DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on December 22, 2025. Claims 1-5, 9, and 11-13 have been amended. Claims 1-17 have been examined and are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 9 are objected to because of the following informalities: the term, “the surgical use” lacks antecedent basis in lines 12 and 7. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zmood WO 2009/003231 A1 in view of Khalife et al. US Publication 20230022785 A1.
Claim 1:
As per claim 1, Zmood teaches a system comprising:
a data hub including an outer housing, a data hub electronics module and a data hub power supply, wherein the data hub electronics module and the data hub power supply are contained within the outer housing, wherein the data hub remains affixed to the medical instrument kit during the steam autoclave sterilization cycle (page 17, lines 17-30 and Figure 2, item 26 and page 10, line 26 to page 11, line 26 “The tray interrogator 26 may include sterilization sensitive components, such as a microprocessor and associated circuitry. The tray interrogator 26 may for example include a controller 32 for controlling interrogation of instruments 12 or implants 14 and for communicating with external devices, an antenna 34, and a memory 36 for storing information, such as identity, usage and life history data. The data may relate to the interrogator itself, the tray 20 or 21 and/or the instruments 12 and implants 14 in tray 20 or 21. The tray interrogator 26 may also include a power source 38 for supplying power to the various components, and may take the form of an active RFID tag. It would also be possible for the antenna 34 and other sterilization-hard circuitry and components to be mounted permanently on tray 20 or 21 , e.g. on an outer wall surface thereof, with the interrogator 26 connecting to them, when it is mounted to tray 20 or 21 , e.g. through a contactless or direct electrical coupling.” and “The cradle may be configured so that the cradle and mounted container will not fit inside an autoclave or other sterilization machine. This can help prevent the interrogator from being accidentally exposed to the rigours of a sterilization process. Other forms of removable interrogator may also be similarly configured, and where an inner holder is provided, the arrangement of the inner holder and interrogator may be such that the inner holder cannot be placed within the container with the interrogator attached. It may also, however be advantageous to provide systems that allow this so that items can be read through the inner holder interrogators whilst in the container. The container may include a closure element, such as a lid, and the container and interrogator may couple together such that the container may only be closed when the interrogator is detached from the tray e.g. by using a suitable mechanical interlock. For example, the lid may have a pin attached to it which prevents the lid from closing properly unless the interrogator is detached. This may help to prevent interrogators from being left on containers during their sterilization, as the container will generally be opened to check the contents prior to sterilization. The closing mechanism may be designed so that the lid can be removed whilst the interrogator is attached, but can then not be refitted. The mechanism may also be designed so that the interrogator may be attachable to the container when the lid is closed. The system may include sterilization apparatus, such as an autoclave or gamma irradiation equipment, and may include an interrogator associated with the apparatus, which monitors for the presence of a container interrogator prior to commencing a sterilization process…”);
wherein the data hub is operable to communicate the node operational data to the remote monitoring location (page 4, lines 24-34 and page 9, lines 10-16 “The system may also allow an external reader to obtain information on tagged items through interrogation of a single container interrogator, rather than having to interrogate multiple item tags. In this regard, the container interrogator may include memory for storing data from the instruments ready for transmission to an external reader. Alternatively, the container interrogator may obtain and relay information from item tags to an external reader without storage of the information. The container interrogator may be programmed to respond to specific commands, e.g. to obtain specific information from the tagged items, and/or to initiate communication, e.g. if it determines that there is an error in the items stored, e.g. incorrect items are in a tray or items are missing. In one implementation, the container interrogator may be written to by an external device, e.g. to log an event or the like during a handling stage of the container. The container interrogator may therefore hold data relating to a container's history, and so the history of the items contained within it. This may be especially useful for example where the item tags are read-only tags.”).
