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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 06/22/2023. Claims 1-20 are currently pending and being examined.
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 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.
Claim Objections
Claims 1-20 are objected to because of the following informalities: Claim 1 recites “drug injection device based on the electrochemical reaction” in line 2. However applicant throughout the rest of the claim set seems to treat “drug injection device based on an electrochemical reaction” as the full name of the device, using “an” as part of the name. Claims 1,2, and 19 are the only ones that use “the”. It does not matter what naming convention is used but it must be clear and consistent. If “the” is used then “an” should only be used once in the first line of the first claim. If “an” is used then “the” should not be used in the phrase in any of the claims. Appropriate correction is required.
Claim 2 is objected to because of the following abnormalities: Claim 2 recites “a driving force” in line 6. However, “driving force” has already been instantiated in claim 1. Examiner suggests reciting “the driving force”. Appropriate correction is required.
Claim 2 is objected to because of the following abnormalities: Claim 2 recites “with drug solution” in line 13. However, “drug solution” lacks antecedent basis. Examiner suggests reciting “a drug solution”. Appropriate correction is required.
Claim 2 is objected to because of the following abnormalities: Claim 2 recites “a drug to a patient” in line 15 and “a patient” in line 16. However, both have already been instantiated in claim 1. Examiner suggests reciting “the drug to the patient”. Appropriate correction is required.
Claim 2 is objected to because of the following abnormalities: Claim 2 recites “the liquid outlet hole” in lines 16 and 17. However, “liquid outlet hole” lacks antecedent basis. Examiner suggests reciting “the at least one liquid outlet hole”. Appropriate correction is required.
Claim 8 is objected to because of the following abnormalities: Claim 8 recites “the skin of a patient” in line 6. However, “skin” lacks antecedent basis and “patient” has already been instantiated in claim 1. Examiner suggests reciting “a skin of the patient”. Appropriate correction is required.
Claim 9 is objected to because of the following abnormalities: Claim 9 recites “a driving force” in line 4. However, “driving force” has already been instantiated in claim 1. Examiner suggests reciting “the driving force”. Appropriate correction is required.
Claim 9 is objected to because of the following abnormalities: Claim 9 recites “an electrode” in line 9. However, “electrode” has already been instantiated. Examiner suggests reciting “the electrode”. Appropriate correction is required.
Claim 9 is objected to because of the following abnormalities: Claim 9 recites “with drug solution” in line 11. However, “drug solution” lacks antecedent basis. Examiner suggests reciting “a drug solution”. Appropriate correction is required.
Claim 9 is objected to because of the following abnormalities: Claim 9 recites “a drug to a patient” in line 13 and “a patient” in line 14. However, both have already been instantiated in claim 1. Examiner suggests reciting “the drug to the patient”. Appropriate correction is required.
Claim 9 is objected to because of the following abnormalities: Claim 9 recites “the liquid outlet hole” in lines 14 and 15. However, “liquid outlet hole” lacks antecedent basis. Examiner suggests reciting “the at least one liquid outlet hole”. Appropriate correction is required.
Claim 19 is objected to because of the following abnormalities: Claim 19 recites “a closed-loop control” in line 2. However “closed loop control” has already been instantiated. Examiner suggests reciting “the closed-loop control”. Appropriate correction is required.
Claim 20 is objected to because of the following abnormalities: Claim 20 recites “an electrode” in line 3, “a driving cavity” in line 4, and “a drug storage component” in line 6. However, all three have already been instantiated. Examiner suggests reciting “the electrode”, “the driving cavity”, and “the drug storage component”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pang (USPN 9,861,525).
In reference to independent claim 1, Pang discloses a drug injection device (fig 4b) based on an electrochemical reaction, wherein the drug injection device (100) based on the electrochemical reaction is used to generate a driving force based on electrochemical reaction (col 14, lines 52-55 discloses “the diaphragm 150 is controllably expanded toward a drug chamber 130 using other methods in addition to, or in place of, inducing gas electrolysis from a fluid held within an electrolysis chamber”), and to automatically drive drug solution under the driving force to administer a drug to a patient (col 11, lines 39-45 discloses “Chemical sensors may be used, for example, to monitor one or more chemical compositions within a treatment site (e.g. monitoring the brains cerebral spinal fluid (CSF) for chemicals such as osmolarity, sugar and infection). The sensors may provide enough feedback to the control circuitry 170 to allow the flow of drugs to be metered by a closed-loop control process.” This cite indicates that the device in fig 4b detects the sugar in the body then automatically administers drugs).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Chiang (WO 2008/094196).
