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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 25 June 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 25 June 2026. As directed by the amendment: claims 36, 38, 40, 46, 49, 52, 54, and 55 have been amended; no claims have been canceled or added. Thus, claims 36-59 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 36-59 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.
Claim Objections
Claims 36 and 54 are objected to because of the following informalities: in the final line respectively, “the chassis component” should be “the chassis”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 36 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al (US 2007/0228273).
Regarding claim 36, Sun discloses:
An electronic module (Fig. 2) for releasable attachment to a drug delivery device (40; the implantable device is fully capable of being a fluid delivering device rather than an energy delivery device), the electronic module comprising a printed circuit board assembly (15), a power source (10) and a particular component (20), wherein the power source (10) is a coin cell (¶0051), and wherein the particular component (20) which is a chassis (¶0048) of the electronic module comprises the following features: at least one attachment element (¶0049 – “a magnetized polymeric material, which allows attachment to the skin by interfacing with a magnetized area having an opposite magnetic polarity that is provided on the surface of the implantable device being charged”) for releasable attachment of the electronic module on the drug delivery device (40) (Fig. 3A), and wherein the coin cell (10) is secured and connected to the printed circuit board assembly by a power source clip (25) which is attached to the chassis component (20).
Allowable Subject Matter
Claims 54-59 are allowed.
Claims 37-53 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Sun et al (US 2007/0228273), fails to disclose or make obvious a device as described in claim 54. Specifically, Sun fails to disclose or make obvious a drug delivery device, in combination with the other elements of the claim, comprising “a dose setting and drive mechanism,” “a container receptacle… adapted to receive a container,” “an electronic module comprising a printed circuit board assembly,” “a power source” in the form of “a coin cell,” “a particular component … which is a chassis of the electronic module,” “at least one attachment element for releasable attachment of the electronic module on the drug delivery device,” and “wherein the coin cell is secured and connected to the printed circuit board assembly by a power source clip which is attached to the chassis component.”
Sun teaches a therapeutic delivery device (40; an implanted energy delivery device) with an electronic module (Fig. 2) comprising a printed circuit board assembly (15), a power source (10) in the form of a coin cell (¶0051), and a chassis (¶0048) with an attachment element (¶0049 – “a magnetized polymeric material, which allows attachment to the skin by interfacing with a magnetized area having an opposite magnetic polarity that is provided on the surface of the implantable device being charged”) for releasable attachment of the electronic module on the drug delivery device (40) (Fig. 3A) and a power source clip (25) that secures the coin cell (10) to the chassis component (20) and the printed circuit board assembly (15). However, the implantable device of Sun is an energy and not a drug delivery device. As a result, Sun fails to teach or make obvious a dose setting and drive mechanism as required. It would not be obvious to modify the implanted device of Sun to have a dose and delivery mechanism to deliver a drug, such as the injection devices taught by Bauer et al (US 2020/0114087) and Carlsson et al (US 2018/0369488), because a user would not be able to interact and replace the cartridge of the implantable device of Sun in the same way. In a similar way, it would not be obvious to a person of ordinary skill in the art to modify the injection devices of Bauer and Carlsson to incorporate the external electronic module of Sun. As such, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed combination of elements as set forth in claim 54. Claims 55-59 are allowed for incorporating the above limitations due to their respective dependencies on the independent claims.
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.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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