Zmood does not teach and a node sensor configured to be received in the medical instrument and including a node enclosure sized to receive a node electronics module and a node power supply, wherein the node electronics module includes a control unit and at least one operational sensor operable to obtain node operation data that is related to the surgical use of the medical instrument, wherein the node electronics module is configured to wirelessly communicate the node operational data to the data hub using a non-RFID wireless communication protocol. However, Khalife teaches Systems, Methods, and Devices for Tracking Surgical Instruments and Devices and further teaches, “FIGS. 3A and 3B illustrate an alternative tracking device 300. Common features between the tracking device 100 and the tracking device 300 will not be described again but are incorporated here in their entirety. The tracking device 300 can include a handle 302 and an instrument receiver 304. The instrument receiver 304 can be coupled to the handle 302. In some embodiments, the handle 302 can house internal components 314. The instrument receiver 304 can be configured to receive one or more surgical instruments. The instrument can include an actuator 306. The actuator 306 can be configured to increment a counter when the one or more surgical instruments are inserted into the instrument receiver 304. In some embodiments, the actuator 306 can be a torque limiter. The torque limiter can be configured to increment the counter when the one or more surgical instruments actuates the torque limiter. In some embodiments, the tracking device can include a strain detector. The strain detector can determine when a user is using or holding the tracking device 300, and the tracking device 300 can prevent the torque limiter incrementing the counter, unless the strain detector determine the user is using or holding the tracking device 300. In some embodiments, the strain detector can be coupled to or embedded in the one or more surgical instruments. In some embodiments, the tracking device 300 can include metal.” (paragraph 0105), “FIG. 1 illustrates a schematic of a tracking device 100. The surgical tracking device can include at least one sensor 102, a circuit 104, a radio interface 106, a memory 108, and a power source 110. The at least one sensor 102 can be configured to detect a location event of a surgical instrument or a surgical instrument tray. The location event can be an acceleration, a change in temperature, a change in light, a change in pressure, a change in magnetic field and/or a vibration. The circuit 104 can be configured to control and/or process signals, data, or other information from the at least one sensor 102 and/or the radio interface 106. The radio interface 106 can be configured to transmit the signals, data, or other information from the at least one sensor 102. In some embodiments, the radio interface 106 can include a cellular antenna and/or an RFID antenna. The memory 108 can be configured to store the signals, data, or other information from at least one sensor 102 and/or the circuit 104. In some embodiments, the tracking device 100 can include a counter 111. The counter can be stored in the memory 108. The circuit 104 can increment the counter 111 when the at least one sensor 102 detects a location event. In some embodiments, the tracking device 100 can include a plurality of counters 111. In some embodiments, as further described below with reference to FIG. 5, the tracking device 100 can be configured to automatically determine a location of the tracking device 100 when the at least one sensor detects a location event, and the tracking device 100 can automatically transmit the location to a computer network on a data analytics platform, as described further below with reference to FIGS. 6-15.” (paragraph 0090), “In some embodiments, the at least one sensor 102 can include an acceleration sensor or an accelerometer. The acceleration sensor can be configured to detect when a surgical instrument or a surgical instrument tray is put in motion. For example, the acceleration sensor can detect when the surgical instrument or surgical instrument tray is picked up, put down, dropped, or otherwise generally moved. In some embodiments, the location event can be the movement of the tracking device 100 detected by the sensor 102. In some embodiments, if the acceleration is greater than a threshold, or a rate of change of the acceleration is greater than a threshold, the tracking device 100, via the sensor 102 and the circuit 104, can determine that the tracking device 100 or the surgical instrument or surgical instrument tray the tracking device 100 is coupled to is damaged. In some embodiments, detection of damage can be a location event.” (paragraph 0092), and “In some embodiments, the devices herein may use an acceleration sensor, or accelerometer, within the devices or coupled to the devices to detect motion of the devices. In some embodiments, the devices may use the acceleration sensor to detect if the devices/instruments are put in motion, either alone, or if a storage platform, such as a hospital/surgical tray, on which the devices/instruments are located is put in motion. In some embodiments, the device may detect wired and/or wireless communication, using hardware and/or software, such as, for example, wireless sniffing, wireless stumbling, or Wi-Fi sniffing, to analyze network communications or packets to obtain network information of networks in proximity to the devices. In some embodiments, the devices may detect network or device information, such as, for example, MAC addresses of a Wi-Fi hotspot or other network node to provide information about the location of the device without using resource intensive sensors such as acceleration sensors. In some embodiments, the devices may obtain accurate geolocation data using network information. In some embodiments, the devices may use a communication protocol or channel, such as a cellular communication channel or Sigfox, to send data wirelessly to the data analytics platform.” (paragraph 0050). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include and a node sensor configured to be received in the medical instrument and including a node enclosure sized to receive a node electronics module and a node power supply, wherein the node electronics module includes a control unit and at least one operational sensor operable to obtain node operation data that is related to the surgical use of the medical instrument, wherein the node electronics module is configured to wirelessly communicate the node operational data to the data hub using a non-RFID wireless communication protocol as taught by Khalife in order to communicate surgical data to the data hub in a wireless manner.
