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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 9/20/24; 1/20/26 has/have been acknowledged and is/are being considered by the Examiner.
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(s) 1-3, 14, 16 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. (U.S. Pub. 2013/0041353 hereinafter, "Shin").
Regarding Claim 1, Shin discloses a device, comprising: a wearable ion pumping system (A needle (e.g., a narrow gauge needle), may be optionally inserted in order to reduce the extent to which its presence is felt by the wearer of the skin-attached drug pumping system in the skin of the belly delivery fluid may comprise a pharmaceutical agent used to treat a condition requiring treatment in humans delivery fluid comprising a drug may further include a solution in which the drug may be dissolved and/or dispersed, [0155]) pumping ions to and from a treatment site (active pharmaceutical ingredients that may be pumped include, heparin (e.g., used to control blood coagulation), interferon (e.g., used in the therapy of C-type hepatitis) or ketamine (e.g., used in pain management, for example, in conjunction with opioid drugs like morphine and its derivatives). Pumping may also be desirable (e.g., advantageous) when therapy is better achieved by maintaining a substantially constant concentration of a drug or substance in a body fluid, such as serum, and/or when therapy requires selective drug delivery to targeted organ or tissue, [0154]; electroosmotic pump Ag+ ions released from the electrodes increase the ionic conductivity of the water-bulk lowering the current efficiency, i.e. flow rate, [0259]) so as to deliver and measure a dose of the ions treating the treatment site (a pump system may comprise one or more sensors. For example, a pump may contain a sensor for detection of the volume of delivery fluid administered to a subject. Delivery fluid volume may be assessed. Sensor may be arranged in communication with a controller, according to some embodiments. A controller in communication with a sensor may adjust the potential difference and/or a current across a membrane (e.g., to adjust delivery to a desired flow rate, dose, volume, duration, [0169]; flow rate on the concentration of added KNO3 for a pump at 10-5 M concentration. At a 10-3 M concentration, the ions halve the flow of the pump operated by applying a constant current, [0264]; increase in the concentration of Ag+ in the water bulk during the operation of the pump on the flow rate is similar to the effects of the purposely added K+ and NO3 - ions, [0265]).
Regarding Claim 2, Shin discloses the device of claim 1, wherein the wearable ion pumping system further comprises a control circuit activating the pumping and measuring the dose (an electro-osmotic fluid delivery system controller assembly may comprise a user. interface configured to permit the magnitude and/or duration of the current to be applied to a pump, the magnitude and/or duration of the potential difference or voltage to be applied to a pump, or both to be set and/or changed by a user, [0014]; a pump system may comprise one or more sensors. For example, a pump may contain a sensor for detection of the volume of delivery fluid administered to a subject. Delivery fluid volume may be assessed … sensor may be arranged in communication with a controller, according to some embodiments. A controller in communication with a sensor may adjust the potential difference and/or a current across a membrane (e.g., to adjust delivery to a desired flow rate, dose, volume, duration, [0169]).
Regarding Claim 3, Shin discloses the device of claim 2, wherein the wearable ion pumping system (A needle (e.g., a narrow gauge needle), may be optionally inserted in order to reduce the extent to which its presence is felt by the wearer of the skin-attached drug pumping system in the skin of the belly delivery fluid may comprise a pharmaceutical agent used to treat a condition requiring treatment in humans delivery fluid comprising a drug may further include a solution in which the drug may be dissolved and/or dispersed, [0155]) further comprises: a housing comprising one or more reservoirs storing a fluid comprising the ions (a reservoir assembly may comprise two compartments. In some embodiments, one compartment may contain pumped water or aqueous solution, and a second compartment may contain a drug solution or of a solution containing multiple drugs, stored in a reservoir suspension, [0132]; A reservoir assembly may comprise, in some embodiments, a housing. A housing (e.g., a rigid and/or semi-rigid housing, [0142]); a system of conduits connected to the housing, the conduits loaded with a fluid between the reservoir and the treatment site (A reservoir assembly may comprise, in some embodiments, a housing. A housing (e.g., a rigid and/or semi-rigid housing), [0142]; a device delivering fluids (e.g., drugs) may include a pump (e.g., drug pump, insulin pump), a reservoir, a controller, one or more sensors, or combinations thereof. A fluid pump system (e.g., a medication pump system) may comprise, in some embodiments, flow-causing components, metering components (e.g., accurate drug dosing components), and/or an implanted needle or cannula, the needle or cannula connected through a plastic tubing to a flow-causing pump. A fluid delivery system may pump- and/or deliver a defined volume of a fluid (e.g., drug containing solution and/or a solution containing multiple drugs), stored in a reservoir, [0155]); and a plurality of electrodes electrically connected to the fluid and the control circuit, wherein in the control circuit activates the pumping by applying one or more voltages to the fluid via the electrodes (a pump system may comprise one or more sensors. For example, a pump may contain a sensor for detection of the volume of delivery fluid administered to a subject. Delivery fluid volume may be assessed … sensor may be arranged in communication with a controller, according to some embodiments. A controller in communication with a sensor may adjust the potential difference and/or a current across a membrane (e.g., to adjust delivery to a desired flow rate, dose, volume, duration, [0169]; current and voltage necessary to drive the flow are generated by the two electrodes at the two sides of the membrane, [0180]; application of a current (or voltage) across electrodes of a pump may drive protons to the cathode, [0181]).