In reference to dependent claim 2, Pang discloses the drug injection device based on an electrochemical reaction according to claim 1, wherein the drug injection device based on the electrochemical reaction is a drug injection pump (100) based on electrochemical reaction (electrolysis), and the drug injection pump comprises a driving component (140) and a drug storage component (130), wherein: the driving component (140) is arranged inside the drug storage component (140 is inside 130, see fig 4B), and is used to generate a driving force based on an electrochemical reaction principle (electrolysis), the driving force is applied inside the drug storage component (col 14, lines 52-55 discloses “the diaphragm 150 is controllably expanded toward a drug chamber 130 using other methods in addition to, or in place of, inducing gas electrolysis from a fluid held within an electrolysis chamber”), the driving component comprises an electrochemical element (240) which is connected to the outside of the drug storage component (130) via a wire (col 24, lines 39 discloses “The electronics may be wirebonded together”) and
is used for receiving a preset current (current in the cite below); the electrochemical element is used for generating a gas based on the preset current, the gas is used for generating the driving force (col 17, lines 60-63 discloses “in operation, when current is supplied to the electrolysis electrodes 240, the electrolyte generates electrolysis gas, expanding the diaphragm 150, and forcing liquid out of the drug chamber 130 through the cannula 120”), and
the electrochemical element (240) is an electrode fabricated by a metal evaporation process (col 5, lines 45-47 discloses “The metal electrode layer may be deposited by E-beam evaporation and patterned by a lift-off process or etching process” E-beam evaporation is a type of metal evaporation), a screen-printing process or a magnetron sputtering process;
the drug storage component (130) is internally loaded with drug solution, and the drug solution is pushed to the outside of the drug storage component along at least one liquid outlet hole on the drug storage component (col 10, lines 25-27 discloses “chamber 130 defines a drug reservoir that contains one or more drugs to be administered in liquid form”) under the driving force (the driving force coming from 140 described above), thus administering a drug to a patient through the liquid outlet hole (hole in cannula 120, fig 4b), or administering the drug solution to a patient along an injection mechanism (120) connected to the liquid outlet hole (hole in cannula 120, fig 4b), however
Pang is silent to an electrode with a nano or micron thickness.
Chiang, a similar electrochemical actuator, teaches an electrode with a micron thickness (Page 15, lines 14-20 discloses “An electrode of an actuator can also range in size from the nanometer scale, to the micrometer scale, and to the macroscopic scale. For example in some embodiments, electrode 114 may have at least one dimension less than or equal to 1 meter, less than or equal to 10 centimeters, less than or equal to 1 centimeter, less than or equal to 1 millimeter, less than or equal to 100 microns, less than or equal to 10 microns, less than or equal to 1 micron, less than or equal to 100 nanometers, or less than or equal to 10 nanometers.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the electrode size as taught in Chang in the device of Pang to “enhance the mechanical performance, stiffness, actuation energy density, actuation strain, reversibility, and/or lifetime of the devices” pg 38, lines 33-2; Chiang.
In reference to dependent claim 3, Pang in view of Chiang discloses the drug injection device based on an electrochemical reaction according to claim 2, Pang further discloses a device wherein the electrode is a metal electrode (col 12, lines 58-59 disclose “the electrolysis electrodes 240 are platinum”), a carbon electrode, or a composite conductive material electrode.
In reference to dependent claim 4, Pang in view of Chiang discloses the drug injection device based on an electrochemical reaction according to claim 3, Pang further discloses a device wherein the electrode is an interdigital electrode (fig 7 is interpreted to be a 3d view of the same electrode that is shown in fig 4, which is equivalent to applicant’s fig 14, an interdigital electrode), a plate electrode, a pillar electrode or an irregularly shaped electrode.
