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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Applicant' s arguments, filed 12/12/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/12/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the currently pending claims hereby under examination. Claims 1 and 12 have been amended.
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 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain.
Regarding claim 1, Becerra‑Fajardo teaches that a sensing system comprising: at least one non-bioresorbable implant adapted to be deployed in a medium of a living body by injection or by catheterization (Becerra-Fajardo, Title/Abstract, Fig. 1 and 2: "implants act as rectifiers... for picking up the HF current and for performing electrical stimulation", p. 2 ‘I. Introduction’, last ¶: “an uplink to send sensing data from the implants to the external unit is a beneficial feature for the proposed method, here we present a proof-of-concept prototype of a bidirectional communication link”, demonstrating an implantable sensing system; p. 545, 'I Introduction', ¶3: “We conceive ultrathin elongated implant bodies (diameter < 300 µm) that can be easily deployed in tissues (e.g. by injection)”, this explicitly teaches deployment by injection; Becerra-Fajardo further discloses implants comprising electronic circuitry and electrodes for rectifying externally applied HF current bursts and enabling sensing and communication with an external unit, and does not disclose biodegradable, bioresorbable, or transient construction, such that under the broadest reasonable interpretation the implant reasonably corresponds to a non-bioresorbable implant), wherein the implant comprises an electronic circuit and at least two electrodes connected to the electronic circuit (Becerra-Fajardo 2015, Fig.2: depicts implant circuitry with two electrodes, "Electrode 1", "Electrode 2"); a reading unit for reading the implant when the implant is deployed in a medium (Becerra-Fajardo 2015, Fig. 4 "External receiver" (i.e., reading unit) and Fig. 2: reading unit depicted at the top of the figure with the implant inside a human arm, thus deployed in a medium), wherein the reading unit comprises two or more electrodes (Becerra-Fajardo 2015, Fig. 2: depicts reading unit using brown electrodes connected to "sensing resistors"; Fig. 5: depicts two "external electrode[s]" which are part of the reading unit); an alternating voltage generator to generate an alternating voltage across the two or more electrodes (Becerra-Fajardo 2015, Fig. 5: depicts an alternating voltage generator with "Amplitude: 75 V" and "Frequency: 1 MHz", connected to the two electrodes), and a control and processing module (Becerra-Fajardo 2015, p. 547, Col. Right, ¶1-2: "LabVIEW... using an ACQ board... and modulated by a function generator... and then amplified (WMA-300 by Falco Systems)", where the PC runs LabVIEW coupled with external components acts as the control and processing module), wherein the reading unit is configured for emitting an interrogation signal comprising at least one burst of an alternating current suitable to reach the implant by volume conduction through the medium (Becerra-Fajardo 2015, p. 545, Col. Right, ¶1-2 "current burst"; Fig. 1: depicts AC generator with bursts of AC current through an arm for reaching the implant (i.e., medium) where the "stimulation method proposes the use of implants as rectifiers of innocuous high frequency current bursts (> 1 MHz), which are conductively supplied to the tissues through external electrodes").
Also regarding claim 1, Becerra-Fajardo does not fully teach that the electronic circuit comprises both a capacitor and a device of asymmetric conductance connected in series between the at least two electrodes. Rather, Becerra-Fajardo teaches an implant including a rectifier diode bridge between two electrodes (Becerra-Fajardo 2015, Fig. 2), but does not show a capacitor directly connected in series with a device of asymmetric conductance.
Ivorra teaches an implant circuit that includes a diode, resistor, and capacitors arranged between two electrodes for rectifying applied high-frequency current bursts and performing charge balance (Ivorra, Figs. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Becerra-Fajardo 2015 in view of Ivorra to include its rectifier which has a capacitor connected in series with a device of asymmetric conductance as well as a resistor between the electrodes. The benefit of making this combination would be to simplify the charge-balancing circuitry by using passive components instead of active regulation, reducing implant complexity, improving miniaturization, lowering power consumption, and increasing reliability.
Also regarding claim 1, the combined Becerra-Fajardo and Ivorra does not fully teach that the electronic circuit further comprises a discharge network connected in parallel with the device of asymmetric conductance for a capacitor discharge, wherein the discharge network comprises at least one electronic component. Becerra-Fajardo discloses an implant rectifier and external receiver which includes a discharge network connected in parallel with a device of asymmetric conductance as shown in Figure 2, but does not specifically teach a discharge network connected in parallel with the diode for capacitor discharge.Ivorra expressly teaches that after each burst “the capacitor will slowly discharge through the implant resistor RD and the tissues until the next burst” (Ivorra, p. 3, ¶2) and shows in Fig. 1 that RD lies across the same electrode nodes as the diode, i.e., in parallel (Ivorra, FIG. 1).It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo and Ivorra in view of Ivorra to provide a discharge network connected in parallel with the device of asymmetric conductance for discharging the capacitor between bursts.It would have been possible to combine by incorporating Ivorra’s simple passive RD path into Becerra-Fajardo’s implant circuit, since both references concern the same class of injectable rectifier-based implants and share the same burst-based operating principle.The benefit of the combination would be to ensure capacitor charge balance and safety by allowing full or near-full discharge between bursts, thereby avoiding DC offsets and electrochemical damage in tissue and providing predictable implant behavior.
Also regarding claim 1, the combined Becerra-Fajardo and Ivorra does not fully teach that at least the capacitor, the device of asymmetric conductance or the electronic component is a transducer configured such that an operational parameter of the transducer is variable depending on at least one of a physical and a chemical condition of the medium when the implant is deployed in the medium. Rather, the combined Becerra‑Fajardo and Ivorra disclose an implant with two electrodes and a rectifying circuit including a diode and capacitor, together with a discharge resistor RD, interrogated via externally applied HF bursts and read by an external receiver measuring signals across a sensing resistor RS (e.g., “The external HF current generator is connected in series to a sensing resistor RS… The electrodes of the implants pick up the HF current… amplitude modulation… can be detected across the external sensing resistor”, Becerra‑Fajardo, p. 546, 'II. PROOF-OF-CONCEPT PROTOTYPE'). However, it does not expressly teach that the capacitor, diode, or discharge component is a transducer whose operational parameter varies with a physical or chemical condition of the surrounding medium.Jain teaches a non-resorbable, implantable sensor platform that includes both physical and chemical transducers and is implemented using corrosion-resistant, biocompatible materials. For physical sensing (temperature/pressure), Jain discloses: "A variety of optional items may be included in the sensor platform. One optional item is a temperature probe. One exemplary temperature probe comprises two probe leads connected to each other through a temperature-dependent element that is formed using a material with a temperature dependent characteristic. An example of a suitable temperature-dependent characteristic is the resistance of the temperature-dependent element..." (Jain, ¶[0091]) and "wherein the sensor element comprises a body temperature sensor, a blood pressure sensor..." (Jain, ¶[0111]). Additionally, for chemical sensing, Jain discloses sensor elements including pH/oxygen/glucose, e.g.: "the sensor element comprises a body temperature sensor, a blood pressure sensor, a pH sensor, an oxygen sensor, a glucose sensor, a lactate sensor, or a combination of two or more of the foregoing sensors"(Jain, claim 7). Further, Jain expressly teaches: "In one embodiment, the sensor element comprises an electrochemical oxygen sensor" (Jain, ¶[0119]) and "In one embodiment, glucose sensor response is determined as a function of temperature, pH and oxygen" (Jain, ¶[0122]). Finally, Jain discloses corrosion-resistant materials and coatings that are appropriate for non-bioresorbable applications, e.g.: "The sensor platform comprises components manufactured from biocompatible materials, such as materials that are corrosion resistant, INCLUDING Pt, SiO, coatings, and glass thin films... coating of the internal unit with titanium, iridium, Parylene..." (Jain, ¶[0092]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo and Ivorra in view of Jain to configure at least one of the implant’s capacitor, diode, or discharge component as, or to include, a transducer whose operational parameter varies with a physical and/or chemical condition of the surrounding medium. Becerra-Fajardo already measures implant-dependent electrical signals at the external electrodes during burst interrogation, while Jain teaches implantable transducers for both physical and chemical sensing, implemented in corrosion-resistant, biocompatible materials, that provide condition-dependent electrical responses suitable for readout. It would have been possible to combine these teachings by incorporating an environment-responsive resistive/capacitive element (e.g., a temperature-dependent resistive element; a chemical sensor element) into the implant-side circuit path of the Becerra-Fajardo/Ivorra implant so that the measured response at the reading unit varies with the physical and/or chemical condition of the medium, while maintaining the same burst-based interrogation and readout approach. The benefit of the combination would be to enable the same burst-based interrogation and external processing chain to provide diagnostic sensing of physical and chemical parameters of the medium while preserving a compact, durable implant form factor suitable for injection or catheterization.
