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 .
Acknowledgment
Claims 1-26 are canceled and claims 27-43 are newly added and filed on 11/2/2025.
Claim Objections
Claim 41 is objected to because of the following informalities:
In line 1 of claim 41,” wherein and the patient” should read as “wherein .
Appropriate correction is required.
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.
Claims 27-35 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.
Claim 27 recites the limitation "the needle" in line 6. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 27-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinar et al. (US2011/0106011A1) (“Cinar”) in view of Connelly et al.(US6,589,229B1) (“Connelly’').
Re claim 27, Cinar discloses a device (Fig. 1, abstract, ¶0006, ¶0053) for delivering a medication to a patient in a drug infusion system (¶0053), the device configured as an integrated wearable apparatus for managing the medication delivery (CGM sensor, ¶0006, and SENSEWEAR armbands. ¶0034, ¶0054), the device comprising: a reservoir for storing the medication to be delivered to the patient (reservoir. ¶0037, ¶0038); a first device (50, ¶0054) configured to pump the medication from the reservoir along a flow path to the needle ( the insulin delivery is subcutaneous means that there is a conduit/ needle/ cannula used for injection under the skin, ¶0054, ¶0078); a needle for delivering the medication from reservoir into the patient (the insulin delivery is subcutaneous means that there is a conduit/ needle/ cannula used for injection under the skin, ¶0054, ¶0078); a continuous glucose monitoring device (CGM 30, ¶0006, ¶0054, Fig. 1) for monitoring glucose levels in the patient (¶0054, ¶0006), wherein the continuous glucose monitoring device is configured to measure a glucose level (¶0006, ¶0054) and converting that glucose level to a first flow rate of medication based on the glucose level measured (¶0037, wherein the blood glucose is used to cautiously adjust the insulin flow rate); and a microcontroller unit (40, ¶0075-¶0076) for receiving and converting the glucose levels from the continuous glucose monitoring device into instructions by control algorithms within the microcontroller unit and for commanding the first device to deliver the medication from the reservoir through the needle at the first flow rate based on the converted instructions (¶0038, ¶0075), but fails to teach that the first device is a first micro-electro-mechanical systems (MEMS) and a second micro-electro-mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device and wherein the microcontroller unit is configured to compare the first flow rate with the actual flow rate sensed and generate an error signal if there is a difference between the first flow rate and the actual flow rate.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises a pump unit (membrane under 36, Fig.7) the pumping unit includes a first MEMS devices ( 36 is piezoelectric actuator, Col. 9, lines 19-25 see ¶0028 the current application that include that memes can be piezoelectric ) and a second MEMS device (a thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) configured as a sensor to measure the actual flow rate of medication at the first MEMS device (Col. 9, lines 27-34); wherein the microcontroller unit is configured to compare the first flow rate with the actual flow rate sensed and generate an error signal if there is a difference between the first flow rate and the actual flow rate (Fig. 11b, 154, Fig. 11b, Col. 11, lines 44-60, the predetermined value, Fig.10, Col. 15, line 61 up to Col. 16, line 20, see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified device of Cinar so that the first device is a first micro-electro-mechanical systems (MEMS) and a second micro-electro-mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device and wherein the microcontroller unit is configured to compare the first flow rate with the actual flow rate sensed and generate an error signal if there is a difference between the first flow rate and the actual flow rate as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication using a precise controlling element (Connelly, Col. 7, lines 50-68).
