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 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(s) 19 is/are 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.
Regarding claim 19, the phrase "two members" in line 3 renders the claim indefinite because it is unclear whether the two members in claim 19 are the same as or different from “the first member” and “the second member” recited in claim 16. For the purpose of compact prosecution, they are interpreted to be the same.
Regarding claim 23, the phrase "the switching feature" in line 5 and in line 6 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “the movable switching feature”. For the purpose of compact prosecution, they are interpreted to be the same.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-22, 27, 31-33, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinrich et al. (WO 2020/035406).
Regarding claim 16, Heinrich discloses
An electronic system (20, figs. 1-6B and page 6 line 33 to page 12 line 7) for a drug delivery device (1, figs. 1 and 3 and page 6 line 33 to page 7 line 23), the electronic system (20) comprising:
a dose setting and drive mechanism (mechanism of 11/12) which is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose (Examiner notes: see page 6 lines 2-5 for turning 12 to set a dose, and see page 6 lines 21-27 for pushing 11 to inject the dose), the dose setting and drive mechanism (mechanism of 11/12) comprising a first member (12) and a second member (11), wherein the dose setting and drive mechanism is configured such that, during at least one of the dose delivery operation or the dose setting operation, the first member moves relative to the second member (Examiner notes: during dose setting, 12 is moved relative to 11 to set a dose and during dose delivering, 11 is moved relative to 12 to inject the dose, see page 6 lines 2-5 and lines 21-27);
a communication unit for communicating with an external device (see page 8 lines 14-24 for the communications interface of 20, see also fig. 5 for communications interface of 20 with external device 60);
an electronic control unit (50, fig. 4 and page 8 line 31 to page 9 line 2) configured to control an operation of the electronic system (see page 11 lines 6-30); and
an electrical use detection unit (detection unit of 50, fig. 4) operatively connected to the electronic control unit (50), and configured to generate a first signal indicative that a user has commenced or finished the relative movement between the first member (12) and the second member (11) (Examiner notes: see page 8 lines 26-29 for detection unit of 50 detecting operation of 53 and generating a first signal to trigger powering of components of system 20 upon movement of 24 relative to 23. See fig. 3 for 24 coupling to 11 and 23 coupling to 12 such that movement of 24 causes movement of 11 relative to 12 and 23),
wherein the electronic system (20) is configured to be switched from a first state in which the communication unit is not activated (see page 8 lines 26-29), into a second state in which the communication unit is activated (see page 8 lines 26-29), thereby inducing the communication unit to establish a communication with the external device (see page 8 lines 26-29 and page 10 lines 13-22 for 53 triggering powering of components and therefore an output 57 is provided and is sent to the external device 60), wherein the switching is in response to the first signal (see page 8 lines 26-29).
Regarding claim 17, Heinrich discloses
The electronic system according to claim 16, wherein the communication unit (see page 8 lines 14-24 for the communications interface of 20, see also fig. 5 for communications interface of 20 with external device 60) comprises a wireless communication interface (see page 8 lines 14-24 and page 10 lines 13-22) for communicating with the external device (60), wherein the electronic system (20) is configured to switch from the first state (non-active state of 20, page 8 lines 26-29) into the second state (active state of 20, page 8 lines 26-29) by the electronic control unit (50), thereby inducing the communication unit to initiate a manual synchronization and/or a pairing with the external device (see page 8 lines 14-29 and page 10 lines 13-22).
Regarding claim 18, Heinrich discloses
The electronic system according to claim 16, wherein the electrical use detection unit (detection unit of 50) is further configured to generate a second signal indicative that the user has commenced the dose setting operation or the dose delivery operation (second signal relate to delivered medicament amounts and/or time stamps for the injections, see page 8 line 31 to page 10 line 26), wherein the electronic system is configured to be switched from the first state or the second state into a third state by the electronic control unit in response to the second signal, wherein dose data is collected in the third state (see page 8 line 31 to page 10 line 26.
Regarding claim 19, Heinrich discloses
The electronic system according to claim 18, wherein the electrical use detection unit (detection unit of 50) is configured to generate the second signal in response to a relative movement of two members of the dose setting and drive mechanism (see page 8 line 31 to page 10 line 26 for relative movement between 11 and 12 during dose delivery generating signal about the delivered medicament amount and/or time stamps for the injection).
