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 .
Drawings
The drawings are objected to because the various rectangular (or near-rectangular) boxes representing functional blocks or components in Figs 1-2 and 5 (e.g. 104-122 and 502-503 and 510), which are blank other than containing a reference numeral, should be provided with “descriptive legends”, per 37 CFR 1.84(o), with reference numeral placed outside the box/block in an appropriate manner. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 10-11, and 18 are objected to because of the following informalities:
Claims 1 and 10-11 mention “configured transition”, should these read “configured to transition”?
Claim 18 mentions “configured that”, should “configured” be removed?
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Young (US Patent No. 9288614 B1), in view of Finlow-Bates (US Patent No. 20200280454 A1) and further in view of Ibarrola (US Patent No. 11364386 B2).
In re claim 1, Young teaches A medical device system (Abstract: “Systems and methods are provided for initiating a bi-directional communication link with an implantable medical device.”) comprising:
an implantable medical device (Col 2, lines 20-22: “FIG. 2 illustrates a block diagram of exemplary internal components of an implantable medical device, according to an embodiment of the present disclosure.”) comprising:
a control circuit configured to control operation of the implantable medical device (Col 5, lines 11-12: “The IMD 101 includes a programmable microcontroller 160 which controls operation.”);
a communication circuit configured to communicate with a remote device (Cols 62-67 and 1-2: “The RF circuit 110 may be configured to handle and/or manage the bi-directional communication link between the IMD 101 and the external device 201. The RF circuit 110 is controlled by the microcontroller 160 and may support a particular wireless communication protocol while communicating with the external device 201, such as Bluetooth low energy, Bluetooth, ZigBee, Medical Implant Communication Service (MICS), or the like.”); and
an RFID circuit (Cols 7-8, lines 62-67 and 1-14: “In another example, the trigger circuit 116 may measure an RFID signal corresponding to the activation field 109. Optionally, the RFID signal may include a unique identifier, such as a string of characters (e.g., numerals, letters, control codes, spaces) corresponding to a communication initialization mode of the wireless protocol for the IMD 101 stored on the memory 194. Additionally or alternatively, the RFID signal may be based on an NFC protocol such as a short range wireless communication protocol or NFC transmission defined in ISO/IEC 18092/ECMA-340, ISO/IEC 21481/ECMA-352, ISO/IEC 14443, or the like. Optionally, once the RFID signal is received by the trigger circuit 116, the trigger circuit 116 may output the RFID signal to the microcontroller 160. The trigger circuit 116 and/or the microcontroller 160 may compare the unique identifier of the RFID signal with stored identification signals on memory 194 to select a communication initialization mode. The stored identification signals may be included within a table or list with corresponding communication initialization modes of the wireless protocol.”), separate from the communication circuit of the implantable medical device (SEE FIG. 2, depicting separate Trigger Circuit 116 and RF Circuit 104),
provide an initialization key (Cols 8-9, lines 50-67 and 1-2: “The memory 194 may also contain a pre-defined algorithm that generates a passkey. The passkey may be used during a pairing and/or bonding procedure between the IMD 101 and the external device 201 to establish a bi-directional communication link over the communication link 104. The passkey may be generated based on passkey seed information. The passkey seed information may include a dynamic seed and/or a static identification or encrypted static identification transmitted by the RF circuit 110 through the communication link 104 from the external device 201 and inputted into the pre-defined algorithm. Optionally, the dynamic seed may be a random number generated by the microcontroller 160, based on the local system clock of the IMD 101, or the like that is transmitted by the RF circuit 110 to the external device 201. Additionally or alternatively, the static identification may be stored on the memory 194 representing a product serial identification number of the IMD 101, which is a unique number assigned to the IMD 101 by a manufacturer of the IMD 101. Optionally, the static identification may be a pre-determined number stored on the memory 194 set by a clinician.”); and
wherein the implantable medical device or the RFID circuit is configured transition a state of the implantable medical device or the communication circuit of the implantable medical device (Col 3, lines 46-58: “When the activation field 109 is detected by the IMD 101, the IMD 101 may be programmed and/or configured to enter a select communication initialization mode corresponding to the activation field 109 detected from the triggering device 102. The select communication initialization mode may be a subset of a plurality of communication initialization modes defined by the wireless protocol to establish a bi-directional communication link 104 between the IMD 101 and the external device 201. For example, the communication initialization mode may correspond to a defined pairing and/or bonding procedure. Optionally, the communication initialization mode may by the IMD 101 from a sleeping and/or power saving state by activating a radio frequency (RF) circuit 110.”) based on the authorization sequence (SEE Cols 7-8, lines 62-67 and 1-14 mapped to above).