Also regarding claim 1, the combined Becerra-Fajardo, Ivorra, and Jain does not fully teach that the reading unit is adapted for measuring the physical and/or chemical parameters of the living body by measuring electrical signals at the two or more electrodes of the reading unit. Rather, the combined Becerra-Fajardo, Ivorra, and Jain measures electrical signals at the external electrodes associated with implant operation, without expressly describing the conversion of those signals into physical or chemical parameter values.Jain teaches that the implant includes sensor elements that produce condition-dependent electrical outputs suitable for determining the underlying physical/chemical parameter(s). For example: "the sensor element comprises a body temperature sensor, a blood pressure sensor, a pH sensor, an oxygen sensor, a glucose sensor, a lactate sensor, or a combination of two or more of the foregoing sensors" (Jain, ¶[0111] and claim 7). Jain further discloses a temperature probe whose resistance provides a temperature-dependent signal: "An example of a suitable temperature-dependent characteristic is the resistance of the temperature-dependent element..." (Jain, ¶[0091]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Jain to adapt the reading unit’s existing electrode-based electrical measurements (as taught by Becerra-Fajardo) to determine a physical and/or chemical parameter of the medium based on the transducer’s operational parameter (as taught by Jain). It would have been possible to combine by integrating an environment-dependent transducer element into the implant and processing the resulting electrode measurements already captured and processed by Becerra-Fajardo’s external receiver to compute a parameter such as temperature (physical) and/or pH/oxygen/glucose (chemical), as taught by Jain. The benefit of the combination would be to extend the existing electrical measurement pathway to yield diagnostic information about the medium without changing the interrogation method, improving utility while preserving system simplicity.
Also regarding claim 1, the combined Becerra-Fajardo, Ivorra, and Jain does not fully teach that said electrical signals depend on the operational parameter of the transducer of the implant during, after or during and after delivering the at least one burst of the alternating current. Rather, the combined Becerra-Fajardo, Ivorra, and Jain generates and measures electrical signals at the external electrodes during burst-based interrogation and during post-burst discharge behavior of the implant circuitry, but does not disclose making these signals depend on an environmental transducer parameter after or during a burst.
Jain teaches that the electrical response of the implant transducer varies as a function of the sensed physical and/or chemical condition. For physical sensing, Jain discloses a temperature transducer in which “the resistance of the temperature-dependent element” varies with temperature (Jain, ¶[0091]), and further discloses pressure sensing via a blood pressure sensor (Jain, ¶[0111]). For chemical sensing, Jain discloses that “one can monitor the current change … to determine glucose concentration” (Jain, ¶[0114]), and further discloses electrochemical oxygen and pH sensor embodiments (Jain, ¶[0119]; ¶[0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Jain such that the electrical signals measured at the reading unit during and/or after delivery of the interrogation burst depend on the operational parameter of the implant transducer that varies with the physical and/or chemical condition of the medium.
It would have been possible to combine because Becerra-Fajardo already applies burst-based electrode interrogation and acquires implant-dependent electrical signals at the external electrodes during burst delivery and after burst cessation, Ivorra provides implant circuitry suitable for predictable burst-time and post-burst behavior, and Jain teaches implantable transducers whose electrical responses vary as a function of physical and chemical conditions. The benefit of the combination would be to enable physical and/or chemical sensing using the same burst-based interrogation and external processing infrastructure, improving diagnostic capability while maintaining compact implant deployment by injection or catheterization.
Regarding claim 2, the combined Becerra-Fajardo, Ivorra, and Jain teaches that wherein the reading unit is adapted to emit bursts of the alternating current at a frequency between 100 kHz and 100 MHz, with bursts duration between 0.1 μs and 10 ms, and a repetition frequency between 0 Hz and 100 kHz (Becerra-Fajardo, Fig. 1; p. 1, 'I. Introduction': "electrical stimulation method... The implant acts as a rectifier of innocuous high frequency (HF) current bursts [> 1 MHz] that are conductively supplied to the tissues using external electrodes"; Fig. 5: depicting the high frequency current generator connected to external electrodes for delivering bursts of alternating current at “Amplitude: 75 V” and “Frequency: 1 MHz”, confirming that the reading unit emits a burst of alternating current in the specified frequency range; p. 546, 'A. Uplink Communications Scheme': "the stimulators generated 500 µs current pulses at a repetition rate of 20 Hz”, showing that the burst duration and repetition frequency fall within the claimed ranges; collectively disclosing that the external generator system and external electrodes (i.e., the reading unit) emit bursts of alternating current at the claimed frequency, burst duration, and repetition frequency).
Regarding claim 3, the combined Becerra-Fajardo, Ivorra, and Jain teaches that the implant further comprises an elongated and flexible body made of an electrically isolating material, and wherein the electronic circuit is housed within the body, and wherein the implant further comprises two metallic electrodes at opposite ends of the body which are electrically connected to the electronic circuit. Rather, the combined Becerra-Fajardo, Ivorra, and Jain discloses an implantable device comprising an electronic circuit connected to two peripheral electrodes and designed to interact with external high frequency currents (Becerra-Fajardo, Section I. Introduction, p. 1, right column; Fig. 2). However, Becerra-Fajardo does not disclose that the implant body is flexible, elongated, made of an electrically insulating material, or that the electronic circuit is explicitly housed within the implant body. Ivorra discloses an implant structure consisting of a tubular silicone body approximately 1 mm in diameter, containing an embedded electronic circuit with two peripheral electrodes located at opposite ends of the body (Ivorra, Abstract, Fig. 5). Silicone is known to be both flexible (as depicted in Fig. 5) and electrically insulating, and Ivorra depicts that the electronic components are located within the implant body and electrically connected to the peripheral electrodes, thereby providing both the structure and electrical functionality consistent with the claimed invention. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to provide an implant comprising an elongated, flexible, electrically insulating body with an embedded electronic circuit. One of ordinary skill in the art would have found it obvious to do so because the use of flexible, insulating materials and embedded electronics, as taught by Ivorra, would enhance biocompatibility, facilitate implantation through minimally invasive techniques such as injection, and protect the internal circuitry from environmental damage. It would have been possible to integrate the structural aspects of Ivorra's implant into Becerra-Fajardo’s implant design without changing the basic operation of rectifying and stimulating through external HF bursts. The benefit of the combination would be improved flexibility and biocompatibility of the implant, enabling less invasive delivery and longer-term functionality within biological tissue.
