secure and intelligent label naturally resistant to tampering or accidental alteration, as taught by Atkinson (see [0045]).
Atkinson further teaches wherein the first label area comprises a first display type and wherein the second label area is of a second display type, and wherein the first display type and the second display type are different display types (“With the addition of one or more sensors, it is likely that the intelligent label 50 will need at least one more electro-optical message indicators 53. It will be appreciated that several electro-optical indicators and even of different types may be useful depending upon the number of sensors and sophistication of the rules for the good associated with intelligent label 50.”, [0065]), and wherein the first display type is one of an electroluminescent display and an electrophoretic display, and wherein the second display type is one of a liquid crystal display, or a light emitting diode display (“The display layer displays the message and may be any of different types including, but not limited to, electrophoretic, liquid crystal, plasma, OLED, and electrochromic.”, [0235]). However, Umami and Atkinson do not expressly state the second information content suitable to assist a user in a proper or intended handling of the injection device and/or dose of the medicament, wherein the first label area comprises an electronic display of a first display type and wherein the electronic display of the second label area is an electronic display of a second display type.
Butler teaches a decoding system for use with a drug delivery device (Abstract) wherein the first label area comprises an electronic display (display 122) wherein the second information content represents at least one of a correct use and a correct handling of the medicament and/or of the injection device (“The display 122 may be configured to display information such as drug dose measurements and menu screens. The display electronics 210 may also show additional information, such as the actual time, the time of the last usage/injection, a remaining battery capacity, one or more warning signs, and/or the like.”, [0046]), and wherein the electronic display of the second label area is an electronic display (display 122; the Examiner notes Butler teaches the claimed invention except for a second display. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include a second display, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second label area of Atkinson to comprise electronic displays. Doing so provides menu screens configured to display information based on user input, as taught by Butler (see [0046]). However, Umami and Atkinson and Butler do not expressly state wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition.
Shah teaches a multiple-conductor electrical lead for use with medical device systems (Abstract) wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament (“, a processor determines a dynamic behavior of the physiological characteristic value and provides an observable indicator based upon the dynamic behavior of the physiological characteristic value so determined”, [0056]), instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition (“ The label on, or associated with, the container indicates the preferred device use. The kit and/or device set may further include other materials desirable from a commercial and user standpoint, including elements or devices designed to facilitate the introduction of the device into an in vivo environment, other buffers, diluents, filters, needles, syringes, and package inserts with instructions for use.”, [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of Umami and Atkinson and Butler to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition. Doing so facilitates the introduction of the device into an in vivo environment with instructions for use for greater ease to the user, as taught by Shah (see [0056; 0069])
Regarding claim 31, Usami in view of Atkinson in view of Butler in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 30, and Usami further teaches the medicament container arranged inside the housing (prefilled syringe, see [0028]).
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Patent Pub. 20150343152), hereinafter Butler, in further view of Atkinson et al. (U.S. Patent Pub. 20170300925), hereinafter Atkinson, in further view of Shah et al. (U.S. Patent Pub. 20110288388), hereinafter Shah.
Regarding claim 32, Butler discloses an adapter configured for a releasable attachment to a housing of an injection device (“supplementary device 116 configured to be releasably attached to the drug delivery device 100”, [0045]; see FIGS. 1-2), the adapter comprising:
a rigid body comprising an outside surface and a counter fastening feature configured to releasably mechanically engage with a fastening feature of the housing of the injection device (“The lower part 118 and upper part 120 are hinged together along one longitudinal edge. The second longitudinal edges of the lower part 118 and upper part 120 engage when the hinge is closed. When the hinge is opened, the supplementary device 116 can be fitted around the drug delivery device 100. Fastening means, such as a clip (not shown), may be provided on the second longitudinal edges of the lower part 118 and upper part 120, allowing the supplementary device 116 to be releasably secured to the drug delivery device 100.”, [0045]); and
a label (display 122) attached to the outside surface, wherein the label comprises:
wherein the first label area comprises an electronic display (display 122) and wherein the electronic display of the second label area is an electronic display (display 122; the Examiner notes Butler teaches the claimed invention except for a second display. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include a second display, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.).
