DETAILED ACTION
Response to Amendment
The amendment filed May 4, 2026 has been entered. Claim 1 has been amended and claims 20 and 21 have been newly added. Claims 1-3 and 5-21 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive with respect to the device being explicitly designed initiate a timer prior to a first use of the device, by a patient or user. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below. The rejection uses the same set of references, but relies on Boyd to explicitly teach that the time lock is initialized prior to a first use of the device by a user or patient as required by the amended claims. For this reason, the grounds of rejection have been altered to align with the new claim language.
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) 1-3 and 5-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bollenbach et al. (US 2009/0149809) in view of Kietzmann et al. (US 2014/0330243), and further in view of Boyd et al. (US 2013/0018310).
Regarding claims 1 and 21, Bollenbach et al. (henceforth Bollenbach) discloses a method of operation of a disposable, single-use injector for drug delivery, the method comprising: unlocking a trigger member (11) permitting a patient or a user to activate an energy source (15; pre-tensed driving spring stores kinetic energy) (paragraph [0069] discloses the trigger element as being unlocked via the movement of switch element 17 so as to allow a user to depress trigger 11 to perform an injection) of the injector, the energy source being configured, upon activation, to actuate a reservoir (5) to deliver the volume of the drug to a patient as a single bolus (Figure 4A; paragraph [0034]). Bollenbach fails to explicitly disclose automatically unlocking a trigger member of the device via a resistance unit and a controller for controlling the release based upon an elapsed time; and further more wherein the release is via a timer prior to a first use or that the device is single-use or that a user is prevented from manually activating the energy source.
Kietzmann et al. (henceforth Kietzmann) teaches a drug injection device (10) which comprises a lockout system configured to automatically unlock a trigger member (e.g., actuation button 17 which is part of drive system 20 for actuating an injection; paragraph [0139] discloses that the interlock may comprise a latch for engaging with a piston rod or any other component of the drive mechanism) for drug delivery (paragraphs [0139]-[0142] discloses that the interlock member engages with the injection button to obstruct displacement of the button thereby preventing dose delivery); and wherein the trigger member is accessible to the patient or user from outside the injector and configured to prevent a patient or user from manually displacing the trigger member (the drive system including the actuation button is locked via the interlock system as disclosed above); wherein the injector comprises: a resistance unit (e.g., latch member described in paragraph [0139] for engaging with any portion of the actuation assembly which would include the activation button) configured to selectively engage and disengage from the trigger member (paragraph [0139]), and a controller (36) configured to determine, based on the timer, that the preselected time period has elapsed and, in response, cause the resistance unit to disengage from the trigger member so as to automatically unlock the trigger member by the patient or user (paragraphs [0139]-[0141] describe the interlock and controller function which is disclosed to automatically unlock the drive system after a pre-determined time interval has elapsed. Kietzmann fails to explicitly disclose this happening prior to a first use of the device.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bollenbach to comprise the automatic locking means of Kietzmann so that the device is unlocked after a certain time-period has elapsed so as to allow an additional dose to be delivered as taught by Kietzmann. In the cited combination, the locking assembly of Kietzmann would be added to the structure of the device of Bollenbach to prevent the movement of the trigger until the time lock function has allowed for the trigger to be depressed to initiate an injection procedure (as per claim 21). Kietzmann is considered to provide adequate disclosure so as to enable one of ordinary skill in the art to apply the time-lock device to function at any point in an injection procedure without change to the structure or intent of the device (see also response to arguments above which describe the motivation one of ordinary skill in the art would have to lock the device prior to a first use). Finally, in the cited combination, the time lock could be placed at any position to control depressing of the trigger of Bollenbach prior to use. This could be a means of blocking elements 16 or 17 via the mechanism of Kietzmann (see e.g., paragraph [0139] which teaches blocking the injection button with the interlock device) which would prevent the device from being used before being placed on the skin or could alternatively allow for the device to be placed on the skin before being unlocked. Bollenbach/Kietzmann further fail to teach the single-use design of the device and the explicit teaching of using the device prior to a first use by a patient or user to deliver the drug to the patient.
Boyd et al. (henceforth Boyd) teaches an injection device comprising a time lock and which is designed for single use (paragraphs [0014] and [0084] disclose single or multiple use), and wherein the device is configured to initiate a timer prior to a first use of the device by a user or patient to deliver a drug to the patient (paragraphs [0077]-[0079] disclose that the timer is started after the module is attached to the pen device and the shield 16 is retracted; this is prior to a first use as it represents the initial activation of the device to deliver a medicament; the timer is set off via exposure of the needle for the first use and prevents use after the pre-determined time period has elapsed).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bollenbach to be a single use device if it were desired to create and injector which is disposable after each use as is known in the art and taught by Boyd. Furthermore, Boyd provides sufficient disclosure which would have provided an obvious motivation for one of ordinary skill in the art at the time of filing to modify the locking system of Bollenbach/Kietzmann to set the lock prior to a first use of the device by a patient or user as claimed. In this manner, the trigger of Bollenbach/Kietzmann would be modified to respond to the time lock to delay the injection until a specific time period has elapsed.