Re claim 28, Cinar fails to disclose wherein the microcontroller unit is further configured to command the first MEMS device to adjust the second flow rate to an adjusted the first flow rate based on the error signal.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and pump unit (membrane under 36, Fig.7) and wherein the controller is monitoring an actual flow rate of medication delivered (Fig. 11b, 154) and comparing the second flow rate with the actual flow rate sensed (Fig. 11b, Col. 11, lines 44-60, the predetermined value) and wherein the microcontroller unit is further configured to command the first MEMS device to adjust the second flow rate to an adjusted the first flow rate based on the error signal ( Fig.10, Col. 15, line 61 up to Col. 16, line 20, see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cinar so that the microcontroller unit is further configured to command the first MEMS device to adjust the second flow rate to an adjusted the first flow rate based on the error signal as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 29, Cinar fails to disclose wherein the first MEMS device is further configured to deliver the medication from the reservoir through the needle into the patient at the adjusted flow rate.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and pump unit (membrane under 36, Fig.7) and wherein the controller is monitoring an actual flow rate of medication delivered (Fig. 11b, 154) and comparing the second flow rate with the actual flow rate sensed (Fig. 11b, Col. 11, lines 44-60, the predetermined value) and wherein the first MEMS device is further configured to deliver the medication from the reservoir through the needle into the patient at the adjusted flow rate ( Fig.10, Col. 15, line 61 up to Col. 16, line 20, see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cinar so that the first MEMS device is further configured to deliver the medication from the reservoir through the needle into the patient at the adjusted flow rate as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 30, Cinar fails to disclose wherein the first flow rate is adjusted by changing a voltage and/or a frequency associated with the adjusted flow rate.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and pump unit (membrane under 36, Fig.7) and wherein the controller is monitoring an actual flow rate of medication delivered (Fig. 11b, 154) and comparing the second flow rate with the actual flow rate sensed (Fig. 11b, Col. 11, lines 44-60, the predetermined value) and wherein the first flow rate is adjusted by changing a voltage and/or frequency associated with the adjusted flow rate ( Fig.10, pulses generating 126, 124 see Col. 13, Ines 62-67, Col. 15, line 61 up to Col. 16, line 20).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cinar so that the microcontroller unit is further configured to command the first MEMS device to adjust the first flow rate to an adjusted flow rate based on the error signal as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 31, Cinar discloses wherein (a) the continuous glucose monitoring device (30, CGM device ¶0006) is configured to measure a glucose level and convert that glucose level to a second flow rate based on the glucose level measured (it is closed loop, the sensor is measuring the glucose, before/during/after insulin delivering (¶0075-¶0076), but it fails to discloses (b) the second MEMS device is configured to measure the actual flow rate of medication at the first MEMS device, and (c) the microcontroller unit is configured to compare the second flow rate with the actual flow rate sensed and generate an error signal if there is a difference between the second flow rate and the actual flow rate.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and (b) the second MEMS device (flow sensor, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) is configured to measure the actual flow rate of medication at the first MEMS device (36, and membrane under 36, Fig.7) and wherein the controller is monitoring an actual flow rate of medication delivered (Fig. 11b, 154) to the patient to determine if that the actual flow rate of the medication delivered is the first flow rate commanded for medication delivery (Fig. 11b, Col. 11, lines 44-60, the predetermined value) and comparing the third flow rate with the actual flow rate sensed; and (4) generating an error signal if there is a difference between the third flow rate and the actual flow rate ( Fig.10, Col. 15, line 61 up to Col. 16, line 20); and (C) the microcontroller unit is configured to compare the third flow rate with an actual flow rate sensed ( Fig.10, Fig. 11b, Col. 15, line 61 up to Col. 16, line 20) and generate an error signal if there is a difference between the third flow rate and the actual flow rate ( Fig.10, see Col. 15, Ines 34-37, Col. 15, line 61 up to Col. 16, line 20).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cinar so that (b) the second MEMS device is configured to measure the actual flow rate of medication at the first MEMS device, and (c) the microcontroller unit is configured to compare the second flow rate with the actual flow rate sensed and generate an error signal if there is a difference between the second flow rate and the actual flow rate as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 32, Cinar discloses continuously adjusting the flow rate of the pump base in response to the continuous glucose monitoring device (¶0006), but it fails to discloses wherein the microcontroller unit is further configured to command the first MEMS device to adjust flow rate continually, in response to subsequent comparison between flow rate generated by the continuous glucose monitoring device and actual flow rate from the first MEMs device until an error signal is reduced to zero.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and pump unit (membrane under 36, Fig.7) and wherein the controller is monitoring an actual flow rate of medication delivered (Fig. 11b, 154) and comparing the second flow rate with the actual flow rate sensed (Fig. 11b, Col. 11, lines 44-60, the predetermined value) and wherein the microcontroller unit is further configured to command the first MEMS device to adjust flow rate continually (Fig.10, Col. 15, line 61 up to Col. 16, line 20), in response to subsequent comparison between flow rate generated by the continuous glucose monitoring device (Col. 20, lines 46-65) and actual flow rate from the first MEMs device until an error signal is reduced to zero ( Fig.10, Col. 15, line 61 up to Col. 16, line 20, the closed-loop control define as to reduce the error in the difference between the target and the delivered and when they are equal to each other/zero error, the algorithms continue to control/adjusting the insulin’s rate util another rate is commanded or to stop see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cinar so that the microcontroller unit is further configured to command the first MEMS device to adjust flow rate continually, in response to subsequent comparison between flow rate generated by the continuous glucose monitoring device and actual flow rate from the first MEMs device until an error signal is reduced to zero as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 33, the modified Cinar discloses wherein the first and second MEMS devices are integrated or separate (36, 38/40 of Connelly, Col. 9, lines 27-35).
Re claim 34, Cinar discloses wherein the medication is insulin (¶0052).
Re claim 35, Cinar discloses wherein the patient is a user of the device (¶0004, ¶0062).