Regarding claim 5, the combined Becerra-Fajardo, Ivorra, and Jain teaches that the device of asymmetric conductance is a diode, a p-n junction of a transistor or a smart diode (Becerra-Fajardo, Fig. 2: schematic diagram showing a bridge rectifier between Electrode 1 and Electrode 2, where the diode symbols are that of Schottky diodes, confirming that the device of asymmetric conductance includes Schottky diodes).
Regarding claim 6, the combined Becerra-Fajardo, Ivorra, and Jain teaches that the capacitor is a transducer whose capacitance is variable depending on the physical and/or chemical condition of the medium (As disclosed in claim 1 above, the LCR circuit electrical properties vary in response to physical or chemical conditions of the environment it is exposed to (i.e. medium)), but does not teach that wherein the electrical or electronic component of the discharge network is a resistor of a given nominal value. As described in claim 1 above, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant utilizing a diode, resistor, and capacitor that responds to physical or chemical conditions of a medium, but do not expressly describe the resistor having nominal value. Ivorra teaches a discharge network that includes “an SMD 1 kΩ resistor (ERJXGNJ102Y by Panasonic)” ('2.1. The implants', p. 3, L-col., last 2 ¶ to p. 4, L-col., first ¶), demonstrating that a specific resistor value is used in the implant circuit to control the discharge behavior. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to include a resistor of a given nominal value in the discharge network. The benefit of making this combination would be to achieve a controlled discharge rate and stable electrical behavior necessary for reliable sensor performance, thereby enhancing system predictability and allowing the implant to maintain safe and consistent operation conditions.
Regarding claim 7, the combined Becerra-Fajardo, Ivorra, and Jain does not fully teach that the capacitor has a given nominal capacitance, and that the electronic component of the discharge network is a resistive transducer. Rather, the combined Becerra-Fajardo, Ivorra, and Jain discloses a sensing implant comprising an electronic circuit that includes a diode, a capacitor, and a resistor arranged between two electrodes, where the circuit performs rectification of externally applied HF bursts and supports sensing via externally measured electrical signals. Ivorra teaches that the implant capacitor has a defined, nominal capacitance value, for example disclosing a capacitor value of approximately 0.6 µF in the implant circuit (Ivorra, §2.1 The implants, p. 3, last paragraph to p. 4, first paragraph). However, while Ivorra teaches a resistor that controls capacitor discharge after each burst, Ivorra does not expressly describe that resistor as a resistive transducer whose resistance varies as a function of a physical or chemical condition of the surrounding medium.
Jain teaches implantable sensing systems in which resistive sensor elements function as transducers whose resistance varies in response to physical and chemical conditions of the body. For physical sensing, Jain discloses temperature-dependent resistive elements whose resistance varies with temperature (Jain, ¶[0091]) and pressure sensing using resistive sensor structures in a blood pressure sensor (Jain, ¶[0111]). For chemical sensing, Jain further discloses electrochemical sensor embodiments in which measured current or resistance varies with analyte concentration, including glucose, oxygen, and pH sensing (Jain, ¶[0114]; ¶[0115]; ¶[0119]).
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Becerra-Fajardo, Ivorra, and Jain implant circuit in view of Jain to implement the discharge-network resistor as a resistive transducer whose resistance varies in response to physical and/or chemical conditions of the medium, while retaining the nominal capacitance value taught by Ivorra. Such a modification would have been obvious because Becerra-Fajardo already interrogates the implant electrically via external electrodes and measures implant-dependent signals, Ivorra establishes a predictable RC discharge behavior using a capacitor of known nominal value, and Jain teaches that resistive transducers are well suited for implantable sensing of physical and chemical parameters using resistance variations. The benefit of this combination would be to enable the implant to dynamically sense environmental conditions such as temperature, pressure, or analyte concentration through resistance variations in the discharge network, while preserving the simple rectifier-based implant architecture, predictable capacitor charging and discharging behavior, and compact form factor suitable for injection or catheter-based deployment.
Regarding claim 8, the combined Becerra-Fajardo, Ivorra, and Jain does not expressly teach the capacitance of the capacitor is within the range 10 pF to 10 nF, and wherein a resistance of the discharge network is within the range 1 kΩ to 10 MΩ. Rather, the combined Becerra-Fajardo, Ivorra, and Jain disclose the implant architecture, including an implant capacitor and a discharge resistor interrogated by high-frequency bursts, as shown above in claim 1, and Becerra-Fajardo also identifies discharge resistance in the with ed range (Becerra-Fajardo, 'III. IN VITRO DEMONSTRATION', ¶2: "The RC is composed of two 10 kΩ resistors and two 330 pF capacitors… The sensing resistor RS has a value of 100 Ω"). However, it does not expressly teach that the implant capacitor’s capacitance is within the range 10 pF to 10 nF.
Ivorra teaches an implant capacitor of 0.6 μF, which is outside the claimed range (Ivorra, p. 3, '2.1 The implants', R-col), while Becerra-Fajardo shows pF-range capacitors in the same system’s high-frequency signal path on the receiver side.
Becerra-Fajardo and Ivorra disclose the implant architecture with an implant capacitor and a discharge resistor used in a burst-driven HF system, and Ivorra identifies that the capacitor should discharge between bursts and that a RD in the order of 1 kΩ is adequate. Selection of R and C to satisfy the burst timing and HF operation are result-effective variables. In HF rectifier/measurement paths, pF–nF capacitors and kΩ–MΩ resistors are routinely selected to set τ and frequency response with predictable results.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to select the implant capacitor within 10 pF–10 nF and the discharge network resistance within 1 kΩ–10 MΩ to achieve the required between-burst discharge and HF responsiveness. Doing so is a straightforward adjustment of known RC parameters to meet known burst-timing constraints, improving responsiveness and supporting miniaturization while preserving the disclosed operating principle and readout pathway.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Foutz et al. (Foutz, Thomas J et al. “Energy Efficient Neural Stimulation: Coupling Circuit Design and Membrane Biophysics.” PloS one 7.12 (2012): e51901–e51901. Web.), hereto referred as Foutz.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim1 as described above.