Young fails to teach wherein the RFID circuit comprises first and second portions of configurable memory, wherein the RFID circuit is configured to implement a patient-specific RFID communication protocol using the first and second portions of configurable memory,
wherein, to implement the patient-specific RFID communication protocol, the RFID circuit is configured to:
using the first portion of configurable memory of the RFID circuit; and
receive an authorization sequence from the remote device using the second portion of configurable memory of the RFID circuit,
stored in the second portion of configurable memory of the RFID circuit.
However, Finlow-Bates teaches wherein the RFID circuit comprises first and second portions of configurable memory (Para [0067]: “The RFID tag 102 may comprise a memory 206. The memory 206 may be implemented as non-volatile RAM, volatile battery-backed RAM, ROM, EEPROM, or other memory for storing and receiving data and/or computer code. Part or all of the memory may comprise a cryptographically secure data storage, which may be implemented either in hardware, software, or a combination of the two. The memory may be compartmentalized into memory sectors, and in some embodiments each memory sector may be accessed only by one or more access keys, either by encrypting data in each memory sector with an access key, or by the RFID tag only transmitting data from a given memory sector when presented with a correct access key.”), wherein the RFID circuit is configured to implement a patient-specific RFID communication protocol using the first and second portions of configurable memory (Para [0069]: “In some embodiments the tag logic 208 may coordinate extracting data from radio signals received via the antenna 202 and responding to commands contained in the data, for example by: writing or overwriting data to the tag memory 206, retrieving further data from the memory and transmitting said further data back to the RFID reader 104, and transforming the further data before transmitting, provided certain conditions are met by the data.”),
wherein, to implement the patient-specific RFID communication protocol, the RFID circuit is configured to (SEE paras [0067] and [0069] mapped to above):
using the first portion of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above); and
using the second portion of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above),
stored in the second portion of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Young to incorporate the teachings of Finlow-Bates to provide wherein the RFID circuit comprises first and second portions of configurable memory, wherein the RFID circuit is configured to implement a patient-specific RFID communication protocol using the first and second portions of configurable memory, wherein, to implement the patient-specific RFID communication protocol, the RFID circuit is configured to: using the first portion of configurable memory of the RFID circuit; and using the second portion of configurable memory of the RFID circuit, stored in the second portion of configurable memory of the RFID circuit with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young. Doing so enables a low overhead challenge and response using a one-time password pad comprising passwords on the RFID tag, as recognized by Finlow-Bates (Abstract).
The combination fails to teach receive an authorization sequence from the remote device.
However, Ibarrola teaches receive an authorization sequence from the remote device (Col 19, lines 28-45: “In one arrangement, the stored data may include a device identifier 1012, one or more device keys 1014 and one or more device trust indicia 1016. For example, device key storage 1014 may store one of a pair of asymmetric encryption keys with the other key stored by a remote server, e.g., a PKI server or other server. The pair of keys for a given device 1000 may be used to securely create and employ validation data according to some embodiments. Although device identifier 1012 is shown as stored in memory 1010, device identifier 1012 may be retained elsewhere in device 1000. For example, many device components (e.g., processors, integrated circuits, wireless communication circuitry, and the like) include identifiers that are hard-encoded in the components and are readily retrievable. In one embodiment, the identifiers of such subcomponents may be used, taken alone or in some combination, as the medical device identifier in lieu of a value stored in memory of device 1000.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young and Finlow-Bates to further incorporate the teachings of Ibarrola to provide receive an authorization sequence from the remote device with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates. Doing so enables to securely create and employ validation data according to some embodiments, as recognized by Ibarrola (Col 19, lines 28-45).
Method claim 14 is rejected for the same reasons as device system claim 1 for having similar limitations and being similar in scope.
