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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 29, 2026 has been entered. Currently claims 1 and 5-22 are pending in this application.
Response to Arguments
Applicant's amendments filed July 29, 2026 have been considered, but have been rendered moot due to the amendments to the rejections required by the amendments to the claims.
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 1-5, 10-12, 15 and 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toong et al. (US 2021/0268276, as previously cited) in view of Shokoueinejad Maragheh (US 2016/0015962, as previously cited) and Hyde (USPN 2018/0047234).
Regarding claim 1 and 17, Toong discloses an apparatus comprising: a smart bandage (e.g. patch 100; [0020]) that includes: a conductive hydrogel (e.g. hydrogel 1626 as shown in Figure 13); and a flexible electronics package (e.g. printed circuity board assembly 1630) having processing circuitry (e.g. control unit 1002 as shown in Figure 2) and a wireless interface for communicating with external processors (e.g. antenna 1010) wherein the processing circuitry includes a built-in closed-loop feedback to receive information from sensors and to actively deliver precise electrical stimulation (e.g. closed-loop system that monitors biometrics related to healing as disclosed in [0018]).
Toong additionally discloses using the closed-loop detection system of to monitor the patient and use the closed-loop feedback to treat the wound with electrical stimulation (as taught in [0091] but does not expressly disclose delivering the stimulation in response to detection of infection based on the closed-loop feedback system. Shokoueinejad Maragheh discloses that it was well known in the art of smart bandages to monitor the healing process for signs of infection (which necessarily occurs after no infection has been found) and eliminate bacterial infections when signs of infection are found (e.g. Abstract; [0037], wherein UV-C is only used if infection is detected). It would have been obvious to one having ordinary skill in the art to use the closed-loop infection detection system of Shokoueinejad Maragheh in the device of Toong since such a modification would provide the system with the predictable results of means of preventing infection.
Neither Toong nor Shokoueinejad Maragheh disclose a conductive hydrogel with reversible tissue adhesion properties. Hyde discloses that it is well known in the art of conformable medical devices to include an electroactive hydrogel that has reversible or switchable adhesion characteristics (e.g. electroactive polymer 1400 as disclosed in Figure 14 and Paragraph 65.) It would have been obvious to one having ordinary skill in the art to include the conductive hydrogel with reversible tissue adhesion properties of Hyde in the device of Toong and Shokoueinejad Maragheh in order to provide the system with the ability to adhere and remove the bandage as desired.
Regarding claim 5, Toong additionally discloses wherein the electrodes are configured to applying electrical stimulus delivered by the processing circuitry (e.g. electrodes 1630 along with hydrogel 1626).
Regarding claim 10, Toong additionally discloses, wherein the flexible electronics package comprises biosensor technology for impedance and temperature (e.g. sensors including temperature sensor as disclosed in [0023]).
Regarding claim 11, Toong additionally discloses wherein the flexible electronics package comprises electrical stimulation controlled by the processing circuitry (e.g. electrical stimulation as disclosed in [0021]).
Regarding claim 12, Toong additionally an antenna for wireless energy harvesting or a rechargeable battery for energy supply (e.g. antenna 1010 as shown in Figure 2 that can be used to recharge battery 1012 as disclosed in [0093]).
Regarding claim 15, Toong additionally discloses wherein wireless interface comprises a Bluetooth unit (e.g. communication as taught in [0093]).
Regarding claim 18, Hyde additionally discloses wherein, for high tissue adhesion, the conductive hydrogel incorporates adhesive interfacial chemistry including one or more of hydrogen bonding and metal-coordination (e.g. reversible microstructures 1408 as disclosed in Figure 14 and Paragraphs 65 and 69-70).
Regarding claim 19, Hyde additionally discloses wherein, for high tissue adhesion, the conductive hydrogel incorporates tuned nanoscopic intermolecular interaction with crosslinking density (e.g. reversible microstructures 1408 as disclosed in Figure 14 and Paragraphs 65 and 69-70).
Regarding claim 20, Hyde additionally discloses wherein conductive hydrogel includes reversible hydrogel chemistry configured to modulate gel adhesion via one or more of temperature triggered phase change and chemical triggered debonding (e.g. thermos-responsive adhesive 1402 or reversible microstructure 1408 adhesive abilities as disclosed in Figure 14 and Paragraphs 65-66 and 69-70).
