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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 27, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on April 27, 2026. As directed by the amendment: claims 1, 6, 8, and 12-14 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks pgs. 8-10, filed April 27, 2026, with respect to the rejection(s) of claim(s) 1, 8, and 13 under 35 U.S.C. 103 have been fully considered and are persuasive. None of Seshadri, Weber, or Xu disclose the amended limitation of an electroactive polymer material configured to release agents in response to an applied electric field by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the agents when a positive voltage is applied across the reservoir. Therefore, the rejection has been withdrawn. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
On pgs. 10-11 of the Remarks, the applicant argues that the motivation for modifying Seshadri with the teachings of Weber and Xu is insufficient. Applicant states that the modifications to Seshadri’s passive delivery device to allow for a voltage to be applied across the reservoir and incorporating microneedles as an outlet of the reservoir would greatly change the nature and function of the device. The examiner respectfully disagrees, as the device of Seshadri already has the components for electrical stimulation (Seshadri, Fig. 6 and [0174, 0187]), therefore the application of an electroactive reservoir for enhanced control over drug delivery, such as that of Weber ([0009-0010]), would be an modification which is an applicable improvement to the device of Seshadri. Additionally, Seshadri discloses that the device aims to have enhanced wound healing via delivery of bioactive agents and electrical stimulation (Seshadri, [0104, 0174]). The modification of microneedles for agent delivery, as disclosed in Xu, would be an obvious modification as the microneedles enhance drug delivery across the skin in safe/painless manner that may also have controllable delivery (Xu, [0050]), thus improving the drug delivery and therapeutic healing. Therefore, the modifications of Seshadri using Weber and Xu provide proper motivation.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8, line 15 recites “antimicrobial reserovir”, should read “antimicrobial reservoir”. Appropriate correction is required.
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.
Claims 1-11, 13-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Seshadri et al. (US 20230329916), hereinafter Seshadri, in view of Weber (US 20110152747), Saaman et al, (US 5750138), hereinafter Saaman, Takada et al. (US 20010022344), hereinafter Takada, and Xu (US 20190388667).
Regarding claim 1, Seshadri discloses a--- smart bandage device (Fig. 4, wound device 34), comprising: a substrate with multiple layers (Fig, 4B, device 34 is formed as a multi-layer substrate); a sensor disposed within a first layer of the substrate (Fig. 4, sensors 46 disposed on upper side 48 of occlusive layer 36), wherein the sensor measures characteristics of a wound (Fig. 4a and [0146-0148], sensor 46A is positioned over the wound to measure temperature of the wound); a reservoir disposed within a second layer of the substrate (Fig. 4 and [0136], moisture absorbing layer 12, which may be loaded with one or more bioactive agents); an outlet disposed within the substrate adjacent to a skin-facing layer of the substrate (Fig. 2a, 4 and [0139-0141, 0163], adhesive patch 53, which is the skin-facing substrate layer may be constructed similarly to adhesive layer 14, such that it comprises an opening in the middle to allow the moisture absorbing layer 12 to interface with the wound); an electrical stimulation module disposed within a third layer of the substrate (Fig. 4 and [0165], device may include a plurality of electrodes 58 (see figs. 6) disposed on the wound side surface of layer 36), wherein the electrical stimulation module produces electrical stimulation to the wound (Fig. 4 and [0174], electrodes can be used to deliver electrical stimulation to the wound site); and a control module (Fig, 4, control module 52) that receives signals from the sensor representative of characteristics of the wound and sends signals to the electrical stimulation module to produce electrical stimulation (Fig. 4, 6, and [0151, 0194-0198], control module 52 may receive signals from the temperature sensors 46, as well as then send signals to apply electrical stimulation to the electrodes 58 for electrical stimulation).
