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 1-24 are canceled and claim 25-49 are newly added and filed on 7/21/2025.
Specification was amended and field on 7/17/2025.
Claim Objections
Claims 25, 27-28, 32, 48 are objected to because of the following informalities:
Please spell out the terms “MEMS” at the first appearance in claim 25, line 8.
In line 2 of claim 27, the limitation “valve actuator” should be “a vale actuator”.
Please spell out the terms “/” in line 1 of claim 28.
Please spell out the terms “/” in last two lines of claim 32.
Please spell out the terms “/” in line 15 of claim 48.
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 32, 38, 45-49 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 32 recites the limitation "a pumping unit…(a ) a pump…(b) a valve” in lines 1-3. It is unclear if is referring to the limitation in claim 25, lines 8-13 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 25 such as "[[a ]] the pumping unit…(a ) a second pump…(b) a second active valve” .
Claim 38 recites “the pumping actuator and valve actuator” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Also, it is unclear if it claim 38 should be depends on claim 37 and claim 37 should depends on claim 36 as “pump actuator” is in claim 36 and “valve actuator” is in claim 37.
Claim 45 recites the limitation "for medication delivery…storing the medication….delivering the medication…regulate flow of the medication …pumping the medication” in lined 5-last.. It is unclear if it is referring to the “insulin delivery” in line 2 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation and amend the limitation such as ” for
Claim 46 recites “the pumping actuator and valve actuator” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Also, it is unclear which valve it is referring to see line 10. Does it refers to inlet valve or outlet valve?.
Claim 47 recite the limitation “a membrane” in line 5. It is unclear if it is referring to the limitation “a common membrane “in line 9 of claim 45 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation and amend the limitation such as “[[a]] the common membrane”.
Claim 48 recites the limitation "storing the medication… pumping the medication...flow of the medication…cause the medication” in lined 3-last.. It is unclear if it is referring to the “insulin delivery” in line 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation and amend the limitation such as ”storing the
Claim 49 recites “the pumping actuator and valve actuator” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Also, it is unclear if is referring to pump actuator only see last 5 lines of claim 48.
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) 25-46, 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinar et al. (US. 20110106011A1) ("Cinar") in view of Yeshurun et al. (US 20040019331A1) ("Yeshurun ").
Re claim 25, Cinar discloses a device (Fig. 1, abstract, ¶0006, ¶0053) for delivering a medication to a patient (¶0053), the device configured as a wearable apparatus (CGM sensor, ¶0006 and SENSWEAR armbands, ¶0034, ¶0054), the device comprising: a reservoir for storing the medication to be delivered to the patient (reservoir ¶0037, ¶0038); a continuous glucose monitoring device (CGM 30, ¶0006, ¶0054, Fig. 1) configured to be inserted into tissue of the patient for monitoring glucose levels in the patient to set flow rates for medication delivery (¶0037, set up the insulin rate); a needle for delivering the medication from reservoir into the patient (the insulin delivery subcutaneous means that there is a needle for injection, ¶0054, ¶0078); and a pumping unit (50, Fig. 1), but it fails to disclose that the pimp unit including a first MEMS device and a second MEMS device configured in series with a common membrane and flow path to enable medication to flow between the first MEMS device and the second MEMS device along the flow path, the first MEMS device configured to function as a pump for pumping the medication from the reservoir through the flow path to the needle at set flow rates and the second MEMS device configured to function as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle.
