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 .
Response to Amendment
The amendment filed 6/11/2026 has been entered. Claims 20-21, 23-35, and 37-40 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21, 23-35, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Steel (US 20150367079 A1) in view of Toporek (US 20180154086 A1), and further in view of Krulevitch (US 20110313395 A1).
Regarding claim 21, Steel discloses a drug delivery device (abstract) comprising: a housing having a proximal end and a distal end (housing 102 and the inside of dial 108 is being interpreted as the housing, [0056] & Fig. 1); a drug delivery mechanism provided at least partially within the housing (first housing part 104 contains a delivery mechanism, [0058] & Fig. 1) and displaceable between a pre-delivery position and a mechanical stop position to dispense medicament from the drug delivery device when a user presses down on a proximal end of the drug delivery mechanism (see [0059]; the mechanical stop position being the distalmost position of the button 416 capable of being reached upon user initiated depression; “The device 100 is configured, once a drug dose has been set by rotation of the rotatable dial 108, to deliver the set drug dose when a user exerts an axial force at the proximal end of the device. The rotatable dial 108 may support a dose delivery button (416 in FIG. 3) which must be depressed in order to deliver the set drug dose.”, [0059] and see [0072]); and
an end of dose switch configured to be triggered prior to the drug delivery mechanism reaching the mechanical stop position (the coupling and decoupling of switch 216 is being interpreted as triggering of the end of dose switch, [0134]; the switch can be triggered prior to the full depression of button 416, see Fig. 17b and 17c), the end of dose switch comprising a first sensor element disposed on the drug delivery mechanism (helical track 308 and deformable arm 258, which are both being interpreted as the first sensor component, are disposed on encoder 406, [0135] & Fig. 14 and 17a) and a second sensor element disposed within the housing (contacts 212a-212g and 212i and conductive ring 256 are disposed in housing 104 and are being interpreted as the second sensor element, [0123], [0135] & Fig. 16);
wherein the end of dose switch is configured to be triggered when relative movement of the first sensor element and the second sensor element causes the first and second sensor elements to move into a switch position (as the button 416 is depressed and let go, conductive ring 256 electrically couples and decouples arms 258 which electrically couples and decouples switch 216; this is being interpreted as the end of dose switch being triggered, see [0131]-[0135] and [0156] & Fig. 17b-17c; the switch position is the being interpreted as the coupled configuration; the Examiner notes that the operation of the switch 216 is being interpreted in its reversed, alternate arrangement as disclosed in [0156]), and wherein the drug delivery mechanism is biased in a proximal direction away from the mechanical stop position, so that, when a user ceases to press on the proximal end of the drug delivery mechanism, the first and second sensor elements move out of the switch position (button 416 has a spring bias in a proximal direction which is away from the mechanical stop, see [0068] and [0134]-[0135] & Fig. 17b; in the alternate arrangement disclosed in [0156], the switch 216 is electrically decoupled when the device 100 is idle, or when the button 416 is not being pressed);
wherein the first and second sensor elements move into the switch position when the second sensor element moves over a distal edge of and toward the first sensor element thereby providing a conductive path between the first sensor element and the second sensor element (in the arrangement disclosed in [0156], in the coupled configuration, ring 256 would move over a distal edge of arm 258, as ring 256 is in contact with both edges of arm 256 when coupled to arm 258 (see Fig. 17b), and toward arm 258 creating an electrical coupling, [0156]; although not illustrated, ring 256 would necessarily be positioned proximally compared to the arrangement illustrated in Fig. 17b-17c as the switch 216 is electrically coupled when button 416 is depressed, connecting tracks 300 and 308);
the drug delivery device further comprising a controller configured to: record when the end of dose switch is triggered (processor 202 is configured to indicate when the switch 216 is decoupled or coupled, signaling dispensing mode, see [0131] and [0156]; this would require the processor 202 to record a triggering event occurring, see [0106] and [0107]); and generate an error code indicative of incorrect use (processor 202 can determine the amount of dose yet to be dispensed if for some reason a user does not dispense the full amount and communicate with display 210 to “show the dose amount yet to be dispensed if a user does not dispense the full amount of a dialed dose.”, see [0060], [0062], [0064], [0106]-[0107] and [0131]; this is being interpreted as the generation of an error code indicative or incorrect use).