Regarding claim 4, the combined Becerra-Fajardo, Ivorra, and Jain does not teach that the discharge network of the implant further comprises a current controlling device for controlling a discharge current of the capacitor and makes a discharge process independent of impedance of the medium and of the at least two electrodes of the implant. Rather, the combined Becerra-Fajardo, Ivorra, and Jain discloses an implantable circuit including a bridge rectifier, a DC-blocking capacitor, and a regulation subcircuit composed of two diodes and a resistor (Becerra-Fajardo, Fig. 2; Section II. Materials and Methods, p. 2). The regulation subcircuit includes a resistor that helps control the magnitude of the stimulation current. However, Becerra-Fajardo does not disclose that the discharge process is made independent of the impedance of the surrounding medium or the electrodes. Foutz discloses a current control architecture for implantable stimulators in which a FET-based constant-current source is used to maintain a stable output current despite variations in tissue impedance (Foutz, Fig. 1; p. 3, 'Adjustable Compliance Voltage'). The compliance voltage is adjusted to keep the FET operating within its desired range, ensuring steady stimulation current delivery across varying load conditions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Foutz to configure the discharge network to use a current control device ensuring the discharge current is maintained independently of tissue and electrode impedance. In particular, one of ordinary skill would recognize from Foutz that implementing a FET-based current regulator into an implantable circuit is straightforward, as the FET current source of Foutz is compatible with implantable stimulation architectures like those of Becerra-Fajardo. The passive discharge network disclosed in Becerra-Fajardo could be modified by incorporating a constant-current FET stage, as taught by Foutz, replacing or supplementing the resistor-based regulation to stabilize the discharge current against variations in biological impedance. It would have been possible to implement this modification by integrating the FET and its compliance control within the implant’s existing electronic structure without fundamentally altering its volume-conduction architecture. One of ordinary skill would have found it obvious to make such a modification in order to enhance the reliability and accuracy of electrical measurements from the implant, by ensuring that discharge current was not distorted by fluctuations in tissue or electrode impedance. The benefit of the combination would be to improve the implant’s robustness and measurement fidelity by making the capacitor discharge behavior stable and independent of variable biological tissue properties, thereby achieving more accurate physiological sensing.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Toumazou et al. US-20130273664-A1), hereto referred as Toumazou.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim 1 as described above.
Regarding claim 9, the combined Becerra-Fajardo, Ivorra, and Jain do not fully teach that wherein the sensing system is suitable for measuring biopotentials, wherein the capacitor has a given nominal capacitance, and wherein the discharge network comprises a transistor, whose gate or base terminal is arranged to be in contact with the medium using a third electrode, wherein conductance of the transistor depends on a voltage at the third electrode. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors and resistive elements capable of detecting electrical changes in the surrounding medium and suitable for biopotential measurement as shown in claim 1 above. Ivorra discloses a nominal capacitance of 0.6 µF (Ivorra, '2.1. The implants', p. 3, L-col., last two ¶ to p. 4, L-col., first ¶). However, these references do not disclose a discharge network comprising a transistor with a gate or base terminal arranged in contact with the medium where conductance depends on a voltage at the third electrode. Toumazou teaches a transistor-based sensing device (ISFET) where the sensing surface is exposed to biological fluids, and the local ion concentration or electrical potential at the sensing surface modulates the transistor's threshold voltage and conductance (Toumazou, ¶[0004]; ¶[0018]–[0024]; ¶[0084]). Toumazou explicitly teaches that the sensing surface connected to the floating gate acts as an additional terminal contacting the medium and functions as a third electrode configuration. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Toumazou to include a third electrode contacting the biological medium and controlling a transistor gate or base terminal to modulate conductance based on the local electrical potential, while utilizing Ivorra's contribution of a nominal capacitance to maintain desired timing and charge-discharge properties in the implant circuit. One of ordinary skill in the art would have been motivated to make this modification in order to improve detection sensitivity, spatial selectivity, and signal-to-noise ratio when measuring localized biopotentials within the tissue environment. The benefit of making this modification would be to enable more localized and selective detection of biopotentials, enhance signal resolution, reduce noise, and allow active conductance modulation in response to physiological conditions, thereby improving the accuracy and utility of the implantable sensing system.
Regarding claim 10, the combined Becerra-Fajardo, Ivorra, and Jain do not fully teach that wherein the sensing system is suitable for measuring chemical species, wherein the capacitor has a given nominal capacitance, and wherein the discharge network comprises a ChemFET transistor or an Ion Selective Field Effect Transistor adapted such that a gate of the transistor is in contact with the medium when the implant is deployed in the medium, and wherein conductance of the transistor depends on a concentration of chemical species at the gate of the transistor. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors and resistive elements capable of detecting environmental and biopotential changes in the surrounding medium as shown in claim 1 above. Ivorra discloses a nominal capacitance of 0.6 µF (Ivorra, '2.1. The implants', p. 3, L-col., last two ¶ to p. 4, L-col., first ¶). However, these references do not disclose a discharge network comprising a ChemFET or ISFET with a gate terminal adapted to contact the medium and having conductance dependent on a concentration of chemical species at the gate. Toumazou teaches an ISFET-based sensing device where the sensing surface is directly exposed to biological fluids and detects changes in ion concentration at the sensing surface, which in turn modulates the conductance of the underlying transistor (Toumazou, ¶[0004]; ¶[0018]–[0024]; ¶[0084]). Toumazou explicitly teaches that the ISFET configuration detects chemical species by interacting with the medium, satisfying the ChemFET/ISFET and chemical concentration sensitivity required by claim 10. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Toumazou to include a ChemFET or ISFET having a gate terminal exposed to the medium to measure chemical concentrations and thereby modulate transistor conductance based on detected chemical species, while utilizing Ivorra's contribution of a nominal capacitance to maintain desired timing and charge-discharge properties in the implant circuit. One of ordinary skill in the art would have been motivated to make this modification in order to enable accurate chemical sensing within the biological environment, improving implant functionality by providing localized detection of chemical species, enhanced sensor selectivity, and better integration with physiological monitoring.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Colvin et al. (US-5517313-A), hereto referred as Colvin.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim 1 as described above.
Regarding claim 11, the combined Becerra-Fajardo, Ivorra, and Jain, do not teach that the capacitor has a given nominal capacitance. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors and resistive elements, but does not explicitly disclose a nominal capacitance value. Ivorra discloses a nominal capacitance of 0.6 μF (Ivorra, '2.1. The implants', p. 3, L-col., last two ¶ to p. 4, L-col., first ¶). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to disclosed nominal capacitance to maintain stable energy storage and timing properties necessary for burst-based sensing operation. The benefit of making this modification would be to ensure consistent and reliable timing performance during implant activation and measurement.
Also regarding claim 11, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that wherein the device of asymmetric conductance is a light emitting semiconductor device, wherein the discharge network comprises a light sensitive conductive device, and wherein an optical material is arranged to transmit, reflect or refract light from the light emitting semiconductor device to the light sensitive conductive device. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach sensing implants comprising capacitors, resistive elements, and circuits configured to detect environmental changes through electrical parameters such as resistance, capacitance, and impedance as shown in claim 1 above; however, they do not disclose a light emitting semiconductor device, a light sensitive conductive device, or an optical material arranged to transmit, reflect, or refract light between these devices. Colvin teaches a light emitting diode (LED) located within the central portion of an indicator layer for emitting excitation light (Colvin, col. 4–5, ll. 60–20), a photodetector means for detecting light comprising a thin substantially flat photodetector (Colvin, col. 4–5, ll. 60–20), and an arrangement where the presence of an analyte reduces the amount of light emitted from the indicator molecules that passes through the glass layer and the high pass filter and is incident upon the photodetector (Colvin, Abstract), thereby showing transmission of light between the light emitting semiconductor device and the light sensitive conductive device. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Colvin to incorporate a light emitting semiconductor device, a light sensitive conductive device, and an optical material arranged to transmit light between the two. The combination would have been possible because both sets of references aim to sense environmental or physiological parameters, and incorporating an optical sensing pathway alongside or in place of an electrical one would have been a predictable design choice to improve sensing capabilities. The benefit of making this modification would be to enable optical-based detection mechanisms sensitive to physical or chemical changes, thereby improving implant sensitivity, specificity, and operational flexibility for a wider range of monitoring applications.
