DETAILED ACTION
Response to Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/16/2026 has been entered.
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.
Claim(s) 1-2, 6-8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hourmand et al. (US 2013/0261558; hereafter Hourmand) in view of Kietzmann et al. (US 10,058,655; hereafter Kietzmann) and further in view of Banov et al (US 2020/0383875; hereafter Banov).
In regard to claim 1, Hourmand discloses a delivery device (1) for self-administration of a predefined, non-user selectable amount of drug (see par. [0028], [0032], and [0050]; the device is configured for single-use and is disposed after; no dose dialing is needed) from an outlet (outlet of 12) of a reservoir (11; needle 12 serves as outlet for syringe barrel loaded with medicine M), comprising: a device operation lock (3) preventing a delivery operation by a spring (8) of the delivery device as shipped (the needle shroud 3 is designed to lock the device until actuated to cause injection; see par. [0053] and [0064]).
Hourmand is silent to a wireless receiver for receiving an unlock command transmitted from a remote HCP or HCES; and an actuator for unlocking the device operation lock and configured to be activated instantaneously and unconditionally upon receipt of the unlock command by the wireless receiver, wherein the unlock command is transmitted in response to a confirmation by the remote HCP or HCES of a suitability of the self-administration.
In a similar art, Kietzmann discloses an auto-injector (10) comprising an interlock member (30) configured to mechanically obstruct displacement of the piston rod 25 if a condition of use of the drive mechanism is not fulfilled. The interlock member 30 may comprise a latch or clutch-mechanism and may mechanically engage with the piston rod 25 in order to obstruct a longitudinal displacement or rotation thereof relative to the housing 12. The interlock member 30 may also releasably engage with any other component of the drive mechanism. Kietzmann further discloses a wireless receiver (34) for receiving an unlock command, and an actuator (36) for unlocking the device operation lock (30) and configured to be activated instantaneously upon receipt of the unlock command. The Kietzmann configuration ascertains at least one predefined condition of use of the drive mechanism and/or of the drug delivery device and is further adapted to determine, if a dose dispensing is actually due and/or if a dose injection matches with the predefined condition of use of the device. Additionally, the configuration links at least one interlock member coupled with the control to directly or indirectly mechanically obstruct delivery if the condition of use is not fulfilled. The predefined condition can be that the device is used for medicament dispense, e.g. according to a predefined prescription schedule; that the drive mechanism is actuated; that a dose of a known size is dispensed that skin contact is established; that the user is authorized to use the device; that the medicament is usable and not spoiled or wasted; that the device requires priming, e.g. to remove air from the dispense channel by filling it with medicament.
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify the device Hourmand to further include the wireless receiver and actuator as disclosed by Kietzmann in order to provide a shroud lock in an unactuatable state until a predefined condition of use can be verified, wherein the predefined condition of use can be a predefined prescription schedule, a verified user, and/or a verified medication. The modification would help to ensure proper use of the single-use Hourmand device.
The combination still does not teach wherein the unlock command is transmitted from a HCP or HCES and wherein the unlock command is transmitted in response to a confirmation by the remote HCP or HCES of a suitability of the self-administration.
In a similar art, Banov discloses a device having a monitored subassembly which detects and transmits relevant device information to a remote management system accessible to a HCP, including detected attempts to alter, access, control or otherwise tamper with the device beyond its prescribed use. Advantageously, HCPs may render sufficient oversight and control over the device and its use to mitigate the risks associated with patients to self-administering potentially dangerous or abusable medication without direct, in-person supervision (see par. [0017]). Banov further teaches functionality of the drug delivery device is remotely monitored and controlled by the patient's physician or other HCP. HCP regulatory commands include, for example, commands to alter the dosing quantity and/or schedule, to permit access to the device for prescription refills, as well as to cease operability of the device should it be tampered with or reported lost or stolen (see par. [0018]). Banov further teaches that the device may be programmed by the HCP to alter the dosing parameters or device functionality based on the availability and specified range of such biometric values. Advantageously, such embodiments provide additional levels of security and safety, ensuring that the device is utilized by the intended people, and that the patient's daily health condition does not warrant a change or cessation of the prescription (see par. [0018]). Banov further teaches the device control commands 590 preferably include a hatch lock command 532. HCP 592 directly or indirectly generates a hatch lock command 532 to unlock such a hatch so that pharmacy 551 may access device 500 and refill the prescription. Although in FIG. 5A hatch lock command 532 is shown as being remotely generated by HCP 592, it should be appreciated that in alternative embodiments, hatch lock command 532 may be generated by pharmacy 551 or other HCP, depending on the protocols established to ensure safe administration of the prescribed medication (see par. [0029] and [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination to have the unlock command come remotely from a HCP as taught by Banov in order to provide a system in which the risks associated with patients self-administering potentially dangerous or abusable medication without direct, in-person supervision is mitigated by granting the HCP control of the device.