However, Steel fails to explicitly disclose the controller configured to measure a duration of time between the end of dose switch being triggered and the first and second sensor elements moving out of the switch position and configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism when a measured duration is less than a predetermined time period.
However, Toporek teaches a controller (processor arrangement 50 and timer 55, Fig. 14) configured to measure a duration of time between the end of dose switch being triggered and the first and second sensor elements moving out of the switch position (“For example, if the timer 55 is triggered on both engagement or disengagement of the first and second electrical contacts 30, 31… then the processor arrangement 50 may use the output from the timer to determine a length of time during which the injection button 11 was pressed, for example to determine the duration of an injection.”; timer 55 can monitor a duration of an injection, as indicated by a time of engagement and disengagement of the first and second electrical contacts 30, 31, [0169]-[0170] & Fig. 3 and 14)
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 device of Steel with Toporek to include the controller configured to measure a duration of time between the end of dose switch being triggered and the first and second sensor elements moving out of the switch position and compare the measured duration of time against a predetermined threshold since such a modification would allow for the duration of an injection to be determined and then used to help determine correct, or incorrect, device use (see [0169]-[0170] of Toporek). As combined, the timer 55 of Toporek can be included in the circuitry 200 of Steel and processor 202 of Steel can include the configuration of processor 50 of Toporek.
Further, Krulevitch teaches a drug injection device (drug devilry pen 200 including knob 204, [0047] & Fig. 6) comprising a controller configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism when a measured duration is less than a predetermined time period (microprocessor 290 and momentary switch 267, [0048] & Fig. 7-8; “the injection is performed by inserting the needle into the skin and (with the user's thumb) fully depressing the knob. Once the knob is fully depressed, it must be held down for a predetermined period of time for the selected dosage to be fully injected. As provided herein, the momentary switch and processor would be able to determine the dosage injection event and duration thereof. Thereafter, the pen records such an event and the duration of the event into its memory.”, [0068]; “If the user releases pressure on the switch prematurely, a warning may be announced or displayed on the data management unit. Alternatively, or in addition, a small display or LEDs on the pen may be used to cue the user as to how long to press on the dial. It is noted, however, that a display is not absolutely necessary--the device could just track the time that the knob is depressed and display a message/warning on the meter if the user does not hold down the button for a sufficient amount of time.”, [0069]).
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 controller of Steel, as modified, with Krulevitch to include the controller configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism since such a modification would provide means to alert the user that the button was not held for a sufficient amount of time to allow for complete/proper dose delivery and yield predictable results pertaining to injection duration monitoring ([0068]-[0069] of Krulevitch). As combined, processor 202 of Steel can include the configuration of processor 290 of Krulevitch.
Regarding claim 23, Steel, as modified, discloses all the limitations of claim 21. Steel further discloses the drug delivery device wherein the end of dose switch is configured to be triggered when the first sensor element moves in a distal direction over the switch position (as the button 416 is depressed and let go, conductive ring 256 electrically couples and decouples arms 258 which electrically couples and decouples switch 216; electrical coupling or decoupling is being interpreted as the end of dose switch being triggered, see [0131]-[0135] and [0156] & Fig. 17b-17c; the switch is triggered, electrically decoupled, when arms 258 move in a distal direction, with respect to conductive ring 256, over the coupled configuration, see [0135] and [0156]).
Regarding claim 24, Steel, as modified, discloses all the limitations of claim 21. Steel further discloses the drug delivery device wherein the first sensor element comprises a conductive strip on the drug delivery mechanism that is electrically connected to the controller (helical track 308 is being interpreted as a conductive strip on member 406, track 308 is electrically connected to processor 202 by switch 216 when the switch is electrically coupled, [0060], [0124] & Fig. 2; bus 208 is connected to battery 214 which powers all the circuitry 200 components and switch 216).
Regarding claim 25, Steel, as modified, discloses all the limitations of claim 24. Steel further discloses the drug delivery device wherein the second sensor element comprises a bridging contact (eighth contact 212i, [0123] & Fig. 16) configured to connect the conductive strip to a live strip on the drug delivery mechanism (contact 212i is linked to processor 202 and batteries 214 by conductive paths or wires, which is being interpreted as the live strip, see [0078]; contact 212i, which is in electrical connection with contacts 212a-212g, creates a connection between track 308 and the conductive path or wire, [0123]-[0124] & Fig. 14-15) to cause an electrical signal to be transmitted to the controller (when contact 212i is connected to track 308 and arms 258 and ring 256 are electrically coupled, contact 212i is energized which electrically signals processor 202, see [0064, [0078], and [0129]).
