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 .
Claim Objections
Claim 4 objected to because of the following informalities: In line 2, the phrase “when the at least one module is couple to the base” contains a grammatical error. It is likely supposed to read “when the at least one module is coupled to the base.” Appropriate correction is required.
Claim 24 objected to because of the following informalities: In line 2, the phrase “by actional of a second spring” appears to contain a typographical error. It is likely supposed to read “by the actuation of a second spring.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 15-17, 21, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Duhamel (US Publication No. 2023/0277762), hereinafter, Duhamel, in view of Vaucher (US Publication No.2024/0173472), hereinafter, Vaucher.
Regarding claim 1, Duhamel discloses a modular disease management system (Duhamel: Single Package Automated Drug Delivery System (SPAID) 102 in figs. 1-5B; comprises delivery patient interface 186 for delivering drugs to patient from reservoir 124 (or two reservoirs 124, 124-2) with delivery insertion mechanism 188 combined with sensor insertion mechanism 111 for both delivery analyte sensing through cannula/needle; para [0079]), comprising:
a first module (Duhamel: SPAID 102 includes delivery insertion mechanism 188 for inserting cannula into user, which may be integral with or attachable to SPAID 102; para [0079]; the insertion/delivery mechanism may comprise a module within SPAID 102 that may be replaceable; para [0110])
a medication bladder (Duhamel: reservoir 124 (and optional reservoir 124-2) for storing liquid drugs such as insulin; para [0079];
a medication pump configured to cause medication to flow from the medication bladder through a cannula configured to be inserted into a tissue site of the patient (Duhamel: SPAID 102 uses one or more positive displacement pumping systems in which drive mechanism 125 (and optional second drive mechanism 125-2) operates to translate a plunger through reservoir 124 for liquid drug delivery through outlet port to patient interface 186; para [0076]); and
a cannula insertion device configured to insert the cannula into the tissue site of the patient (Duhamel: SPAID 102 includes delivery insertion mechanism 188 for inserting cannula into user, which may be integral with or attachable to SPAID 102; para [0079]) by actuation of a spring released by a triggering component (Duhamel: a dual spring system wherein one spring is used to install the device into the skin and a second spring is used to retract the device; para [0113]; Duhamel uses a dual spring system with mechanisms for enabling and disabling spring engagement between the installation spring and retraction springs to prevent one from applying force to the other; para [0114]).
Duhamel does not, however, explicitly disclose a base configured to at least partially couple to skin of a patient; and
at least one module configured to removably couple to the base, the at least one module comprising:
a first module and what the first module comprises.
Vaucher teaches a base (Vaucher: pad 102 is coupled to applicator 100 via pad skeleton 104 in fig. 2A; para [0051]) configured to at least partially couple to skin of a patient (Vaucher: disposed on surface of pad 102, adhesive 105, is disposed on skin-facing surface of pad 102 such that the pump-pad assembly may be attached to ta wearer in fig. 2A, para [0051]); and
at least one module configured to removably couple to the base (Vaucher: pump 300 is designed to be removably coupled to cap 400 and pad 102 to form a patch pump, which is configured to deliver doses of medication through cannula 200 transcutaneously to the patient from cartridge 500; para [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the integrated SPAID device of Duhamel by configuring the delivery components (reservoir, pump, and insertion mechanism) as a first module that is removably coupled to a base, as taught by Vaucher, in order to allow the expensive or complex components to be reused while enabling periodic replacement of the fluid-contacting and skin-adhered portions for improved hygiene and cost efficiency.
Regarding claim 2, modified Duhamel discloses the modular disease management system of Claim 1, wherein the base comprises at least one physical interface configured to removably couple the at least one module (pump 300 is designed to be removably coupled to cap 400 and pad 102 to form a patch pump, which is configured to deliver doses of medication through cannula 200 transcutaneously to the patient from cartridge 500; para [0045]).