However, Butler does not expressly state wherein the label comprises: a flexible substrate configured for attachment to the housing of the injection device, a first label area on the substrate provided with a durable first information content, the first information content comprising at least one visual sign or character indicative at least one of the type and/or properties of a medicament located within the injection device, a second label area on the substrate non-overlapping with the first label area, wherein the second label area comprises an electronic display configured to display a second information content, and a processor connected to the electronic display and configured to modify at least the second information content.
Akinson teaches an intelligent display device (claim 23) a flexible substrate configured for attachment to the housing of the injection device (“label 10 is intended for attachment to a good using an adhesive backing”, [0047]; “ In a preferred embodiment, the intelligent label comprises an integrated electro-optic display comprising a bistable electrophoretic layer and a permanently irreversible electrochromic layer (such as that described in patent application US20110096388A1 “Flexible and Printable Electro-optic Devices) and common electrodes.”, [0107]),
a first label area on the substrate provided with a durable first information content (See FIG. 1), the first information content comprising at least one visual sign or character (print information in [0053]) indicative at least one of the type and/or properties of a medicament located within the injection device (see product descriptions of medical equipment in [0133]),
a second label area on the substrate non-overlapping with the first label area, wherein the second label area comprises an electronic display configured to display a second information content different from the first information content (“message indicator 33 may be more complex and structured in a way that can build textual or numeric information”, [0057]), the second information content suitable to assist a user in a proper or intended handling of the injection device and/or dose of the medicament (the Examiner notes Butler discloses the display 122 may be configured to display information such as drug dose measurements and menu screens in [0046] of Butler), and
a processor connected to the electronic display and configured to modify at least the second information content (“In operation, electro-optic message indicator 33 would be transitioned according to rules set in the processor for the particular good that is being shipped. These rules would be implemented using processor 28, and when a rule is satisfied, the processor 28 would cause an appropriate electronic signal to transition the electro-optical material in the message indicator 33”, [0058]),
wherein the first label area comprises a first display type and wherein the second label area is of a second display type, and wherein the first display type and the second display type are different display types (“With the addition of one or more sensors, it is likely that the intelligent label 50 will need at least one more electro-optical message indicators 53. It will be appreciated that several electro-optical indicators and even of different types may be useful depending upon the number of sensors and sophistication of the rules for the good associated with intelligent label 50.”, [0065]), and wherein the first display type is one of an electroluminescent display and an electrophoretic display, and wherein the second display type is one of a liquid crystal display, or a light emitting diode display (“The display layer displays the message and may be any of different types including, but not limited to, electrophoretic, liquid crystal, plasma, OLED, and electrochromic.”, [0235]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the label of Butler to include a flexible substrate configured for attachment to the housing of the injection device, a first label area and second label, wherein the second label area comprises an electronic display, both labels configured to display information content, and a processor connected to the display to modify the second information content. Doing so would provide a secure and intelligent label naturally resistant to tampering or accidental alteration, as taught by Atkinson (see [0045]). However, Butler and Atkinson do not expressly state wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition.
Shah teaches a multiple-conductor electrical lead for use with medical device systems (Abstract) wherein the processor is configured to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament (“, a processor determines a dynamic behavior of the physiological characteristic value and provides an observable indicator based upon the dynamic behavior of the physiological characteristic value so determined”, [0056]), instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition (“The label on, or associated with, the container indicates the preferred device use. The kit and/or device set may further include other materials desirable from a commercial and user standpoint, including elements or devices designed to facilitate the introduction of the device into an in vivo environment, other buffers, diluents, filters, needles, syringes, and package inserts with instructions for use.”, [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of Butler and Atkinson to modify the second information content dynamically based at least in part on one or more attributes of a dose of the medicament, instructions to the user related to the administration of the dose, and/or at least one environmental or ambient condition. Doing so facilitates the introduction of the device into an in vivo environment with instructions for use for greater ease to the user, as taught by Shah (see [0056; 0069])
Regarding claim 33, Butler in view of Atkinson in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 32, and Atkinson further teaches wherein the label further comprises at least one of a device sensor or an ambient sensor, wherein the device sensor is configured to determine at least one of a position or orientation of at least one of a dose tracker or a piston rod of the injection device relative to a housing or body of the injection device and wherein the ambient sensor is configured to determine at least one of an ambient brightness, an acceleration, a temperature, or a variation of ambient air pressure (“intelligent label 50 has a sensor 55…sensor 55 could be a temperature sensor, a humidity sensor, and altitude sensor, a pressure sensor, an optical sensor, a vibration sensor (including a shock sensor), a humidity sensor, biological or a chemical sensor (including a gas sensor, a pH sensor), a magnetic sensor, and a smoke sensor, etc.”, [0063]).