In re claim 2, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Young further teaches wherein to transition the state of the implantable medical device includes to enable communication between the remote device and the communication circuit of the implantable medical device (Col 3, lines 46-58: “When the activation field 109 is detected by the IMD 101, the IMD 101 may be programmed and/or configured to enter a select communication initialization mode corresponding to the activation field 109 detected from the triggering device 102. The select communication initialization mode may be a subset of a plurality of communication initialization modes defined by the wireless protocol to establish a bi-directional communication link 104 between the IMD 101 and the external device 201. For example, the communication initialization mode may correspond to a defined pairing and/or bonding procedure. Optionally, the communication initialization mode may by the IMD 101 from a sleeping and/or power saving state by activating a radio frequency (RF) circuit 110.”) based on the authorization sequence (SEE Cols 7-8, lines 62-67 and 1-14 mapped to above).
The combination fails to teach stored in the second portion of configurable memory of the RFID circuit.
However, Finlow-Bates teaches stored in the second portion of configurable memory of the RFID circuit (SEE para [0067] and [0069] mapped to above).
Method claim 15 is rejected for the same reasons as device system claim 2 for having similar limitations and being similar in scope.
In re claim 3, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Young further teaches wherein the RFID circuit is configured to authenticate the remote device (SEE Cols 7-8, lines 62-67 and 1-14) for secure remote programming of the implantable medical device (Col 4, lines 7-11: “The external device 201 is configured to establish the bi-directional communication link 104 with the IMD 101. The communication link 104 allows the external device 201 to receive measurements from the IMD 101, and to program or send instructions to the IMD 101.”) without activating the communication circuit of the implantable medical device (Cols 7-8, lines 62-67 and 1-14: “In another example, the trigger circuit 116 may measure an RFID signal corresponding to the activation field 109. Optionally, the RFID signal may include a unique identifier, such as a string of characters (e.g., numerals, letters, control codes, spaces) corresponding to a communication initialization mode of the wireless protocol for the IMD 101 stored on the memory 194. Additionally or alternatively, the RFID signal may be based on an NFC protocol such as a short range wireless communication protocol or NFC transmission defined in ISO/IEC 18092/ECMA-340, ISO/IEC 21481/ECMA-352, ISO/IEC 14443, or the like. Optionally, once the RFID signal is received by the trigger circuit 116, the trigger circuit 116 may output the RFID signal to the microcontroller 160. The trigger circuit 116 and/or the microcontroller 160 may compare the unique identifier of the RFID signal with stored identification signals on memory 194 to select a communication initialization mode. The stored identification signals may be included within a table or list with corresponding communication initialization modes of the wireless protocol.”).
The combination fails to teach using the first and second portions of configurable memory of the RFID circuit.
However, Finlow-Bates teaches using the first and second portions of configurable memory of the RFID circuit (SEE para [0067] and [0069] mapped to above).
Method claim 16 is rejected for the same reasons as device system claim 3 for having similar limitations and being similar in scope.
In re claim 4, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Finlow-Bates further teaches wherein the RFID circuit is a passive or semi-passive RFID circuit configured to receive power from the remote device separate from the implantable medical device (Para [0058]: “In some embodiments the RFID tag 102 may comprise a passive tag powered by scavenging power from radio waves produced by the RFID reader 104.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Finlow-Bates to provide wherein the RFID circuit is a passive or semi-passive RFID circuit configured to receive power from the remote device separate from the implantable medical device with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables tag powered by scavenging power from radio waves, as recognized by Finlow-Bates (Para [0058]).
Method claim 17 is rejected for the same reasons as device system claim 4 for having similar limitations and being similar in scope.
In re claim 5, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Young further teaches wherein the implantable medical device includes a power source configured to supply power to the control circuit and the communication circuit (Col 10, lines 7-8: “The IMD 101 additionally includes a battery 113, which provides operating power to all of the circuits shown.”).
The combination fails to teach wherein the RFID circuit is a passive RFID circuit configured to receive power from the remote device separate from the implantable medical device and does not receive power from the power source of the implantable medical device.
However, Finlow-Bates teaches wherein the RFID circuit is a passive RFID circuit configured to receive power from the remote device separate from the implantable medical device and does not receive power from the power source of the implantable medical device (Para [0058]: “In some embodiments the RFID tag 102 may comprise a passive tag powered by scavenging power from radio waves produced by the RFID reader 104.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Finlow-Bates to provide wherein the RFID circuit is a passive RFID circuit configured to receive power from the remote device separate from the implantable medical device and does not receive power from the power source of the implantable medical device with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables tag powered by scavenging power from radio waves, and reducing exhaustion of the battery 210 by utilising power from other sources such as the RFID reader radio transmissions, thus extending a lifespan of the battery 210, as recognized by Finlow-Bates (Para [0065]).