In reference to dependent claim 5, Pang in view of Chiang discloses the drug injection device based on an electrochemical reaction according to claim 4, Pang further discloses a device wherein a substrate of the interdigital electrode is a hard substrate (col 10, lines 66-2 discloses “the electrolysis electrodes 240 are coupled, or imbedded within, may include a substrate formed from a material including, but not limited to, alumina, zirconium oxide, and/or sapphire” all three would be considered “hard” substrates), a flexible substrate or a stretchable elastic substrate.
In reference to dependent claim 6, Pang in view of Chiang discloses the drug injection device based on an electrochemical reaction according to claim 5, Pang further discloses a device wherein the shape of the substrate is curved, planar (the substrate of the electrodes 240 are planar in fig 4b), serrated, wrinkled, or micro-needled.
In reference to dependent claim 7, Pang in view of Chiang discloses the drug injection device based on an electrochemical reaction according to claim 2, Pang further discloses a device wherein the driving component (140) further comprises a driving cavity (cavity of 140) covering the electrochemical element (240), and the driving cavity (140) is located inside the drug storage component (140 is inside 130 in fig 4b); the driving cavity is used for loading an electrolyte (col 33, lines 38-46 discloses “an electrolysis chamber 140 may be formed by thermally bonding the edges of a parylene film with platinum electrodes with a corrugated parylene diaphragm 150. The diaphragm 150 may have a step (e.g., 0.4 mm high) on the edge so that when it is placed upside down, the recess can be filled with electrolyte and the edges then thermally bonded (through, for example, local heating only) to seal the electrolyte inside the chamber”), and
the electrolyte (in chamber 140) undergoes electrochemical reaction under the action of the electrochemical element to enable the driving cavity to deform, and the driving force on the drug solution is generated by the deformation of the driving cavity (col 14, lines 52-55 discloses “the diaphragm 150 is controllably expanded toward a drug chamber 130 using other methods in addition to, or in place of, inducing gas electrolysis from a fluid held within an electrolysis chamber”).
In reference to dependent claim 20, Pang in view of Chiang discloses a device constructed by the fabrication method for a drug injection pump, which is used for fabricating the drug injection pump according to claim 7, Pang further discloses a device wherein the fabrication method includes the steps of:
manufacturing an electrode on a substrate (col 32, lines 56-65 discloses “The manufacturing steps include: (a) Spin-coating a thin photoresist layer (e.g., 1 μm) onto a silicon substrate as a sacrificial layer for releasing the finished device from the substrate. The first parylene layer (typically 20 μm) is deposited. (b) Depositing a metal (e.g., 0.2 μm platinum) by E-beam evaporation (or other appropriate deposition method) and patterned by a conventional lift-off process or etching process.”);
bonding a driving cavity to the substrate to completely cover the electrode (col 33, lines 39-42 discloses “an electrolysis chamber 140 may be formed by thermally bonding the edges of a parylene film with platinum electrodes with a corrugated parylene diaphragm 150”), and
perfusing an electrolyte in the driving cavity (col 33, lines 42-46 discloses “The diaphragm 150 may have a step (e.g., 0.4 mm high) on the edge so that when it is placed upside down, the recess can be filled with electrolyte and the edges then thermally bonded (through, for example, local heating only) to seal the electrolyte inside the chamber.”); and
forming a drug storage component in the substrate (fig 4b shows a pocket 130 inside the substrate that forms the base), and
enabling the drug storage component (130) to completely encase the driving cavity (140, fig 4b).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Gross (USPN 5,800,420).