Regarding claim 3, modified Duhamel discloses the modular disease management system of Claim 2, but fails to disclose that the at least one physical interface comprises a rigid portion of the base.
Vaucher teaches that the at least one physical interface comprises a rigid portion of the base (Vaucher: pad 102 is coupled to applicator 100 via pad skeleton 104, which may be a frame to securely couple adhesive pad 102 to applicator 100 in figs. 2A-2B; para [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of modified Duhamel to include at least one physical interface to comprise a rigid portion configured to removably couple the at least one module, as taught by Vaucher, in order to allow secure yet removable attachment of the delivery components to the base for improved modularity and ease of replacement.
Regarding claim 4, modified Duhamel discloses the modular disease management system of Claim 2, with at least one physical interface, but fails to disclose that the physical interface forms a seal when the at least one module is coupled to the base.
Yang teaches a physical interface that forms a seal when the at least one module is coupled to the base. (Yang: control mechanism module 100 contains an electrical contact 103 that is tightly embedded in the housing 101, keeping control mechanism module 100 isolated from the outside; para [0083]; “tightly embedded means that there is no gap between electrical contact 103 and housing 101, keeping control mechanism 100 tightly sealed; para [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the physical interface between the module and base of modified Duhamel to form a seal when the module is coupled to the base, as taught by Yang, in order to prevent fluid leakage and/or ingress of contaminants at the coupling interface.
Regarding claim 5, modified Duhamel discloses the modular disease management system of Claim 1, but fails to explicitly disclose that the base comprises a flexible portion.
Vaucher, however, suggests that the base comprises a flexible portion (Vaucher: pad 102 is attached to wearer’s skin, using adhesive 105, for up to 10 days or more which necessitates some flexibility to maintain adhesion and comfort to the wearer; para [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of modified Duhamel to comprise a flexible portion, as suggested by Vaucher, in order to allow the adhesive pad to conform to the wearer’s skin and maintain adhesion during normal daily movement.
Regarding claim 15, modified Duhamel discloses the modular disease management system of Claim 1, wherein the at least one module further comprises a second module, the second module comprising (Duhamel: SPAID 102 comprises delivery patient interface 186 for delivering drugs to patient from reservoir 124 with delivery insertion mechanism 188 combined with sensor insertion mechanism 111 for both delivery analyte sensing through cannula/needle; para [0079]):
an analyte sensor configured to be inserted into a second tissue site of the patient (Duhamel: analyte sensors 108 are provided on sensor insertion mechanism 111 for insertion of sensor patient interface 110; may be a needle , cannula, or other sensing element inserted under the skin of the user; para [0077]); and
a sensor insertion device configured to insert the analyte sensor into the second tissue site of the patient by actuation of a second spring released by a second triggering component (Duhamel: analyte sensors 108 are provided on sensor insertion mechanism 111 for insertion of sensor patient interface 110; may be a needle , cannula, or other sensing element inserted under the skin of the user via actuation, or triggering component; para [0077]).
Regarding claim 16, modified Duhamel discloses the modular disease management system of Claim 15, wherein the analyte sensor is an electrochemical sensor (Duhamel: electrochemical sensing can be used to sense glucose and other analytes in the various drug delivery system in figs. 6-8; para [0115-0123]).
Regarding claim 17, modified Duhamel discloses the modular disease management system of Claim 15, wherein the analyte sensor is an optical sensor (Duhamel: opto-fluorescent sensing can be used to sense glucose in the various drug delivery systems described in figs. 23-26; para[0145- 0150]).
Regarding claim 21, modified Duhamel discloses the modular disease management system of Claim 1, but fails to explicitly disclose that the cannula insertion device comprises a needle associated with the cannula.
Vaucher teaches a cannula insertion device that comprises a needle associated with the cannula (Vaucher: needle 150 is associated with cannula 200 in figs. 3A-3B; para [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula insertion device of modified Duhamel to comprise a needle associated with the cannula, as taught by Vaucher, in order to facilitate accurate and controlled insertion of the cannula into the tissue site.
