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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 39-49) in the reply filed on 29 July 2025 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 902 (Fig. 9). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 39 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al (US 2020/0171246) in view of Liskow (US 2018/0352666).
Regarding claim 39, Byerly discloses:
An electronic module (80; Fig. 5) comprising: a detector unit (84) for detecting an amount of a drug arranged for delivery (¶0061); an electronic unit (76) operatively coupled to the detector unit (84) (¶0045), wherein the electronic module (80) is configured to be removably coupled to a proximal end region of a mechanical module (14; Fig. 2); a substrate (116; Fig. 7) that carries a part of the electronic unit (76), a chassis (90) comprising a part of the detector unit (84) and an electrical sensor (110).
Byerly is silent regarding “wherein one or more sides of the substrate is covered at least partially by a potting compound” and the chassis is “configured to separate the potting compound from” the electrical sensor. However, Liskow teaches an electronics module of a device (Fig. 5), thus being in the same field of endeavor, that uses a potting compound (7) on one side of a circuit board (2) to form a fluid-tight seal to protect the electronics of the device (¶0069). As applied to Byerly, the body wall (115) of the chassis (90) would physically separate the potting compound from the sensor (110). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Byerly to incorporate a potting compound as taught by Liskow in order to protect the electronics of the device, as recognized by Liskow.
Regarding claim 49, Byerly in view of Liskow discloses:
The electronic module according to claim 39, wherein the electronic module (80) comprises: a module part (98; Fig. 6) comprising at least one side wall (102), and one or more of an electrical power source (¶0045 – coin cell battery) carried by the module part or by a mechanical carrier (115), a delivery button (92) comprising a delivery surface configured to be pressed to initiate a delivery of a drug from a drug delivery device (¶0063), the delivery button (92) carried by the module part or by the mechanical carrier (115), and a lateral setting surface (90) configured to set a dose of the drug for delivery (¶0061).
Allowable Subject Matter
Claims 40-48 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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