In reference to dependent claim 8, Pang discloses the drug injection device based on an electrochemical reaction according to claim 1, Pang further discloses a device wherein the drug injection device based on an electrochemical reaction is an injection system (col 17, lines 60-63 discloses “in operation, when current is supplied to the electrolysis electrodes 240, the electrolyte generates electrolysis gas, expanding the diaphragm 150, and forcing liquid out of the drug chamber 130 through the cannula 120” the cannula injects into the treatment site 190), the injection system comprises a drug injection pump (100) based on electrochemical principle (the electrolysis above), a first sensor (col 11, lines 39-45 discloses “Chemical sensors may be used, for example, to monitor one or more chemical compositions within a treatment site (e.g. monitoring the brains cerebral spinal fluid (CSF) for chemicals such as osmolarity, sugar and infection). The sensors may provide enough feedback to the control circuitry 170 to allow the flow of drugs to be metered by a closed-loop control process.” This cite indicates that the device in fig 4b detects the sugar in the body then automatically administers drugs), a sensor circuit module (portion of circuitry between 170 and the sensors), a pump drive circuit module (circuit connected to electrodes 240), and a controller (170), however
Pang is does not teach injecting insulin, wherein the first sensor is attached to the skin of a patient and is used for generating a current signal based on glucose in subcutaneous tissue fluid; the sensor circuit module is connected to the first sensor, and is used for receiving the current signal and outputting a glucose concentration matched with the current signal through an output end of the sensor circuit module; the controller is provided with a signal input end and a signal output end, the signal input end is connected to the output end of the sensor circuit module and is used for receiving the glucose concentration, and the signal output end is configured to output a control signal matched with the glucose concentration; the pump drive circuit module is respectively connected to the signal output end and an electrode of the drug injection pump, and is used to output a driving current or a driving voltage matched with the control signal to the drug injection pump; the drug injection pump is used for injecting insulin into the patient based on electrochemical reaction under the drive of the driving current or the driving voltage
Gross, a similar electrolysis powered drug pump, teaches a controller (microprocessor 21, fig 1), wherein the first sensor (22) is attached to the skin of a patient and is used for generating a current signal based on glucose in subcutaneous tissue fluid (col 19, lines 41-46 discloses “the sensor needle (not shown) penetrates through the epidermis and into the dermis (depending on the length of the sensor needle, it may also penetrate through the dermis to the subcutaneous tissue) to allow contact between the enzymatic coating on the sensor needle and the subject's plasma” the sensor then generates an electrical current to communicate with the controller 21); the sensor circuit module is connected to the first sensor (22), and is used for receiving the current signal and outputting a glucose concentration matched with the current signal through an output end of the sensor circuit module (col 16, lines 4-9 discloses “current through the circuit is limited by the numbers of electrons available at sensor needle 23. This means that, since the electrons are produced by hydrogen peroxide oxidation and the hydrogen peroxide is produced by the enzymatic oxidation of glucose, that the current depends on the glucose concentration in the bloodstream”); the controller (21) is provided with a signal input end (connected to the sensor 22) and a signal output end (connected to the electrolytic cell 19), the signal input end is connected to the output end of the sensor circuit module and is used for receiving the glucose concentration (disclosed in the cite above), and
the signal output end is configured to output a control signal matched with the glucose concentration (from sensor 23); the pump drive circuit module (a portion of 21) is respectively connected to the signal output end and an electrode (in the electrolytic cell) of the drug injection pump (10), and is used to output a driving current or a driving voltage matched with the control signal to the drug injection pump (described below); the drug injection pump is used for injecting insulin into the patient based on electrochemical reaction under the drive of the driving current or the driving voltage (col 16, lines 15-24 discloses “The microprocessor 21 maintains this concentration by controlling the current flowing through electrolytic cell 19, since any increase or decrease in the amount of gas produced by electrolytic cell 19 results in a corresponding increase or decrease in the amount of insulin injected into the subject via needle 15. In effect, therefore, device 10 acts as an artificial pancreas which continually monitors the glucose concentration in the bloodstream and constantly adjusts the on-going rate of insulin administration to take account of the measured glucose level.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the glucose control method of Gross in the device of Pang “to devise a system which provides the subject's entire insulin requirement without there being any need for self-injection of bolus insulin” col 3, lines 17-19.