Regarding claim 34, Butler in view of Atkinson in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 33, and Atkinson further teaches wherein the processor is operable to modify at least one of the first information content or the second information content depending on an electric signal received from at least one of the device sensor or the ambient sensor (see [0063-0065]; “processor can then cause state detector 62 to confirm that the electro-optic material has changed states. This can be done, for example, using electrical measurements across the electro-optic indicator, or using optical sensors”, [0066]).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Patent Pub. 20150343152), hereinafter Butler, in further view of Atkinson et al. (U.S. Patent Pub. 20170300925), hereinafter Atkinson, in further view of Shah et al. (U.S. Patent Pub. 20110288388), hereinafter Shah, in further view of Kim et al. (U.S. Patent No. 20060221045), hereinafter Kim.
Regarding claim 35, Butler in view of Atkinson in view of Shah teaches the claimed invention as discussed above concerning the rejection of claim 33, however, Butler in view of Atkinson in view of Shah does not expressly state wherein the device sensor comprises an electrode structure on the substrate configured to measure at least one of an electric capacitance, an electric field, or a magnetic field (the Examiner notes Atkinson does disclose a magnetic sensor 55 on the label, see [0063]; “an electrophoretic display forms images by rearranging charged pigment particles (pixels) with an applied electric field”, [0059]; “Typically, the pixels on the display will be activated using an electrode or electrode set to provide an electric stimulation or signal to each individual pixel. It will be understood that the process for activating pixels with electrodes is well understood.”, [0074]).
Kim teaches a backlight unit and a liquid crystal display device (Abstract) wherein the device sensor comprises an electrode structure on the substrate (“second electrodes 220 are arranged on the inner surface of the second substrate 200”, [0025]) configured to measure at least one of an electric capacitance, an electric field, or a magnetic field (“second electrodes 220 are electrically coupled with a voltage applying unit. Here, the first electrode 130 is grounded. When applying a discharge voltage that exceeds a minimum discharge voltage to the second electrodes 220, a discharge is generated between the first electrode 130 and the second electrodes 220”, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Butler in view of Atkinson in view of Shah to include the device sensor with an electrode structure on the substrate configured to measure at least one of an electric capacitance, an electric field, or a magnetic field. Doing so would decrease the amount of heat and electromagnetic interference (EMI) that affects the display panel, as taught by Kim (see [0010]).
Regarding claim 36, Butler in view of Atkinson in view of Shah in view of Kim teaches the claimed invention as discussed above concerning the rejection of claim 35, and Kim further teaches wherein the electronic display comprises at least one electrically conductive grid electrode (“The first electrode 130 may be formed as a single film, or it may be formed in various patterns… such as a grid.”, [0024]) at least partially spatially overlapping with the electrode structure of the device sensor (second electrodes 220), and wherein the at least one electrically conductive grid electrode provides an electromagnetic shield for the electrode structure of the device sensor (“shield discharge and electromagnetic waves”, [0024]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 1/26/2025, with respect to the rejection(s) of claim(s) 17-36 under U.S.C. 103 to Atkinson (U.S. Patent Pub. 20170300925), Butler (U.S. Patent Pub. 20150343152), Kim (U.S. Patent No. 20060221045), and Usami (U.S. Patent No. 20180090106) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 as being unpatentable over Shah (U.S. Patent Pub. 20110288388), Atkinson (U.S. Patent Pub. 20170300925), Butler (U.S. Patent Pub. 20150343152), Kim (U.S. Patent No. 20060221045), and Usami (U.S. Patent No. 20180090106).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
4/02/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783