Seshadri fails to disclose wherein the reservoir comprises an electroactive polymer material configured to release agents in response to an applied electric field; and apply the electric field to the reservoir to dispense agents. However, Weber discloses wherein the reservoir comprises an electroactive polymer material configured to release agents in response to an applied electric field (Fig. 1A-B and [0015-0017], reservoir 52 comprises an electroactive polymer configured to release agent 62 in response to an applied electrical potential by an electrode 60); and apply the electric field to the reservoir to dispense agents (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri, see Seshadri [0194]) can apply an electrical potential to the reservoir 52 to allow the electroactive polymer within reservoir 52 to release the therapeutic agent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri to incorporate the disclosures of Weber and modify the reservoir to comprise an electroactive polymer material configured to release agents in response to an applied electric field; and modify the device to apply the electric field to the reservoir to dispense agents. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Seshadri, in view of Weber, fails to disclose wherein the polymer material is configured to release agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the agents. However, Saaman discloses wherein the polymer material is configured to release agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the agents (C. 2:48-56, polymer may constitute carboxylic groups which contract when protonated, thus allowing medication from within the polymer material to be delivered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, to incorporate the disclosures of Saaman and modify the polymer material to be configured to release agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the agents. Doing so provides a drug delivery reservoir which may have delayed delivery of the drug by modification of the structure of the reservoir membrane caused by an external stimulus, thus allowing for administration over a long term period (Saaman, C. 2:6-26).
Seshadri, in view of Weber and Saaman, fails to disclose protonation-induced contraction when a positive voltage is applied across the reservoir, so as to dispense agents by applying the positive voltage across the reservoir. However, Takada discloses protonation-induced contraction when a positive voltage is applied across the reservoir, so as to dispense agents by applying the positive voltage across the reservoir (Fig. 2 and [0047], substances which have a strong proton affinity/apt to be converted to protonated ions (such as the carboxylic groups of Saaman) may have a positive voltage applied to them via an electrode for causing protonation and said downstream effects).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber and Saaman, to incorporate the disclosures of Takada and modify the protonation-induced contraction to occur when a positive voltage is applied across the reservoir, so as to dispense agents by applying the positive voltage across the reservoir. Doing so would stimulate the substance with a voltage that has a polarity which is applicable to the properties of the substance and its ion affinity (Takada, [0047]).
Seshadri, in view of Weber, Saaman, and Takada, fails to disclose wherein the outlet is in fluid communication with the reservoir and is configured to dispense agents from the reservoir; and the control module sends signals to the outlet to dispense agents. However, Xu discloses wherein the outlet is in fluid communication with the reservoir and is configured to dispense agents from the reservoir (Figs. 4A-B and [0053, 0055], beneath drug reservoir layer 230 may be microneedles 240 which may be in fluid communication with the drug reservoir layer 230 to dispense drug agent from the drug reservoir layer 230).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, and Takada, to incorporate the disclosures of Xu and modify the device outlet to comprise microneedles which are in in fluid communication with the reservoir and configured to dispense agents from the reservoir. Doing so would allow the device to transfer the drug across the skin without stimulating nerves associated with pain, thus enhancing drug delivery in a painless way, promoting self-administration, especially among those with needle phobia (Xu, [0050]).
Regarding claim 2 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the smart bandage device of claim 1, further comprising a wireless communication module that connects the smart bandage device to another wireless device (Fig. 4 and [0194], control module 52 may comprise a communication module which wirelessly communicates information from the wound device 34 with a remote device 54).
Regarding claim 3, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses the--- smart bandage device of claim 1, as explained above. Seshadri, in view of Weber, Saaman, and Takada, is silent to wherein the sensor is a biosensor configured to detect at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level. However, Xu further discloses wherein the sensor is a biosensor configured to detect at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level ([0070], the device may comprise sensors which are electrochemical biosensors configured to detect metabolites).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Xu and modify the sensors to include electrochemical biosensors configured to detect metabolites. Doing so would allow the device to achieve multi-channel acquisition of physiological signals and other vital signs regarding the status of human health (Xu, [9996]).
