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 .
Claim Objections
Claim 23 is objected to because of the following informalities: in line 2, “the mounting wall” should be “the skin contact wall”. Appropriate correction is required.
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 18-20 and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Grygus et al (US 2020/0086051) in view of Burren et al (US 2020/0405951).
Regarding claim 18, Grygus discloses:
A drug delivery device (Figs. 1, 4) comprising a housing (3), a delivery unit (Fig. 4) including a drug container (1302; Fig. 4B), and a control unit (1402; ¶0036 – “controller of auto-injector 2”) mounted within the housing (3), the control unit comprising an on-body sensing system (1410; Fig. 2) including an electrode connected to an electronic control system of the control unit for measuring a capacitance value (¶0083 – “a capacitive sensing electrode”) configured to detect whether the drug delivery device is positioned against a patient's skin (¶0083), a skin contact wall of the housing (3) having an inner side facing an inside of the housing (3) in which the delivery unit and control unit are mounted (¶0083 – “Contact of portions of housing 3 and/or adhesive patch 12 near the capacitive sensing electrode may cause the capacitance of the electrode to increase, for example, by about 1 to about 10 pF, indicating placement of auto-injector 2 on a skin surface”), and an outer mounting side facing the outside of the housing (3) and intended to be placed against the skin of a patient (¶0083).
Grygus is silent regarding “the electrode comprises a layer of metal mounted directly against the inner side of the skin contact wall.” However, Burren teaches a drug delivery device (Fig. 1a), thus being in the same field of endeavor, with capacitive sensors that forms the sensors using metal on one side of the sensor (¶0023). 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 provided the sensor of Grygus with metal as taught by Burren in order to provide sufficient structure to measure capacitance change over a surface.
Regarding claim 19, Grygus in view of Burren discloses the drug delivery device according to claim 18, wherein the metal layer of the electrode taught by Burren in the rejection of claim 18 consists of a metal layer directly deposited on said inner surface of the contact wall (¶0023).
Regarding claim 20, Grygus in view of Burren discloses the drug delivery device according to claim 18, wherein the direct deposit metal layer taught by Burren in the rejection of claim 18 is a galvanic plating layer (¶0023).
Regarding claim 28, Grygus in view of Burren discloses:
The drug delivery device according to claim 18, wherein the on-body sensing system (1410) is configured to measure a capacitance value between said electrode and a ground value (¶0083).
Regarding claim 29, Grygus in view of Burren discloses:
The drug delivery device according to claim 18, wherein the delivery unit (Fig. 4) further includes a liquid flow system (300; Fig. 5), a pumping system (1366), and a casing (1490) enclosing therein the drug container (1302), the pumping system (312) and at least a part of the liquid flow system (300), and the control unit (1402) includes a power source (1406; Fig. 4A) and a pump drive (¶0059 - motor) coupled to the pumping system (1366).
Regarding claim 30, Grygus in view of Burren discloses:
The drug delivery device according to claim 29, wherein the pump drive comprises a rotary electrical motor (¶0059) and a coupling interface (¶0060 – leadscrew mechanism) coupled to an output shaft of the rotary electrical motor (¶0060), the coupling interface coupling to a drive coupling interface of the pumping system (1366) of the delivery unit (¶0060), the pump drive (¶0059) providing torque to a rotor of the pumping system (1366).
Regarding claim 31, Grygus in view of Burren discloses:
The drug delivery device according to claim 29, comprising an injection delivery system (Fig. 5) including an injection needle (306) and an injection needle actuation mechanism (20) configured to move the injection needle (306) from a retracted position within a housing (3) of the drug delivery device to an extended delivery position where the injection needle (306) projects through the skin contact wall of the housing (3) (¶0041).
Regarding claim 32, Grygus in view of Burren discloses:
The drug delivery device according to claim 31, wherein the injection needle actuation mechanism (20) includes a rotary actuation wheel (360) and an actuation lever (344) coupled to a slidable injection needle support (340) on which the injection needle (306) is mounted (¶0044-0045), the actuation wheel (360) being directly coupled or integrally formed with a rotor of a pump engine of the pumping system (¶0046).
Regarding claim 33, Grygus in view of Burren discloses:
The drug delivery device according to claim 18, wherein the skin contact wall comprises an adhesive layer (12) and a protective film covering the adhesive layer prior to use (¶0038).
Allowable Subject Matter
Claims 21-27 and 34 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.
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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