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 .
Response to Amendment
This office action is responsive to the amendment filed 22 December 2025. As directed by the amendment: claims 1-15 remain cancelled and claims 16-35 are pending.
Response to Arguments
Applicant's arguments filed 22 December 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 7-9, that the part 118 in Kühn is not a dose dispensing part, however, as previously pointed out in the Non-Final Rejection on 26 September 2025, the part 118 is part of the dose dispensing mechanism of the device as it is integral to the device actually dispensing the amount of medication that is required. The device mechanism includes the parts 116 and 118 for proper function and the dispensing process is listed in multiple paragraphs of Kühn and specifically cited in the action in paragraphs 0023 and 0024. The dispensing and setting mechanism of the device are both connected and the device 100 of Kühn is an injection device which uses multiple parts to perform said injection. Additionally, applicant argues that “the part” of the dose dispensing mechanism needs to be aligned with a window. As previously stated, 118 is the “the part” and 116 is aligned with 118.
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.
Claim(s) 16-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kühn (EP 3016699).
Regarding claim 16, Kühn discloses an apparatus (Figs. 1, 2 & 4) comprising:
an accessory (Fig. 2, 200); and
an injection device (Fig. 2, 100) wherein:
the accessory has an attachment portion configured to attach the accessory to the injection device (¶[0027]), and a body that houses an optical sensor arrangement (¶[0029] & [0034]);
the injection device comprises a cartridge assembly and a housing, the housing contains a dose dispensing mechanism configured to inject the dose (¶[0023]-[0024]) and a dose setting mechanism for selecting the dose to be injected(Fig. 1, ¶[0023]-[0024] [0041]),
wherein the dose dispensing mechanism comprises a part that is configured to move in response to the movement of the dose setting mechanism (¶[0024], where the part is 118 that is connected to 104 in the housing and moves in response to the dosing knob 114) and indicate a dose dialed by movement of the dose setting mechanism (where 116 and 118 indicated the dose that is dialed by 114), and the housing comprises a window aligned with the part of the dose dispensing mechanism (116),
wherein the attachment portion is configured to align the optical sensor arrangement to the window in the injection device to allow the optical sensor arrangement to detect a location of the part that moves in response to movement of the dose setting mechanism to determine the dose dialed by the dose setting mechanism (¶[0034], 116, 118, where the window shows the dosage and the optical sensor detects movement internally from 118).
Regarding claim 17, Kühn discloses wherein the optical sensor arrangement comprises a sensor array configured to capture an image of the part (¶[0029], where the second sensor 200 is one of multiple sensors configured to gather data on the device).
Regarding claim 18, Kühn discloses wherein the sensor array is a one-dimensional array (Fig. 4, where the primary and secondary sensors are arranged in a one-dimensional format)
Regarding claim 19, Kühn discloses wherein the accessory is configured to cause the sensor array to capture a first image of the part that moves in response to movement of the dose setting mechanism after it has been detected that an injection has been completed (¶[0034]-[0035])
Regarding claim 20, Kühn discloses wherein the accessory is further configured to cause the sensor array to capture a second image of the part that moves in response to movement of the dose setting mechanism prior to an injection having started (¶[0027]-[0029] & [0033]-[0035]).
Regarding claim 21, Kühn discloses wherein the accessory is configured to use both the first and second images to calculate a displacement of the part (¶[0034]-[0035], where the information gathered between the two images determines the amount of insulin delivered between the first and second images by reading characters on the mechanism).
Regarding claim 22, Kühn discloses wherein the accessory is configured to calculate the displacement of the part by detecting locations of edges in the first and second images and by comparing the positions of the edges between the first and second images (¶[0034]-[0035], where the OCR sensor reads characters or images and compares the difference between them to determine the dose dialed).
Regarding claim 23, Kühn discloses wherein the accessory comprises a communication module and is configured to use the communication module to communicate images acquired by the optical sensor arrangement to an external device for processing (¶[0031] & [0046]).
Regarding claim 24, Kühn discloses wherein the communications module is a wireless communications module (¶[0046]).