Also regarding claim 11, the combined Becerra-Fajardo, Ivorra, Jain, and Colvin do not teach that the implant further comprises an optically reactive material, arranged in the implant to be in contact with the medium when the implant is deployed in the medium, and wherein an optical property of the transducer is variable depending on the physical or chemical condition of the medium. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach various electrical components for sensing environmental or biological parameters through electrical properties such as resistance, capacitance, and impedance as shown in claim 1 above; however, they do not disclose an optical reactive material arranged to contact the medium, nor do they disclose that an optical property of a material varies depending on a physical or chemical condition of the medium. Colvin teaches an indicator layer embedded with fluorescent molecules that emit light in response to excitation from a light emitting diode (Colvin, Abstract), where the emission intensity is modulated based on the local presence of oxygen interacting with the indicator molecules, causing the fluorescence to vary according to the ambient oxygen concentration (Colvin, col. 1, ll. 13–30). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Colvin to include an optical reactive material arranged to contact the medium, wherein the optical property of the material varies with physical or chemical conditions. The combination would have been possible because both sets of references are directed toward sensing environmental or physiological conditions using changes in material properties, and substituting or supplementing electrical property detection with optical property detection would have been a straightforward design choice within the abilities of one skilled in the art to improve versatility. The benefit of making this modification would be to provide real-time optical feedback on environmental conditions, thereby enhancing the implant's functionality, improving sensing accuracy, and enabling non-invasive optical monitoring in addition to traditional electrical measurements.
Regarding claim 12, the combined Becerra-Fajardo, Ivorra, and Jain, do not teach that the capacitor has a given nominal capacitance. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors and resistive elements, but does not explicitly disclose a nominal capacitance value. Ivorra discloses a nominal capacitance of 0.6 μF (Ivorra, '2.1. The implants', p. 3, L-col., last two ¶ to p. 4, L-col., first ¶). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to disclosed nominal capacitance to maintain stable energy storage and timing properties necessary for burst-based sensing operation. The benefit of making this modification would be to ensure consistent and reliable timing performance during implant activation and measurement.
Also regarding claim 12, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that the implant further comprises a transmitting, reflecting, or refractive optically reactive material, wherein the optical reactive material is arranged in the implant to be in contact with the medium when the implant is deployed in the medium, and wherein the discharge network is connected in parallel with the device of asymmetric conductance, and comprises a light emitting semiconductor device, wherein the light emitting semiconductor device emits light during the capacitor discharge, and a light sensitive conductive device connected in parallel, and wherein the optically reactive material is arranged to transmit, reflect or refract light from the light emitting semiconductor device to the light sensitive conductive device. Rather, combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors, resistive elements, and circuits configured to detect environmental changes through electrical parameters such as resistance, capacitance, and impedance, as shown in claim 1 above; however, they do not disclose a light emitting semiconductor device arranged to emit light during capacitor discharge, a light sensitive conductive device connected in parallel with the light emitting semiconductor device, or an optical material arranged to transmit, reflect, or refract light between the devices. Colvin teaches an arrangement where a light emitting diode (LED) is embedded within an indicator layer (Colvin, col. 4–5, ll. 60–20), and where indicator molecules fluoresce in response to excitation light and vary their emission depending on an environmental condition (Colvin, Abstract). Colvin further teaches that a thin photodetector detects the light transmitted through optical filters and the glass layer (Colvin, Abstract; col. 4–5, ll. 60–20). While Colvin describes the optical path generally, one of ordinary skill in the art would have understood that the LED and photodetector operate together during periods when the LED is powered, and that these devices are electrically connected in parallel to allow coordinated emission and detection during the excitation cycle. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Colvin to incorporate a light emitting semiconductor device and a light sensitive conductive device connected in parallel across the discharge network, with the optical reactive material positioned to transmit, reflect, or refract light between them. It also would have been obvious to synchronize the light emission with the capacitor discharge event, because in Becerra-Fajardo and Ivorra the sensing implants are driven by burst cycles where the capacitor is charged and then discharged, and utilizing the discharge energy to drive the LED output would have been a straightforward adaptation to maintain efficient implant operation without adding independent power supplies. The benefit of making this modification would be to enable detection of environmental conditions through optical signals emitted and sensed during controlled energy discharge periods, thereby improving implant sensitivity, reducing power consumption, and enhancing.
Regarding claim 13, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that the sensing system further comprising optical filters or diffraction grids placed on the light emitting semiconductor device or on the light sensitive conductive device to select specific light wavelengths or bands of operation. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach a sensing implant comprising capacitors, resistive elements, and LED/sensor combinations, and circuits configured to detect environmental changes through electrical parameters as shown in claim 1 and 11 above; however, they do not disclose optical filters or diffraction grids placed on the light emitting semiconductor device or on the light sensitive conductive device to select specific light wavelengths or bands of operation. Colvin teaches the use of a high pass filter placed over the photodetector to selectively detect desired light wavelengths, allowing the system to focus on specific bands of emission related to the analyte concentration (Colvin, Abstract, col. 6, ll. 11–45). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, Jain and Colvin in view of Colvin to include optical filters or diffraction grids associated with the light emitting semiconductor device or the light sensitive conductive device to select specific light wavelengths or bands of operation. This modification would have been possible because it represents a predictable improvement to increase sensitivity and selectivity in environmental sensing systems by optimizing the wavelengths detected or emitted. The benefit of making this modification would be to enhance the implant’s ability to discriminate between different chemical or physical conditions based on optical signal characteristics, improving specificity and reducing potential interference from background signals.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Edmonson et al. (US-10143847-B1), hereto referred as Edmonson, and further in view of Najafi et al. (US-20090105557-A1), hereto referred as Najafi.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim 1 as described above.
Regarding claim 14, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that the sensing system further comprises a capsule having at least a part made of a flexible material, and wherein the electronic circuit is housed within the capsule, the implant further comprising the at least two electrodes passing through the capsule and connected with the electronic circuit. The combined Becerra-Fajardo, Ivorra, and Jain teach an implantable body containing an electronic circuit and electrodes connected to the circuit, as shown in claim 1 above, but they do not expressly describe the body as having a flexible portion configured for external force transmission. Ivorra illustrates a structure where the electronic circuit is encapsulated within a flexible tubular silicone body, with electrodes extending through the ends of the body and connected internally (Ivorra, Fig. 3; Abstract). The flexibility of the silicone body is shown by the description and depiction of the implant as thin, tubular, and compliant with adjacent tissues (Ivorra, Fig. 2). One of ordinary skill in the art would have understood that the flexible silicone not only protects the internal circuitry but would also permit mechanical forces from the external environment, such as pressure changes, to be transmitted through the capsule to the internal components without significant obstruction. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Ivorra to provide a capsule structure having a flexible portion with exposed electrodes connected to the internal circuit. Such flexibility would be advantageous for minimizing mechanical mismatch with surrounding biological tissues and, where desired, could also support pressure sensing functionalities through the flexible capsule wall in later device adaptations. The benefit of making this modification would be to improve mechanical biocompatibility, reduce implant-induced tissue stress, and preserve the ability to sense physiologic parameters influenced by external mechanical forces in future device iterations.