However, Yeshurun discloses a device (Fig. 11- 17) for delivering a medication to a patient in a drug infusion system (¶0002), the device configured as a fully autonomous (¶0132 closed-loop system accessible) and the device comprising: a reservoir (130), a continuous glucose monitoring device (¶0134 closed-loop system has continuous monitoring) for monitoring glucose levels (¶0121) and a pumping unit (112, 116, 118) including one or more MEMS devices (Abstract, pumping configurations are MEMs; ¶0119 MEMs flow valves included in pumping unit) configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle (¶0116, pump112) and an active valve (118) for regulating flow of the medication in the flow path from the reservoir through the needle (¶0119 one way valve 118 is implemented using micro-electromechanical structures) configured in series with a common membrane (membrane between 112 and valves 116, 118) and flow path to enable medication to flow between the first MEMS device and the second MEMS device along the flow path (flow path from reservoir toward needle chamber, Fig. 16), and the second MEMs act as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle (¶0117).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the pumping unit including a first MEMS device and a second MEMS device configured in series with a common membrane and flow path to enable medication to flow between the first MEMS device and the second MEMS device along the flow path, the first MEMS device configured to function as a pump for pumping the medication from the reservoir through the flow path to the needle at set flow rates and the second MEMS device configured to function as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 26, Cinar fails to disclose wherein the first MEMS device includes as a pumping section comprising a pumping chamber, pumping actuator and the membrane between the pumping chamber and pumping actuator, the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the first MEMS device (112) includes as a pumping section comprising a pumping chamber (chamber 112, Fig. 12), pumping actuator (¶0030, 124, ¶0118), and the membrane (114, Fig. 22) between the pumping chamber and pumping actuator (Fig, 22), the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the first MEMS device includes as a pumping section comprising a pumping chamber, pumping actuator and the membrane between the pumping chamber and pumping actuator, the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 27, Cinar fails to disclose wherein the second MEMS device includes an active valve comprising a valve chamber, valve actuator and the membrane between the valve chamber and valve actuator, the valve actuator configured to move the membrane and prevent or permit medication to flow along the flow path.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the second MEMS device includes an active valve (118) comprising a valve chamber ( chamber between 116 and 118), valve actuator (124 or 126) and the membrane between the valve chamber and valve actuator (Fig. 22), the valve actuator configured to move the membrane and prevent or permit medication to flow along the flow path (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the second MEMS device includes an active valve comprising a valve chamber, valve actuator and the membrane between the valve chamber and valve actuator, the valve actuator configured to move the membrane and prevent or permit medication to flow along the flow path as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 28, Cinar fails to disclose wherein the first MEMS device and/or second MEMS device includes an actuator for moving the membrane to control flow of the medication along the flow path.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the first MEMS device and/or second MEMS device includes actuator (124 or 126) for moving the membrane to control flow of the medication along the flow path (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the first MEMS device and/or second MEMS device includes an actuator for moving the membrane to control flow of the medication along the flow path as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 29, Cinar fails to disclose wherein the actuator includes a piezoelectric transducer.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the first MEMS device and/or second MEMS device includes actuator (124 or 126) and wherein the actuator 124 includes a piezoelectric transducer (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the actuator includes a piezoelectric transducer as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 30, Cinar discloses further comprises a microcontroller unit (40, ¶0075-¶0076) in communication with the continuous glucose monitoring device (Fig, 1, ¶0075) and pumping unit (Fig. 1), the microcontroller unit configured to control the operation of pumping unit to deliver medication from the reservoir through the needle at the set flow rates over specified time intervals based on data from the continuous glucose monitoring device (¶0038, ¶0075) and a battery and power controller (¶0031) in communication with the pumping unit and microcontroller for powering the pumping unit and microcontroller unit (Fig. 1 , ¶0031).
Re claim 31, Cinar discloses wherein the continuous glucose monitoring device is powered by the battery and power controller via the microcontroller unit (¶0031).
Re claim 32, Cinar fails to disclose wherein a pumping unit further including a third MEMS device configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle, the first, second and third MEMS devices configured in series with the common membrane and flow path or regulating flow of the medication in the flow path from the reservoir through the needle or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device.
However, Yeshurun discloses that the pump unit (Fig. 11-22) including a third MEMS device (116) configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle or (b) a valve (¶0116) for regulating flow of the medication in the flow path from the reservoir through the needle (¶0116), the first, second and third MEMS devices configured in series with the common membrane and flow path or regulating flow of the medication in the flow path from the reservoir through the needle (Fig. 16) or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that a pumping unit further including a third MEMS device configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle, the first, second and third MEMS devices configured in series with the common membrane and flow path or regulating flow of the medication in the flow path from the reservoir through the needle or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 33, Cinar discloses wherein the medication is insulin and the patient is a user with diabetes (¶0052).
Re claim 34, the modified Cinar discloses wherein the pumping unit and needle are connected directly without tubing (Fig. 1 of Cinar, Fig. 16 of Yeshurun).
Re claim 35, Cinar discloses a device (Fig. 1, abstract, ¶0006, ¶0053) for delivering a medication to a patient (¶0053), the device configured as a wearable apparatus for managing the medication delivery (CGM sensor, ¶0006 and SENSWEAR armbands, ¶0034, ¶0054), the device comprising: a continuous glucose monitoring device (CGM 30, ¶0006, ¶0054, Fig. 1) configured to be inserted into tissue of the patient for monitoring glucose levels in the patient to set flow rates for medication delivery to the patient (¶0054); a reservoir for storing the medication to be delivered to the patient (reservoir ¶0037, ¶0038); a needle for delivering the medication from reservoir into the patient (needle for injection, ¶0054, ¶0078); but it fails to disclose first and second MEMS devices in communication with the reservoir and the needle, the first MEMS device and a second MEMS device configured in series with a common flow path to enable medication to flow between the first MEMS device and the second MEMS device through the flow path, the first MEMS device configured to function as a pump for pumping the medication along a flow path of medication from the reservoir to the needle and the second MEMS device configured as a valve for regulating flow of the medication along the flow path.
