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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 July 2025 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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0010594 (“Holt”) in view U.S. Publication No. 2015/0209505 (“Hanson”) and U.S. Publication No. 2012/0078216 (“Smith”).
Regarding Claim 1, Holt discloses a drug delivery device (50) comprising:
A casing (72, 74, 76, 70) having a bottom surface (70);
A container (154) for storing the drug (152), the container being received within the casing (see Fig. 2);
A stopper (156) movably disposed within the container for expelling the drug;
An injection drive (150) comprising an energy source operably coupled to the stopper for selectively moving the stopper through the container to expel the drug (Par. -70-75;
A processing unit (60) which controls the various operations of the device;
An adhesive pad (100) covering substantially all of the bottom surface of the casing (see Fig. 1 and 2 – excluding openings defining inlets/outlet openings providing through the casing bottom surface), the adhesive pad adapted to removably attach the casing to a patient (Par. 20);
A device activation mechanism (184) for selectively activating the injection drive (Par. 77, 87).
Holt discloses the invention substantially as claimed except that the drug delivery device comprises a contact sensor coupled to the device activation mechanism, wherein the drug delivery device undergoes an external state change from a dormant state, when the sensor occupies a first state when out of contact with a body of the patient, to a ready state when in contact with the body of the patient, upon the sensor occupying the second state, indicating that the drug delivery device is ready for at least one of injection or insertion, in response to only the sensor changing from the first state to the second state by generating a first signal to the processing unit.
However, such contact sensors are notoriously well-known in the art. For example, Hanson discloses a related skin-patch type drug delivery device (10), wherein the device is configured to be adhesively affixed to the skin of the patient (Par. 70). Hanson discloses that the drug delivery device comprises a contact sensor (24) having a first state (see Fig. 1C – i.e. the sensor detecting no contact with the sensor tang protruding from the base of the device) when the drug delivery device is out of connect with a body of a patient, and having a second state (not shown – Par. 36, i.e. the sensor activated by contact with the patient), wherein the sensor is operatively coupled to the device activation mechanism such that “the activation mechanism cannot be engaged unless the drug pump 10 is in contact with the body of the user” by generating a first signal to the processing unit (400) (Par. 36). Hanson discloses that the drug delivery device may undergo an external state change from a dormant state when the sensor occupies the first state (e.g. the sensor tang is extended from the housing) to a ready state upon the sensor occupying the second state (e.g. the sensor tang becomes depressed from contact with the skin and/or activation of the “status indicator 16”), indicating that the drug delivery device is ready for at least one of injection or insertion, in response to only the sensor changing from the first state to the second state (Par. 36-38). Specifically, in instances where the on body contact sensor is “electro mechanical” (see Par. 36) the physical act of the sensor becoming depressed and transitioning from the extended state to the depressed flush state can itself be considered an “external state change” of the drug delivery device. Hanson discloses that “the power and control system 400 interfaces with the control arm 40 to identify when the on-body sensor 24 and/or the activation mechanism 14 have been activated. The power and control system 400 may also interface with the status indicator 16 of the pump housing 12, which may be a transmissive or translucent material which permits light transfer, to provide visual feedback to the user… Such status indication may be presented to the user via auditory tones, such as through the audible alarms, and/or via visual indicators, such as through the LEDs” [emphasis added] (Par. 38) and that “the power and control system 400 may be configured such that after the on-body sensor and/or trigger mechanism have been pressed, the power and control system 400 provides a ready-to-start status signal via the status indicator 16 if device start-up checks provide no errors” [emphasis added] (Par. 38). As such, Hanson obviates configurations wherein activation of the on-body sensor (24) alone (note the use of the “and/or” conjunction) activates a “ready-to-start” status indicator which may take the form of a variety of external state changes of the drug delivery device including, but not limited to, “auditory tones” and/or “visual indicators”.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the device of Holt to include an electromechanical, on-body contact sensor operative connected to the device activation mechanism via the processor to prevent a user from activating the device UNLESS the device detects on-body contact and conveys a signal indicative to this detection to the processor, as disclosed by Hanson, whereby in response to ONLY the sensor transitioning from a first, non-contact state to a second, contact state the drug delivery device may undergo a variety of external state changes in order to indicate to a user that the device is “read-to-start” including the physical transition associated with depressing the sensor in mechanical embodiments of the sensor as well as auditory tones and visual indicators, as disclosed by Hanson. The ordinary artisan would have been compelled to perform such a modification of Holt in order to ensure that the device cannot be accidentally activated when not in contact with the patient’s skin and to allow the device to convey the status of the device to the user in order to indicate to the user that the device is “ready-to-start”.
