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) 31 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 31, the phrase "detect movement of the actuation member from the second position relative to the housing to the second position relative to the housing" renders the claim indefinite because it is unclear how the actuation member moves between the second positions.
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) 16-23, 26-27, 29-30, 32-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helmer et al. (WO 2019/121452).
Regarding claim 16, Helmer discloses
An injection device (10, figs. 1-16 and page 8 line 7 to page 22 line 9) comprising:
a housing (9, fig. 2 and page 8 lines 19-25);
an actuation member (52, fig. 3 and page 10 lines 12-34) movable between a first position relative to the housing (position of 52 before 50 being mounted on 10) and a second position relative to the housing (position of 52 after 50 being mounted on 10), the actuation member (52) being arranged to inhibit a mechanical operation of the injection device when the actuation member is in the first position and allow the mechanical operation of the injection device when the actuation member is in the second position (see page 11 line 31 to page 12 line 23 for the determination of a selected dosage and of an injection by the electronics of 50 is inhibited before 50 being mounted on 10 and is allowed after 50 being mounted on 10);
an actuation sensing arrangement (switch detecting the mounting of 50 on 10, page 11 line 31 to page 12 line 23) configured to detect movement of the actuation member from the first position relative to the housing to the second position relative to the housing (see page 11 line 31 to page 12 line 23); and
electronic circuitry (100/101, fig. 17 and page 15 line 24 to page 17 line 8) configured to be activated in response to detection by the actuation sensing arrangement (switch of 50) that the actuation member (52) has moved from the first position relative to the housing to the second position relative to the housing (see page 11 line 31 to page 12 line 23 and page 15 line 24 to page 17 line 8).
Regarding claim 17, Helmer discloses
The injection device according to claim 16, wherein the mechanical operation comprises a dose programming operation (see page 11 line 31 to page 12 line 23 for the determination of a selected dosage and of an injection).
Regarding claim 18, Helmer discloses
The injection device according to claim 16, wherein the mechanical operation comprises a dose dispensing operation (see page 11 line 31 to page 12 line 23 for the determination of a selected dosage and of an injection).
Regarding claim 19, Helmer discloses
The injection device according to claim 16, wherein activation of the electronic circuitry comprises switching the electronic circuitry from a low-power state (no power) to a high-power state (with power to detect the selected dosage and the injection, page 11 line 31 to page 12 line 23).
Regarding claim 20, Helmer discloses
The injection device according to claim 16, wherein the actuation member (52) comprises a hinged member (53) pivotally coupled to the housing (9, see fig. 3) such that the hinged member (53) can pivot between the first position (position of 53 before 52 being pressed) and the second position (position of 53 after 52 being pressed) relative to the housing (see fig. 3).
Regarding claim 21, Helmer discloses
The injection device according to claim 20, wherein the actuation sensing arrangement (switch) comprises a plurality of conductive contacts (contacts of switch), and the hinged member (53) comprises an electrically conductive portion (see fig. 3 and page 11 line 31 to page 12 line 23).
Regarding claim 22, Helmer discloses
The injection device according to claim 21, wherein the conductive contacts and the electrically conductive portion are arranged such that: the electrically conductive portion forms an electrical connection between the conductive contacts when the actuation member is in one of the first position and the second position; and there is no electrical connection between the conductive contacts via the electrically conductive portion when the actuation member is in the other one of the first position and the second position (see page 11 line 31 to page 12 line 23 for electrical connection when 50 is mounted on 10, and no electrical connection when 50 is not mounted on 10).
Regarding claim 23, Helmer discloses
The injection device according to claim 20, wherein the actuation sensing arrangement (switch of 50) comprises a hinge switch (sensor of 53, see fig. 4) arranged to detect whether the hinged member is in the first position or the second position (see page 10 line 20 to page 11 line 14).
Regarding claim 26, Helmer discloses
The injection device according to claim 20, further comprising a dosage knob (13) that is biased from a first linear position relative to the housing (position of 13 before being pressed down) towards a second linear position relative to the housing (position of 13 after being pressed down), the hinged member (53) being configured to inhibit movement of the dosage knob from the first linear position to the second linear position when the hinged member is in the first position, and the dosage knob being configured to move from the first linear position to the second linear position in response to the hinged member being moved from the first position to the second position (page 11 line 31 to page 12 line 23).
Regarding claim 27, Helmer discloses
The injection device according to claim 26, wherein the actuation sensing arrangement (switch) is configured to detect movement of the dosage knob (13) from the first linear position relative to the housing (position of 13 before being pressed down) to the second linear position relative to the housing (position of 13 after being pressed down), and the electronic circuitry is configured to be activated in response to the detection by the actuation sensing arrangement that the dosage knob has moved from the first linear position relative to the housing to the second linear position relative to the housing (see page 12 lines 15-21 for the circuitry of 50 detecting the begin of an injection based on the movement of 52/13).
Regarding claim 29, Helmer discloses
The injection device according to claim 16, wherein the actuation member (52) comprises a collar (51) threadingly engaged with the housing (23 of 9) of the injection device (see fig. 3), the collar (51) being movable along the housing from the first position relative to the housing (when 50 is not mounted to 10) to the second position relative to the housing (when 50 is mounted to 10).
Regarding claim 30, Helmer discloses
The injection device according to claim 29, wherein the actuation sensing arrangement (switch) is configured to detect movement of the collar from the first position relative to the housing to the second position relative to the housing (page 11 line 31 to page 12 line 23), and the electronic circuitry is configured to be activated in response to detection by the actuation sensing arrangement that the collar has moved from the first position relative to the housing to the second position relative to the housing (see page 11 line 31 to page 12 line 23).
Regarding claim 32, Helmer discloses
The injection device according to claim 16, further comprising a container (18) containing a medicament (16, see fig. 1B).
Regarding claim 33, Helmer discloses
The injection device according to claim 16, wherein the injection device is an injection pen or a patch pump (see figs. 1A-1B).
Regarding claim 34, Helmer discloses
A method (figs. 1-16 and page 8 line 7 to page 22 line 9) comprising:
detecting, by an actuation sensing arrangement (switch detecting the mounting of 50 on 10, page 11 line 31 to page 12 line 23) of an injection device (10), movement of an actuation member (52) of the injection device from a first position (when 50 is not mounted on 10) relative to a housing (9) of the injection device (10) to a second position (when 50 is mounted on 10) relative to the housing (page 11 line 31 to page 12 line 23), the actuation member (52) being arranged to inhibit a mechanical operation of the injection device when the actuation member is in the first position and allow the mechanical operation of the injection device when the actuation member is in the second position (see page 11 line 31 to page 12 line 23 for the determination of a selected dosage and of an injection by the electronics of 50 is inhibited before 50 being mounted on 10 and is allowed after 50 being mounted on 10); and
activating electronic circuitry (100/101, fig. 17 and page 15 line 24 to page 17 line 8) of the injection device in response to the detected movement that the actuation member has moved from the first position relative to the housing to the second position relative to the housing (see page 11 line 31 to page 12 line 23 and page 15 line 24 to page 17 line 8).
Regarding claim 35, Helmer discloses
The method of claim 34, wherein the mechanical operation comprises a dose programming operation or a dose dispensing operation (see page 11 line 31 to page 12 line 23 for the determination of a selected dosage and of an injection).
Allowable Subject Matter
Claim(s) 24-25, 28 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