The combined device of Bollenbach/Kietzmann/Boyd further teaches wherein the trigger member is locked prior to a first use of the injector to deliver the drug to the patient (in the cited combination, Kietzmann teaches in paragraph [0021] that the interlock mechanism prevents movement of the piston rod, or any other portion of the drive system which might include the actuation button, after a dose is delivered and as such it would be obvious to modify the trigger means of Bollenbach to be locked by such a timer system as it is the element which provides for the movement of the piston to deliver a dose as claimed). See also paragraph [0085] of Boyd which discloses that the timer is set via movement of the needle guard (16) which allows for a specific function of the device to be performed within a certain time period, before a first use of the device.
Regarding claims 2, 3, and 16, Bollenbach/Kietzmann/Boyd teach wherein the timer is performed only once (paragraphs [0140] and [0142]; and in the cited combination the device is only single-use as taught by Boyd; see also paragraph [0079] of Boyd which discloses that the device is single use and the lockout timer is initialized only once during retraction of the needle shield).
Regarding claim 5, Bollenbach/Kietzmann/Boyd teach wherein the timer is configured with the preselected time period prior to the first use of injector by the patient or user (e.g., Kietzmann paragraphs [0140] and [0142] disclose the time period and the cited combination would be obvious to provide this unlocking before a first use as set forth above; see also paragraph [0079] of Boyd which teaches that the time lock is a function of the spring, damper, and gas orifice which are all set during design of the device).
Regarding claim 6, Bollenbach/Kietzmann/Boyd further teach wherein the timer is configured to determine, only once, whether any preselected time period has elapsed (it’s a single use device so the timer will only be used once by the cited combination to unlock the device; see also paragraph [0079] of Boyd which teaches that the time lock is a function of the spring, damper, and gas orifice which are all set during design of the device and therefore the timer is set for only one actuation).
Regarding claim 7, Bollenbach further teaches wherein the injector comprises a guard (16) and a delivery member (6), the guard member having an initial state (Figure 1A), wherein at least a portion of the delivery member is disposed inside of the guard, and a delivery state (Figure 4A), wherein the at least a portion of the delivery member extends outside of the guard for insertion into the patient.
Regarding claim 8, Bollenbach further teaches wherein the trigger member is configured to move relative to a housing of the injector upon application of a force by the patient or user (Figures 1A-4A; the trigger moves laterally inward through the housing to release the locking mechanism).
Regarding claim 9, Bollenbach further teaches wherein the injector comprises a resistance unit configured to resist movement of the trigger member relative to the housing when the trigger member is locked, and permit movement of the trigger member relative to the housing when the trigger member is unlocked (e.g., frictional force prior to the release of the trigger mechanism; paragraph [0059] discloses the locking element which prevents release of the forward feed element thereby creating the resistance to movement of the trigger as claimed).
Regarding claim 10, Bollenbach further teaches (paragraph [0156] discloses a skin touch sensor for determining when the device has been engaged with the skin of a patient) wherein the injector comprises an output element configured to generate a detectable output after at least one condition has been satisfied to notify the patient or a user of the satisfaction of the at least one condition.
Regarding claim 11, Bollenbach/Kietzmann further teach, wherein the at least one condition comprises the preselected time period, and the output element is configured to generate the detectable output after the timer has determined that the preselected time period has elapsed (see paragraphs [0153]-[0155] which disclose a number of control means for generating feedback relative to the device; in the modified device this may include hindering the device mechanism if the timer hasn’t elapsed).
Regarding claim 12, wherein the timer comprises a spring configured to have an energized state at a beginning of the preselected time period and a de-energized state at an end of the preselected time period (e.g., paragraph [0056] of Bollenbach).
Regarding claim 13, Kietzmann further discloses a memory for the timer (paragraph [0152]).
Regarding claim 14, Bollenbach/Kietzmann further teach an initiator connected to or in communication with the timer permitting the patient or user to initiate the timer (e.g., via depression of the trigger).
Regarding claim 15, Bollenbach/Kietzmann further teach wherein the length of the preselected time period cannot be adjusted by the patient or the user (e.g., it’s set before delivery as per Kietzmann paragraph [0034]; see also paragraph [0012] which discloses that the timer circuit enforces a minimum time thereby preventing the setting of a time period less than that minimum time; see also paragraph [0079] of Boyd wherein the timer duration is set during manufacture and cannot be adjusted as it’s mechanical).
Regarding claim 17, Bollenbach further discloses wherein the injector comprises a housing (1) containing at least a portion of the energy source (the entire drive system is housed therein), and wherein at least a portion of the trigger member (11) is disposed outside of and/or adjacent to an exterior of the housing (Figure 1A).
Regarding claim 18, Bollenbach/Kietzmann/Boyd teach wherein the trigger member (11) is configured in the locked state, the trigger member is immobile or substantially immobile relative to the housing (in the cited combination, the trigger lock prevents any element in the drive system, including the trigger, to be displaced until the drive system is unlocked).
Regarding claim 19, Bollenbach/Kietzmann/Boyd further teach unlocking the trigger member comprises configuring the trigger member such that the patient or user can move the trigger member relative to the housing (as set forth above, the combined device teaches a time-lock release for an injection device which maintains the trigger in the locked state via locking of the drive assembly; after the unlocking step the trigger is free to be depressed and the injection performed).
Regarding claim 20, Boyd further teaches wherein initiating the timer comprises a healthcare professional initiating the timer (via application of the device to the injection site which moves the guard proximally, thereby initiating the timer; paragraph [0079]), wherein the healthcare professional is not the patient or user of the injector (it’s usable by anyone capable of performing an injection the method can be performed by a medical professional as it most likely would be during standard use).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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