Regarding claim 4 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the smart bandage device of claim 2, further comprising one or more processors and a non-transitory computer readable storage medium ([0152-0155], control module 52 comprises one or more processors and a system memory which may store non-transitory media) that includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive signals from the sensor representative of characteristics of the wound; and transmit the received signals via the wireless communication module to an external device ([0151, 0161, 0194], the system memory may store instructions that are executed by the one or more processors to perform the methods of receiving signals from the temperature sensors 46, and transmit information to remote device 54 via wireless communication).
Regarding claim 5 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses the smart bandage device of claim 2, further comprising one or more processors and a non-transitory computer readable storage medium ([0152-0155], control module 52 comprises one or more processors and a system memory which may store non-transitory media) that includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive signals from an external device via the wireless communication module ([0161, 0194, 0238-0240], the system memory may store instructions that are executed by the one or more processors to perform the methods of using remote device 54 as a user interface which may control the wound device 34 for application of electrical stimulation, therefore the control module 52 can receive signals from remote device 54 via wireless communication), and transmit signals to the electrical stimulation module representative of a wound treatment plan, wherein the wound treatment plan comprises an electrical stimulation ([0194-0198, 0238-0240], control module 52 may send signals to apply electrical stimulation to the electrodes 58 for electrical stimulation to the wound site).
As noted above Seshadri fails to disclose the control module sends signals to the outlet to dispense agents, and is thus silent to transmitting signals to the outlet representative of a wound treatment plan, wherein the wound treatment plan comprises a distribution of agent. However, Weber further discloses transmitting signals to the outlet representative of a wound treatment plan, wherein the wound treatment plan comprises a distribution of agent (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri, see Seshadri [0194]) can apply an electrical potential to the reservoir 52 to allow the electroactive polymer within reservoir 52 to release the therapeutic agent to an outlet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Weber and modify the non-transitory computer readable storage medium that includes instructions to send signals to the device to dispense agents through the microneedles. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Regarding claim 6 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the smart bandage device of claim 1, wherein the reservoir is a hydrogel layer ([0136], moisture absorbing layer 136 may be formulated as a hydrogel with bioactive agents having the desired release profile).
Seshadri is silent to the hydrogel layer being electroactive. However, Xu further discloses the hydrogel layer being electroactive (Fig 6 and [0062-0063], drug release layer may include a hydrogel which is controlled/stimulated by application of current by an electrode.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Xu and modify the hydrogel layer to be electroactive. Doing so would increase the viscosity of the fluid the active agent is provided in and also allow for drug release rate from the hydrogel layer to be electrically controlled (Xu, [0062]).
Regarding claim 7 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the smart bandage device of claim 6, wherein the flexible multi-layer substrate is a topical bandage (Fig. 4b and [0006], the multilayer substrate of wound device 34 is an adhesive wound dressing for topically attaching to non-wounded perimeter of the wound site, in order to cover the wound site. Therefore, the wound dressing meets the definition of a bandage as defined by Oxford Languages Online Dictionary as "a strip of material used to bind a wound or to protect an injured part of the body").
Regarding claim 8, Seshadri discloses a--- smart bandage device for monitoring and treating wounds (Fig. 4 and [0143], wound device 34 for monitoring and healing a wound site), comprising: a flexible multi-layer (Fig. 4B and [0120], device 34 is formed as a multi-layer flexible substrate); a plurality of sensors disposed within the flexible multi-layer substrate (Fig. 4, sensors 46 disposed on upper side 48 of occlusive layer 36 of substrate), wherein the plurality of sensors measure wound characteristics and produce signals reflective of the wound characteristics (Fig. 4a and [0008, 0146-0148], sensors 46 are positioned over and around the wound to measure temperature of the wound and its surrounding area which can help determine the status of the wound); a control module (Fig, 4, control module 52) that receives the signals from the sensors and performs a bioanalysis of the wound characteristics (Fig. 4, 6, and [0151, 0166-0170], control module 52 may receive signals from the temperature sensors 46, and analyze the signals to find temperature difference to determine an infection status of the wound site), wherein the control module generates a wound treatment plan ([0161, 0194, 0238-0240], control module 52 may then determine the treatment application by initiating/modifying the application of electrical stimulation by the wound device 34) an antimicrobial reservoir disposed on an external surface of the flexible multi-layer substrate (Fig. 4 and [0104, 0136, 0139-0141], moisture absorbing layer 12, which may be loaded with one or more bioactive antimicrobial agents and disposed on an external surface of the device 34, as moisture absorbing layer 12 is located within the central opening of adhesive patch layer 53, in order for moisture absorbing layer 12 to interface with the wound); an electrical stimulation module disposed within the flexible multi-layer substrate, wherein the electrical stimulation module produces electrical stimulation (Fig. 4 and [0165], device may include a plurality of electrodes 58 (see figs. 6) disposed on the wound side surface of layer 36), wherein the electrical stimulation module produces electrical stimulation (Fig. 4 and [0174], electrodes can be used to deliver electrical stimulation to the wound site); and a wireless communication module disposed within the flexible multi-layer substrate that connects the smart bandage to a wireless device (Fig. 4 and [0194], control module 52 may comprise a communication module which wirelessly communicates information from the wound device 34 with a remote wireless device 54).