Regarding claim 26, Steel, as modified, discloses all the limitations of claim 25. Steel further discloses the drug delivery device wherein the bridging contact is formed as a pressing (electrical contact 212i is being interpreted as a pressing, [0064] & Fig. 16) and comprises contact points disposed at ends of cantilevered members of the pressing (the tip of contact 212i has a contact point at an end of a cantilevered member, Fig. 16; the contact, as seen in Fig. 16, is only supported at one end and is being interpreted as a cantilevered member), said contact points being configured to contact the live strip and the first sensor element respectively to electrically connect the live strip with the first sensor element (the tip of contact 212i is configured to electrically connect the conductive path or wire to track 308, [0123]). Steel is silent to the exact material that the contacts are comprised of but does disclose the contacts as being conductive ([0094]) and metal as being conductive ([0090]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the pressing be metallic since the pressing is disclosed as conductive and Steel teaches metal is an art effective conductive material which would yield the same predictable result of electrical connection.
Regarding claims 27 and 28, Steel, as modified, discloses all the limitations of claim 26. Steel further discloses the drug delivery device wherein the second sensor element comprises two or more bridging contacts spaced around an inner surface of the housing (contacts 212a-212g, [0123] & Fig. 16) and are provided at the proximal end of the housing (contacts 212a-212g are provided at a proximal end of housing 102, see Fig. 1 and 16).
Regarding claim 29, Steel, as modified, discloses all the limitations of claim 27. Steel further discloses the drug delivery device wherein the drug delivery mechanism comprises a dose setting component (dial 108 and member 406, [0059] & Fig. 1), the dose setting component being rotatable relative to the housing to set a drug dose to be administered (see [0059]); and wherein the first sensor element comprises a series of conductive strips spaced around an outer surface of the dose setting component (section b) and track 308 are being interpreted as the series of conductive strips which are spaced around the outer surface 440 of encoder 406, [0122] & Fig. 15).
Regarding claim 30, Steel, as modified, discloses all the limitations of claim 29. Steel further discloses the drug delivery device wherein said dose setting component further comprises conductive dose encoding strips (conductive segments 302, [0127] & Fig. 15) and live strips alternately spaced around the outer surface of the dose setting component (non-conductive segments 304 are being interpreted as live strips, [0123] & Fig. 15), the conductive dose encoding strips each being electrically connected to the controller (segments 302 are connected to power line 306 and contacts 212a-212g which are connected to processor 202, [0090] and [0094]), and wherein the two or more bridging contacts connect and disconnect the conductive dose encoding strips to the live strips when the dose setting component rotates relative to the housing to transmit electrical signals to the controller and encode a set drug dose (contacts 212a-212g connect and disconnect segments 302 and 304 as the encoder 406 rotates to transmit electrical signals to processor 202 and encode a set drug dose, see [0097], [0102]- [0103], and [0123]).
Regarding claim 31, Steel, as modified, discloses all the limitations of claim 30. The drug delivery device according to claim 30, wherein the first sensor element comprises a series of conductive strips spaced around a proximal end of the dose setting component (section b) and track 308 are spaced around a proximal end of member 406, see Fig. 14).
Regarding claim 32, Steel, as modified, discloses all the limitations of claim 31. Steel further discloses the drug delivery device wherein the series of conductive strips of the first sensor element are spaced apart to allow the conductive dose encoding strips to extend in between the series of conductive strips of the first sensor element and into electrical connection with the controller (track 308 and section b) are spaced apart in a manner that allows conductive segments 302 to extend in-between track 308 and in electrical connection with processor 202 through switch 216 and contacts 212a-212g, see [0124]).
Regarding claim 33, Steel, as modified, discloses all the limitations of claim 31. Steel further discloses the drug delivery device wherein the conductive strips and/or conductive dose encoding strips are printed, plated or etched onto an exterior surface of the dose setting component (helical track 300, which comprises segments 302, comprises conductive ink printed onto a non-conductive substrate, [0089] & Fig. 14).