Regarding claim 25, modified Duhamel discloses the modular disease management system of Claim 1, but fails to disclose that the cannula is inserted into the tissue site of the patient at approximately a 45 degree angle.
Vaucher, however, teaches that the cannula is inserted into the tissue site of the patient at approximately a 45 degree angle (Vaucher: elongated shaft 152 of needle 150 and cannula 200 average angle relative to wearer’s skin surface at point of insertion is in the range -10 to 45 degrees; para [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula insertion device of modified Duhamel to insert the cannula at approximately a 45-degree angle, as taught by Vaucher, in order to achieve optimal subcutaneous placement of the cannula.
Regarding claim 26, modified Duhamel discloses the modular disease management system of Claim 1, wherein the triggering component (Duhamel: a dual spring system wherein one spring is used to install the device into the skin and a second spring is used to retract the device; para [0113]) comprises:
a trigger pin configured to release the spring when actuated by a trigger arm; and a retracting wire configured to contract, causing the trigger arm to actuate the trigger pin (Duhamel: uses a dual spring system with mechanisms for enabling and disabling spring engagement between the installation spring and retraction springs to prevent one from applying force to the other; para [0114]; alternatively, a motor driven screw drive mechanism may be employed to draw back the sensor slowly along a guide track. This system would also serve to rewind/reload the initial installation spring so it can be re-used to fire/reinstall the sensor and cannula and would necessitate a pin or other mechanism to hold the spring in place before the next use; para [0114]).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Duhamel in view of Vaucher, as applied to claim 1, and further in view of Yang (US Publication No. 2024/0017000), hereinafter, Yang.
Regarding claim 6, modified Duhamel discloses the modular disease management system of Claim 1, but fails to disclose that the base comprises an electrical connector configured to electrically connect the at least one module to the base.
Yang, however, teaches that the base comprises an electrical connector configured to electrically connect the at least one module to the base (Yang: control mechanism module 100 contains an electrical contact 103 that is tightly embedded in the housing 101, keeping control mechanism module 100 isolated from the outside; para [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of modified Duhamel to include an electrical connector configured to electrically connect the at least one module to the base, as taught by Yang, in order to enable a reliable power and signal communication between the base and the removable modules.
Regarding claim 7, modified Duhamel discloses the modular disease management system of Claim 6 comprising a first module, but fails to disclose a first module that further comprises a printed circuit board (PCB), the PCB electrically coupled to at least the electrical connector and the medication pump.
Yang, however, teaches a first module that further comprises a printed circuit board (PCB), the PCB electrically coupled to at least the electrical connector and the medication pump (Yang: circuit boards 107 and related electronic modules are disposed on the control mechanism module 100 of housing 101 in figs. 3-4; for receiving signals or issuing control instructions, as well as other mechanical modules for realizing the infusion function, which would include a medication pump; para [0080]; circuit board 107 is a hard/rigid circuit board or a flexible circuit board; para [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first module of modified Duhamel to further comprise a printed circuit board (PCB) electrically coupled to at least the electrical connector and the medication pump, as taught by Yang, in order to integrate control on electrical functionality within the removable module.
Regarding claim 8, modified Duhamel discloses the modular disease management system of Claim 7, wherein the PCB comprises a flex PCB (Yang: circuit board 107 is a hard/rigid circuit board or a flexible circuit board; para [0118]).
Regarding claim 9, modified Duhamel discloses the modular disease management system of Claim 1, comprising one or more computer processors (Duhamel: SPAID 102 contains computing hardware (e.g., a processor, memory, firmware, etc.) that executes some or all of the algorithm that computes times and dosages of delivery of the medication; para [0072]).
Duhamel fails, however, to expressly disclose that the at least one module further comprises a controller module.