The combined Becerra-Fajardo, Ivorra, and Jain do not teach that wherein the sensing system is suitable to be implanted inside an artery or a vein, further comprising a capsule having at least a part made of a flexible material that allows pressure transmission from an exterior of the capsule to an interior of the capsule, wherein the capacitor is a capacitive pressure sensor, such as the capacitor and the flexible part of the capsule are arranged relative to each other wherein the capacitance of the pressure sensor depends on the blood pressure, wherein each electrode of the at least two electrodes is a flexible structure configured to anchor the implant to the artery or vein. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach capacitive sensing implants generally, as shown in claim 1 above, as well as a flexible capsule, but do not teach a capacitive pressure sensor specifically configured for blood pressure monitoring within a vascular structure, nor do they describe the arrangement of a pressure sensor within a flexible capsule that transmits external pressure variations to an internal sensing element. Edmonson teaches implantable capacitive pressure sensors configured for placement within arteries, such as the pulmonary artery, where the capacitance of the sensor varies based on blood pressure (Edmonson, col. 4, ll. 62 to col. 5, ll. 26; col. 12, ll. 60 to col. 13, ll. 24). Edmonson further describes positioning the sensing element “fully exposed to the blood in the vessel, without obstruction from the housing” (Edmonson, col. 11, ll. 48 to col. 13, ll. 8), emphasizing direct responsiveness to vascular pressure. Although Edmonson focuses on direct exposure, one of ordinary skill in the art would have understood that minimal obstruction could also be achieved through a thin, flexible, biocompatible encapsulation material. Ivorra teaches encapsulating electronics in a thin silicone body designed to flex with tissue and transmit mechanical forces without significant attenuation (Ivorra, Fig. 2–3; Abstract). Najafi further confirms that capacitive pressure sensors can be embedded within flexible materials such as silicone or polymers while still accurately sensing external pressure changes (Najafi, ¶[0003]; ¶[0022]; ¶[0028]). Thus, it would have been obvious to adapt Edmonson’s sensing structure to be embedded within a flexible silicone capsule as taught by Ivorra, allowing external blood pressure forces to transmit effectively to the sensor while providing mechanical protection and improving biocompatibility. Edmonson further teaches that the electrodes may take the form of fixation elements configured to secure the implant within the blood vessel (Edmonson, col. 13, ll. 5–25). Although Edmonson does not expressly state that the electrodes are flexible, it teaches that the electrodes expand from a collapsed delivery configuration to an expanded deployed configuration (Edmonson, Fig. 2; col. 13, ll. 5–25; col. 11, ll. 48 to col. 13, ll. 8), and one of ordinary skill in the art would have understood that such expansion requires sufficient flexibility for anchoring and conforming to the vessel wall. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Edmonson and Najafi to include a capacitive pressure sensor encapsulated within a flexible portion of the implant, wherein blood pressure variations are transmitted through the flexible capsule to the internal sensor, with flexible electrodes configured to anchor the implant to the vascular wall. Combining these teachings would have been straightforward because Edmonson demonstrates that capacitive sensing and fixation techniques are highly suitable for vascular implantation, and Ivorra shows that flexible capsule designs allow external mechanical forces to be transmitted to internal electronic components without substantial attenuation. The benefit of making this modification would be to enable real-time, minimally invasive blood pressure monitoring through capacitance measurements in an implantable device that is flexible, biocompatible, and optimized for reliable operation in dynamic vascular environments, improving diagnostic performance while minimizing patient risk.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Foutz et al. (Foutz, Thomas J et al. “Energy Efficient Neural Stimulation: Coupling Circuit Design and Membrane Biophysics.” PloS one 7.12 (2012): e51901–e51901. Web.), hereto referred as Foutz, and further in view of Miller et al. (US-20200412164-A1), hereto referred as Miller.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim 1 as described above.
Regarding claim 15, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that the discharge network comprises a current controlling device incorporating a transducer wherein current control depends on a parameter of the transducer, and wherein the current controlling device is a JFET transistor and the transducer is a resistive transducer. Rather, the combined Becerra-Fajardo, Ivorra, and Jain teach an implant circuit including a rectifier, capacitor, and resistor in a regulation subcircuit, as shown in claim 1 above, but they do not teach a discharge network comprising a current controlling device incorporating a transducer where current control depends on a parameter of the transducer. Foutz teaches a constant-current source based on a field-effect transistor (FET) that regulates stimulation current independently of variations in load impedance (Foutz, Fig. 1; p. 3, 'Adjustable Compliance Voltage'). In a FET, the gate-source voltage serves as a control parameter that modulates channel resistance, such that the FET operates as a transducer controlling current flow in response to an input signal. Thus, Foutz teaches a current control device wherein current depends on a varying parameter, satisfying the transducer aspect of the claim. Miller further supplements this by expressly listing JFETs (junction field-effect transistors) among electronic components suitable for current control in implantable systems (Miller, ¶[0104]). Miller confirms that JFETs were recognized by one of ordinary skill in the art as devices appropriate for regulating current flow, reinforcing the use of a JFET as the specific type of current controller referenced in the claim. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Foutz and Miller to configure the discharge network to include a current controlling device incorporating a transducer where current control depends on a parameter of the transducer, and optionally where the current controlling device is a JFET transistor and the transducer is a resistive transducer. One of ordinary skill would have recognized from Foutz the benefits of implementing a stable constant-current regulation scheme in implantable circuits, and would have found it straightforward based on Miller to select a JFET for this purpose to replace or supplement the passive resistor-based subcircuit of Becerra-Fajardo. The benefit of making this modification would be to ensure reliable and consistent discharge currents independent of biological impedance variations, thereby improving the implant’s ability to generate accurate electrical signals for diagnostic sensing while minimizing variability and measurement error caused by changing tissue conditions.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Potyrailo et al. (US-20140025313-A1), hereto referred as Potyrailo.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim1 as described above.
Regarding claim 16, the combined Becerra-Fajardo, Ivorra, and Jain teaches that the reading unit is additionally adapted for processing a sensed voltage and/or current(Becerra-Fajardo, p. 546, “II. PROOF-OF-CONCEPT PROTOTYPE”: “The external HF current generator is connected in series to a sensing resistor RS”, this shows the reader measures current via the voltage drop across RS; p. 546, “B. Receiver architecture”: “A receiver contained in the external unit (Fig. 4) is triggered in order to capture, demodulate and decode this signal”, this shows the reader processes the sensed electrical signal), but it does not teach calculating a capacitance of the capacitor, a resistance of the discharging network or impedance of the medium surrounding the implant when the implant is deployed in the medium, and for processing a calculated value to obtain a measurement of interest.
Rather, the combined Becerra-Fajardo, Ivorra, and Jain teaches a reader that senses electrical signals (voltage/current) from the external electrodes and performs digital processing, but it does not teach calculating a capacitance of the implant capacitor, a resistance of the discharge network, or an impedance of the surrounding medium, nor processing such calculated values to obtain a measurement of interest. For example, Becerra-Fajardo states: “The external unit includes the HF current generator. This generator is connected in series with the sensing resistor RS … A receiver contained in the external unit (Fig. 4) is triggered in order to capture, demodulate and decode this signal” (Becerra-Fajardo, p. 546–547, “II. PROOF-OF-CONCEPT PROTOTYPE”; “B. Receiver architecture”), and further that “The activation of these current sources causes an amplitude modulation of the rectified HF current across the implants which can be detected across the external sensing resistor” (Becerra-Fajardo, p. 546, “II. PROOF-OF-CONCEPT PROTOTYPE”).