Claim 9:
As per claim 9, Zmood teaches a medical instrument kit comprising:
a one or more medical instruments (Figures 2 and 5-6, item 12 and page 16, lines 27-29 “In Fig. 2, the surgical instruments 12 are tagged with RFID tags 24 that are sterilization-hard (can withstand the sterilization of the instruments and retain functionality).”);
and a data hub including an outer housing, a data hub electronics module and a data hub power supply, wherein the data hub electronics module and the data hub power supply are contained within the outer housing, wherein the data hub remains affixed to the medical instrument kit during the steam autoclave sterilization cycle (page 17, lines 17-30 and Figure 2, item 26 and page 4, lines 24-34 and page 10, line 26 to page 11, line 26 “The tray interrogator 26 may include sterilization sensitive components, such as a microprocessor and associated circuitry. The tray interrogator 26 may for example include a controller 32 for controlling interrogation of instruments 12 or implants 14 and for communicating with external devices, an antenna 34, and a memory 36 for storing information, such as identity, usage and life history data. The data may relate to the interrogator itself, the tray 20 or 21 and/or the instruments 12 and implants 14 in tray 20 or 21. The tray interrogator 26 may also include a power source 38 for supplying power to the various components, and may take the form of an active RFID tag. It would also be possible for the antenna 34 and other sterilization-hard circuitry and components to be mounted permanently on tray 20 or 21 , e.g. on an outer wall surface thereof, with the interrogator 26 connecting to them, when it is mounted to tray 20 or 21 , e.g. through a contactless or direct electrical coupling.” and “The system may also allow an external reader to obtain information on tagged items through interrogation of a single container interrogator, rather than having to interrogate multiple item tags. In this regard, the container interrogator may include memory for storing data from the instruments ready for transmission to an external reader. Alternatively, the container interrogator may obtain and relay information from item tags to an external reader without storage of the information. The container interrogator may be programmed to respond to specific commands, e.g. to obtain specific information from the tagged items, and/or to initiate communication, e.g. if it determines that there is an error in the items stored, e.g. incorrect items are in a tray or items are missing. In one implementation, the container interrogator may be written to by an external device, e.g. to log an event or the like during a handling stage of the container. The container interrogator may therefore hold data relating to a container's history, and so the history of the items contained within it. This may be especially useful for example where the item tags are read-only tags.” and “The cradle may be configured so that the cradle and mounted container will not fit inside an autoclave or other sterilization machine. This can help prevent the interrogator from being accidentally exposed to the rigours of a sterilization process. Other forms of removable interrogator may also be similarly configured, and where an inner holder is provided, the arrangement of the inner holder and interrogator may be such that the inner holder cannot be placed within the container with the interrogator attached. It may also, however be advantageous to provide systems that allow this so that items can be read through the inner holder interrogators whilst in the container. The container may include a closure element, such as a lid, and the container and interrogator may couple together such that the container may only be closed when the interrogator is detached from the tray e.g. by using a suitable mechanical interlock. For example, the lid may have a pin attached to it which prevents the lid from closing properly unless the interrogator is detached. This may help to prevent interrogators from being left on containers during their sterilization, as the container will generally be opened to check the contents prior to sterilization. The closing mechanism may be designed so that the lid can be removed whilst the interrogator is attached, but can then not be refitted. The mechanism may also be designed so that the interrogator may be attachable to the container when the lid is closed. The system may include sterilization apparatus, such as an autoclave or gamma irradiation equipment, and may include an interrogator associated with the apparatus, which monitors for the presence of a container interrogator prior to commencing a sterilization process…”).
Zmood does not teach a node sensor received in each of the medical instruments and including a node enclosure sized to receive a node electronics module and a node power supply, wherein the node electronics module includes a control unit and at least one operational sensor operable to obtain node operation data that is related to the surgical use of the medical instrument, wherein the node electronics module is configured to obtain the node operational data. However, Khalife teaches Systems, Methods, and Devices for Tracking Surgical Instruments and Devices and further teaches, “FIGS. 3A and 3B illustrate an alternative tracking device 300. Common features between the tracking device 100 and the tracking device 300 will not be described again but are incorporated here in their entirety. The tracking device 300 can include a handle 302 and an instrument receiver 304. The instrument receiver 304 can be coupled to the handle 302. In some embodiments, the handle 302 can house internal components 314. The instrument receiver 304 can be configured to receive one or more surgical instruments. The instrument can include an actuator 306. The actuator 306 can be configured to increment a counter when the one or more surgical instruments are inserted into the instrument receiver 304. In some embodiments, the actuator 306 can be a torque limiter. The torque limiter can be configured to increment the counter when the one or more surgical instruments actuates the torque limiter. In some embodiments, the tracking device can include a strain detector. The strain detector can determine when a user is using or holding the tracking device 300, and the tracking device 