Regarding claim 34, Steel, as modified, discloses all the limitations of claim 30. Steel further discloses the drug delivery device wherein the controller is configured to record an encoded set drug dose when the end of dose switch is triggered (see [0130]-[0132] and [0134]-[1035]; processor 202 records the set drug dose when the switch 216 is in dialing mode, see [0126]-[0128], and record the delivered dose when switch 216 is in dispensing mode, see [0107]).
Regarding claim 35, Steel, as modified, discloses all the limitations of claim 29. Steel does not explicitly disclose the drug delivery device wherein the controller is provided at a proximal end of the dose setting component. However, Toporek teaches the controller provided at a proximal end of the dose setting component (processor 50 is seen disposed on the proximal end of knob 81, see Fig. 14) as an art effective placement for a processor.
Further, there are a limited number of options available regarding the placement of the processor. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the processor of Steel at a proximal end of the dose setting component since it can either be placed proximally or distally. One of ordinary skill would be able to select from the limited number of options to achieve a desirable configuration in which the processor could function with the delivery device and such a placement has been proven as effective in the art by Toporek and would yield the same predictable result of providing control.
Regarding claim 39, Steel, as modified, discloses all the limitations of claim 21. Steel further discloses the drug delivery device wherein the drug delivery device is configured to provide a visual and/or audio cue to a user of the drug delivery device to signal that a set drug dose has been administered (display 112, which includes display 210, is configured to display information concerning the drug dose which has been set and delivered, see [0059]-[0060])
However, Steel fails to explicitly disclose signaling that a set drug dose has been administered following expiration of the predetermined time period. However, Toporek teaches signaling that a set drug dose has been administered following expiration of the predetermined time period (“...if the elapsed time is very short, it may indicate that the user is administering a medicament amount as a “split dose”... In such a scenario the elapsed time is compared with a predetermined threshold in the range of a few seconds”, [0170]; once a predetermined time period is met, there is an indication that a certain drug dose has been administered).
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 device of Steel with Toporek to include signaling that a set drug dose has been administered following expiration of the predetermined time period since such a modification would aid in determining a duration of an injection and in accurately determining how much medicament a user is intending to administer or has administered (see [0169] and [0170] of Toporek).
Regarding claim 40, Steel, as modified, discloses all the limitations of claim 21. Steel, as modified, further discloses the drug delivery device wherein the drug delivery device is configured to provide a visual and/or audio cue to a user of the drug delivery device to warn a user that a set drug dose may not have been completely administered (circuitry 200 may include an audible alarm that indicates when a dialed dose has not been fully disposed, see [0061]; “The display 112 may be configured to display information concerning the drug dose which has been set and/or delivered. The display 112 may further show additional information, such as… one or more warning signs indicating that a dialed dose has not been fully dispensed, and/or the like.”, [0059]-[0060]) when
the user ceases to press on the proximal end of the drug delivery mechanism prior to an end of the predetermined time period (processor 202, as modified by Krulevitch, would be configured to control display 210, or the audible alarm, to provide a warning to the user that a drug dose may not have been administered if the user prematurely releases the injection button prior to an end of the predetermined time period; “Once the knob is fully depressed, it must be held down for a predetermined period of time for the selected dosage to be fully injected. As provided herein, the momentary switch and processor would be able to determine the dosage injection event and duration thereof… If the user releases pressure on the switch prematurely, a warning may be announced or displayed”, [0068]-[0069] of Krulevitch).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Steel (US 20150367079 A1) in view of Toporek (US 20180154086 A1), in view of Krulevitch (US 20110313395 A1), and further in view of Berey (US 20190001067 A1).
Regarding claim 37, Steel, as modified, discloses all the limitations of claim 21. However, Steel fails to explicitly disclose the drug delivery device wherein the predetermined time period is between 0.2s and 0.25s.
However, Berey teaches a drug delivery device comprising a controller (drug delivery device 200 comprising an electronic subassembly 130, comprising a processor 135, sensor 132, and circuit board 137, abstract, [0036], [0042] & Fig. 1A, 3, and 8-9) configured to measure a duration of time and configured to generate a code indicative of early release of pressure from the proximal end of the drug delivery mechanism when the measured duration is less than a predetermined time period, wherein the predetermined time period is between 0.2s and 0.4s (“When the push-button is released (305), the device tests (306) if the duration of holding down the button was longer or shorter than a second predetermined period IT (which is preferably e.g. 0.3 seconds). If it is longer, the data acquisition means maps the pressing of the button with an insulin administration event, and stores (307) the duration… of pressing the button in the memory unit. If it is shorter, said means continues its operation… by skipping the three steps (steps 307 to 309) following the test.”, [0051] & Fig. 9 and 11; if the measured duration of holding down the button is less than 0.3 seconds, than a wireless communication signal is sent indicative of device use, step 310, [0053] and [0022] & Fig. 11).
