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 .
Status of Claims
This office action is responsive to the amendment filed 29 July 2025.
Claims 6-9 are canceled.
Claims 1, 4, and 5 are amended.
Claims 10-21 are added.
Claims 1-5 and 10-21 are presently pending in this application.
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 13 and 14 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.
Claims 13 and 14 recite the limitation "the flow path" in lines 2 and 3 of both claims. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the flow path” to mean –the fluid path--.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Iddan et al. (US Patent Application No. 20080234630 A1), hereinafter Iddan, in view of Chong et al. (US Patent No. 8979808 B1), hereinafter Chong.
Regarding claim 1, Iddan discloses a device (Iddan: Fig. 1-4, system 1000) for delivering medication to a user (system 1000 is directed to an insulin infusion device; para. 0007), the device configured as a wearable apparatus (system 1000 is autonomous, has integrated controller 12, and is adhered to the skin of the user; para. 0058 and 0070), the device (Fig. 1-4, system 1000) comprising: a reservoir (Fig. 1-4, reservoir 4 is pressurized when full; para. 0072) for storing a medication (reservoir 4 is for containing therapeutic fluid to be infused; para. 0054) for subsequent delivery of the medication to the user (reservoir 4 is for containing therapeutic fluid to be infused into a patient; para. 0054); a needle (Fig. 1, cannula 82) for delivering the medication (fluid is delivered through cannula 82 into the patient subcutaneously from reservoir 4; para. 0055 and 0056) to the user subcutaneously (fluid is delivered subcutaneously; para. 0055); a microvalve (Fig. 5a-c, inlet valve 36 and outlet valve 40) in a fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) between the reservoir and needle (Fig. 1, valves 36 and 40 of pump 6 are between the reservoir 4 and cannula 82 of delivery tool 8; para. 0056) for controlling flowrate of medication (valves 36 and 40 can be opened or closed, allowing or preventing fluid passage respectively; para. 0082) through the needle (Fig. 1, cannula 82) as the reservoir (Fig. 1-4, reservoir 4 is pressurized when full; para. 0072) discharges (para. 0056); a micropump (Fig. 1-5a, pump 6) configured to increase flowrate of the medication (pump 6 enables precise flow rate manipulation; para. 0079) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056); wherein the micropump (Fig. 1-5a, pump 6) and microvalve (Fig. 5a-c, inlet valve 36 and outlet valve 40) function together to control the flowrate and pressure in the fluid path (valves 36 and 40 can be opened or closed, allowing or preventing fluid passage respectively, alongside precise flowrate manipulation by the pump 6; para. 0079 and 0082); a flow sensor (Fig. 1, sensors 30) configured to measure flowrate (sensors 30 provide flow rate measurements downstream of pump 6; para. 0076) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) for controlling the microvalve and micropump (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120); and control circuitry (Fig. 1, controller 12) connected to the microvalve, micropump and flow sensor (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120) for controlling operation of the micropump and microvalve (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120).
Iddan does not expressly disclose a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges.
Chong teaches a self-pressurized reservoir (Chong: Fig. 29, pressurized reservoir 1306), wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges (therapeutic agent is released through the injection device via pressurized reservoir 1306; col 16, ln 32-40). Examiner interprets that the self-pressurized reservoir of Chong is analogous to the self-pressurized reservoir of the present application and, therefore, would be expected to operate in the same manner, thereby allowing the device to operate at any orientation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reservoir of Iddan such that it is a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges as taught by Chong in order to a desired pressurization for the therapeutic fluid (Chong: col 13, ln 66 – col 14, ln 5).
Regarding claim 2, Iddan in view of Chong discloses the device above, wherein the micropump and/or microvalve (Iddan: Fig. 5a, valves 36 and 40) includes one or more MEMS devices (valves 36 and 40 are electromagnetically openable and closeable and implement MEMS; para. 0064 and 0076) that provide pumping and/or valve functionality (valves 36 and 40 are electromagnetically openable and closeable and implement MEMS; para. 0064 and 0076).
Regarding claim 3, Iddan in view of Chong discloses the device above, wherein the micropump (Iddan: Fig. 1-5, pump 6) is configured to increase pressure (pump 6 enables precise flow rate manipulation; para. 0079) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) at a time in which flowrate decreases beyond a level (pump 6 guarantees selected set flow rate is held steady, irrespective of backpressure variations; para. 0079).
Regarding claim 4, Iddan in view of Chong discloses the device above, wherein the user is a patient with diabetes (Iddan: para. 0002).
Regarding claim 5, Iddan in view of Chong discloses the device above, wherein the medication is insulin (Iddan: para. 0054).
Regarding claim 11, Iddan in view of Chong discloses the device above, wherein the micropump (Iddan: Fig. 1-5, pump 6) is configured as a booster pump in the fluid path to ensure constant flowrate as the pressure drops in the fluid path (pump 6 guarantees selected set flow rate is held steady, irrespective of backpressure variations; para. 0079).