Seshadri fails to disclose wherein the control module sends signals to the antimicrobial reservoir to release antimicrobial agents when threshold wound characteristics are met; wherein the antimicrobial reservoir comprises an electroactive polymer material configured to release the antimicrobial agents in response to the applied electric field. However, Weber discloses wherein the control module sends signals to the antimicrobial reservoir to release antimicrobial agents when threshold wound characteristics are met (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri, see Seshadri [0194]) can apply an electrical potential to the reservoir 52 to allow an electroactive polymer within reservoir 52 to release the therapeutic agent); wherein the antimicrobial reservoir comprises an electroactive polymer material configured to release the antimicrobial agents in response to the applied electric field (Fig. 1A-B and [0015-0017], reservoir 52 comprises an electroactive polymer configured to release agent 62 in response to an applied electrical potential by an electrode 60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri to incorporate the disclosures of Weber and modify the reservoir to comprise an electroactive polymer material configured to release agents in response to an applied electric field; modify the control module to send signals to the antimicrobial reservoir to release antimicrobial agents when threshold wound characteristics are met; and modify the antimicrobial reservoir to comprise an electroactive polymer material configured to release the antimicrobial agents in response to the applied electric field. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Seshadri, in view of Weber, fails to disclose wherein the electroactive polymer material is configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the antimicrobial agents. However, Saaman discloses wherein the electroactive polymer material is configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the antimicrobial agents (C. 2:48-56, polymer may constitute carboxylic groups which contract when protonated, thus allowing medication from within the polymer material to be delivered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, to incorporate the disclosures of Saaman and modify the electroactive polymer material to be configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the antimicrobial agents. Doing so provides a drug delivery reservoir which may have delayed delivery of the drug by modification of the structure of the reservoir membrane caused by an external stimulus, thus allowing for administration over a long term period (Saaman, C. 2:6-26).
Seshadri, in view of Weber and Saaman, fails to disclose protonation-induced contraction when a positive voltage is applied across the antimicrobial reservoir. However, Takada discloses protonation-induced contraction when a positive voltage is applied across the antimicrobial reservoir (Fig. 2 and [0047], substances which have a strong proton affinity/apt to be converted to protonated ions (such as the carboxylic groups of Saaman) may have a positive voltage applied to them via an electrode for causing protonation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber and Saaman, to incorporate the disclosures of Takada and modify the protonation-induced contraction to occur when a positive voltage is applied across the antimicrobial reservoir. Doing so would stimulate the substance with a voltage that has a polarity which is applicable to the properties of the substance and its ion affinity (Takada, [0047]).
Seshadri, in view of Weber, Saaman and Takada, fails to disclose releasing antimicrobial agents out of antimicrobial agent outlets. However, Xu discloses releasing antimicrobial agents out of antimicrobial agent outlets (Figs. 4A-B and [0052-0055], beneath drug reservoir layer 230 may be microneedles 240 through which the released drug may flow, allowing the released agent to flow through the microneedles 240 and into the epidermis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman and Takada, to incorporate the disclosures of Xu and modify the antimicrobial reservoir to comprise microneedles such that the antimicrobial agents may dispense through the microneedles. Doing so would allow the device to transfer the drug across the skin without stimulating nerves associated with pain, thus enhancing drug delivery in a painless way, promoting self-administration, especially among those with needle phobia (Xu, [0050]).
