DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19, 2025 has been entered.
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the cited combination fails to teach the claims as amended, which recite the device is locked prior to a first use of the injector, the Examiner respectfully disagrees. As set forth in the final rejection mailed November 18, 2025, the cited combination teaches the aspects of the locking injection device in a manner sufficient to provide motivation to one of ordinary skill in the art to design the system to lock the injection device prior to a first use as claimed. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103. Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S. Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103. Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S. Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant(s) have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103 because it is no more than the predictable use of prior art elements according to their established functions, resulting in the simple substitution of one known element for another, or the mere application of a known technique to a piece of prior art ready for improvement. It would have been obvious to one having ordinary skill in the art at the time of filing to have combined the time lock actuation obstruction system of Kietzmann with the lockable injection system of Bollenbach so as to provide a means of preventing use of the device until a set time has been achieved which might also include a first use of the device. Kietzmann teaches various means for blocking the trigger (drive system and any desired structure therein; e.g., paragraph [0139]) to prevent use until a time duration has elapsed to prevent unwanted use of the device. All the claimed elements and methodology were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing. For this reason, and when provided with the cited prior art references, one of ordinary skill in the art would have had sufficient motivation to modify the combined prior art device to prevent use before a first use of the device as claimed. For this reason, the rejection is considered proper and is maintained below.
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 5-19 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 claim 1, 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. Furthermore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the resultant device to utilize the time-lock system prior to delivery as Kietzmann teaches that the lock functionality is provided to prevent unwanted use of the device and one of ordinary skill in the art, when provided with the disclosure of Kietzmann, would have sufficient motivation to apply the automatic locking feature of the device to be an initial lock to prevent use of the device before a first use as claimed. 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.
Boyd et al. (henceforth Boyd) teaches an injection device comprising a time lock and which is designed for single use (paragraph [0014]).
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.
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).
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).
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).
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).
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).
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).
Conclusion
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