Regarding claim 12, Iddan discloses a device (Iddan: Fig. 1-4, system 1000) for delivering medication to a user (system 1000 is directed to an insulin infusion device; para. 0007), the device configured as a wearable apparatus (system 1000 is autonomous, has integrated controller 12, and is adhered to the skin of the user; para. 0058 and 0070), the device (Fig. 1-4, system 1000) comprising: a reservoir (Fig. 1-4, reservoir 4 is pressurized when full; para. 0072) for storing a medication (reservoir 4 is for containing therapeutic fluid to be infused; para. 0054) for subsequent delivery to a patient (reservoir 4 is for containing therapeutic fluid to be infused into a user; para. 0054); a needle (Fig. 1, cannula 82) for delivering the medication (fluid is delivered through cannula 82 into the patient subcutaneously from reservoir 4; para. 0055 and 0056) to the user subcutaneously (fluid is delivered subcutaneously; para. 0055); a first MEMS device (valves 36 and 40 are electromagnetically openable and closeable and implement MEMS; para. 0064 and 0076) configured as a microvalve (inlet valve 36 and outlet valve 40) in a fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) between the reservoir and needle (Fig. 1, valves 36 and 40 of pump 6 are between the reservoir 4 and cannula 82 of delivery tool 8; para. 0056) for controlling flowrate of medication (valves 36 and 40 can be opened or closed, allowing or preventing fluid passage respectively; para. 0082) through the needle (Fig. 1, cannula 82) as the self- pressurized reservoir (Fig. 1-4, reservoir 4 is pressurized when full; para. 0072) discharges (para. 0056); and a second MEMs device (pump 6 implements an electromagnetic membrane pump 61, which operates using membrane 38; para. 0080) configured as a micropump (Fig. 1-5a, pump 6) configured to increase flowrate of the medication (pump 6 enables precise flow rate manipulation; para. 0079) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) to ensure a constant flowrate (pump 6 guarantees selected set flow rate is held steady, irrespective of backpressure variations; para. 0079) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) as a pressure decreases as the reservoir (Fig. 1-4, reservoir 4 is pressurized when full; para. 0072) discharges (para. 0056); wherein the first MEMS device (Fig. 5a-c, inlet valve 36 and outlet valve 40) and second MEMS device (Fig. 5a-c) function together to control the flowrate and pressure in the fluid path (valves 36 and 40 can be opened or closed, allowing or preventing fluid passage respectively, alongside precise flowrate manipulation by the pump 6; para. 0079 and 0082); a flow sensor (Fig. 1, sensors 30) configured to measure flowrate (sensors 30 provide flow rate measurements downstream of pump 6; para. 0076) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056) for controlling the microvalve and micropump (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120); and control circuitry (Fig. 1, controller 12) connected to the first MEMS device, the second MEMS device, and flow sensor (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120) for controlling operation of the first MEMS device and second MEMS device (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120).
Iddan does not expressly disclose a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges.
Chong teaches a self-pressurized reservoir (Chong: Fig. 29, pressurized reservoir 1306), wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges (therapeutic agent is released through the injection device via pressurized reservoir 1306; col 16, ln 32-40). Examiner interprets that the self-pressurized reservoir of Chong is analogous to the self-pressurized reservoir of the present application and, therefore, would be expected to operate in the same manner, thereby allowing the device to operate at any orientation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reservoir of Iddan such that it is a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges as taught by Chong in order to a desired pressurization for the therapeutic fluid (Chong: col 13, ln 66 – col 14, ln 5).
Regarding claim 13, Iddan in view of Chong discloses the device above, wherein the first and second MEMS devices (Fig. 5a-c, inlet valve 36 and outlet valve 40 and pump 6) are in series (Fig. 5a-c, membrane 38 is between valves 36 and 40 in sequence) wherein the second MEMS (Fig. 5a-c, membrane 38) device follows the first MEMS device (Fig. 5a, membrane 38 follows valve 36 in series) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056).
Regarding claim 14, Iddan in view of Chong discloses the device above, wherein the first and second MEMS devices (Fig. 5a-c, inlet valve 36 and outlet valve 40 and pump 6) are in series (Fig. 5a-c, membrane 38 is between valves 36 and 40 in sequence) wherein the second MEMS (Fig. 5a-c, membrane 38) device follows the first MEMS device (Fig. 5a, membrane 38 follows valve 36 in series) in the fluid path (Fig. 1, comprised of reservoir 4, pump 6, tube 50, valve 32, and delivery tool 8; para. 0056).
Regarding claim 15, Iddan in view of Chong discloses the device above, wherein the medication is insulin (Iddan: para. 0054).
Regarding claim 16, Iddan in view of Chong discloses the device above, wherein the user is a patient with diabetes (Iddan: para. 0002).