Regarding claim 9, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses the--- smart bandage device of claim 8, as explained above. Seshadri, in view of Weber, Saaman, and Takada, is silent to wherein the plurality of sensors are configured to detect at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level. However, Xu further discloses wherein the plurality of sensors are configured to detect at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level ([0070], the device may comprise sensors which are electrochemical biosensors configured to detect metabolites).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Xu and modify the sensors to include electrochemical biosensors configured to detect metabolites. Doing so would allow the device to achieve multi-channel acquisition of physiological signals and other vital signs regarding the status of human health (Xu, [9996]).
Regarding claim 10 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses the smart bandage device of claim 8, wherein the control module further comprises one or more processors and a non-transitory computer readable storage medium ([0152-0155], control module 52 comprises one or more processors and a system memory which may store non-transitory media) that includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive signals from the plurality of sensors representative of characteristics of the wound ([0151, 0161], the system memory may store instructions that are executed by the one or more processors to perform the methods of receiving signals from the temperature sensors 46), and transmit signals when threshold wound characteristics are met ([0166-0174], control module can transmit signals for aiding in healing of the wound site when wound characteristics, such as measured temperature difference between wound site and ambient skin temperature ([0147]), is determined to be no longer within the appropriate temperature range, indicating infection status or ischemic status of the wound site).
As noted above Seshadri fails to disclose the control module sends signals to the antimicrobial reservoir to release antimicrobial agents, and is thus silent to transmitting signals to the antimicrobial reservoir. However, However, Weber further discloses transmitting signals to the antimicrobial reservoir. (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri, see Seshadri [0194]) can apply an electrical potential to the reservoir 52 to allow the electroactive polymer within reservoir 52 to release the therapeutic agent to an outlet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Weber and modify the non-transitory computer readable storage medium that includes instructions transmit signals to the antimicrobial reservoir when threshold wound characteristics are met. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Regarding claim 11 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the smart bandage device of claim 8, wherein the control module further comprises one or more processors and a non-transitory computer readable storage medium ([0152-0155], control module 52 comprises one or more processors and a system memory which may store non-transitory media) that includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive signals from the plurality of sensors representative of characteristics of the wound; ([0151, 0161], the system memory may store instructions that are executed by the one or more processors to perform the methods of receiving signals from the temperature sensors 46), and transmit signals to the electrical stimulation module when threshold wound characteristics are met ([0166-0174], control module can transmit signals for applying electrical stimulations via electrodes for aiding in healing of the wound site when wound characteristics, such as measured temperature difference between wound site and ambient skin temperature ([0147]), is determined to be no longer within the appropriate temperature range, indicating infection status or ischemic status of the wound site).