Method claim 18 is rejected for the same reasons as device system claim 5 for having similar limitations and being similar in scope.
In re claim 6, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Finlow-Bates further teaches wherein the RFID circuit comprises a memory circuit comprising a limited amount of configurable memory, wherein the limited amount of configurable memory consists of the first and second portions of configurable memory (Para [0067]: “The RFID tag 102 may comprise a memory 206. The memory 206 may be implemented as non-volatile RAM, volatile battery-backed RAM, ROM, EEPROM, or other memory for storing and receiving data and/or computer code. Part or all of the memory may comprise a cryptographically secure data storage, which may be implemented either in hardware, software, or a combination of the two. The memory may be compartmentalized into memory sectors, and in some embodiments each memory sector may be accessed only by one or more access keys, either by encrypting data in each memory sector with an access key, or by the RFID tag only transmitting data from a given memory sector when presented with a correct access key.”).
Method claim 19 is rejected for the same reasons as device system claim 6 for having similar limitations and being similar in scope.
In re claim 7, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Young further teaches wherein the implantable medical device comprises a data bus configured to enable communication between the communication circuit of the implantable medical device and the control circuit of the implantable medical device (Col 8, lines 32-33: “The microcontroller 160 is coupled to memory 194 by a suitable data/address bus 196…” and SEE FIG. 2, RF Circuit 110 coupled to microcontroller 160 via data/address bus.),
[wherein the RFID circuit comprises an RFID antenna], separate from an antenna of the communication circuit (SEE FIG. 2, depicting separate RF Circuit 110 and Trigger Circuit 116).
The combination fails to teach wherein the RFID circuit comprises an RFID control circuit and an internal data bus between the RFID control circuit and the configurable memory of the RFID circuit, [wherein the RFID circuit comprises an RFID antenna], configured to receive energy to power the internal data bus of the RFID circuit.
However, Finlow-Bates teaches wherein the RFID circuit comprises an RFID control circuit and an internal data bus between the RFID control circuit and the configurable memory of the RFID circuit (SEE FIG. 2, depicting memory 206 connecting to Tag Logic 208 and para [0068]: “The RFID tag 102 may comprise a tag logic 208. The tag logic may be implemented through an array of logic gates, a general purpose processor, a programmable logic controller (PLC), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof configured to implement methods detailed in the present disclosure.”), [wherein the RFID circuit comprises an RFID antenna] (SEE FIG. 2, depicting Antenna 202), configured to receive energy to power the internal data bus of the RFID circuit (Para [0058]: “In some embodiments the RFID tag 102 may comprise a passive tag powered by scavenging power from radio waves produced by the RFID reader 104.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Finlow-Bates to provide wherein the RFID circuit comprises an RFID control circuit and an internal data bus between the RFID control circuit and the configurable memory of the RFID circuit, [wherein the RFID circuit comprises an RFID antenna], configured to receive energy to power the internal data bus of the RFID circuit with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables tag powered by scavenging power from radio waves, as recognized by Finlow-Bates (Para [0058]).
In re claim 9, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Finlow-Bates further teaches wherein the initialization key is a random sequence provided by the RFID circuit (Para [0098]: “In other embodiments a preimage list and derived access key list may be constructed through other processes, for example through a generation of a random list of preimages using a secure random number generator.”),
and stored in the second portion of configurable memory of the RFID circuit (SEE para [0067] and [0069] mapped to above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Finlow-Bates to provide wherein the initialization key is a random sequence provided by the RFID circuit with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables generation of a random list of preimages for a low overhead challenge and response using a one-time password pad comprising passwords on the RFID tag, as recognized by Finlow-Bates (Para [0098] and Abstract).
The combination fails to teach wherein the authorization sequence is a patient-specific passkey generated by an authentication circuit separate from the remote device,
wherein the implantable medical device or the RFID circuit is configured to transition the state of the implantable medical device or the communication circuit of the implantable medical device based on the patient-specific passkey generated by the authentication circuit.
