DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 does not contain proper punctuation. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 3, 5, and 8-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the phrase “early detection after hemostasis has been achieved.” This phrase is unclear, as it is not known how the detection is determined.
The terms “good skin adhesion”, “robustness”, and “low impedance” in claim 5 are relative term which renders the claim indefinite. The terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 8 recites the phrase “wherein the conductive hydrogel incorporates adhesive interfacial chemistry.” This phrase is unclear, as it is not know how a hydrogel can “incorporate interfacial chemistry”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 10-11, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bogie et al. (US 2020/0061379).
Regarding claim 1, Bogie discloses the claimed apparatus comprising: a smart bandage (e.g. Figures 1-3, (100), [0002], [0040], [0041]) that includes:
a conductive hydrogel (e.g. fig. 1A, (128), [0045]); and
a flexible electronics package electronics (e.g. fig. 1A, (104), (110), (112), "flexible printed circuit board layer", [0003], [0041], [0047], [0049]) having processing circuitry (fig. 1A, 1B, 3, (130), [0046], [0049]) and a wireless interface for communicating with external processors (fig. 4, paragraphs [0035], [0039]).
Regarding claim 10, Bogie additionally discloses, wherein the flexible electronics package comprises biosensor technology for impedance and temperature (e.g. temperature sensors 124 and determining impedance between the electrodes as disclosed in [0053]).
Regarding claim 11, Bogie additionally discloses wherein the flexible electronics package comprises electrical stimulation controlled by the processing circuitry (e.g. electrical stimulation of [0003], [0016], [0019]).
Regarding claim 14, Bogie additionally discloses wherein the flexible electronics package comprises a temperature sensitive resistor for temperature sensing (e.g. temperature sensors 124 that use temperature coefficient of resistance as disclosed in [0050]).
Regarding claim 15, Bogie additionally discloses wherein wireless interface comprises a Bluetooth unit (e.g. Bluetooth as disclosed in [0035]).
Claims 1-5, 10-12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toong et al. (US 2021/0268276).
Regarding claim 1, 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).
Regarding claim 2, Toong additionally discloses 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]).
Regarding claim 3, Toong additionally discloses wherein the processing circuitry is configured to deliver stimulation in response to the detection of early infection after hemostasis has been achieved (e.g. the closed-loop detection system of Toong monitors the patient and is capable of delivering stimulation in response to the detection of infection as taught in [0091]).
Regarding claim 4, Toong additionally discloses wherein the smart bandage further includes reversible skin-adhesive electrodes (e.g. electrodes 1630 that include fabric tape 1612 that can be placed in multiple different orientations and is thus “reversible”).
Regarding claim 5, as best the claim can be understood, Toong additionally discloses wherein the electrodes possess good skin adhesion, robustness, and low impedance for electrical stimulation (e.g. electrodes 1630 along with hydrogel 1626 will necessarily have “good” skin adhesion, “robustness” and low impedance for electrical stimulation, since all of those properties are necessary for electrical stimulation and the claims do not include any more limitations as to what those values include.
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]).
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bogie or Toong 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, Bogie and Toong 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 Bogie or Toong, 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 Bogie or Toong in view of Arbabian et al. (US 2014/0336474).
Regarding claim 13, Bogie or Toong 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 Bogie or Toong since such a modification would provide the system with the predictable results of a reliable means of measuring impedance.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bogie and Toong in view of O’Brien et al. (US 2021/0137410).
Regarding claim 16, Bogie or Toong 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 a 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 Bogie or Toong 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