However, Yeshurun discloses a device (Fig. 11- 17) for delivering a medication to a patient in a drug infusion system (¶0002), the device configured as a fully autonomous (¶0132 closed-loop system accessible) and the device comprising: a reservoir (130), a continuous glucose monitoring device (¶0134 closed-loop system has continuous monitoring) for monitoring glucose levels (¶0121) and a pumping unit (112, 116, 118) including one or more MEMS devices (Abstract, pumping configurations are MEMs; ¶0119 MEMs flow valves included in pumping unit) configured in series with a common flow path ( from reservoir to the needle, Fig, 16) to enable medication to flow between the first MEMS device and the second MEMS device through the flow path (¶0118) and first MEMS is configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle (¶0116, pump112) and second mems acts as an active valve (118) for regulating flow of the medication in the flow path from the reservoir through the needle (¶0119 one way valve 118 is implemented using micro-electromechanical structures) configured in series with a common membrane (membrane between 112 and valves 116, 118) and flow path to enable medication to flow between the first MEMS device and the second MEMS device along the flow path (flow path from reservoir toward needle chamber, Fig. 16), and the second MEMs act as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle (¶0117).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that first and second MEMS devices in communication with the reservoir and the needle, the first MEMS device and a second MEMS device configured in series with a common flow path to enable medication to flow between the first MEMS device and the second MEMS device through the flow path, the first MEMS device configured to function as a pump for pumping the medication along a flow path of medication from the reservoir to the needle and the second MEMS device configured as a valve for regulating flow of the medication along the flow path as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 36, Cinar fails to disclose wherein the first MEMS device comprises a pumping section including a pumping chamber along the flow path, a pumping actuator and a membrane between the actuator and pumping chamber to thereby drive the medication through the pumping chamber along the flow path.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the first MEMS device (112) includes as a pumping section comprising a pumping chamber along flow path (chamber 112, Fig. 12), pumping actuator (¶0030, 124, ¶0118), and the membrane (114, Fig. 22) between the pumping chamber and pumping actuator (Fig, 22), the pumping actuator configured to move the membrane to drive the medication through the pumping chamber (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the first MEMS device comprises a pumping section including a pumping chamber along the flow path, a pumping actuator and a membrane between the actuator and pumping chamber to thereby drive the medication through the pumping chamber along the flow path as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 37, Cinar fails to disclose wherein the valve includes (a) a valve chamber in communication with the pumping chamber to enable medication to flow through pumping section and valve along the flow path, (b) a valve actuator and (c) the membrane of the pumping section positioned between the valve actuator and the valve chamber.
However, Yeshurun discloses that the pump unit (Fig. 11-22) comprising the second MEMS device includes an active valve (118) comprising a valve chamber ( chamber between 116 and 118) to enable medication to flow through pumping section and valve along the flow path (¶0118, Fig. 16), valve actuator (124 or 126) and the membrane between the valve chamber and valve actuator (Fig. 22), the valve actuator configured to move the membrane and prevent or permit medication to flow along the flow path (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the valve includes (a) a valve chamber in communication with the pumping chamber to enable medication to flow through pumping section and valve along the flow path, (b) a valve actuator and (c) the membrane of the pumping section positioned between the valve actuator and the valve chamber as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 38, the modified Cinar discloses wherein the pumping actuator and valve actuator each include a piezoelectric transducer for moving the membrane (Yeshurun, ¶0118, ¶0136).
Re claim 39, Cinar fails to disclose further including a third MEMS device (116) adjacent first MEMS device configured to function as a valve for regulating flow of the medication from the reservoir through the needle.
However, Yeshurun discloses that the pump unit (Fig. 11-22) including a third MEMS device (116) configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle or (b) a valve (¶0116) for regulating flow of the medication in the flow path from the reservoir through the needle (¶0116), the first, second and third MEMS devices configured in series with the common membrane and flow path or regulating flow of the medication in the flow path from the reservoir through the needle (Fig. 16) or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so including a third MEMS device (116) adjacent first MEMS device configured to function as a valve for regulating flow of the medication from the reservoir through the needle as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 40, the modified Cinar discloses wherein the first, second and third MEMS devices are configured in series (Fig. 16 of Yeshurun).