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 device of Steel, as modified, with Berey to include the predetermined time period between 0.2s and 0.25s since Berey teaches such a threshold, which can be dependent on a particular dosage, to be an effective duration of time for determining if actuation of an injection button corresponds to drug administration (see [0051]-[0052] of Berey).
Regarding claim 38, Steel, as modified, discloses all the limitations of claim 37. Steel as combined with Berey teaches a preferable time period of 0.3 seconds (see [0051] & Fig. 11) but fails to explicitly disclose the drug delivery device wherein the predetermined time period is 0.25s.
However, Berey teaches that the threshold is based on a user’s typical ingrown dose duration time (see [0014]) which can deviate (see [0020]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the predetermined time period of Steel as combined with Berey to be 0.25s, instead of 0.3s, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, as Berey teaches a time period that is substantially the same as the claimed time period, the claimed predetermined time period is simply a deviation from Berey’s disclosed time period that one of ordinary skill in the art could discover by routine experimentation to better suit the chosen population of device users.
Claims 21, 23-24, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Toporek (US 20180154086 A1), in view of Krulevitch (US 20110313395 A1).
Regarding claims 21 and 40, Toporek discloses a drug delivery device (injection device 1 and data collection device 20, abstract and [0074] & Fig. 1-3) comprising: a housing having a proximal end and a distal end (housing 10, which is being interpreted as the distal end, and first portion 23, which is being interpreted as a proximal end, [0067] and [0075] & Fig. 3); a drug delivery mechanism provided at least partially within the housing and displaceable between a pre-delivery position and a mechanical stop position to dispense medicament from the drug delivery device when a user presses down on a proximal end of the drug delivery mechanism (outer portion 26, including end plate 22, functions to initiate medicament delivery, is provided within first portion 23, and is displaceable between a pre-delivery position (Fig. 3) and a mechanical stop position to dispense medicament when a user presses down on portion 26, [0094], [0108], [0113] and [0126]; the mechanical stop position is the position in which portion 26 is pressed); and an end of dose switch configured to be triggered prior to the drug delivery mechanism reaching the mechanical stop position (first and second electrical contacts 30 and 31 configured to be triggered prior to portion 26 reaching the mechanical stop position as the contacts are triggered prior to full depression of portion 26 and button 11, [0094], [0108], [0116], and [0169] & Fig. 3), the end of dose switch comprising a first sensor element disposed on the drug delivery mechanism and a second sensor element disposed within the housing (first electrical contact 30 disposed on portion 26 and second electrical contact disposed within portion 23, [0094] & Fig. 3);
wherein the end of dose switch is configured to be triggered when relative movement of the first sensor element and the second sensor element causes the first and second sensor elements to move into a switch position (“When a user presses the endplate 22, the outer portion 26 moves axially towards the inner portion, establishing a connection between the first and second electrical contacts 30, 31.”, [0094], [0153], and [0169]; when portion 26 is pressed distally, first contact 30 moves relative to second contact 31 to create connection, which is being interpreted as a switch position), and wherein the drug delivery mechanism is biased in a proximal direction away from the mechanical stop position, so that, when the user ceases to press on the proximal end of the drug delivery mechanism, the first and second sensor elements move out of the switch position (“the outer portion 26 can be moved axially relative to the inner portion 27 and one or more resilient members, such as springs 29, may be provided to bias the outer portion 26 away from the inner portion 27.”, [0092] & Fig. 3; when the user ceases to press on portion 26, contacts 30 and 31 disengage, Fig. 3),
wherein the first and second sensor elements move into the switch position when the second sensor element moves over a distal edge of and toward the first sensor element thereby providing a conductive path between the first sensor element and the second sensor element (contacts 30 and 31 move into the switch position when second contact 31 moves over a distal edge of and toward first contact 30, providing an electrical connection between contacts 30 and 31, [0094], [0153], [0166], and [0169] & Fig. 3 and 11); the drug delivery device further comprising a controller (processor arrangement 50 and timer 55, Fig. 14) configured to: record when the end of dose switch is triggered (“…if the timer 55 is triggered on both engagement or disengagement of the first and second electrical contacts 30, 31, or both operation and ceasing of operation of the switch 53, then the processor arrangement 50 may use the output from the timer to determine a length of time during which the injection button 11 was pressed, for example to determine the duration of an injection…”, [0169]-[0170] & Fig. 3 and 11); measure a duration of time between the end of dose switch being triggered and the first and second sensor elements moving out of the switch position (“For example, if the timer 55 is triggered on both engagement or disengagement of the first and second electrical contacts 30, 31… then the processor arrangement 50 may use the output from the timer to determine a length of time during which the injection button 11 was pressed, for example to determine the duration of an injection.”; timer 55 can monitor a duration of an injection, as indicated by a time of engagement and disengagement of the first and second electrical contacts 30, 31, [0169]-[0170] & Fig. 3 and 14). Toporek further discloses use of an optical indicator ([0110]-[0111]).
