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 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.
Claim(s) 1 – 11 and 13 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huiszoon et al. (US PGPUB 2019/0060556).
Regarding claim 1, Huiszoon discloses a medical implant including: an implant component configured to be implanted in a patient (e.g. Fig. 1); an electrode array comprising sensor electrodes spaced apart on the implant component (e.g. ¶ 27-29); an energy storage device within the implant component (e.g. ¶ 30); a wireless communication interface within the implant component, configured to communicate with the wireless communication circuit of the remote computing device (e.g. ¶ 33); and implant circuitry within the implant component and operative to supply voltage to at least one of the sensor electrodes to measure characteristics associated with when a biofilm is forming on the implant component (e.g. ¶ 30 – 32), and communicate signaling indicating the electrical and/or chemical characteristics through the wireless communication interface for receipt by the wireless communication circuit (e.g. ¶ 73).
Regarding claim 2¸ Huiszoon discloses the implant circuitry is further operative to determine presence of the biofilm based on the electrical and/or chemical characteristics, and generate the signaling to indicate the presence of the biofilm and/or indicate the electrical and/or chemical characteristics, based on the determined presence of the biofilm (e.g. ¶ 31-32)
Regarding claim 3, Huiszoon discloses the implant circuitry is further operative to generate the signaling to further indicate locations on the implant component that correspond to where the electrical and/or chemical characteristics indicate the presence of the biofilm (e.g. ¶ 31-32).
Regarding claim 4, Huiszoon discloses the medical implant includes the stimulation electrodes spaced apart on the implant component, and the implant circuitry, under control of the remote computing device, is further operative to electrically stimulate at least one of the stimulation electrodes on a part of the implant component associated with the biofilm by supplying current from the energy storage device at a level which reduces the biofilm (e.g. ¶ 73).
Regarding claim 5, Huiszoon discloses the electrode array further comprises stimulation electrodes spaced apart on the implant component, and the implant circuitry is further operative to receive a message through the wireless communication interface identifying at least one of the stimulation electrodes to be electrically stimulated, and electrically stimulate the at least one of the stimulation electrodes identified by the message (e.g. ¶ 73).
Regarding claim 6, Huiszoon discloses the electrode array further comprises stimulation electrodes spaced apart on the implant component, and the implant circuitry is further operative to detect a location of the biofilm and/or the type of bacteria in the biofilm based on the electrical and/or chemical characteristics, and stimulate the stimulation electrodes in the location based on the detected presence of the biofilm and/or based on the detected type of bacteria (e.g. ¶ 32-33, 73).
Regarding claim 7, Huiszoon discloses the implant circuitry is further operative to control the duration and/or level of stimulation of the stimulation electrodes based on the detected type of bacteria (e.g. ¶ 47-48).
Regarding claim 8, Huiszoon discloses the implant circuitry further comprises a memory and is further operative to save data in the memory indicating the electrical and/or chemical characteristics and to generate the signaling to indicate values of the saved data indicating the electrical and/or chemical characteristics (e.g. ¶ 41).
Regarding claim 9, Huiszoon discloses the medical implant further comprises:a power receiver circuitry that wirelessly receives radio frequency (RF) signals from the wireless communication circuit, converts the received RF signals to direct current (DC) power, and charges the energy storage device with the DC power (e.g. ¶ 30).
Regarding claim 10, Huiszoon discloses the electrical and/or chemical characteristics of the sensor electrodes indicate at least one of impedance, conductivity, and potential hydrogen (pH) (e.g. ¶ 31).
Regarding claim 11, Huiszoon discloses the electrode array further comprises stimulation electrodes spaced apart on the implant component, and the implant circuitry is further operative to electrically stimulate at least one of the stimulation electrodes by current supplied by the energy storage device to be at a level which reduces the biofilm on at least part of the implant component while implanted in the patient (e.g. ¶ 73).
Regarding claim 13, Huiszoon discloses the implant circuitry, under control of the processing circuit, is further operative to simultaneously measure the electrical and/or chemical characteristics through the sensor electrodes and to electrically stimulate the stimulation electrodes (e.g. ¶ 73).
Regarding claim 14, Huiszoon discloses the implant circuitry is further operative to increase or decrease the current supplied by the energy storage device to the stimulation electrodes responsive to the electrical and/or chemical characteristics (e.g. ¶ 73 – 74).
Regarding claim 15, Huiszoon discloses the sensor arrays include at least one reference electrode, and the implant circuitry is further operative to supply voltage to the at least one reference electrode while measuring electrical and/or chemical characteristics through the reference electrode, and communicate signaling indicating the electrical and/or chemical characteristics through the at least one reference electrode through the wireless communication interface (e.g. ¶ 52 – 54).
Regarding claim 16, Huiszoon discloses the implant circuitry is further operative to compare the electrical and/or chemical characteristics through the at least one reference electrode and the electrical and/or chemical characteristics through the sensor electrodes, and generate the signaling to indicate the presence of the biofilm and/or indicate the electrical and/or chemical characteristics through the at least one reference electrode and the sensor electrodes, based on the electrical and/or chemical characteristics through the at least one reference electrode having at least a threshold difference from the electrical and/or chemical characteristics through the sensor electrodes (e.g. ¶ 32).
Regarding claim 17, Huizoon discloses one of the sensor electrodes is configured to detect presence of a type of bacterial species (e.g. ¶ 35 and 42-46).
Regarding claim 18, Huiszoon discloses the one of the sensor electrodes includes a coating of a bio-recognition element adapted to bind to a type of bacterial species (e.g. ¶ 35).
Regarding claim 19, Huiszoon discloses the implant circuitry is further operative to supply a defined range of frequencies to the sensor electrodes to measure electrical and/or chemical characteristics, wherein the defined range of frequencies is adapted to electrically excite one or more types of bacterial species (e.g. ¶ 42 – 46).
Regarding claim 20, Huiszoon discloses the sensor electrodes comprise a first zone of at least one sensor electrode of the sensor electrodes and a second zone of at least one electrode of the sensor electrodes, wherein the first zone and second zone are separate, and the implant circuitry is further operative to compare the electrical and/or chemical characteristics from the at least one sensor electrode in the first zone to the electrical and/or chemical characteristics of the second zone, and generate the signaling to indicate the presence of the biofilm and/or indicate the electrical and/or chemical characteristics from the at least one sensor electrodes in the first zone and second zone, based on the electrical and/or chemical characteristics from the at least one sensor electrode in the first zone being a threshold difference from the electrical and/or chemical characteristics from the at least one sensor electrode in the second zone (e.g. ¶ 52 – 54).
Allowable Subject Matter
Claim 12 is 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. Fedon et al. (US PGPUB 2024/0148328) teadches an implant having a biofilm sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796