However, Ibarrola teaches wherein the authorization sequence is a patient-specific passkey generated by an authentication circuit separate from the remote device (Col 7, lines 41-49: “Broadly, embodiments herein utilize certain unique information from a patient's IMD in association with a suitable key structure system (e.g., a public key infrastructure (PKI) system) operating as a secure credentials management system with respect to a clinician device and a patent device for registration and generation of trust associations, preferably prior to establishing a remote therapy/programming session therebetween.”),
wherein the implantable medical device or the RFID circuit is configured to transition the state of the implantable medical device or the communication circuit of the implantable medical device based on the patient-specific passkey generated by the authentication circuit (Col 7, lines 41-49: “Broadly, embodiments herein utilize certain unique information… preferably prior to establishing a remote therapy/programming session therebetween.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Ibarrola to provide wherein the authorization sequence is a patient-specific passkey generated by an authentication circuit separate from the remote device, wherein the implantable medical device or the RFID circuit is configured to transition the state of the implantable medical device or the communication circuit of the implantable medical device based on the patient-specific passkey generated by the authentication circuit with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables a secure communication session may be established, e.g., by the clinician operating the authorized clinician device and/or the patient operating the patient device, for providing/consuming remote care, as recognized by Ibarrola (Col 8, lines 8-12).
In re claim 10, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Finlow-Bates further teaches stored in the second portion of configurable memory of the RFID circuit (SEE para [0067] and [0069] mapped to above).
The combination fails to teach wherein the implantable medical device is configured transition a state of the communication circuit of the implantable medical device based on the authorization sequence.
However, Ibarrola teaches wherein the implantable medical device is configured transition a state of the communication circuit of the implantable medical device based on the authorization sequence (Col 7, lines 41-49: “Broadly, embodiments herein utilize certain unique information from a patient's IMD in association with a suitable key structure system (e.g., a public key infrastructure (PKI) system) operating as a secure credentials management system with respect to a clinician device and a patent device for registration and generation of trust associations, preferably prior to establishing a remote therapy/programming session therebetween.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Ibarrola to provide wherein the implantable medical device is configured transition a state of the communication circuit of the implantable medical device based on the authorization sequence with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables a secure communication session may be established, e.g., by the clinician operating the authorized clinician device and/or the patient operating the patient device, for providing/consuming remote care, as recognized by Ibarrola (Col 8, lines 8-12).
In re claim 11, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Finlow-Bates further teaches stored in the second portion of configurable memory of the RFID circuit (SEE para [0067] and [0069] mapped to above).
The combination fails to teach wherein the RFID circuit is configured transition a state of the implantable medical device based on the authorization sequence.
However, Ibarrola teaches wherein the RFID circuit is configured transition a state of the implantable medical device based on the authorization sequence (Col 19, lines 9-21: “In one arrangement, device 1000 may include suitable communications circuitry 1030 to conduct communication sessions with an external device (e.g., clinician device 1100 described in detail below and/or a patient device) after implantation using any known or heretofore unknown short-range communications technologies, e.g., involving communication protocols that may include but not limited to inductive communication protocols, BLE, NFC, Zigbee, UHF RFID, Bluetooth, and the like. In one arrangement, communications circuitry 1030 of device 1000 may also include circuitry to conduct communication sessions with networked devices over a network using appropriate technologies as set forth above in reference to FIG. 1.” and lines 28-45: “In one arrangement, the stored data may include a device identifier 1012, one or more device keys 1014 and one or more device trust indicia 1016. For example, device key storage 1014 may store one of a pair of asymmetric encryption keys with the other key stored by a remote server, e.g., a PKI server or other server. The pair of keys for a given device 1000 may be used to securely create and employ validation data according to some embodiments. Although device identifier 1012 is shown as stored in memory 1010, device identifier 1012 may be retained elsewhere in device 1000. For example, many device components (e.g., processors, integrated circuits, wireless communication circuitry, and the like) include identifiers that are hard-encoded in the components and are readily retrievable. In one embodiment, the identifiers of such subcomponents may be used, taken alone or in some combination, as the medical device identifier in lieu of a value stored in memory of device 1000.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Ibarrola to provide wherein the RFID circuit is configured transition a state of the implantable medical device based on the authorization sequence with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables a secure communication session may be established, e.g., by the clinician operating the authorized clinician device and/or the patient operating the patient device, for providing/consuming remote care, as recognized by Ibarrola (Col 8, lines 8-12).