In reference to dependent claim 9, Pang in view of Gross discloses the drug injection device based on an electrochemical reaction according to claim 8, Pang further discloses a device wherein the drug injection pump (100) comprises a driving component (140) and a drug storage component (130); the driving component is arranged inside the drug storage component (140 is inside 130, see fig 4b), and is used to generate a driving force based on an electrochemical reaction principle (electrolysis), the driving force is applied inside the drug storage component (col 14, lines 52-55 discloses “the diaphragm 150 is controllably expanded toward a drug chamber 130 using other methods in addition to, or in place of, inducing gas electrolysis from a fluid held within an electrolysis chamber”), the driving component comprises an electrochemical element (240) which is connected to the outside of the drug storage component (130) via a wire (col 24, lines 39 discloses “The electronics may be wirebonded together”) and
is used for receiving a preset current (current in the cite below); the electrochemical element is used for generating a gas based on the preset current, the gas is used for generating the driving force (col 17, lines 60-63 discloses “in operation, when current is supplied to the electrolysis electrodes 240, the electrolyte generates electrolysis gas, expanding the diaphragm 150, and forcing liquid out of the drug chamber 130 through the cannula 120”), and
the electrochemical element (240) is an electrode with a nano or micron thickness fabricated by a metal evaporation process (col 5, lines 45-47 discloses “The metal electrode layer may be deposited by E-beam evaporation and patterned by a lift-off process or etching process” E-beam evaporation is a type of metal evaporation), a screen-printing process or a magnetron sputtering process;
the drug storage component (130) is internally loaded with drug solution, and the drug solution is pushed to the outside of the drug storage component along at least one liquid outlet hole on the drug storage component (col 10, lines 25-27 discloses “chamber 130 defines a drug reservoir that contains one or more drugs to be administered in liquid form”) under the driving force (the driving force coming from 140 described above), thus administering a drug to a patient through the liquid outlet hole (hole in cannula 120, fig 4b), or administering the drug solution to a patient along an injection mechanism (120) connected to the liquid outlet hole (hole in cannula 120, fig 4b).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Gross (USPN 5,800,420) in reference to claim 8 above, and further in view of Keenan (USPAP 2010/0162786).
In reference to dependent claim 10, Pang in view of Gross discloses the drug injection device based on an electrochemical reaction according to claim 8, however
Pang and Gross is silent to wherein the first sensor comprises a tubular structure and a plurality of sensor electrodes, the plurality of sensor electrodes are arranged on an outer wall of the tubular structure and are connected to the sensor circuit module.
Keenan, as similar human biological sensor teaches a first sensor (14, fig 1-7) comprises a tubular structure (fig 7 shows the sensor has a tubular structure) and a plurality of sensor electrodes (20, fig 4), the plurality of sensor electrodes (20) are arranged on an outer wall of the tubular structure (fig 7 shows that the electrodes 20 are on an “outer wall” due to the opening in 14) and are connected to the sensor circuit module (para 0044 discloses “glucose monitor 100 may be worn by a user while connected to a surface mounted glucose sensor set 10” 14 is a portion of 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensor as taught in Keenan in the device of Pang in view of Gross “may enable an accurate estimate of a relationship between signal values generated by a glucose sensor and blood-glucose concentration, leading to more effective applications of glucose sensors and better treatment of diabetes patients” para 0039; Keenan.
In reference to dependent claim 11, Pang in view of Gross and Keenan discloses the drug injection device based on an electrochemical reaction according to claim 10, Keenan further discloses a sensor wherein the cross section of the tubular structure is circular (fig 7 shows a circular cross section), square or polygonal.
Claims 12, 15-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Kosel (USPAP 2022/0134072).