Regarding claim 13, Seshadri discloses a--- method of monitoring and treating a wound using a smart bandage (Fig. 4 and [0166], method of monitoring an healing a wound site using wound device 34 ), comprising: applying a smart bandage to a wound on a patient (Fig. 4 and [0174], wound device 34 is applied to the wound site), wherein the smart bandage comprises: a substrate with multiple layers (Fig, 4B, device 34 is formed as a multi-layer substrate); a sensor disposed within a first layer of the substrate (Fig. 4, sensors 46 disposed on upper side 48 of occlusive layer 36), wherein the sensor measures characteristics of a wound (Fig. 4a and [0146-0148], sensor 46A is positioned over the wound to measure temperature of the wound); an antimicrobial reservoir disposed within a second layer of the substrate (Fig. 4 and [0104, 0136], moisture absorbing layer 12, which may be loaded with one or more antimicrobial bioactive agents); an antimicrobial outlet disposed within the substrate adjacent to a skin-facing layer of the substrate (Fig. 2a, 4 and [0139-0141, 0163], adhesive patch 53, which is the skin-facing substrate layer may be constructed similarly to adhesive layer 14, such that it comprises an opening in the middle to allow the moisture absorbing layer 12 to interface with the wound); an electrical stimulation module disposed within a third layer of the substrate (Fig. 4 and [0165], device may include a plurality of electrodes 58 (see figs. 6) disposed on the wound side surface of layer 36), wherein the electrical stimulation module produces electrical stimulation to a patient (Fig. 4 and [0174], electrodes can be used to deliver electrical stimulation to the wound site of the patient); and a control module (Fig, 4, control module 52) that receives signals from the sensor representative of characteristics of the wound and sends signals to the electrical stimulation module to produce electrical stimulation (Fig. 4, 6, and [0151, 0194-0198], control module 52 may receive signals from the temperature sensors 46, as well as then send signals to apply electrical stimulation to the electrodes 58 for electrical stimulation); receiving signals from the sensors representative of wound characteristics, wherein the received signals are transmitted to the control module ([0151, 0161, 0194], the control module 52 receive signals from the temperature sensors 46 which represent wound characteristics (wound temperature)); comparing the received signals representative of wound characteristics to threshold wound characteristics values ([0169,0172], control module can compare the detected wound site temperature to the optimum wound site temperature for healing (33 C) and/or the clinically relevant temperature range (~35-~40 C)); and applying a treatment to the wound when the threshold wound characteristics values are exceeded by the received signals representative of wound characteristics ([0166-0174], control module can transmit signals for aiding in healing of the wound site when wound characteristics, such as measured temperature is determined to exceed optimum healing temperature and/or clinically relevant temperature range, indicating infection status of the wound site).
Seshadri fails to disclose wherein the antimicrobial reservoir comprises an electroactive polymer material configured to release antimicrobial agents in response to an applied electric field; and apply the electric field to the antimicrobial reservoir to dispense the antimicrobial agents. However, Weber discloses wherein the antimicrobial reservoir comprises an electroactive polymer material configured to release antimicrobial agents in response to an applied electric field (Fig. 1A-B and [0015-0017], reservoir 52 comprises an electroactive polymer configured to release agent 62 in response to an applied electrical potential by an electrode 60); and apply the electric field to the antimicrobial reservoir to dispense the antimicrobial agents (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri) can apply an electrical potential to the reservoir 52 to allow the electroactive polymer within reservoir 52 to release the therapeutic agent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri to incorporate the disclosures of Weber and modify the antimicrobial reservoir to comprise an electroactive polymer material configured to release agents in response to an applied electric field; and modify the device to apply the electric field to the antimicrobial reservoir to dispense agents. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Seshadri, in view of Weber, fails to disclose wherein the electroactive polymer material is configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer to expel fluid carrying the antimicrobial agents. However, Saaman discloses wherein the electroactive polymer material is configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer to expel fluid carrying the antimicrobial agents (C. 2:48-56, polymer may constitute carboxylic groups which contract when protonated, thus allowing medication from within the polymer material to be delivered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, to incorporate the disclosures of Saaman and modify the electroactive polymer to be configured to release antimicrobial agents by protonation-induced contraction of the electroactive polymer material to expel fluid carrying the antimicrobial agents. Doing so provides a drug delivery reservoir which may have delayed delivery of the drug by modification of the structure of the reservoir membrane caused by an external stimulus, thus allowing for administration over a long term period (Saaman, C. 2:6-26).
Seshadri, in view of Weber and Saaman, fails to disclose protonation-induced contraction when a positive voltage is applied across the antimicrobial reservoir, so as to dispense agents by applying the positive voltage across the antimicrobial reservoir. However, Takada discloses protonation-induced contraction when a positive voltage is applied across the antimicrobial reservoir, so as to dispense agents by applying the positive voltage across the antimicrobial reservoir (Fig. 2 and [0047], substances which have a strong proton affinity/apt to be converted to protonated ions (such as the carboxylic groups of Saaman) may have a positive voltage applied to them via an electrode for causing protonation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber and Saaman, to incorporate the disclosures of Takada and modify the protonation-induced contraction to occur when a positive voltage is applied across the antimicrobial reservoir, so as to dispense agents by applying the positive voltage across the antimicrobial reservoir. Doing so would stimulate the substance with a voltage that has a polarity which is applicable to the properties of the substance and its ion affinity (Takada, [0047]).
