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 .
Status of claim(s)
Claims 200, 202, 204-211, 229-230 have been examined. Claims 229-230 have been previously added. Claims 201, 203 have been previously canceled. Claims 212-221 have been canceled.
Claim Objections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 222-228 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 222 depends from claim 221.
Claim 223 is in the dependency of claim 222.
Claim 224 is in the dependency of claim 223.
Claim 225 is in the dependency of claim 224.
Claim 226 is in the dependency of claim 225.
Claim 227 is in the dependency of claim 226.
Claim 228 is in the dependency of claim 228.
However, claim 221 has been canceled.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 200 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20220387724 hereinafter Helmer)
With respect to Claim 200, Helmer teaches an ambulatory medicament device comprising a hardware processor and a haptic motor, wherein the hardware processor is further configured to execute the specific computer- executable instructions to at least:
generate a haptic alarm signal through the haptic motor based on an urgency of the alarm condition(‘724; Abstract: Helmer describes a medical handheld device that includes an actuating feature configured to generate a trigger signal, a sensor configured to detect a functionality of the medical handheld device in response to the trigger signal, and a haptic source configured to generate a haptic signal including information associated with the functionality of the medical handheld device; Para 0030: the processor 148 can be configured to determine the amount of the medicament within the injection device based at least in part on the electrical signal and transmit the data including the amount of the medicament to the display 114. The processor 148 can be configured to compare the values detected by the sensor 146 to corresponding threshold or reference values to generate a trigger signal in response to identifying critical operations or unusual conditions; Para 0031).
wherein the urgency is based on an amount of harm that may be caused to a subject when the alarm condition is not resolved (‘724; Para 0030: he processor 148 can be configured to compare the values detected by the sensor 146 to corresponding threshold or reference values to generate a trigger signal in response to identifying critical operations or unusual conditions. The processor 148 can be configured to transmit the trigger signal to haptic one or more elements 120 a, 120 b, 120 c to generate a haptic signal to alert a user of the injection device 102 of the critical condition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to make use the system of Helmer in order to provide the haptic alarm signal on the ambulatory medicament device.
Claim(s) 202, 204-211, 229-230 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US20220387724A1 hereinafter Helmer) in view of Albertini et al. (WO 2021059211A1 hereinafter Albertini).
With respect to Claim 202, Helmer teaches, according to the ambulatory medicament device as defined in claim 200, configured to manage a medicament therapy regimen based on motion data associated with movement of the ambulatory medicament device, the ambulatory medicament device comprising:
a touchscreen controller configured to output display signals configured to generate user interface screens on a touchscreen and to receive user input signals corresponding to user interaction with the touchscreen (‘724; Para 0037: the display 212 can include touch screen features. The display 212 can provide a visual indication of the status of the injection device 200, such as a mode the injection device 200 is in, a battery status, and/or whether a power supply is connected to the injection device 200);
However, Helmer does not disclose a motion sensor configured to collect the motion data;
However, Albertini teaches
a motion sensor configured to collect the motion data (‘211; Para 00148);
a memory configured to store specific computer-executable instructions; wherein the hardware processor in communication with the memory and configured to execute the specific computer-executable instructions to at least:
receive a touch input from the subject (‘211; Para 0087: The programmed parameters for controlling the pump 216 are stored in and retrieved from the memory 297 which is in communication with the processor 296. The user interface 280 may take the form of a touch screen or a keypad; Para 0132: The display screen can allow input thereto directly (e.g., as a touch screen));
determine whether an alarm is active; and in response to determining there are no alarms pending, wake the touchscreen the aforementioned features (‘211; Para 00217)
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the haptic feedback device of Helmer with the technique of drug delivery adjustment as taught by Albertini and the motivation is to provide the alarm on the touch screen of the ambulatory medicament device.
With respect to Claim 204, the combined art teaches the ambulatory medicament device of 202, wherein the motion sensor comprises an accelerometer, and wherein the motion data includes an acceleration of the ambulatory medicament device (‘211; Para. 00148)
With respect to Claim 205, the combined art teaches the ambulatory medicament device of claim 204, wherein the hardware processor is further configured to execute the specific computer executable instructions to at least: receive the touch input by detecting an acceleration of the ambulatory medicament device caused by the touch input (‘211; Para 0086)
With respect to Claim 206, the combined art teaches the ambulatory medicament device of claim 205, wherein the touch input comprises one or more of: a single tap, a double tap, multi-tap, a multi-location tap, a pinch gesture, or a swipe gesture (‘211; Para 0086, 00132).
With respect to Claim 207, the combined art teaches the ambulatory medicament device of claim 206, wherein the touch input comprises one or more touches on one or more corners of the touchscreen (‘211; Para 0086, 00132).
With respect to Claim 208, the combined art teaches the ambulatory medicament device of claim 207, wherein the touch input comprises a first touch on a first corner of the touchscreen, a second touch on a second corner of the touchscreen, and a third touch on a third corner of the touchscreen (‘211; Para 0086, 00132).
With respect to Claim 209, the combined art teaches the ambulatory medicament device of claim 208, wherein the touch input comprises one or more touches on the ambulatory medicament device (‘211; Para 0086, 00132).
With respect to Claim 210, the combined art teaches the ambulatory medicament device of claim 209, wherein the hardware processor is further configured to execute the specific computer- executable instructions to at least:
unlock the touchscreen and the ambulatory medicament device based on the touch input (‘211; Para 00170).
With respect to Claim 211, the combined art teaches the ambulatory medicament device of claim 210, wherein the touch input comprises a gesture password, and wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least:
determine whether the gesture password matches a stored password; and in response to determining that the gesture password matches a stored password, unlock the touchscreen and the ambulatory medicament device (‘211; Para 00129).
With respect to Claim 229, Helmer does not teach, according to the ambulatory medicament device of claim 200, wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least: collect motion data from a motion sensor, wherein the haptic alarm signal is further based on the motion data.
However, Albertini discloses the aforementioned feature (‘211; Para 0148).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the system of Saint/Toth with the technique of providing the motion data via a motion sensor.
With respect to Claim 230, the combined art teaches the ambulatory medicament device of claim 229, wherein the motion data indicates driving in vehicle, and wherein the haptic alarm signal is further based on the driving (‘211; Para 00189).
Response to Arguments
In the Remark filed 09/19/2025, Applicant’s arguments with respect to claims 221-222 have been considered but are moot because the arguments do not apply to the references of Helmer being used in the current rejection.
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686