In regard to claim 2, Hourmand and Kietzmann both disclose wherein the delivery device is an auto-injector.
In regard to claim 6, Kietzmann further teaches comprising a wireless transmitter (46) adapted to send an unlock request message (see col. 14, lines 25-58).
In regard to claim 7, Kietzmann further teaches comprising a device-activation sensor to detect a user-initiated preparation of the delivery device (see col. 4, line 15- col. 5, line 33).
In regard to claim 8, Kietzmann further teaches comprising drug delivery sensor means configured to monitor and report the delivery operation of the delivery device (see col. 4, line 15- col. 5, line 33).
In regard to claim 18, Banov teaches, further comprising, before receiving the unlock command, establishing an electronic communication between the patient and the HCP or the HCES, and inquiring about the self-administration (see par. [0017]-[0018], [0029], [0075]).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over
Hourmand and Kietzmann and Banov in further view of Bosshard et al. (US 2007/0112326; hereafter Bosshard).
In regard to claim 9, the combination is silent as to the actuator comprising a shape-memory-alloy element.
Bosshard teaches at paragraph [0064] that it is known in the art of spring coil
actuators to use the claimed material (shape-memory alloy) to manufacture the spring
coil.
In view of the teaching of Bosshard, it would have been obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention to
manufacture the actuators of the combination with the recited material, because it
amounts to selection of a known material based on its known suitability for the purpose.
Claim(s) 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hourmand and Kietzmann and Banov in further view of Vouillamoz et al. (US 2014/0207104; hereafter Vouillamoz).
In regard to claims 10-12, the combination is silent as to wherein the device operation lock comprises a thermo-sensitive element configured to melt, evaporate, soften and/or otherwise become structurally weakened when subjected to an elevated temperature, wherein the actuator comprises heating means for heating the device operation lock and/or the thermo-sensitive element to the elevated temperature conditionally upon the receipt of the unlock command, wherein the device operation lock is adapted to engage a proximal end of a plunger rod of an auto-injector prior to the receipt of the unlock command, and wherein a syringe of the auto-injector is adapted to be moved in a distal direction by the plunger rod in an unlocked state. In a similar art, Vouillamoz discloses (see par. [0091] and Fig. 12B), as a security against inadvertent activation, a locking construct 470 that prevents the push buttons 442a and 442b from being depressed. Alternately, a film retainer strap around the springs and affixed (e.g., bonded) to the housing may be used to lock the structure, the film being made of a material which may be selectively melted by applying a resistance or magnetic induction to an attached metal strip. The heated strip melts the retainer strap releasing the device to perform an injection and retraction. Materials with a low melting point, such as polypropylene or Tyvek may be used. A metal component, made, for example, of titanium or other conductor that changes temperature in response to current, may be used. The metal component is in contact with the film. The metal may be titanium, for example, or other conductor that changes temperature in response to current. An external device applies current to metal component by direct contact or via magnetic induction. The metal rod heats and applies local heat to the film, melting a portion thereof so as to initiate a tear and breakage, thereby releasing the springs, initiating the injection and retraction cycle.
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the meltable locking mechanism and interacting features of Vouillamoz into the devices of the combination in order to provide an art- recognized equivalent for releasing a drug injection system.
Allowable Subject Matter
Claim 19 is allowed.
The following is an examiner’s statement of reasons for allowance: Applicant’s remarks filed on 9/16/2026 in regard to claim 19 are persuasive in distinguishing the claimed limitations over the cited art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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