Regarding Claim 14, Shin discloses the device of claim 3, wherein the ions comprise H+ ions or protons (composition of electrically conductive materials may be selected such that the application of a potential difference results in a reaction by which one or more ions (e.g., Ag+, H+, OH- or the like) move across and/or through a membrane according to some embodiments. For example, it may be desirable to select a composition such that protons (H+) move across and/or through a membrane, [0107]).
Regarding Claim 16, Shin discloses the device of claim 2, wherein the ion pumping system comprises a microfluidic system pumping a fluid comprising the ions (electroosmotic pump Ag+ ions released from the electrodes increase the ionic conductivity of the water-bulk lowering the current efficiency, i.e. flow rate, [0259]; flow rate was measured by monitoring the displacement of a calibrated micro-syringe connected to the outlet of the pump. The applied pressure opposing the flow was adjusted by changing the height of water-filled tubing connected to the outlet of the pump, [0263]).
Regarding Claim 23, Shin discloses the device of claim 1, further comprising a bandage, dressing, or patch attaching the device to the treatment site and covering the treatment site (may be effective in treatment of infections of the respiratory tract, skin, bones, joints, urogenital system, meningitis, and septicemia, [0153]; wearer of the skin-attached drug pumping system in the skin of the belly, the tip of the needle residing in the fatty tissue may often be found below the skin of the belly, [0155]; adhesive patch for attachment of the system to a subject, [0160]).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin as applied to claims 1-3, 14, 16 and 23 above, and further in view of Puttananjegowda et al. (U.S. Pub. 2021/0369157 hereinafter “Puttananjegowda”).
Regarding Claim 4, Shin discloses the device of claim 3, but fails to explicitly disclose wherein the control circuit comprising a potentiostat applying the one or more voltages and sensing one or more currents flowing through the treatment site. Puttananjegowda is in the field of control circuits (title; abstract) and teaches wherein the control circuit comprising a potentiostat applying the one or more voltages and sensing one or more currents flowing through the treatment site (sensing unit is observed to be capable of detecting an electrochemical current ranging from 2 UA to 200 UA from a SiCNPs-ENFM glucose sensor working electrode chronoamperometric, potentiostat (having a constant reference current generator, voltage control unit a low-power consumption of 540 µW for a 1.48 V supply compared to existing potentiostats. The integration of a:SiCNPs-ENFM glucose sensor with a chronoamperometric potentiostat provides the basis for future wearable and portable biosensors, [0018]; potentiostat circuit contains both a voltage control unit (VCU) and the electrochemical current measuring/current to voltage converter unit called a transimpedance amplifier (TIA). In turn, the CE provides a path for the sensing current to the grounded WE, and the current through the cell is controlled by the potentiostat, [0025]; an electrospun nanofibrous membrane which is biocompatible and suitable for implantable glucose sensing electrode for continuous blood glucose monitoring systems; and/or the integration of a novel low-power and low-noise chronoamperometric potentiostat. for continuous blood glücose monitoring in a patient, [0035]). It would have been obvious to one of ordinary skill in the art at the time of the invention to use the control circuit of Shin and the control circuit with a potentiostat as taught by Puttananjegowda to provide a potentiostat with a significant improvement in performance showing low noise, better gain, less-power dissipation, better sensitivity, stability, and durability. ([0032]; Puttananjegowda).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin as applied to claims 1-3, 14, 16 and 23 above, and further in view of Melodia et al. (U.S. Pub. 2018/0027077 hereinafter “Melodia”).
Regarding Claim 13, Shin discloses the device of claim 3, but fails to explicitly show that the system is capable of using breakout boards. However, Melodia discloses that breakout boards are commonly used in systems as taught in paragraph 82 to provide I/O connections where there is a limited number of pins available on the circuit board and circuitry. It would be obvious to one having ordinary skill in the art at the time of the invention to modify the system of Shin, with well-known breakout boards to provide for extra I/O connections in a circuit when there are limited number of connection on the circuit board and circuits to allow for fully functional designs (Melodia; Paragraph 82).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin as applied to claims 1-3, 14, 16 and 23 above, and further in view of Viola (U.S. Pub. 2010/0252612).