Yang teaches that the at least one module further comprises a controller module (Yang: control mechanism module 100 of housing 101 in figs. 3-4; circuit boards 107 and related electronic modules are disposed on control mechanism module 100 for receiving signals or issuing control instructions; para [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified disease management system of Duhamel to comprise a control mechanism module, as taught by Yang, in order to provide centralized computing and control functionality within a distinct removable module.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Duhamel in view of Vaucher and Yang, as applied to claims 1 and 9, and further in view of Bellusci (US Publication No. 2024/0207511), hereinafter, Bellusci.
Regarding claim 13, modified Duhamel discloses the modular disease management system of Claim 9, wherein the controller module is reusable (Yang: control mechanism module 100 can be reused; para [0070]), but fails to disclose that the base and the first module are disposable.
Bellusci teaches that the base and the first module are disposable (Bellusci: dispensing module 2, which contains base wall 12, is disposable; see figs. 1-3; para [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base and first module of modified Duhamel to be disposable, as taught by Bellusci, in order to allow cost-effective reuse of the expensive electronics while replacing the fluid path and skin-contacting components for hygiene and reduce per-use cost.
Regarding claim 14, modified Duhamel discloses the modular disease management system of Claim 9, but fails to disclose that the controller module is configured to be disconnected from the base and connected to a second base associated with a different disease management system.
Bellusci teaches that the controller module is configured to be disconnected from the base and connected to a second base associated with a different disease management system (Bellusci: control module 3 can be used several times, by coupling it from time to time with a new dispensing module 2 in figs. 1-3; para [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller module of modified Duhamel to be configured to be disconnected from the base and connected to a second base associated with a different disease management system, as taught by Bellusci, in order to enable reuse of the controller module across multiple replacement cycles of the disposable components.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Duhamel in view of Vaucher, as applied to claims 1 and 21, and further in view of Kiani (US Publication No. 2021/0236729), hereinafter, Kiani.
Regarding claim 22, modified Duhamel discloses the modular disease management system of Claim 21, but fails to disclose that the needle comprises a U-shaped cavity encompassing the cannula.
Kiani, however, teaches that the needle comprises a U-shaped cavity encompassing the cannula (Kiani: needle 1616 may also be a U-shaped needle with a hollow center and the cannula 1510B may have a smaller diameter than the hollow center of the U-shaped needle which allows the cannula 1510B to fit within the U-shaped needle; para [0404]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of modified Duhamel to comprise a U-shaped cavity encompassing the cannula, as taught by Kiani, in order to securely hold and guide the cannula during the insertion process.
Regarding claim 23, modified Duhamel discloses the modular disease management system of Claim 21, wherein to insert the cannula into the tissue site of the patient (Duhamel: SPAID 102 includes delivery insertion mechanism 188 for inserting cannula into user, which may be integral with or attachable to SPAID 102; para [0079]), the needle is inserted along with the cannula into tissue site by the actuation of the spring (Duhamel: a dual spring system wherein one spring is used to install the device into the skin and a second spring is used to retract the device; para [0113]).
Regarding claim 24, modified Duhamel discloses the modular disease management system of Claim 23, wherein the cannula insertion device is further configured to remove the needle from the tissue site of the patient by the actuation of a second spring (Duhamel: a dual spring system wherein one spring is used to install the device into the skin and a second spring is used to retract the device; para [0113]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Duhamel in view of Vaucher, as applied to claims 1 and 26, and further in view of Kamen (US Publication No. 2007/0219597), hereinafter, Kamen.
Regarding claim 27, modified Duhamel discloses the modular disease management system of Claim 26, but fails to disclose that the retracting wire comprises a nitinol wire.
Kamen teaches that the retracting wire comprises a nitinol wire (Kamen: nitinol wire 278 allows biasing spring 243 to return plunger 54 to its retracted state after application of electrical field ceases; para [0302]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spring (retracting wire) of modified Duhamel to comprise a nitinol wire, as taught by Kamen, in order to provide a compact, electrically controllable actuator for the triggering mechanism.
Conclusion
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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