However, Toporek fails to explicitly disclose the controller configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism when the measured duration is less than a predetermined time period, and
wherein the drug delivery device is configured to provide a visual and/or audio cue to the user of the drug delivery device to warn the user that a set drug dose may not have been completely administered when the user ceases to press on the proximal end of the drug delivery mechanism prior to an end of the predetermined time period.
Further, Krulevitch teaches a drug injection device (drug devilry pen 200 including knob 204, [0047] & Fig. 6) comprising a controller configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism when a measured duration is less than a predetermined time period (microprocessor 290 and momentary switch 267, [0048] & Fig. 7-8; “the injection is performed by inserting the needle into the skin and (with the user's thumb) fully depressing the knob. Once the knob is fully depressed, it must be held down for a predetermined period of time for the selected dosage to be fully injected. As provided herein, the momentary switch and processor would be able to determine the dosage injection event and duration thereof. Thereafter, the pen records such an event and the duration of the event into its memory.”, [0068]; “If the user releases pressure on the switch prematurely, a warning may be announced or displayed on the data management unit. Alternatively, or in addition, a small display or LEDs on the pen may be used to cue the user as to how long to press on the dial. It is noted, however, that a display is not absolutely necessary--the device could just track the time that the knob is depressed and display a message/warning on the meter if the user does not hold down the button for a sufficient amount of time.”, [0069]),
wherein the drug delivery device is configured to provide a visual cue to the user of the drug delivery device to warn the user that a set drug dose may not have been completely administered when the user ceases to press on the proximal end of the drug delivery mechanism prior to an end of the predetermined time period (“If the user releases pressure on the switch prematurely, a warning may be announced or displayed on the data management unit. Alternatively or in addition, a small display or LEDs on the pen may be used to cue the user as to how long to press on the dial. It is noted, however, that a display is not absolutely necessary--the device could just track the time that the knob is depressed and display a message/warning on the meter if the user does not hold down the button for a sufficient amount of time… the pen can: alert… the user if the injection is incomplete”, [0069]).
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 controller of Steel, as modified, with Krulevitch to include the controller configured to generate an error code indicative of early release of pressure from the proximal end of the drug delivery mechanism when the measured duration is less than a predetermined time period, wherein the drug delivery device is configured to provide a visual cue to the user of the drug delivery device to warn the user that a set drug dose may not have been completely administered when the user ceases to press on the proximal end of the drug delivery mechanism prior to an end of the predetermined time period, since such a modification would provide means to alert the user that the button was not held for a sufficient amount of time to allow for complete/proper dose delivery and yield predictable results pertaining to injection duration monitoring and patient safety ([0068]-[0069] of Krulevitch). As combined, processor 50 of Toporek can include the configuration of processor 290 of Krulevitch.
Regarding claim 23, Toporek, as modified, discloses all the limitations of claim 21. Toporek further discloses the drug delivery device wherein the end of dose switch is configured to be triggered when the first sensor element moves in a distal direction over the switch position (contacts 30 and 31 move into the switch position when first contact 30 moves distally over second contact 31, providing an electrical connection between contacts 30 and 31, [0094], [0153], [0166], and [0169] & Fig. 3 and 11).