Regarding Claim 15, Shin discloses the device of claim 14, wherein the fluid in the conduits (pumps of the present disclosure may be of the type that deliver insulin stored in a remote reservoir fluidically connected (e.g., by tubing) to a cannula. Delivery may be accomplished by putting a pump in fluid communication with one or more tissues [more than one tubing pathway], [0099]) and the fluid in the reservoirs comprises a solution comprising the ions (A reservoir assembly may comprise, in some embodiments, a housing. A housing (e.g., a rigid and/or semi-rigid housing), [0142]; a device delivering fluids (e.g., drugs) may include a pump (e.g., drug pump, insulin pump), a reservoir, a controller, one or more sensors, or combinations thereof. A fluid pump system (e.g., a medication pump system) may comprise, in some embodiments, flow-causing components, metering components (e.g., accurate drug dosing components), and/or an implanted needle or cannula, the needle or cannula connected through a plastic tubing to a flow-causing pump. A fluid delivery system may pump- and/or deliver a defined volume of a fluid (e.g., drug containing solution and/or a solution containing multiple drugs), stored in a reservoir, [0155]; systems are built with two-compartment reservoirs, [0248]; increase in the concentration of Ag+ in the water bulk during the operation of the pump on the flow rate is similar to the effects of the purposely added K+ and NO3 - ions, [0265]). but fails to explicitly disclose wherein the fluid in the conduits comprises a hydrogel. Viola is in the field of medical treatments (title; abstract) and teaches wherein the fluid in the conduits comprises a hydrogel (wound closure applicator assembly includes at least one conduit extending along at least a length of the driving member, and at least one reservoir in fluid communication with the at least one conduit the conduit having at least one opening and being adapted to provide wound closure material, [0013]; wound closure material is selected from the group consisting of hydrogel materials, Claim 17). It would have been obvious to one of ordinary skill in the art al the time of the invention to use the conduit for hydrogel of Shin and conduit as taught by Viola. The motivation being to provide treatment method that includes- hydrogel as a wound closure to increase the simplicity and decrease the amount of devices to provide treatment to the wound. ([0013]; Viola).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin as applied to claims 1-3, 14, 16 and 23 above, and further in view of in view of CN 106693031 to Tianjin Polytechnic University (hereinafter, "Tianjin") (cited in the IDS filed on 9/21/24).
Regarding Claims 17-18, Shin discloses the device of claim 2, but fails to explicitly disclose wherein the ions control a pH of the treatment site. Tianjin is in the field of controlling pH value of a treatment location (title; abstract) and teaches wherein the ions control a pH of the treatment site (controlling the pH value of the wound takes the calcium alginate hydrogel as a base layer, SO that the defect of low mechanical strength when an acting layer of the intelligent dressing is independently used as the dressing is overcome. After the intelligent dressing action layer is contacted with the wound, the hypoxia-moist closed environment can be effectively kept, and the pH of wound exudate is intelligently adjusted to be about 5.5, so that the wound healing rate is accelerated, Abstract; hydrogel of the wound contact action layer swells and absorbs calcium ions in the calcium chloride solution. After swelling balance, 20ml of sodium alginate solution with the mass fraction of 1.5 percent and uniform preparation is flatly paved on the hydrogel of the action layer contacting with the wound in the mold, the hydrogel of the action layer starts to release calcium ions, P. 6, Lns. 11-20). It would have been obvious to one of ordinary skill in the art at the time of the invention to use the the ions of Shin and the ions to control a pH as taught by Tianjin. The motivation being to control the ions released lo the wound to a desired pH level, which further provides a wound healing rate that is accelerated: (P. 6, Lns. 11-20; Tianjin).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin as applied to claims 1-3, 14, 16 and 23 above, and further in view of in view of Hetz (U.S. Pub. 2020/0384287).
Regarding Claim 19, Shin discloses a system comprising the device of claim 2, but fails to explicitly disclose coupled to a camera forming images of the wound, wherein the control circuit provides closed loop control of the pumping based on healing of the wound observed in the images. Hetz is in the field of wound treatment (title; abstract) and teaches coupled to a camera forming images of the wound, wherein the control circuit provides closed loop control of the pumping based on healing of the wound observed in the images (one or more pumps for pumping the coolant or cooling media to the patient site or site on the phototherapy device, [0238]; phototherapy device can be used to treat open wounds and speed healing through the general benefits of the administration of phototherapy. A wound may require different doses inside and outside the edges of the wound. The computer control unit may use spectrometry imaging to subsequently adjust the dose differently for each section of the wound, [0295]; Blood vessels and/or the flow of blood could be visualized with infrared imaging, ultrasonic imaging, and/or other vessel structure or blood flow imaging technologies imaging techniques could also detect the temperature of the vessels to allow for real-time adjustments in dose, rate, [0298]; closed-circuit CO2 system described above, the heated CO2 gas may be pumped CCU 3217 may similarly control or automatically adjust the CO2 gas flow rate within the closed-circuit CO2 system (e.g., via an RPM speed of a gas pump motor based on temperature information received from temperature sensors, [0573]). It would have been obvious to one of ordinary skill in the art at the time of the invention to use the the pumping treatment of Shin and the pumping control based on images by Hetz. The motivation being to control the treatment based on the wound images to improve treatment efficacy. ([0239]; Hetz).
Allowable Subject Matter
Claims 5-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Toong et al. (U.S. Pat. 2021/0268276) – teacheas a wound healing patch that provides for iontophoresis through ion pumps and reservoirs (e.g. Paragraphs 26-27 and 94-98).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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