Regarding claim 20, Heinrich discloses
The electronic system according to claim 18, wherein the electrical use detection unit (detection unit of 50) is configured to generate the second signal (page 9 lines 24-26) in response to a relative rotational movement between a third member (23) of the dose setting and drive mechanism, and one of the first member and the second member (11) during the dose delivery operation (page 9 lines 24-26).
Regarding claim 21, Heinrich discloses
The electronic system according to claim 16, further comprising a movable switching feature (26) that is operatively coupled to one or both of the first member and the second member (11) such that an axial displacement of the first member (12) relative to the second member (11) causes a movement of the switching feature (26) relative to the first member and/or the second member (page 7 line 25 to page 8 line 29), and wherein the electronic system is configured such that an axial movement of the switching feature is used to trigger generation of the first signal (page 8 lines 26-29).
Regarding claim 22, Heinrich discloses
The electronic system according to claim 21, wherein the movable switching feature (26) is linearly guided (see fig. 3).
Regarding claim 27, Heinrich discloses
The electronic system according to claim 16, wherein the first member (12) is a dial sleeve (see fig. 3 and page 6 lines 2-3) or is a member axially and/or rotationally locked to the dial sleeve such that the first member (12) is rotatable relative to a housing (10) of the dose setting and drive mechanism at least in the dose setting operation (page 6 lines 2-3), and wherein the second member (11) is a dose and/or injection button (see fig. 3 and page 6 lines 21-27) or a member axially and/or rotationally locked to the dose and/or injection button such that the second member (11) is axially displaceable relative to the first member (12) and rotationally constrained to the housing (10) at least in the dose setting operation (page 6 lines 21-27).
Regarding claim 31, Heinrich discloses
The electronic system according to claim 16, wherein the first member (12) is a dial sleeve (page 5 line 36 to page 6 line 16) or is a member axially and/or rotationally locked to the dial sleeve such that first member (12) is axially displaceable relative to a housing of the dose setting and drive mechanism at least in the dose delivery operation (Examiner notes: see page 6 lines 14-16 for 12 being rotated on a helical path, and see page 7 lines 11-12 for 12 being rotated during dose delivery operation), and wherein the second member (11) is a member axially displaceable relative to the first member upon abutment with the housing or a member axially locked to the first member at least in the dose delivery operation (see fig. 3 and page 6 lines 23-25).
Regarding claim 32, Heinrich discloses
The electronic system according to claim 31, wherein the second member (11) is guided in a dose and/or injection button or a member axially and/or rotationally locked to the dose and/or injection button such that the second member abuts the housing (see fig. 3 and page 6 lines 23-25 for 11 being the injection button).
Regarding claim 33, Heinrich discloses
The electronic system according to claim 31, wherein the second member (11) is a member axially locked to the dose and/or injection button only if the dose and/or injection button is axially displaced against a bias of a spring (see fig. 3 and page 6 lines 23-25 for 11 being the injection button).
Regarding claim 35, Heinrich discloses
A drug delivery device (1, fig. 1 and page 5 line 36 to page 6 line 31) comprising:
a cartridge (14) containing a medicament (page 6 lines 22-23); and
an electronic system (20, figs. 1-6B and page 6 line 33 to page 12 line 7) comprising
a dose setting and drive mechanism (mechanism of 11/12) which is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose (Examiner notes: see page 6 lines 2-5 for turning 12 to set a dose, and see page 6 lines 21-27 for pushing 11 to inject the dose), the dose setting and drive mechanism (mechanism of 11/12) comprising a first member (12) and a second member (11), wherein the dose setting and drive mechanism is configured such that, during at least one of the dose delivery operation the dose setting operation, the first member moves relative to the second member (Examiner notes: during dose setting, 12 is moved relative to 11 to set a dose and during dose delivering, 11 is moved relative to 12 to inject the dose, see page 6 lines 2-5 and lines 21-27),
a communication unit for communicating with an external device (see page 8 lines 14-24 for the communications interface of 20, see also fig. 5 for communications interface of 20 with external device 60),
an electronic control unit (50, fig. 4 and page 8 line 31 to page 9 line 2) configured to control an operation of the electronic system (see page 11 lines 6-30),
an electrical use detection unit (detection unit of 50, fig. 4) operatively connected to the electronic control unit (50), and configured to generate a first signal indicative that a user has commenced or finished the relative movement between the first member (12) and the second member (11) (Examiner notes: see page 8 lines 26-29 for detection unit of 50 detecting operation of 53 and generating a first signal to trigger powering of components of system 20 upon movement of 24 relative to 23. See fig. 3 for 24 coupling to 11 and 23 coupling to 12 such that movement of 24 causes movement of 11 relative to 12 and 23),
wherein the electronic control unit (50) is configured to be switched from a first state in which the communication unit is not activated (see page 8 lines 26-29), into a second state in which the communication unit is activated (see page 8 lines 26-29), thereby inducing the communication unit to establish a communication with the external device (see page 8 lines 26-29 and page 10 lines 13-22 for 53 triggering powering of components and therefore an output 57 is provided and is sent to the external device 60), wherein the switching is in response to the first signal (see page 8 lines 26-29).