Potyrailo teaches acquiring an impedance spectrum with a reader, extracting sensor spectral parameters, and expressly obtaining “calculated values of C and R,” and further teaches determining environmental parameters from the impedance spectrum using multivariate analysis: “measuring a real part and an imaginary part of the impedance spectrum … calculating at least six spectral parameters … determining one or more environmental parameters from the impedance spectrum” and “determining a resistance and a capacitance of the single resonant sensor antenna coated with a sensing material,” with “calculated values of C and R” (Potyrailo, ¶[0039]; ¶[0054]; ¶[0010]; ¶[0012]; claim 8, 27).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, and Jain in view of Potyrailo to adapt the reading unit’s processing to calculate a capacitance of the capacitor, a resistance of the discharging network, or an impedance of the medium from the sensed voltage and/or current, and to process the calculated value to obtain a measurement of interest. It would have been possible to combine these teachings because Becerra-Fajardo already acquires the necessary electrical signals via a series sensing resistor and performs digital capture/demodulation in a control/processing module, while Potyrailo provides reader-side algorithms to compute C, R, and environmental parameters from measured electrical responses; implementing Potyrailo’s calculations in Becerra-Fajardo’s existing processing chain is a routine software/firmware extension of the disclosed readout path. The benefit of the combination is to endow the existing implant system with quantitative sensing capability (deriving C, R, or impedance and converting those into environmental/physiological measurements) without adding bulky hardware, thereby improving diagnostic utility while leveraging the same interrogation bursts and receiver architecture already disclosed.
Regarding claim 17, the combined Becerra-Fajardo, Ivorra, Potyrailo, and Jain does not fully teach that the reading unit is adapted for reading the implant by monitoring a time course of relative changes of a burst current amplitude ipeak as the capacitor charges, for fitting recorded variations of the time course of relative changes of the burst current amplitude ipeak to a model by adjusting a characteristic value, and for calculating a desired measurement from the characteristic value. Rather, the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo discloses burst-based interrogation with external voltage and current measurement at the sensing resistor RS and teaches that the burst current through the implant decreases as the capacitor charges during the burst (Becerra-Fajardo 2015, p. 547, ‘B. Receiver architecture’; p. 547, ‘II. PROOF-OF-CONCEPT PROTOTYPE’; Ivorra, p. 6, §3.2), but does not expressly describe fitting the recorded time course of relative changes in the burst current amplitude ipeak to a model by adjusting a characteristic value, nor calculating a desired measurement from the resulting value.
Potyrailo teaches reader-side analysis workflows that extract characteristic electrical parameters from measured responses by model-based fitting. For example, Potyrailo teaches that calculated values of sensor resistance R and capacitance C are derived from measured electrical responses and used in sensing determinations (Potyrailo, ¶[0054]–¶[0055]; ¶[0096]). Potyrailo further teaches applying analytical techniques to measured response curves to determine characteristic values corresponding to sensed conditions.
Jain teaches that implantable sensor elements produce electrical responses that vary as a function of physical and/or chemical conditions and that these electrical responses are used to determine measurements of interest. For physical sensing, Jain discloses a temperature probe in which the resistance of a temperature-dependent element varies with temperature (Jain, ¶[0091]) and further discloses pressure sensing via a blood pressure sensor (Jain, ¶[0111]). For chemical sensing, Jain discloses that current changes are monitored to determine glucose concentration (Jain, ¶[0114]) and further discloses electrochemical oxygen and pH sensor embodiments (Jain, ¶[0119]; ¶[0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, Potyrailo, and Jain in view of Potyrailo and Jain to monitor the time course of relative changes of the burst current amplitude ipeak as the capacitor charges, fit the recorded variations to a model by adjusting a characteristic value, and calculate a desired measurement from the resulting value. It would have been possible to combine these teachings because Becerra-Fajardo already acquires burst-time voltage and current data via the RS measurement pathway, Ivorra establishes that the implant current exhibits a predictable decay profile during capacitor charging, Potyrailo provides reader-side model-based parameter extraction techniques for deriving characteristic values from measured electrical responses, and Jain teaches that those characteristic electrical parameters correspond to physical and chemical measurements of interest. The benefit of the combination would be to enable quantitative physical and/or chemical sensing based on model-based analysis of the burst-time current amplitude behavior using the same HF-burst interrogation and external receiver infrastructure, thereby enhancing sensing functionality without adding implant complexity and while maintaining compact implant deployment by injection or catheterization.
Regarding claim 18, the combined Becerra-Fajardo, Ivorra, Potyrailo, and Jain does not explicitly disclose that the reading unit is adapted for reading the implant by monitoring the voltage across the two or more electrodes during the capacitor discharge after a burst cessation, for fitting a recorded voltage waveform to a model by adjusting a characteristic value, and for processing a calculated value to obtain a measurement of interest. Rather, the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo discloses burst-based interrogation with external voltage measurement at the sensing resistor RS and teaches that, after cessation of a burst, the implant capacitor discharges through the implant resistor and surrounding tissue, producing a decaying electrical response available for monitoring (Becerra-Fajardo 2015, p. 546, ‘B. Receiver architecture’; Ivorra, p. 3, §2.1; p. 6, §3.2), but does not expressly describe fitting a recorded post-burst discharge voltage waveform to a model by adjusting a characteristic value, nor processing a calculated value to obtain a measurement of interest.
Potyrailo provides a reader-side, model-based analysis needed to fit recorded electrical responses and extract characteristic values for sensing, by describing a “general mutual inductance coupling circuit model” and the relation “Z T =Z C+(ω2 M 2 /Z S)” that links the reader’s measured impedance to sensor characteristics (Potyrailo, ¶[0058], “The interaction between the RFID sensor 12 and the pickup coil 22 can be described using a general mutual inductance coupling circuit model” … “Z T =Z C+(ω2 M 2 /Z S)”), teaching that “the relations between calculated sensor resistance R and calculated sensor capacitance C are illustrated in plot 78” (Potyrailo, ¶[0096]) and that “results of phase shift measurements of an impedance spectrum and the peak shift of the resonance of the sensor were compared” (Potyrailo, ¶[0104]), and further that “the sensor’s multivariable response was modeled using the first, second, and third principal components (PCs) of the built PCA model” with “excellent correlation coefficients” between actual and predicted concentrations (Potyrailo, ¶[0092]).
Jain teaches that implantable sensor elements produce electrical responses that vary as a function of physical and/or chemical conditions and that such electrical responses are processed to obtain measurements of interest. For physical sensing, Jain discloses a temperature probe in which the resistance of a temperature-dependent element varies with temperature (Jain, ¶[0091]) and further discloses pressure sensing via a blood pressure sensor (Jain, ¶[0111]). For chemical sensing, Jain discloses that current changes are monitored to determine glucose concentration (Jain, ¶[0114]) and further discloses electrochemical oxygen and pH sensor embodiments (Jain, ¶[0119]; ¶[0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo in view of Potyrailo and Jain in view of Potyrailo and Jain to monitor the post-burst discharge voltage across the electrodes, fit the recorded discharge waveform to an electrical model by adjusting a characteristic value, and process the resulting characteristic value to obtain a measurement of interest, with predictable results and a reasonable expectation of success. Such a modification would have been obvious because Becerra-Fajardo already captures and digitally processes electrode-path voltage signals indicative of implant behavior, Ivorra identifies a predictable post-burst capacitor discharge that produces a decaying waveform suitable for modeling, Potyrailo provides reader-side, model-based parameter extraction techniques that mathematically relate measured electrical responses to characteristic values, and Jain teaches that extracted electrical parameters such as resistance or conductance correspond to physical and chemical measurements including temperature, pressure, and analyte concentration. Leveraging the naturally occurring post-burst discharge window enables quantitative extraction of characteristic circuit values using the same electrode and sensing-resistor readout pathway without additional implant hardware, thereby enabling accurate physical and chemical measurements while preserving the compact, injection- or catheter-deployable implant architecture. Potyrailo further demonstrates that such model-based analysis yields robust discrimination and quantitative prediction with excellent correlation between modeled and measured values (Potyrailo, ¶[0092]), reinforcing the technical motivation to combine these teachings for improved sensitivity, accuracy, and measurement reliability.