Re claim 36, Cinar discloses a method of managing delivery of a medication to a patient (abstract, Fig. 1, ¶0006, ¶0053) including medication dosage control and medication flow rate control for the patient (40, ¶0053), the method manages the delivery using a device for delivering (¶0037 the insulin delivery is subcutaneous means that there is a conduit/ needle/ cannula used for injection under the skin, ¶0054, ¶0078); the medication that comprises (a) a needle (the insulin delivery is subcutaneous means that there is a conduit/ needle/ cannula used for injection under the skin, ¶0054, ¶0078), (b) a pumping unit (50) for pumping the medication through the needle (¶0037) including a first device (pumping device 50) configured to pump the medication from the reservoir along a flow path to the needle (¶0054) (c) a continuous glucose monitoring device for measuring glucose level in the patient (using the glucose sensor 30, CGM device ¶0006, and SENSEWEAR armband 36, ¶0034, ¶0054), and (d) a microcontroller for controlling the operation of the pumping unit the method (40, ¶0054) comprising:(a) controlling flow rate of the medication to be delivered to the patient through the needle that is subcutaneously inserted into the patient (¶0078) including (1) monitoring glucose levels in the patient using a continuous glucose monitoring device (30, CGM device ¶0006, and SENSEWEAR armband 36, ¶0034, ¶0054); (2) converting the glucose levels from the continuous glucose monitoring device into instructions by control algorithms within a microcontroller unit (unit 40, ¶0075-¶0076); (3) commanding the first device to deliver the medication through the needle at a flow rate based on the converted instructions (¶0075); and (4) delivering the medication through the needle into the patient at the flow rate (¶0038, ¶0075); but it fails to disclose that the first device is a first MEMS device and a second micro- electro-mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device, (b) adjusting the flow rate pumped by the pumping unit continually to reduce a difference between an actual flow rate measured in the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and a first MEMES device (a disk-type piezoelectric element 36) and a second MEMS device (thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device (Col. 9, lines 27-34); and adjusting the flow rate pumped by the pumping unit continually(Fig.10, Col. 15, line 61 up to Col. 16, line 20) to reduce a difference between actual flow rate measured off of the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device (Fig. 11b, 154) to the patient to determine if that the actual flow rate of the medication delivered is converted flow rate (target) commanded for medication delivery (Fig. 11b, Col. 11, lines 44-60, the predetermined value, Fig.10, Col. 15, line 61 up to Col. 16, line 20, see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication flow rate control of the method of Cinar so that the first device is a first MEMS device and a second micro- electro-mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device, (b) adjusting the flow rate pumped by the pumping unit continually to reduce a difference between an actual flow rate measured in the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 37, Cinar discloses a converted flow rate from the glucose level measured by the continuous glucose monitoring device (30, CGM device ¶0006, ¶0075-¶0076), but it fails to disclose wherein adjusting the flow rate includes comparing the actual flow rate with the converted flow rate and generating a difference between the actual flow rate measured in the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and adjusting the flow rate pumped by the pumping unit continually(Fig.10, Col. 15, line 61 up to Col. 16, line 20) to reduce a difference between actual flow rate measured off of the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device (Fig. 11b, 154) and adjusting the flow rate includes comparing the actual flow rate with the converted flow rate and generating the difference between actual flow rate measured off of the pumping unit and a converted flow rate (Fig. 11b, Col. 11, lines 44-60, the predetermined value).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication flow rate control of the method of Cinar so that adjusting the flow rate includes comparing the actual flow rate with the converted flow rate and generating a difference between the actual flow rate measured in the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 37, Cinar fails to disclose wherein the difference is reduced to zero value.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the microcontroller unit is further configured to command the first MEMS device to adjust flow rate continually (Fig.10, Col. 15, line 61 up to Col. 16, line 20), in response to subsequent comparison between flow rate generated by the continuous glucose monitoring device (Col. 20, lines 46-65) and actual flow rate from the first MEMs device until an error signal is reduced to zero ( Fig.10, Col. 15, line 61 up to Col. 16, line 20, the closed-loop control define as to reduce the error in the difference between the target and the delivered and when they are equal to each other/zero error see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Cinar so that the difference (difference between actual flow rate and a converted flow rate) is reduced to zero value as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 39, Cinar fails to disclose wherein adjusting the flow rate includes monitoring an actual flow rate of medication delivered to the patient to determine if that the actual flow rate of the medication delivered is the flow rate commanded for medication delivery.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises; a reservoir (Col. 7, lines 15-20) , a needle (92 (Fig. 4); a controller (132, Fig. 10) and flow sensors (a disk-type piezoelectric element 36, thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) and adjusting the flow rate pumped by the pumping unit continually(Fig.10, Col. 15, line 61 up to Col. 16, line 20) to reduce a difference between actual flow rate measured off of the pumping unit and a converted flow rate converted from the glucose level measured by the continuous glucose monitoring device (Fig. 11b, 154) and adjusting the flow rate includes monitoring an actual flow rate of medication delivered to the patient to determine if that the actual flow rate of the medication delivered is the flow rate commanded for medication delivery (Fig. 11b, Col. 11, lines 44-60, the predetermined value).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication flow rate control of the method of Cinar so that the method comprises the step of adjusting the flow rate includes monitoring an actual flow rate of medication delivered to the patient to determine if that the actual flow rate of the medication delivered is the flow rate commanded for medication delivery as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication (Connelly, Col. 11, lines 30-40).