Re claim 41, Cinar discloses wherein the medication is insulin and the patient is a user with diabetes (¶0052).
Re claim 42, Cinar discloses further comprises a microcontroller unit (40, ¶0075-¶0076) in communication with the continuous glucose monitoring device (Fig, 1, ¶0075), the microcontroller unit configured to control the operation of the first and second MEMS devices to deliver medication from the reservoir through the needle at the set flow rates over specified time intervals based on data from the continuous glucose monitoring device (¶0038, ¶0075), but it fails to disclose that the controller is in communication with and first and second MEMS devices.
However, Yeshurun discloses that the pump unit (Fig. 11-22) including the controller is in communication with and first and second MEMS devices (¶0118).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the controller is in communication with and first and second MEMS devices as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0131).
Re claim 43, the modified Cinar discloses further comprises a battery (¶0031) and power controller in communication with the first and second MEMS devices and microcontroller for powering the first and second MEMS devices and microcontroller unit (¶0031).
Re claim 44, the modified Cinar discloses wherein the continuous glucose monitoring device is powered by the battery and power controller via the microcontroller unit (¶0031).
Re claim 45, Cinar discloses a device (Fig. 1, abstract, ¶0006, ¶0053) for delivering a insulin to a patient (¶0053), the device configured as a wearable apparatus for delivery of the insulin (CGM sensor, ¶0006 and SENSWEAR armbands, ¶0034, ¶0054), the device comprising: a continuous glucose monitoring device (CGM 30, ¶0006, ¶0054, Fig. 1) configured to be inserted into tissue of the patient for monitoring glucose levels in the patient to set flow rates for medication delivery to the patient (¶0054); a reservoir for storing the medication to be delivered to the patient (reservoir ¶0037, ¶0038); a needle for delivering the medication from reservoir into the patient (needle for injection, ¶0054, ¶0078); but it fails to disclose a plurality of MEMS devices in communication with the reservoir and needle, the plurality of MEMS devices configured in series with a common membrane and flow path, the plurality of MEMS devices including an inlet valve and outlet valve that function as active valves to regulate flow of the medication along the flow path and a pumping section between the inlet and out valves, the pumping section configured as a pump for pumping the medication along the flow path from the reservoir to the needle.
However, Yeshurun discloses a device (Fig. 11- 17) for delivering a medication to a patient in a drug infusion system (¶0002), the device configured as a fully autonomous (¶0132 closed-loop system accessible) and the device comprising: a reservoir (130), a continuous glucose monitoring device (¶0134 closed-loop system has continuous monitoring) for monitoring glucose levels (¶0121) and a pumping unit (112, 116, 118) including one or more MEMS devices (Abstract, pumping configurations are MEMs; ¶0119 MEMs flow valves included in pumping unit) configured in series with a common flow path ( from reservoir to the needle, Fig, 16) to enable medication to flow between the first MEMS device and the second MEMS device through the flow path (¶0118) and first MEMS is configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle (¶0116, pump112) and second MEMES acts as inlet active valve (118) and a third MEMES act as outlet valve (116, Fig. 16) for regulating flow of the insulin in the flow path from the reservoir through the needle (¶0119 one way valve 116 and 118 are implemented using micro-electromechanical structures) configured in series with a common membrane (membrane between 112 and valves 116, 118) and flow path to enable medication to flow between the first MEMS device and the second and third MEMS devices along the flow path (flow path from reservoir toward needle chamber, Fig. 16), and the second MEMs act as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle (¶0117).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that a plurality of MEMS devices in communication with the reservoir and needle, the plurality of MEMS devices configured in series with a common membrane and flow path, the plurality of MEMS devices including an inlet valve and outlet valve that function as active valves to regulate flow of the medication along the flow path and a pumping section between the inlet and out valves, the pumping section configured as a pump for pumping the medication along the flow path from the reservoir to the needle as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 46, the modified Cinar discloses wherein the pumping actuator and valve actuator include a piezoelectric transducer (Yeshurun, ¶0118, ¶0136).