Seshadri, in view of Weber, Saaman, and Takada, fails to disclose wherein the antimicrobial outlet dispenses antimicrobial agents from the antimicrobial reservoir. However, Xu discloses wherein the antimicrobial outlet dispenses antimicrobial agents from the antimicrobial reservoir (Figs. 4A-B and [0053, 0055], beneath drug reservoir layer 230 may be microneedles 240 through which the released drug may flow).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, and Takada, to incorporate the disclosures of Xu and modify the device outlet to comprise microneedles in communication with the antimicrobial reservoir to dispense agents through the microneedles. Doing so would allow the device to transfer the drug across the skin without stimulating nerves associated with pain, thus enhancing drug delivery in a painless way, promoting self-administration, especially among those with needle phobia (Xu, [0050]).
Regarding claim 14 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the method of claim 13, as explained above. As noted above Seshadri fails to disclose the control module sends signals to apply the electric field to the antimicrobial reservoir to dispense the antimicrobial agents, and is thus silent to wherein applying treatment further comprises administering the antimicrobial agent to the wound on the patient. However, Weber further discloses wherein applying treatment further comprises administering the antimicrobial agent to the wound on the patient (Fig. 1B and [0016-0017], electrode 60 (which can be connected to/receive signals from the control module 52 of Seshadri, similar to electrodes 58 of Seshadri, see Seshadri [0194]) can apply an electrical potential to the reservoir 52 to allow the electroactive polymer within reservoir 52 to release the therapeutic agent to an outlet, thus delivering the agent to the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Weber and modify the applying treatment method to include administering the antimicrobial agents to the wound on the patient. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Regarding claim 15 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the method of claim 13, wherein applying treatment further comprises administering an electrical stimulation to the wound on the patient ([0166-0174], control module can transmit signals for applying electrical stimulations via electrodes for aiding in healing of the wound site).
Regarding claim 18, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses the--- method of claim 13, as explained above. Seshadri, in view of Weber, Saaman, and Takada, is silent to wherein receiving signals from the sensors representative of wound characteristics comprises receiving signals from a sensor configured to measure at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level. However, Xu further discloses wherein receiving signals from the sensors representative of wound characteristics comprises receiving signals from a sensor configured to measure at least one of metabolites, amino acids, vitamins, minerals, hormones, antibodies, pH, UA level, ammonia level, lactate level, CRP level, and glucose level ([0070], the device may comprise sensors which are electrochemical biosensors configured to receive signals that detects metabolites).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to further incorporate the disclosures of Xu and modify the sensors to include electrochemical biosensors, such that the method includes receiving signals from a sensor configured to measure metabolites. Doing so would allow the device to achieve multi-channel acquisition of physiological signals and other vital signs regarding the status of human health (Xu, [9996]).
Regarding claim 20 and Seshadri, in view of Weber, Saaman, Takada, and Xu, Seshadri further discloses ---the method of claim 13, further comprising wirelessly communicating with another wireless device (Fig. 4 and [0194], control module 52 may comprise a communication module which wirelessly communicates information from the wound device 34 with a remote device 54).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Seshadri (US 20230329916) in view of Weber (US 20110152747), Saaman (US 5750138), Takada (US 20010022344), and Xu (US 20190388667), as applied to claim 8 above, and further in view of Al Kobaisi et al. (US 20190125661), hereinafter Al Kobaisi.