Re claim 40, Cinar discloses wherein the medication is insulin (¶0037, the insulin is delivered subcutaneously and pumped by the pump through a conduit to the patient, ¶0078).
Re claim 41, Cinar discloses wherein and the patient is a user of the device (¶0004, ¶0062).
Re claim 42, Cinar discloses a device for delivering a medication to a user in a drug infusion system (Fig. 1, abstract, ¶0006, ¶0053), the device configured as integrated wearable apparatus for managing the medication delivery (the device has CGM sensor, ¶0006, and SENSEWEAR armband, ¶0034, ¶0054), the device comprising: a reservoir for storing the medication to be delivered to the user (¶0038, reservoir for insulin, ¶0037); a first device configured to pump the medication from the reservoir along a flow path to the needle (¶0037, the insulin is delivered subcutaneously and pumped by the pump through a conduit to the patient, ¶0078 using a pumping unit 50); a needle for delivering the medication from reservoir into the user (a conduit to the patient for delivering the insulin subcutaneously, ¶0078); and a continuous glucose monitoring device for monitoring glucose levels in the user (30, CGM device ¶0006, ¶0034, ¶0054), wherein the continuous glucose monitoring device is configured to measure a glucose level (¶0034, ¶0054) and converting that glucose level to a first flow rate of medication based on the glucose level measured (¶0038, ¶0075); and a microcontroller unit (40, ¶0075-¶0076) for receiving and converting the glucose levels from the continuous glucose monitoring device into instructions by control algorithms within the microcontroller unit and for commanding the first device to deliver the medication from the reservoir through the needle at the first flow rate based on the converted instructions (¶0038, ¶0075); but it fails to disclose that the first device is MEMS device and a second micro-electro mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the; flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device; wherein the microcontroller unit is configured to monitor an actual flow rate of medication delivered to the user to determine if that the actual flow rate of the medication delivered is the first flow rate commanded for medication delivery.
However, Connelly discloses a medication dosage control and medication flow rate control (Figs. 1-22, abstract, Col. 3, lines 1-27) and wherein the device (30. 34) comprises a pump unit (membrane under 36, Fig.7) the pumping unit includes first MEMS device ( 36 is piezoelectric actuator, Col. 9, lines 29-25 see ¶0028 the current application that include that memes can be piezoelectric ) and a second MEMS device (a thermal emitter 38 and thermal detector 40 extend slightly beyond the bottom surface of the bottom cover 46, Fig. 2) configured as a sensor to measure the actual flow rate of medication at the first MEMS device (Col. 9, lines 27-34); wherein the microcontroller unit is configured to monitor an actual flow rate of medication delivered to the user to determine if that the actual flow rate of the medication delivered is the first flow rate commanded for medication delivery (Fig. 11b, 154, Fig. 11b, Col. 11, lines 44-60, the predetermined value, Fig.10, Col. 15, line 61 up to Col. 16, line 20, see Col. 14, lines 10-23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified device of Cinar so that that the first device is MEMS device and a second micro-electro mechanical systems (MEMS) device in series with the first MEMS device and configured to enable fluid to flow through the first and second MEMS device along the; flow path, the second MEMS device further configured as a sensor to measure an actual flow rate of medication at the first MEMS device; wherein the microcontroller unit is configured to monitor an actual flow rate of medication delivered to the user to determine if that the actual flow rate of the medication delivered is the first flow rate commanded for medication delivery as taught by Connelly for the purpose of providing a precise control over the flow rate of the liquid medication using a precise controlling element (Connelly, Col. 7, lines 50-68).
Re claim 43, the modified Cinar discloses wherein the first and second MEMS devices are integrated or separate (36, 38/40 of Connelly, Col. 9, lines 27-35).
Response to Arguments
Applicant's arguments filed 11/5/2025 have been fully considered but they are not persuasive. The applicant argues with regards to claims 27, 36 and 42 that Cinar and Connelly fails to discloses a first MEMS device and a second MEMS device in series with the first MEMS device with regards to the measuring the actual flow rate. This is found not persuasive as Connelly does disclose the first valve ( pump like 36) and a second flow sensor devices (38, 40) in series see Fig. 7 of Connelly and the second MEMS device measure the actual flow rate and the controller control the target flow and the actual flow rate and adjust the pump accordingly.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783