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 § 102
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.
Claims 10-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sjostedt et al. (US 20200061300 A1).
Regarding claim 10, Sjostedt discloses a medicament delivery device (1, Fig. 1) comprising:
a housing (7) having a first region (Half of housing 7 adjacent to dose setting means 5) and a second region (Half of housing 7 adjacent to needle 42), wherein the housing is configured to receive a medicament container (40) containing a medicament (Paragraph [0056]);
a delivery needle (42) extending from the second region of the housing (Fig. 5), wherein the delivery needle is configured to penetrate a skin of a user to thereby deliver the medicament from the medicament container into the user (Paragraph [0061]);
a skin sensor (35) positioned at least partially within the housing (Fig. 14);
a transmitter positioned within the housing (Paragraph [0107]);
at least one memory storage element (38, Fig. 17) including unique identification data associated with the medicament delivery device and/or the user (Paragraph [0114]);
at least one processor (19, Fig. 10); and
data storage including program instructions stored thereon (200, Fig. 17, Paragraph [0114]) that when executed by the at least one processor, cause the medicament delivery device to:
determine, via the skin sensor, whether or not the medicament delivery device is attached to the skin of the user (Fig. 14, Paragraphs [0103] and [0105]);
in response to a determination that the medicament delivery device is attached to the skin of the user, prevent transmission of the unique identification data from the transmitter (Paragraph [0105], the sensor 35 can be arranged to cease to send a signal when there is an object within the threshold distance); and
in response to a determination that the medicament delivery device is not attached to the skin of the user, transmit, via the transmitter, the unique identification data to one or more external receivers (Paragraphs [0105] and [0125], the sensor 35 can be arranged to continuously send a signal if there is no object within the threshold distance, the processing unit 19 receives a signal from proximity sensor 35).
Regarding clam 11, Sjostedt discloses the medicament delivery device of claim 10, wherein the skin sensor comprises one or more of a capacitive sensor, a temperature sensor, an ambient light sensor, a pulse oximeter, a heart rate sensor, or an inertial measurement unit (Paragraph [0106]).
Regarding claim 12, Sjostedt discloses the medicament delivery device of claim 10, wherein the second region of the housing includes a cutout (Fig. 14, Paragraph [0112], an opening in housing 7).
Regarding claim 13, Sjostedt discloses the medicament delivery device of claim 12, wherein the skin sensor is positioned in the housing such that the skin sensor is aligned with the cutout in the second region of the housing (Paragraph [0112]).
Regarding claim 14, Sjostedt discloses the medicament delivery device of claim 10, wherein the skin sensor is configured to contact the skin of the user when the medicament delivery device is attached to the skin of the user (Fig. 21, Paragraph [0112], proximity sensor 35 is places close to the tip of the needle as practically possible).
Regarding claim 15, Sjostedt discloses the medicament delivery device of claim 10, wherein the skin sensor is configured to be spaced away from the skin of the user when the medicament delivery device is attached to the skin of the user (Fig. 22, Paragraph [0149], the distance the distance from the sensor to the tip of the needle D1 is larger than the distance from the sensor to an object D2).
Regarding claim 16, Sjostedt discloses the medicament delivery device of claim 10, further comprising an activation button (12) positioned on the first region of the housing (Fig. 1, Paragraph [0078]).
Regarding claim 18, Sjostedt discloses the medicament delivery device of claim 10, further comprising the first region is located on one side of the housing and the second region is located on another side of the housing (Fig. 1).
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.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sjostedt et al. (US 20200061300 A1) in view of Caspers (US 20170259015 A1).
Regarding claim 17, Sjostedt discloses the medicament delivery device of claim 10, but is silent regarding an antenna operably connected to the transmitter.
In analogous art, Caspers teaches a medicament delivery device (1, Fig. 1) wherein an antenna is operably connected to a transmitter (Fig. 2, Paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the transmitter of Sjostedt to include an antenna, as taught by Caspers, in order to transmit data to an external device (Paragraph [0036]).
Regarding claim 19, Sjostedt discloses a medicament delivery device (1, Fig. 1) comprising:
a housing (7) having a first region (Half of housing 7 adjacent to dose setting means 5) and a second region (Half of housing 7 adjacent to needle 42), wherein the housing is configured to receive a medicament container (40) containing a medicament (Fig. 1, Paragraph [0056]) having a longitudinal axis (Fig. 1, the axis aligning with needle 42);
a delivery needle (42) extending from the second region of the housing (Fig. 5);
a skin sensor (35, Fig. 14) positioned and aligned within a cut-out located in the second region (Fig. 14, Paragraph [0112], an opening in housing 7) such the skin sensor will contact skin or be adjacent to the skin when the medicament delivery device is attached to the skin (Fig. 22, Paragraph [0149], the distance the distance from the sensor to the tip of the needle D1 is larger than the distance from the sensor to an object D2);
a transmitter positioned within the housing (Paragraph [0107]);
a memory storage element (38, Fig. 17) including unique identification data associated with the medicament delivery device or the user (Paragraph [0114]);
a processor (19, Fig. 10); and
data storage comprising stored program instructions (200, Fig. 17, Paragraph [0114]) that when executed by the processor, cause the medicament delivery device to:
determine, using signals received from the skin sensor, whether or not the medicament delivery device is attached to the skin of the user (Fig. 14, Paragraphs [0103] and [0105]);
in response to a determination that the medicament delivery device is attached to the skin of the user, prevent transmission of the unique identification data from the transmitter (Paragraph [0105], the sensor 35 can be arranged to cease to send a signal when there is an object within the threshold distance); and
in response to a determination that the medicament delivery device is not attached to the skin of the user causing the transmitter to transmit the unique identification data to one or more external receivers (Paragraphs [0105] and [0125], the sensor 35 can be arranged to continuously send a signal if there is no object within the threshold distance, the processing unit 19 receives a signal from proximity sensor 35).
Sjostedt is silent regarding a delivery needle extending from the second region of the housing along an axis that is transverse to the longitudinal axis of the medicament container.
In analogous art, Caspers teaches a medicament delivery device (1, Fig. 1) comprising a delivery needle (6) extending from a region of the housing (2) along an axis that is transverse to the longitudinal axis of the medicament container (Fig. 1, the longitudinal axis of cannula 6 is perpendicular to the longitudinal axis of reservoir 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the position of the medicament container of Sjostedt to have a longitudinal axis transverse to an axis of the delivery needle, as taught by Caspers, in order to allow for the needle to be retractable (Paragraph [0032)].
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments, on page 6, that Sjostedt does not teach “determine, via the skin sensor, whether or not the medicament delivery device is attached to the skin of the user”, the Examiner respectfully disagrees. Paragraph [0105] discloses that the proximity sensor 35 is arranged to continuously send a signal if there is no object within the threshold distance, but to cease to send the signal when there is an object within the threshold distance. The threshold distance T is defined as shown in FIG. 14. If the needle was inserted into a patient (within the threshold distance T), the proximity sensor would cease to send the signal because an object (the body of the patient) would be within the threshold distance and if the device patient was not within the threshold distance, the proximity sensor would continuously send a signal (which is further evidenced by Figs. 20-21), therefore teaching the limitation of determining, via the skin sensor, whether or not the medicament delivery device is attached to the skin of the user.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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