Regarding claim 25, wherein the part is a last dose nut threaded to a drive member of the dose setting mechanism, the last dose nut being arranged to advance along the drive member through a threaded engagement and in response to operation of the dose setting mechanism (¶[0039]-[0041]).
Regarding claim 26, Kühn discloses wherein the injection device includes a receiving portion for receiving the attachment portion, and wherein the receiving portion is not covered by a cap of the injection device when the cap is operatively installed (Fig. 1 & Fig. 3, where the cap 212 only covers the discharging end of the device and module 200 is attached to 214 at a proximal end of the device away from the cap).
Regarding claim 27, Kühn discloses an accessory (Fig. 2, 200) for an injection device, the accessory comprising:
an attachment portion configured to attach the accessory to the injection device comprising a dose setting mechanism for dialing a dose and a dose dispensing mechanism configured to inject the dose and including a part that is configured to move in response to the movement of the dose setting mechanism (¶[0023]-[0024],[0027], where 118 is a part that moves in response to a dose setting mechanism and the dose dispensing process includes the parts 116 and 118 for the device to properly dispense the required dose when the device is ready to be used and button 120 is pressed); and
a body that houses an optical sensor arrangement (¶[0029] & [0034]),
wherein the attachment portion is configured to align the optical sensor arrangement to a window in the injection device, the window being aligned with the part to determine a dose dialed by the dose setting mechanism (¶[0034], 116, 118, where the window shows the dosage and the optical sensor detects movement internally).
Regarding claim 28, Kühn discloses further comprising: a communication module for communicating images acquired by the optical sensor arrangement to a remote device for image processing (¶[0034] & [0046]).
Regarding claim 29, Kühn discloses wherein the optical sensor arrangement is configured to capture a first image of the part that moves in response to movement of the dose setting mechanism after it has been detected that an injection has been completed (¶[0034]-[0035] & [0037]-[0038]).
Regarding claim 30, Kühn discloses wherein the optical sensor arrangement is further configured to capture a second image of the part that moves in response to movement of the dose setting mechanism prior to an injection having started (¶[0027]-[0029], [0033]-[0034] & [0037]).
Regarding claim 31, Kühn discloses further comprising: a processor configured to use both the first and second images to calculate a displacement of the part (¶[0034]-[0035], [0037], where the information gathered between the two sensors determines the amount of insulin delivered between the first and second sensor and makes a calculation).
Regarding claim 32, Kühn discloses wherein the processor is configured to calculate the displacement of the part by detecting locations of edges in the first and second images and by comparing the positions of the edges between the first and second images (¶[0034]-[0035], [0037], where the information gathered between the two sensors determines the amount of insulin delivered between the first and second sensor and makes a calculation and the edges of both of those sensors imaging will be taken when the displacement is calculated).
Regarding claim 33, Kühn discloses an injection device (Figs. 1-2) comprising:
a cartridge assembly (¶[0041]); and
a housing containing a dose dispensing mechanism configured to inject the dose (¶[0023]-[0024]) and a dose setting mechanism for selecting a dose to be injected(¶[0023]-[0024], [0039]-[0044]),
wherein the dose dispensing mechanism includes a last dose nut that is configured to move in response to the movement of the dose setting (¶[0024], where the part is 118 that is connected to 104 in the housing and moves in response to the dosing knob 114) and indicate a dose dialed by movement of the dose setting mechanism (where 116 and 118 indicated the dose that is dialed by 114 and allow for proper dispensing to occur because the parts are moved in the correct position),and
the housing comprising a window aligned with the last dose nut (¶[0040]).
Regarding claim 34, Kühn discloses further comprising:
a cap (Fig. 1, 112) that, when operatively connected to the injection device, covers part of the cartridge assembly (¶[0023]), and
a receiving portion for receiving an attachment portion of an accessory, the receiving portion being uncovered by the cap when the cap is operatively connected (¶[0027], [0029] & [0040]).
Regarding claim 35, Kühn discloses wherein the cartridge assembly comprises a cartridge containing medicament (¶[0041]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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