In reference to dependent claim 12, Pang discloses the drug injection device based on an electrochemical reaction according to claim 1, Pang further discloses a device wherein the drug injection device based on an electrochemical reaction is a closed-loop control system (col 11, lines 42-45 discloses “The sensors may provide enough feedback to the control circuitry 170 to allow the flow of drugs to be metered by a closed-loop control process.”), the closed-loop control system comprises: an electrochemical micropump (100), a second sensor, and a control module (170); the electrochemical micropump comprises a pump body (160 and 235), the pump body is provided with an accommodation region (130) in which media solution and an electrode layer (240) connected to an inner wall of the pump body are provided (see fig 4b), and the pump body is provided with an expansion membrane (150) covering the accommodation region (130);
the second sensor (col 10, lines 60-61 discloses “one or more chemical or pressure sensors”) comprises a substrate (col 11, lines 22-26 discloses “Chemical sensors may be used, for example, to monitor one or more chemical compositions within a treatment site (e.g. monitoring the brains cerebral spinal fluid (CSF) for chemicals such as osmolarity, sugar and infection)” in order ), the expansion membrane (150) is connected to the substrate of the second sensor, an input end of the control module (170) is connected to an output end of the second sensor, an output end of the control module (170) is connected to an input end of the electrochemical micropump (100), the control module (170) is used for receiving an electrical signal output by the second sensor (disclosed in the site above) and controlling the turn-on and turn-off of the electrochemical micropump according to the electrical signal (col 11, lines 39-45 discloses “Chemical sensors may be used, for example, to monitor one or more chemical compositions within a treatment site (e.g. monitoring the brains cerebral spinal fluid (CSF) for chemicals such as osmolarity, sugar and infection). The sensors may provide enough feedback to the control circuitry 170 to allow the flow of drugs to be metered by a closed-loop control process.” This cite indicates that the device in fig 4b detects the sugar in the body then automatically administers drugs). however
Pang is silent to a microneedle array, and an electrode overlying the substrate, the microneedle array is integrally molded with the substrate, and comprises a plurality of hollow microneedles, and each hollow microneedle is internally provided with an injection channel; and the tip of the hollow microneedle faces one side away from the expansion membrane;
Kosel, a similar electrolysis powered drug pump, teaches a microneedle array (112, fig 2), and an electrode (104) overlying the substrate, the microneedle array is integrally molded with the substrate (para 0040 discloses “the microneedles 112 are integrally manufactured by 3D printing using a two-photon polymerization (TPP) technique” once combined the microneedles are integrally manufactured, as shown in Kosel, in the base of Pang), and comprises a plurality of hollow microneedles (112), and each hollow microneedle is internally provided with an injection channel (112, fig 2 have a channel in the center); and the tip of the hollow microneedle faces one side away from the expansion membrane (once combined the microneedles would be placed on the bottom of the pump 100 to pierce into the body 210 and would show the structure as outlined by the claim, 170 would be shrunk to not cover the whole bottom of the pump).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the structural features of Kosel in the device of Pang so it “is capable of delivering the drug directly to the target, that can control the amount and rate of the drug being delivered to the target, is small enough to fit on the target, and is also biocompatible with the target.” para 0007; Kosel.
In reference to dependent claim 15, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, Pang further discloses a device wherein the expansion membrane is made of at least one of polytetrafluoroethylene, polydimethylsiloxane, polyacrylate, silica gel, rubber, latex, polyurethane, parylene (col 10, lines 36-38 discloses “diaphragm 150 may be manufactured from one or more parylene films and/or a composite material”), or polyimide.
In reference to dependent claim 16, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, Pang further discloses a device wherein the electrode layer is made of a hard membrane (col 10, lines 66-2 discloses “the electrolysis electrodes 240 are coupled, or imbedded within, may include a substrate formed from a material including, but not limited to, alumina, zirconium oxide, and/or sapphire” all three would be considered “hard” substrates) or a flexible membrane.
In reference to dependent claim 17, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, Pang further discloses a device wherein the electrode comprises a working electrode and a power supply electrode (380, fig 7 which is interpreted to be similar to fig 4 shows two separate interdigital electrodes one being the working electrode and the other being the power supply electrode).
In reference to dependent claim 19, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, Pang further discloses wherein the drug injection device based on the electrochemical reaction is a closed-loop control system for insulin injection (col 10, lines 4-11 discloses “In one exemplary embodiment, a pump may be implanted --- in a pancreas that does not respond well to glucose to provide agents (e.g., proteins, viral vectors, etc.) that will trigger insulin release”), and the closed-loop control system for insulin injection comprises a closed-loop control system (col 11, lines 42-45 discloses “The sensors may provide enough feedback to the control circuitry 170 to allow the flow of drugs to be metered by a closed-loop control process.”).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Kosel (USPAP 2022/0134072) in reference to claim 12 above and further in view of El-Khatib (USPAP 2021/0016006).