Regarding claim 12, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses ---the smart bandage device of claim 8, as explained above. Seshadri is silent to wherein the antimicrobial reservoir comprises an electroactive polymer material. However, Weber further discloses wherein the antimicrobial reservoir comprises an electroactive polymer material (Fig. 1A-B and [0015-0017], reservoir 52 comprises an electroactive polymer configured to release agent 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber and Xu, to further incorporate the disclosures of Weber and modify the antimicrobial reservoir to comprise an electroactive polymer material. Doing so would provide a reservoir which can be controlled by simple electrical stimulation and used for controlled release of a therapeutic agent (Weber, [0009, 0011]).
Seshadri, in view of Weber, Saaman, Takada, and Xu, fails to disclose the electroactive polymer material comprising a sulfated glycosaminoglycan hydrogel. However, Al Kobaisi discloses the electroactive polymer material comprising a sulfated glycosaminoglycan hydrogel ([0146], electroactive hydrogel material is composed of sulfated glycosaminoglycans, such as chondroitin sulfate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber and Xu, to incorporate the disclosures of Al Kobaisi and modify the electroactive polymer material to comprise a sulfated glycosaminoglycan hydrogel. Doing so would provide a polymer material which can carry a net charge at physiological pH, thus assisting with modulating the release of the agents within the polymer material layer (Al Kobaisi, [0146]).
Claims 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Seshadri (US 20230329916) in view of Weber (US 20110152747), Saaman (US 5750138), Takada (US 20010022344), and Xu (US 20190388667), as applied to claim 13 above, and further in view of Cao et al. (US 20190374712), hereinafter Cao.
Regarding claim 16, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses ---the method of claim 13.
Seshadri, in view of Weber, Saaman, Takada, and Xu, fails to disclose wherein the threshold wound characteristics values are programmed into the control module. However, Cao discloses wherein the threshold wound characteristics values are programmed into the control module (Fig. 6 and [0022, 0037], control unit 101 may have threshold values for parameters programmed to the control unit 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to incorporate the disclosures of Cao and modify the method and device such that the threshold wound characteristics values are programmed into the control module. Doing so would allow for the device to detect a designated condition based on the magnitude of change in parameter value, which aids in applying the proper treatment to the wound (Cao, [0018, 0037-0038]).
Regarding claim 17, Seshadri, in view of Weber, Saaman, Takada, Xu, and Cao, discloses ------the method of claim 16, as explained above. As noted above Seshadri, Weber, Saaman, Takada, and Xu fails to disclose threshold wound characteristics values are programmed into the control module, and is thus silent to wherein the threshold wound characteristics are dynamically adjusted by a medical provider during wound treatment. However, Cao further discloses wherein the threshold wound characteristics are dynamically adjusted by a medical provider during wound treatment (Fig. 1 and [0022], the control unit 101 may be programmed by users via user device 109 in order to adjust the thresholds used to control the drug delivery during treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, Xu and Cao, to further incorporate the disclosures of Cao and such that the threshold wound characteristics are dynamically adjusted by a medical provider during wound treatment. Doing so would allow for the device to detect a designated condition based on the magnitude of change in a parameter value, the logic of which is set by the user, which aids in applying the proper treatment to the wound (Cao, [0018, 0022, 0037-0038]).
Regarding claim 19, Seshadri, in view of Weber, Saaman, Takada, and Xu, discloses ---the method of claim 13.
Seshadri, in view of Weber, Saaman, Takada, and Xu, fails to expressly disclose wherein applying treatment to the wound when the threshold wound characteristics values are exceeded is done autonomously. However, Cao discloses wherein applying treatment to the wound when the threshold wound characteristics values are exceeded is done autonomously (Fig. 6 and [0037-0039], control unit is programmed to automatically adjust and activate the drug delivery unit of the device to apply treatment when the sensed parameter values have exceeded the stored threshold values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Seshadri, in view of Weber, Saaman, Takada, and Xu, to incorporate the disclosures of Cao and modify the method such that applying treatment to the wound when the threshold wound characteristics values are exceeded is done autonomously. Doing so would allow for the device to detect a designated condition based on the magnitude of change in parameter value, which aids in applying the proper treatment to the wound (Cao, [0018, 0037-0038]).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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