Claim(s) 16, 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinrich et al. (WO 2020/035406 – Examiner notes: the limitations “a first member” and “a second member” are interpreted differently than the rejection above).
Regarding claim 16, Heinrich discloses
An electronic system (20, figs. 1-6B and page 6 line 33 to page 12 line 7) for a drug delivery device (1, figs. 1 and 3 and page 6 line 33 to page 7 line 23), the electronic system (20) comprising:
a dose setting and drive mechanism (mechanism of 11/12) which is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose (Examiner notes: see page 6 lines 2-5 for turning 12 to set a dose, and see page 6 lines 21-27 for pushing 11 to inject the dose), the dose setting and drive mechanism (mechanism of 11/12) comprising a first member (11) and a second member (12), wherein the dose setting and drive mechanism is configured such that, during at least one of the dose delivery operation or the dose setting operation, the first member moves relative to the second member (Examiner notes: during dose setting, 12 is moved relative to 11 to set a dose and during dose delivering, 11 is moved relative to 12 to inject the dose, see page 6 lines 2-5 and lines 21-27);
a communication unit for communicating with an external device (see page 8 lines 14-24 for the communications interface of 20, see also fig. 5 for communications interface of 20 with external device 60);
an electronic control unit (50, fig. 4 and page 8 line 31 to page 9 line 2) configured to control an operation of the electronic system (see page 11 lines 6-30); and
an electrical use detection unit (detection unit of 50, fig. 4) operatively connected to the electronic control unit (50), and configured to generate a first signal indicative that a user has commenced or finished the relative movement between the first member (11) and the second member (12) (Examiner notes: see page 8 lines 26-29 for detection unit of 50 detecting operation of 53 and generating a first signal to trigger powering of components of system 20 upon movement of 24 relative to 23. See fig. 3 for 24 coupling to 11 and 23 coupling to 12 such that movement of 24 causes movement of 11 relative to 12 and 23),
wherein the electronic system (20) is configured to be switched from a first state in which the communication unit is not activated (see page 8 lines 26-29), into a second state in which the communication unit is activated (see page 8 lines 26-29), thereby inducing the communication unit to establish a communication with the external device (see page 8 lines 26-29 and page 10 lines 13-22 for 53 triggering powering of components and therefore an output 57 is provided and is sent to the external device 60), wherein the switching is in response to the first signal (see page 8 lines 26-29).
Regarding claim 34, Heinrich discloses
The electronic system according claim 16, wherein the first member (11) is a dose and/or injection button (see fig. 3 and page 6 lines 23-25), and the second member (12) is a chassis or skirt of a dosage knob (see fig. 3), wherein the dose and/or injection button (11) is axially displaceable and/or axially elastically deformable relative to the second member (see page 6 lines 23-25), and wherein the electrical use detection unit (detection unit of 50, fig. 4) comprises an axial switch (53) such that an axial displacement of at least a portion of the dose and/or injection button relative to the second member actuates the axial switch (page 8 lines 26-29).
Allowable Subject Matter
Claim(s) 23-26, 28-30 is/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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783