Regarding claim 17, Iddan teaches a device (Fig. 1-4, system 1000) for delivering fluid to a user (system 1000 is directed to an insulin infusion device), the device (Fig. 1-4, system 1000) comprising: a reservoir (Fig. 1-4, reservoir 4) for storing the fluid (Fig. 1-4, reservoir 4 is for containing fluid; para. 0054), the reservoir (Fig. 1-4, reservoir 4) being configured to be self-pressurized(Fig. 1-4, reservoir 4 is pressurized when full; para. 0072); a needle (Fig. 1, cannula 82) for delivering the fluid to the user subcutaneously (fluid is delivered through cannula 82 into the patient subcutaneously from reservoir 4; para. 0055 and 0056); a microvalve (Fig. 5a, inlet valve 36 and outlet valve 40) communicating with the reservoir (Fig. 1, valves 36 of pump 6 are downstream from reservoir 4; para. 0056) for controlling output flowrate of fluid from the reservoir (Fig. 1-4, reservoir 4) to the needle (valves 36 and 40 can be opened or closed, allowing or preventing fluid passage respectively. Pump 6 is downstream of reservoir 4 and upstream of fluid delivery tool 8; para. 0056 and 0082); a flow sensor (Fig. 1, sensors 30) configured to measure flowrate (sensors 30 provide flow rate measurements downstream of pump 6; para. 0076) for controlling the microvalve and micropump (controller 12 receives fluid pressure data from sensors 30 and corrects pump 6 output; para. 0120); and a micropump (Fig. 1-5a, pump 6) fluidly communicating with reservoir (Fig. 1, pump 6 is downstream of reservoir 4; para. 0056 and 0082) for increasing the flowrate of the fluid (pump 6 enables precise flow rate manipulation; para. 0079) to maintain a constant flowrate of the fluid as the reservoir (Fig. 1-4, reservoir 4) discharges (para. 0056).
Iddan does not expressly disclose a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges.
Chong teaches a self-pressurized reservoir (Chong: Fig. 29, pressurized reservoir 1306), wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges (therapeutic agent is released through the injection device via pressurized reservoir 1306; col 16, ln 32-40). Examiner interprets that the self-pressurized reservoir of Chong is analogous to the self-pressurized reservoir of the present application and, therefore, would be expected to operate in the same manner, thereby allowing the device to operate at any orientation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reservoir of Iddan such that it is a self-pressurized reservoir, wherein the device operates independent of orientation of the device to ensure constant flowrate in the fluid path as the self-pressurized reservoir discharges as taught by Chong in order to a desired pressurization for the therapeutic fluid (Chong: col 13, ln 66 – col 14, ln 5).
Regarding claim 18, Iddan in view of Chong discloses the device above, wherein the microvalve (Fig. 5a, inlet valve 36 and outlet valve 40) includes one or more MEMS devices (valves 36 and 40 are electromagnetically openable and closeable and implement MEMS; para. 0064 and 0076).
Regarding claim 19, Iddan in view of Chong discloses the device above, wherein the micropump (Fig. 1-5a, pump 6) includes one or more MEMS devices (pump 6 implements an electromagnetic membrane pump 61; para. 0080).
Regarding claim 20, Iddan in view of Chong discloses the device above, wherein the medication is insulin (Iddan: para. 0054).
Regarding claim 21, Iddan in view of Chong discloses the device above, wherein the user is a patient with diabetes (Iddan: para. 0002).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Iddan in view of Chong, in further view of Lanier et al. (US Patent Publication No. 20170246383 A1), hereinafter Lanier.
Regarding claim 10, Iddan in view of Chong discloses the device above, wherein the micropump (Iddan: Fig. 1-5, pump 6) is configured as a booster pump to ensure continued pressure as the reservoir depletes (pump 6 guarantees selected set flow rate is held steady, irrespective of backpressure variations; para. 0079).
Iddan does not expressly disclose a self-pressurized reservoir.
Chong teaches a self-pressurized reservoir (Chong: Fig. 29, pressurized reservoir 1306).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reservoir of Iddan such that it is a self-pressurized reservoir as taught by Chong in order to a desired pressurization for the therapeutic fluid (Chong: col 13, ln 66 – col 14, ln 5).
Iddan in view of Chong does not expressly disclose a second micropump to provide pump functionality.
Lanier teaches a second micropump (Lanier: control assembly 812 may have one or more pumps; para. 0444) to provide pump functionality (control assembly 812 may have one or more pumps for controlling the flow of fluid; para. 0444).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Iddan in view of Chong such that it included a second micropump to provide functionality as taught by Lanier in order to control the flow of infusible fluid (Lanier: para. 0444).
Response to Arguments
Applicant’s arguments, see page 8, filed 29 July 2025, with respect to the objection to the drawings have been fully considered and are persuasive. The objections of the drawings has been withdrawn.
Applicant’s arguments, see page 8, filed 29 July 2025, with respect to the rejections of claims 1-6 under 35 USC 112 (b) have been fully considered and are persuasive. The rejections of claims 1-6 has been withdrawn.
Applicant’s arguments, see page 9-11, filed 29 July 2025, with respect to the rejections of claims 1-4 and 6-9 under 35 USC 102(a)(2) and claim 5 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Iddan in view of Chong as cited above.
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.
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/LEI GONZALEZ/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783