Regarding claim 19, the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo does not fully teach that the reading unit is adapted for reading the implant by delivering bursts of different amplitude and monitoring current unbalances between positive and negative semicycles, for fitting recorded unbalances to a model by adjusting a characteristic value, and for calculating a measurement from the characteristic value. Rather, the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo discloses externally applied HF bursts measured across a series sensing resistor RS with explicit semicycle-resolved features and burst-time evolution of the implant response, but does not expressly disclose deliberately delivering bursts of different amplitude to induce and monitor current unbalances between positive and negative semicycles, nor fitting those recorded unbalances to a model to extract a characteristic value for calculating a measurement of interest. For example, Becerra-Fajardo teaches that “The external HF current generator is connected in series to a sensing resistor RS… The electrodes of the implants pick up the HF current… [and] amplitude modulation… can be detected across the external sensing resistor,” and further teaches semicycle-resolved detection in which “Positive and negative peaks were detected using the local maxima and minima algorithm” (Becerra-Fajardo, ‘B. Receiver architecture’; Fig. 5; Fig. 6). Ivorra explains that “During the HF bursts, rectified current will flow… thus progressively charging CB… [and] as CB becomes charged… the mean voltage across the implant electrodes will decrease” (Ivorra, §3.2), establishing a predictable burst-time current and voltage evolution that gives rise to semicycle-dependent amplitude differences.
Potyrailo provides a reader-side, model-based analysis needed to fit recorded electrical responses and extract characteristic values for sensing, by describing a “general mutual inductance coupling circuit model” and the relation “Zₜ = Zc + (ω²M² / Zs)” that links the reader’s measured impedance to sensor characteristics (Potyrailo, ¶[0058]), teaching that “the relations between calculated sensor resistance R and calculated sensor capacitance C are illustrated in plot 78” (Potyrailo, ¶[0096]) and that “results of phase shift measurements of an impedance spectrum and the peak shift of the resonance of the sensor were compared” (Potyrailo, ¶[0104]), and further that “the sensor’s multivariable response was modeled using the first, second, and third principal components (PCs) of the built PCA model” with “excellent correlation coefficients” between actual and predicted concentrations (Potyrailo, ¶[0092]).
Jain teaches that implantable sensor elements produce electrical responses that vary as a function of physical and/or chemical conditions and that such electrical responses are processed to obtain measurements of interest. For physical sensing, Jain discloses a temperature probe in which the resistance of a temperature-dependent element varies with temperature (Jain, ¶[0091]) and further discloses pressure sensing via a blood pressure sensor (Jain, ¶[0111]). For chemical sensing, Jain discloses that current changes are monitored to determine glucose concentration (Jain, ¶[0114]) and further discloses electrochemical oxygen and pH sensor embodiments (Jain, ¶[0119]; ¶[0115]).
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Becerra-Fajardo, Ivorra, Jain, and Potyrailo in view of Potyrailo and Jain to deliver bursts of different amplitude, monitor the resulting current unbalances between positive and negative semicycles, fit the recorded unbalances to a model by adjusting a characteristic value, and calculate a measurement of interest from the resulting value, with predictable results and a reasonable expectation of success. Such a modification would have been obvious because Becerra-Fajardo already provides amplitude-controlled burst generation and RS-based acquisition of semicycle-resolved current features, Ivorra establishes a stable and predictable burst-time response of the implant circuit, Potyrailo provides reader-side modeling and parameter-extraction techniques that mathematically relate measured electrical responses to characteristic values, and Jain teaches that extracted electrical parameters correspond to physical and chemical measurements including temperature, pressure, and analyte concentration. Stepping the burst amplitude to accentuate semicycle-dependent current unbalances yields richer, model-informative features that improve identifiability of characteristic circuit parameters (e.g., resistance and capacitance) and sensed conditions using the same electrode and sensing-resistor readout pathway, thereby enhancing sensitivity and robustness without additional implant hardware while preserving the compact, injection- or catheter-deployable implant architecture.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Becerra-Fajardo et al. (Becerra-Fajardo, Laura, and Antoni Ivorra. “Bidirectional Communications in Wireless Microstimulators Based on Electronic Rectification of Epidermically Applied Currents.” 2015 7th International IEEE/EMBS Conference on Neural Engineering (NER). IEEE, 2015. 545–548. Web), hereto referred as Becerra-Fajardo, and further in view of Ivorra et al. (Ivorra, Antoni, Laura Becerra-Fajardo, and Quim Castellví. “In Vivo Demonstration of Injectable Microstimulators Based on Charge-Balanced Rectification of Epidermically Applied Currents.” Journal of neural engineering 12.6 (2015): 066010–066010. Web.), hereto referred as Ivorra, and further in view of Jain et al. (US-20080154101-A1), hereto referred as Jain, and further in view of Potyrailo et al. (US-20140025313-A1), hereto referred as Potyrailo, and further in view of Edmonson et al. (US-10143847-B1), hereto referred as Edmonson.
The combined Becerra-Fajardo, Ivorra, and Jain teaches claim 1 as described above.
Regarding claim 20, the combined Becerra-Fajardo, Ivorra, and Jain do not teach that the reading unit is an external battery powered hand-held unit, or wherein the reading unit comprises: an implantable sub-unit adapted for reading the implant; an external sub-unit adapted for presenting information related to the readings of the implantable sub-unit; wherein the implantable sub-unit and the external sub-unit are wirelessly communicated. Rather, the combined Becerra-Fajardo, Ivorra, and Jain collectively teach an external system for reading implant signals and wirelessly monitoring implantable devices, but they do not explicitly describe the reading unit being battery-powered and handheld. Edmonson teaches an external device (component 14) that is a handheld, battery-powered device (such as a smartphone or tablet) that wirelessly communicates with an implantable medical device to retrieve physiological information and present it to a user (Edmonson, Figs. 1A-B; col. 20, ll. 5–25; col. 6, ll. 10–21). Edmonson thus explicitly discloses both a battery-powered hand-held external device and a system comprising an implantable sub-unit adapted for sensing and an external sub-unit adapted for presenting readings, with wireless communication between them. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined teachings of Becerra-Fajardo, Ivorra, and Jain in view of Edmonson to configure the reading unit as either (i) a battery-powered handheld external device capable of emitting interrogation bursts and receiving implant signals or (ii) a system comprising an implantable sub-unit that performs sensing and an external sub-unit that processes and presents the data, with wireless communication between the sub-units. One of ordinary skill would have found it obvious to implement this modification because Becerra-Fajardo and Ivorra already separate the sensing and control components between internal and external locations, and Edmonson provides an explicit teaching of using portable, battery-powered external units for such wireless implant monitoring and data presentation. The benefit of making this modification would be to increase the portability, usability, and clinical practicality of the implant system by enabling handheld monitoring, or distributed implant-external reader systems, with minimal additional complexity beyond known wireless telemetry and portable electronic technologies.
Response to Arguments
Objections
Applicant's arguments filed 12/12/2025, page 10, regarding the previous Objections of claim 12 have been fully considered and are persuasive. The previous Objections to claim 12 have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 12/12/2025, pages 10-17, regarding the previous 103 Rejections of claims 1-20 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791