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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/4/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and Species A (claims 1-2 and 6-12) in the reply filed on 12/3/2025 is acknowledged.
Claims 3-5 and 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/3/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 9, it is unclear if the recited “an actuator” is intended to be the same structure as “an actuator” of claim 1. The examiner’s understanding is that these structures are the same and therefore claim 9 should be amended to “the actuator”. Claim 9 is examined with this understanding in mind.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corbett et al. (US 2020/0086046; hereafter Corbett).
In regard to claim 1, Corbett discloses a delivery device (100) for self-administration of a predefined amount of drug from an outlet of a reservoir (syringes are known devices for self-administration of predefined amounts), comprising: a device operation lock (212) preventing a delivery operation of the delivery device as shipped (see at least par. [0059], [0069], [0070]; “as shipped” is a functional limitation; the Corbett device can be locked and shipped); a wireless receiver (204) for receiving an unlock command (see at least par. [0066], [0067], [0069], [0070], [0088]); and an actuator (210) for unlocking the device operation lock and configured to be activated instantaneously upon receipt of the unlock command (see at least par. [0059] and [0066]-[0072]).
In regard to claim 6, Corbett discloses further comprising a wireless transmitter adapted to send an unlock request message (see at least par. [0090]-[0094]; in addition to receiving structure, the device includes structure for sending information to a server).
In regard to claim 7, Corbett discloses further comprising a device-activation sensor to detect a user-initiated preparation of the delivery device (see at least par. [0090]-[0094]; in addition to receiving structure, the device includes structure for sending information to a server).
In regard to claim 8, Corbett discloses further comprising drug delivery sensor means configured to monitor and report the delivery operation of the delivery device (see at least par. [0090]-[0094]; the syringe can record injections and report to providers to ensure compliance) .
Claim(s) 1-2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hutchinson et al. (US 2015/005703; hereafter Hutchinson).
In regard to claim 1, Hutchinson discloses a delivery device (see Figs 11-14) for self-administration of a predefined amount of drug from an outlet of a reservoir (patch injectors are known devices for self-administration of predefined amounts), comprising: a device operation lock (1240) preventing a delivery operation of the delivery device as shipped (see par. [0056]-[0058], [0065]-[0066]); “as shipped” is a functional limitation; the Hutchinson device can be locked and shipped); a wireless receiver (“RF link”) for receiving an unlock command (see at least see par. [0056]-[0058], [0065]-[0066]); and an actuator (1250, 1260) for unlocking the device operation lock and configured to be activated instantaneously upon receipt of the unlock command (see at least see par. [0056]-[0058], [0065]-[0066]).
In regard to claim 2, Hutchinson discloses wherein the delivery device is an auto-injector or a patch-injector (see at least par. [0002]).
In regard to claim 6, Hutchinson discloses further comprising a wireless transmitter adapted to send an unlock request message (see at least par. [0069]; remote control is notified via sensor signals of plunger position).
In regard to claim 7, Hutchinson discloses further comprising a device-activation sensor to detect a user-initiated preparation of the delivery device (see at least par. [0029], [0036], [0044], [0063], [0069]).
In regard to claim 8, Hutchinson discloses further comprising drug delivery sensor means configured to monitor and report the delivery operation of the delivery device (see at least par. [0029], [0036], [0044], [0063], [0069]).
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) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett or Hutchinson in view of Bosshard et al. (US 2007/0112326; hereafter Bosshard).
In regard to claim 9, Corbett and Hutchinson are 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 Corbett or Hutchinson with the recited material, because it amounts to selection of a known material based on its known suitability for the purpose.
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Corbett or Hutchinson in view of Vouillamoz et al. (US 2014/0207104; hereafter Vouillamoz).
In regard to claims 10-12, Corbett and Hutchinson are both 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 Corbett and Hutchinson in order to provide an art-recognized equivalent for releasing a drug injection system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
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