In re claim 12, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 1 stated above where Young further teaches wherein, to implement the patient- specific RFID communication protocol, the RFID circuit is configured to:
detect, at a first time, a wake-up signal from the remote device (Cols 7-8, lines 62-67 and 1-14: “In another example, the trigger circuit 116 may measure an RFID signal corresponding to the activation field 109. Optionally, the RFID signal may include a unique identifier, such as a string of characters (e.g., numerals, letters, control codes, spaces) corresponding to a communication initialization mode of the wireless protocol for the IMD 101 stored on the memory 194. Additionally or alternatively, the RFID signal may be based on an NFC protocol such as a short range wireless communication protocol or NFC transmission defined in ISO/IEC 18092/ECMA-340, ISO/IEC 21481/ECMA-352, ISO/IEC 14443, or the like. Optionally, once the RFID signal is received by the trigger circuit 116, the trigger circuit 116 may output the RFID signal to the microcontroller 160. The trigger circuit 116 and/or the microcontroller 160 may compare the unique identifier of the RFID signal with stored identification signals on memory 194 to select a communication initialization mode. The stored identification signals may be included within a table or list with corresponding communication initialization modes of the wireless protocol.”);
receive, at a second time subsequent to the first time, an identifier of the remote device (Cols 7-8, lines 62-67 and 1-14: “In another example, the trigger circuit 116 may measure an RFID signal corresponding to the activation field 109. Optionally, the RFID signal may include a unique identifier, such as a string of characters (e.g., numerals, letters, control codes, spaces) corresponding to a communication initialization mode of the wireless protocol for the IMD 101 stored on the memory 194.”);
provide, at a third time subsequent to the second time, the initialization key (Cols 8-9, lines 50-67 and 1-2: “The memory 194 may also contain a pre-defined algorithm that generates a passkey. The passkey may be used during a pairing and/or bonding procedure between the IMD 101 and the external device 201 to establish a bi-directional communication link over the communication link 104. The passkey may be generated based on passkey seed information. The passkey seed information may include a dynamic seed and/or a static identification or encrypted static identification transmitted by the RF circuit 110 through the communication link 104 from the external device 201 and inputted into the pre-defined algorithm. Optionally, the dynamic seed may be a random number generated by the microcontroller 160, based on the local system clock of the IMD 101, or the like that is transmitted by the RF circuit 110 to the external device 201. Additionally or alternatively, the static identification may be stored on the memory 194 representing a product serial identification number of the IMD 101, which is a unique number assigned to the IMD 101 by a manufacturer of the IMD 101. Optionally, the static identification may be a pre-determined number stored on the memory 194 set by a clinician.”);
authenticate, at a fifth time subsequent to the fourth time, the remote device (SEE Cols 7-8, lines 62-67 and 1-14) for secure remote programming of the implantable medical device using the communication circuit of the implantable medical device (Col 4, lines 7-11: “The external device 201 is configured to establish the bi-directional communication link 104 with the IMD 101. The communication link 104 allows the external device 201 to receive measurements from the IMD 101, and to program or send instructions to the IMD 101.”) and the initialization key (Cols 8-9, lines 50-67 and 1-2).
The combination fails to teach activate an internal data bus of the RFID circuit;
using one of the first or second portions of configurable memory of the RFID circuit;
using the first portion of configurable memory of the RFID circuit;
receive, at a fourth time subsequent to the third time, the authorization sequence from the remote device using the second portion of configurable memory of the RFID circuit; and
based on the authorization sequence.
However, Finlow-Bates teaches activate an internal data bus of the RFID circuit (SEE FIG. 2, depicting memory 206 connecting to Tag Logic 208 and para [0068]: “The RFID tag 102 may comprise a tag logic 208. The tag logic may be implemented through an array of logic gates, a general purpose processor, a programmable logic controller (PLC), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof configured to implement methods detailed in the present disclosure.”);
using one of the first or second portions of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above);
using the first portion of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above);
using the second portion of configurable memory of the RFID circuit (SEE paras [0067] and [0069] mapped to above).
The combination fails to teach receive, at a fourth time subsequent to the third time, the authorization sequence from the remote device,
based on the authorization sequence.