Holt, as modified, discloses the invention substantially as claimed except that that the sensor is adapted to send a second signal to the processing unit in response to changing from the second state to the first state in order to control operation of a deactivation sequence of the injection drive. However, Smith discloses a related skin-patch type pump (200) configured to be affixed to the skin, wherein the pump comprises a related body contact sensor (650) configured to detect a contact state of the pump by transitioning between undepressed (Fig. 44) and depressed (Fig. 43) states. Smith discloses that system is configured to detect if the pump has been removed/dislodged from contact with the skin and send a “fall-off signal” to the processor in order to activate an alarm and/or stop the motor/injection device (Par. 341), whereby the sensor generating the signal in response from the sensor changing from a second state (Fig. 43) to a first state (Fig. 44) (Par. 342-344). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the sensor arrangement of modified Holt to allow a change in the sensor from the depressed, in-contact state to the undepressed non-contact state to generate a signal to cause the processor to control operation of a deactivation sequence of the injection device, as disclosed by Smith, in order to cause the pump to stop delivery when the device detects that it has been removed from the skin, thereby preventing the motor from misdelivering medicament.
Regarding Claim 2, Holt discloses the casing comprises a top wall, a bottom wall, and side walls extending between the top wall and the bottom wall (see Fig. 2); and the adhesive pad covers the entire bottom wall (wherein such “entire” coverage is presumed to exclude any openings which might be present through the bottom wall such as the opening for the inlet (162) or the opening for the cannula/needle (54/58) in accordance with the broadest reasonable interpretation in light of Applicant’s instant specification.
Regarding Claim 3, Holt discloses a drug delivery member (re: the cannula/needle 54/58) fluidly coupled to the container (see Fig. 2); and wherein the bottom wall of the casing (as modified by Hanson to provide the necessary space to allow the contact sensor to communicate with the skin) and the adhesive pad include aligned first and second openings, the first openings adapted to receive the drug delivery member (see Holt, Fig. 2) and the second openings (provided in view of Hanson to provide passage of skin sensor 24) aligned with the sensor (see Hanson; generally Fig. 1A and 1C – wherein while the adhesive pad is not shown in Fig. 1C of Hanson based on the arrangement of the sensor 24 to extend from the casing in a protruding fashion it must be understood that the adhesive pad 26 must have an opening therethrough so as to not prevent the sensor 24 from extending).
Regarding Claim 4, Holt discloses a removable barrier film (104) disposed on the adhesive pad.
Regarding Claim 5, Holt, as modified by Hanson, discloses a light source, and wherein the external state change comprises the light source illuminating a surface (see Par. 36, 38 – Hanson).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0010594 (“Holt”) in view U.S. Publication No. 2015/0209505 (“Hanson”) and U.S. Publication No. 2012/0078216 (“Smith”) as applied above, and further in view of U.S. Publication No. 2007/0219480 (“Kamen”).
Regarding Claim 6, Holt, as modified by Hanson, discloses the external state change comprises sound/tones (see Par. 36, 38 – Hanson). However, Hanson fails to explicitly disclose that it is necessarily a “speaker” which provides these audible indicator sounds. However, a speaker constitutes merely one predictable solution, known to the prior art (see Kamen) which is recognized as being useful for creating audible indicator alarms/tones in order to convey that information to a user (Par. 25) and as such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to embody the audible warning system of modified Holt to comprise a speaker, as disclosed by Kamen, in order to affect the transmission of a sound in a known and predictable manner to obtain only the expected outcome of generating a indicator noise that can be heard and recognized by a user to convey the status of the device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0010594 (“Holt”) in view U.S. Publication No. 2015/0209505 (“Hanson”) and U.S. Publication No. 2012/0078216 (“Smith”) as applied above, and further in view of WO 97/23252 (“Kriesel”)
Regarding Claim 8, Holt, as modified, discloses the invention substantially as claimed except that the casing further comprises a closure or removable portion allowing insertion and removal of the container. However, the prior art (see Kriesel), discloses a related drug delivery device (Fig. 64) wherein the casing is composed of several discrete portions. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the device of Holt to comprise removable portion(s), as disclosed by Kriesel, in order to assist in both assembly and disassembly of the device allowing for used, damaged, or faulty components (inclusive to the container) to be removed and replaced as needled as well as permitting access to any components which may be reused or recycled in order to allow the device to be more environmentally and economically friendly. It has been held that constructing a device as a plurality of separate parts is obvious requiring only routine and customary skill and knowledge in the art, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Response to Arguments
Applicant's arguments filed with respect have been fully considered but they are not persuasive. Specifically, further inclusion of the Smith reference obviates a wearable, patch-type pump having a body contact sensor that is configured to engage in a deactivation sequence by having the sensor convey a signal to the processor to deactivate the delivery drive motor if the sensor detects a state change indicative of removal of the device from the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 11/10/2025