Re claim 48, Cinar discloses a device (Fig. 1, abstract, ¶0006, ¶0053) for delivering insulin to a patient that is a user with diabetes (¶0053, ¶0119), the device configured as a wearable apparatus (CGM sensor, ¶0006 and SENSWEAR armbands, ¶0034, ¶0054), the device comprising: a reservoir for storing the medication to be delivered to the patient (reservoir ¶0037, ¶0038); a continuous glucose monitoring device (CGM 30, ¶0006, ¶0054, Fig. 1) configured to be inserted into tissue of the patient for monitoring glucose levels in the patient to set flow rates for delivery of insulin (¶0037, set up the insulin rate); a needle for delivering the insulin from reservoir into the patient (the insulin delivery subcutaneous means that there is a needle for injection, ¶0054, ¶0078); and a pumping unit (50, Fig. 1), but it fails to disclose that the pumping unit including a first MEMS device and a second MEMS device configured in series with a common membrane and flow path to enable the insulin to flow between the first MEMS device and the second MEMS device along the flow path, the first MEMS device and second MEMS device are each configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle at set flow rates or (b) an active valve for regulating flow of the medication in the flow path from the reservoir through the needle or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device, wherein first MEMS device and second MEMS device each includes as a pumping section comprising a pumping chamber, pumping actuator and the membrane between the pumping chamber and pumping actuator, the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber.
However, Yeshurun discloses a device (Fig. 11- 17) for delivering a medication to a patient in a drug infusion system (¶0002), the device configured as a fully autonomous (¶0132 closed-loop system accessible) and the device comprising: a reservoir (130), a continuous glucose monitoring device (¶0134 closed-loop system has continuous monitoring) for monitoring glucose levels (¶0121) and a pumping unit (112, 116, 118) including one or more MEMS devices (Abstract, pumping configurations are MEMs; ¶0119 MEMs flow valves included in pumping unit) configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle (¶0116, pump112) and an active valve (118) for regulating flow of the medication in the flow path from the reservoir through the needle (¶0119 one way valve 118 is implemented using micro-electromechanical structures) configured in series with a common membrane (membrane between 112 and valves 116, 118) and flow path to enable medication to flow between the first MEMS device and the second MEMS device along the flow path (flow path from reservoir toward needle chamber, Fig. 16), and the second MEMs act as an active valve for regulating flow of the medication in the flow path from the reservoir through the needle (¶0117) and wherein first MEMS device and second MEMS device each includes as a pumping section comprising a pumping chamber (112 or chamber between 116 and 118), pumping actuator (124) and the membrane (114) between the pumping chamber and pumping actuator, the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber (¶0118, ¶0119).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that pumping unit including a first MEMS device and a second MEMS device configured in series with a common membrane and flow path to enable the insulin to flow between the first MEMS device and the second MEMS device along the flow path, the first MEMS device and second MEMS device are each configured to function as (a) a pump for pumping the medication from the reservoir through a flow path to the needle at set flow rates or (b) an active valve for regulating flow of the medication in the flow path from the reservoir through the needle or (c) a sensor for sensing pressure, insulin flow or air in the first MEMS device and/or second MEMS device, wherein first MEMS device and second MEMS device each includes as a pumping section comprising a pumping chamber, pumping actuator and the membrane between the pumping chamber and pumping actuator, the pumping actuator configured to move the membrane and cause medication to flow into and out of the pumping chamber as taught by Yeshurun for the purpose of having unit with greater reliability and speed of response (Yeshurun, ¶0119).
Re claim 49, Cinar discloses wherein the pumping actuator and valve actuator each include a piezoelectric transducer for deforming the membrane (Yeshurun, ¶0118).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinar in view of Yeshurun and further in view of Maguire (US 20180117243 A1).
Re claim 47, the modified Cinar discloses wherein the pumping section comprises a pumping chamber (112, Yeshurun) that communicates with the valve chamber of the inlet valve and outlet valve (Yeshurun , Fig. 16) and a pumping actuator (124, Yeshurun) and a membrane (114, Yeshurun) between the actuator and pumping chamber (Fig. 16), whereby the actuator causes the membrane to move and drive insulin along the flow path from the inlet valve chamber into the pumping chamber and out through the outlet valve chamber (¶0118-¶0119, Yeshurun), but it fails to discloses wherein the inlet valve and outlet valve each comprises a valve chamber, a valve actuator and the membrane between the valve actuator and valve chamber.
However, Maguire discloses a device (Fig. 1-4) and the inlet valve (let valve has 44 and outlet valve (right valve has 50) each comprises a valve chamber (chamber right 44 and chamber 50), a valve actuator (46, 54, ¶0066) and the membrane (48, 56) between the valve actuator and valve chamber.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Cinar so that the inlet valve and outlet valve each comprises a valve chamber, a valve actuator and the membrane between the valve actuator and valve chamber as taught by Maguire for the purpose of controlling the flow and restrict the backflow (Maguire, ¶0066 ).
Response to Arguments
Applicant’s arguments, see remark filed on 7/17/2025 with respect to the rejection(s) of claim(s)1 under Yeshurun have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Cinar in view of Yeshurun .
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 Custom.
/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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