However, Ibarrola teaches receive, at a fourth time subsequent to the third time, the authorization sequence from the remote device (Col 19, lines 28-45: “In one arrangement, the stored data may include a device identifier 1012, one or more device keys 1014 and one or more device trust indicia 1016. For example, device key storage 1014 may store one of a pair of asymmetric encryption keys with the other key stored by a remote server, e.g., a PKI server or other server. The pair of keys for a given device 1000 may be used to securely create and employ validation data according to some embodiments. Although device identifier 1012 is shown as stored in memory 1010, device identifier 1012 may be retained elsewhere in device 1000. For example, many device components (e.g., processors, integrated circuits, wireless communication circuitry, and the like) include identifiers that are hard-encoded in the components and are readily retrievable. In one embodiment, the identifiers of such subcomponents may be used, taken alone or in some combination, as the medical device identifier in lieu of a value stored in memory of device 1000.”),
based on the authorization sequence (SEE Cols 7-8, lines 37-67 and 1-12).
In re claim 13, Young, Finlow-Bates and Ibarrola teach all of the limitations of claim 12 stated above where Ibarrola further teaches wherein to authenticate the remote device comprises to perform multi-factor authentication of a clinician providing programming instructions for secure remote programming of the implantable medical device (Col 8, lines 61-67: “FIGS. 3-5 depict message flow diagrams illustrative of one or more message and/or work flows that exemplify additional details with respect to registering clinician and patient devices and effectuating trusted associations based on the patent's IMD via a remote care session manager according to some embodiments of the present patent disclosure.” and col 9, lines 8-12: “Accordingly, at least a portion of the operations involving clinician 302 in this message flow diagram may comprise operations relative to initial enrollment/registration of clinician 302 and associated clinician programmer/device (CP/CD) 304.” and lines 36-40: “Responsive thereto, a UI display is presented to the clinician/agent 302 for facilitating input of appropriate user registration credentials (e.g., usernames, passwords, multi-factor authentication tokens etc.)…”), perform second-level approval by a second clinician of the programming instructions for secure remote programming of the implantable medical device, or perform patient approval of the clinician providing programming instructions or programming instructions for secure remote programming of the implantable medical device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Young, Finlow-Bates and Ibarrola to further incorporate the teachings of Ibarrola to provide wherein to authenticate the remote device comprises to perform multi-factor authentication of a clinician providing programming instructions for secure remote programming of the implantable medical device with the Systems And Methods For Initiating A Communication Link Between An Implantable Medical Device And An External Device of Young as modified by Finlow-Bates and Ibarrola. Doing so enables a secure communication session may be established, e.g., by the clinician operating the authorized clinician device and/or the patient operating the patient device, for providing/consuming remote care, as recognized by Ibarrola (Col 8, lines 8-12).
Allowable Subject Matter
Claims 8 and 20 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not expressly teach or render obvious, in the context of the claims taken as a whole,
Regarding claim 8, wherein the RFID control circuit is configured to control activation of the data bus between the communication circuit of the implantable medical device and the control circuit of the implantable medical device based on the authorization sequence stored in the second portion of configurable memory of the RFID circuit.
Regarding claim 20, comprising:
enabling communication between the communication circuit of the implantable medical device and the control circuit of the implantable medical device using a data bus of the implantable medical device;
enabling communication between an RFID control circuit of the RFID circuit and the configurable memory of the RFID circuit using an internal data bus of the RFID control circuit;
receiving energy to power the internal data bus of the RFID circuit using an RFID antenna of the RFID circuit, separate from an antenna of the communication circuit; and
controlling, using the RFID control circuit, activation of the data bus between the communication circuit of the implantable medical device and the control circuit of the implantable medical device based on the authorization sequence stored in the second portion of configurable memory of the RFID circuit.
Moreover, modifying the prior art to achieve the claim limitation can only be achieved by hindsight, as no other reference includes these limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20240079147 A1 teaches An implantable medical device and a method of deduplicating data collected by the implantable medical device are provided. The method includes storing data, captured by the implantable medical device, in a non-volatile memory device of the implantable medical device, assigning a unique number, generated from a random number generator or counter, to each data block of the data, and deduplicating the data by deleting at least one of two or more data blocks that are associated with the same unique number.
US 12598458 B2 teaches an apparatus for powering an implant for a human patient and a method for powering an implant for a human patient. Wherein said apparatus comprises an implantable energy source for providing energy to the implant, an energy provider connected to the implantable energy source and connected to an energy consuming part of the implant, the energy provider being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider is configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power during startup of the energy consuming part.
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/JAMES E MUNION/Examiner, Art Unit 2688 06/19/2026
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