Regarding claim 24, Toporek, as modified, discloses all the limitations of claim 21. Toporek further discloses the drug delivery device wherein the first sensor element comprises a conductive strip on the drug delivery mechanism that is electrically connected to the controller (first electrical contact 30 is a long, narrow piece of material, or a strip, as seen in Fig. 3).
Regarding claim 39, Toporek, as modified, discloses all the limitations of claim 21. Toporek The drug delivery device wherein the drug delivery device is configured to provide a visual cue to the user of the drug delivery device to signal that a set drug dose has been administered following expiration of the predetermined time period (“When the injection finishes, which is detected by… the ceasing of operation of the switch 53, the optical indicator arrangement of the data collection device indicates that a dwell time period is in place… When the dwell period is finished, the optical indicator arrangement may remain illuminated, to indicate the end of the sequence and the end of the dwell period.”, [0111]; the optical indicator provides a visual cue to signal that the dwell period has begun, which occurs when injection has finished; the predetermined time period would have necessarily expired once injection finishes and the dwell period begins; operation of switch 53 and contacts 30 and 31 is synonymous, see [0169]).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Toporek (US 20180154086 A1), in view of Krulevitch (US 20110313395 A1), and further in view of Berey (US 20190001067 A1).
Regarding claim 37, Toporek, as modified, discloses all the limitations of claim 21. However, Toporek fails to explicitly disclose the drug delivery device wherein the predetermined time period is between 0.2s and 0.25s.
However, Berey teaches a drug delivery device comprising a controller (drug delivery device 200 comprising an electronic subassembly 130, comprising a processor 135, sensor 132, and circuit board 137, abstract, [0036], [0042] & Fig. 1A, 3, and 8-9) configured to measure a duration of time and configured to generate a code indicative of early release of pressure from the proximal end of the drug delivery mechanism when the measured duration is less than a predetermined time period, wherein the predetermined time period is between 0.2s and 0.4s (“When the push-button is released (305), the device tests (306) if the duration of holding down the button was longer or shorter than a second predetermined period IT (which is preferably e.g. 0.3 seconds). If it is longer, the data acquisition means maps the pressing of the button with an insulin administration event, and stores (307) the duration… of pressing the button in the memory unit. If it is shorter, said means continues its operation… by skipping the three steps (steps 307 to 309) following the test.”, [0051] & Fig. 9 and 11; if the measured duration of holding down the button is less than 0.3 seconds, than a wireless communication signal is sent indicative of device use, step 310, [0053] and [0022] & Fig. 11).
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 device of Toporek, as modified, with Berey to include the predetermined time period between 0.2s and 0.25s since Berey teaches such a threshold, which can be dependent on a particular dosage, to be an effective duration of time for determining if actuation of an injection button corresponds to drug administration (see [0051]-[0052] of Berey).
Regarding claim 38, Toporek, as modified, discloses all the limitations of claim 37. Toporek as combined with Berey teaches a preferable time period of 0.3 seconds (see [0051] & Fig. 11) but fails to explicitly disclose the drug delivery device wherein the predetermined time period is 0.25s.
However, Berey teaches that the threshold is based on a user’s typical ingrown dose duration time (see [0014]) which can deviate (see [0020]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the predetermined time period of Toporek as combined with Berey to be 0.25s, instead of 0.3s, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, as Berey teaches a time period that is substantially the same as the claimed time period, the claimed predetermined time period is simply a deviation from Berey’s disclosed time period that one of ordinary skill in the art could discover by routine experimentation to better suit the chosen population of device users.
Response to Arguments
Applicant's arguments filed 6/11/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments to claim 37, the Examiner finds that Berey teaches “a predetermined time period, wherein the predetermined time period is between 0.2s and 0.4s (“When the push-button is released (305), the device tests (306) if the duration of holding down the button was longer or shorter than a second predetermined period IT (which is preferably e.g. 0.3 seconds).”, ([0051). Applicant’s claimed range of 0.2-0.25s is contemplated by Berey as it falls within 0.2-0.4s. The claimed predetermined time period is simply a deviation from Berey’s disclosed time period that one of ordinary skill in the art could discover by routine experimentation to better suit the chosen population of device users ([0014] and [0020]).
In response to Applicant’s arguments to claim 21, the Examiner finds that Steel discloses an alternate, reverse configuration of the switch in paragraph [0156], which is being relied upon for rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. BARUCH (US-20200078525-A1) Fig. 13.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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