In reference to dependent claim 13, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, however
Pang and Kosel are silent to wherein the control module comprises a first conversion subunit, a control subunit, and a second conversion subunit; an input end of the first conversion subunit is connected to an output end of the second sensor, an output end of the first conversion subunit is connected to an input end of the control subunit, and the first conversion subunit is used for receiving and converting the electrical signal output by the second sensor; the control subunit is used for receiving an electrical signal converted by the first conversion subunit and sending a command to the second conversion subunit according to the electrical signal; an input end of the second conversion subunit is connected to an output end of the control subunit, and an output end of the second conversion subunit is connected to an input end of the electrochemical micropump, and the second conversion subunit is used for receiving and converting the command output by the control subunit, and transmitting the converted command signal to the electrochemical micropump to control the turn-on or turn-off of the electrochemical micropump.
El-Khatib, a similar medical delivery teaches the control module comprises a first conversion subunit (304, fig 3), a control subunit (202), and a second conversion subunit (306); an input end of the first conversion subunit is connected to an output end of the second sensor (308), an output end of the first conversion subunit is connected to an input end of the control subunit, and the first conversion subunit (304) is used for receiving and converting the electrical signal output by the second sensor (para 0053 “ The ECI includes a sensor interface 304 configured to receive a glucose level signal from a sensor 110 such as a continuous glucose monitor (CGM).”); the control subunit is used for receiving an electrical signal converted by the first conversion subunit and sending a command to the second conversion subunit according to the electrical signal (para 0053 discloses “The sensor 110 can be operatively connected to a subject in order to generate a glucose level signal that corresponds to a blood glucose estimate or measurement of the subject. The glucose level signal can be used by the controller 202 to generate a dose control signal.”); an input end of the second conversion subunit (306) is connected to an output end of the control subunit (202), and an output end of the second conversion subunit (306) is connected to an input end of the pump (212), and the second conversion subunit (306) is used for receiving and converting the command output by the control subunit (202), and transmitting the converted command signal to the pump to control the turn-on or turn-off of the pump (para 0053 discloses “The glucose level signal can be used by the controller 202 to generate a dose control signal. The dose control signal can be provided to a pump 212 via a pump interface 306.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the controller of El-Khatib in the device of Pang in view of Kosel to “provide effective automated control without receiving explicit information regarding either meals that the subject” para 0059, El-Khatib.
In reference to dependent claim 14, Pang in view of Kosel and El-Khatib discloses the drug injection device based on an electrochemical reaction according to claim 13, El-Khatib further teaches wherein the first conversion subunit (304, fig 3) is a first signal converter (para 0053 discloses “the glucose control system 200 includes circuitry that implements an electronic communications interface (ECI) 302 configured to send and receive electronic data from one or more electronic devices” the ECI has components that convert the signals for communicating with the controller); the control subunit (202) is a microcontroller (para 0340 discloses “The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a processing unit or processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like.”); the second conversion subunit (306) is a second signal converter (para 0053 discloses “the glucose control system 200 includes circuitry that implements an electronic communications interface (ECI) 302 configured to send and receive electronic data from one or more electronic devices” the ECI has components that convert the signals for communicating with the controller).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pang (USPN 9,861,525) in view of Kosel (USPAP 2022/0134072) in reference to claim 12 above and further in reference Li (USPAP 2018/0104408).
In reference to dependent claim 18, Pang in view of Kosel discloses the drug injection device based on an electrochemical reaction according to claim 12, however
Pang and Kosel are silent to the power supply electrode is a counter electrode; or, the power supply electrode is a counter electrode or a reference electrode.
Li, a similar electrolysis powered drug pump, teaches the power supply electrode is a counter electrode; or, the power supply electrode (one of the three electrodes) is a counter electrode or a reference electrode (para 0008 discloses “the electrode includes not less than three electrodes, two of the electrodes are applied as positive and negative, one of the electrodes is applied as a reference electrode”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use one of the electrodes as a reference electrode as taught in Li in the device of Pang in view of Kosel “to prevent IR drop” para 0008; Li.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Santini (USPAP 2008/0015494) discloses a pump with multiple medicaments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm 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, Michael Tsai can be reached at (571) 270-5246. 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.
/CHARLES W NICHOLS/Examiner, Art Unit 3783