Regarding claim 21, Hyde additionally discloses wherein the conductive hydrogel provides a tight interface for robust signal transduction and energy delivery during operation, while providing easy detachment to avoid possible secondary skin damage during device removal (e.g. electroactive polymer 1400 that is configured to reversibly transition between the nonadhesive state and the adhesive state responsive to the one or more energy signals from the circuitry 106, as disclosed in Paragraph 65).
Regarding claim 22, Hyde additionally discloses a thermally controlled reversible phase transition mechanism to a backbone of the conductive hydrogel that achieves two orders of magnitude lower adhesion at elevated temperature when compared to the normal skin temperature (e.g. thermos-responsive adhesive 1402 as disclosed in Figure 14, and Paragraph 66).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Toong, Shokoueinejad Maragheh, and Hyde, in further view of Isabel del Agua Lopez, "Conducting Polymer Materials for Bioelectronics Applications," Thesis, University of the Basque Country UPV/EHU, Donostia-San Sebastian, Spain, 2018, htto://hdl. handle. net/10810/34588. 153 pages. (hereinafter “Isabel”, as provided by Applicant).
Regarding claims 6 and 7, Toong, Shokoueinejad Maragheh, and Hyde disclose the claimed invention except the express mention of a smart bandage comprises an electronic-ionic dual conducting polymer complex. wherein the polymer complex comprises polymerized biocompatible (meth)acrylate monomers in the presence of conducting polymers based on PEDOT:PSS. Isabel discloses that it was well known in the art of wound dressings to includes such conducting polymers (e.g. as discussed on Pages 55-57). It would have been obvious to one having ordinary skill in the art to include the polymer of Isabel in the devices of Toong, Shokoueinejad Maragheh, and Hyde since such a modification would provide the system with the predictable results of a reliable means of connecting the electrodes to tissue.
Regarding claim 8, Isabel additionally discloses a conductive hydrogel comprises a polymer-based dual-conducting hydrogel (e.g. Pages 55-57).
Regarding claim 9, Isabel additionally discloses the claimed conductive hydrogel as disclosed above, which will necessarily incorporate adhesive interfacial chemistry comprising hydrogen bonding or metal-coordination, and tuned nanoscopic intermolecular interaction.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Toong, Shokoueinejad Maragheh, and Hyde in view of Arbabian et al. (US 2014/0336474, as previously cited).
Regarding claim 13, Toong, Shokoueinejad Maragheh, and Hyde disclose the claimed invention except the express mention of a flexible electronics package comprises a ring oscillator for AC impedance measurement. Arbabian discloses that it was well known in the art of low power sensors to use ring oscillators for impedance measurements (e.g. ring oscillator as disclosed in [0019]). It would have been obvious to one having ordinary skill in the art to include the ring oscillator of Arbabian in the device of Toong, Shokoueinejad Maragheh, and Hyde since such a modification would provide the system with the predictable results of a reliable means of measuring impedance.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Toong, Shokoueinejad Maragheh, and Hyde in view of Bogie et al. (US 2020/0061379, as previously cited).
Regarding claim 14, Toong, Shokoueinejad Maragheh, and Hyde disclose the claimed invention except the express mention of a flexible electronics package comprises a temperature sensitive resistor for temperature sensing. Bogie discloses that it was well known in the art of wound dressings for a flexible electronics package to comprise a temperature sensitive resistor for temperature sensing (e.g. temperature sensors 124 that use temperature coefficient of resistance as disclosed in [0050]). It would have been obvious to one having ordinary skill in the art to include the temperature sensitive resistor of Bougie in the device of Toong, Shokoueinejad Maragheh, and Hyde since such a modification would provide the system with the predictable results of a reliable means of sensing temperature to more easily detect infection.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Toong, Shokoueinejad Maragheh, and Hyde in view of O’Brien et al. (US 2021/0137410, as previously cited).
Regarding claim 16, Toong, Shokoueinejad Maragheh, and Hyde disclose the claimed invention except the express mention of a conductive hydrogel is coupled to the processing circuitry through gold wires. O’Brien discloses that it was well known in the art of medical devices to include gold wires to attach sensor electronics (e.g. gold wires as disclosed in Figures 18-20 and [0223]). It would have been obvious to one having ordinary skill in the art to include the gold wires of O’Brien in the device of Toong, Shokoueinejad Maragheh, and Hyde since such a modification would provide the system with the predictable results of a reliable means transferring sensor data.
Conclusion
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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