300 can prevent the torque limiter incrementing the counter, unless the strain detector determine the user is using or holding the tracking device 300. In some embodiments, the strain detector can be coupled to or embedded in the one or more surgical instruments. In some embodiments, the tracking device 300 can include metal.” (paragraph 0105), “FIG. 1 illustrates a schematic of a tracking device 100. The surgical tracking device can include at least one sensor 102, a circuit 104, a radio interface 106, a memory 108, and a power source 110. The at least one sensor 102 can be configured to detect a location event of a surgical instrument or a surgical instrument tray. The location event can be an acceleration, a change in temperature, a change in light, a change in pressure, a change in magnetic field and/or a vibration. The circuit 104 can be configured to control and/or process signals, data, or other information from the at least one sensor 102 and/or the radio interface 106. The radio interface 106 can be configured to transmit the signals, data, or other information from the at least one sensor 102. In some embodiments, the radio interface 106 can include a cellular antenna and/or an RFID antenna. The memory 108 can be configured to store the signals, data, or other information from at least one sensor 102 and/or the circuit 104. In some embodiments, the tracking device 100 can include a counter 111. The counter can be stored in the memory 108. The circuit 104 can increment the counter 111 when the at least one sensor 102 detects a location event. In some embodiments, the tracking device 100 can include a plurality of counters 111. In some embodiments, as further described below with reference to FIG. 5, the tracking device 100 can be configured to automatically determine a location of the tracking device 100 when the at least one sensor detects a location event, and the tracking device 100 can automatically transmit the location to a computer network on a data analytics platform, as described further below with reference to FIGS. 6-15.” (paragraph 0090), “In some embodiments, the at least one sensor 102 can include an acceleration sensor or an accelerometer. The acceleration sensor can be configured to detect when a surgical instrument or a surgical instrument tray is put in motion. For example, the acceleration sensor can detect when the surgical instrument or surgical instrument tray is picked up, put down, dropped, or otherwise generally moved. In some embodiments, the location event can be the movement of the tracking device 100 detected by the sensor 102. In some embodiments, if the acceleration is greater than a threshold, or a rate of change of the acceleration is greater than a threshold, the tracking device 100, via the sensor 102 and the circuit 104, can determine that the tracking device 100 or the surgical instrument or surgical instrument tray the tracking device 100 is coupled to is damaged. In some embodiments, detection of damage can be a location event.” (paragraph 0092), and “In some embodiments, the devices herein may use an acceleration sensor, or accelerometer, within the devices or coupled to the devices to detect motion of the devices. In some embodiments, the devices may use the acceleration sensor to detect if the devices/instruments are put in motion, either alone, or if a storage platform, such as a hospital/surgical tray, on which the devices/instruments are located is put in motion. In some embodiments, the device may detect wired and/or wireless communication, using hardware and/or software, such as, for example, wireless sniffing, wireless stumbling, or Wi-Fi sniffing, to analyze network communications or packets to obtain network information of networks in proximity to the devices. In some embodiments, the devices may detect network or device information, such as, for example, MAC addresses of a Wi-Fi hotspot or other network node to provide information about the location of the device without using resource intensive sensors such as acceleration sensors. In some embodiments, the devices may obtain accurate geolocation data using network information. In some embodiments, the devices may use a communication protocol or channel, such as a cellular communication channel or Sigfox, to send data wirelessly to the data analytics platform.” (paragraph 0050). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include a node sensor received in each of the medical instruments and including a node enclosure sized to receive a node electronics module and a node power supply, wherein the node electronics module includes a control unit and at least one operational sensor operable to obtain node operation data that is related to the surgical use of the medical instrument, wherein the node electronics module is configured to obtain the node operational data as taught by Khalife in order to communicate surgical data to the data hub in a wireless manner.
Zmood does not teach wherein the node sensor is operable to wirelessly communicate the node operational data to the data hub using a non-RFID wireless communication protocol and the data hub is operable to wirelessly communicate the node operational data to a remote monitoring location. However, Khalife teaches Systems, Methods, and Devices for Tracking Surgical Instruments and Devices and further teaches, “In some embodiments, the secondary device 408 can automatically send the retrieved information to an external device. The secondary device 408 can send the retrieved information via a cellular network, W-Fi, Bluetooth, or any other communication network protocols. In some embodiments, the external device can include a computing device and/or a computer network. In some embodiments, the external device can include a data analytics platform, as described below with reference to FIGS. 6-14.” (paragraph 0113) and “FIG. 1 illustrates a schematic of a tracking device 100. The surgical tracking device can include at least one sensor 102, a circuit 104, a radio interface 106, a memory 108, and a power source 110. The at least one sensor 102 can be configured to detect a location event of a surgical instrument or a surgical instrument tray. The location event can be an acceleration, a change in temperature, a change in light, a change in pressure, a change in magnetic field and/or a vibration. The circuit 104 can be configured to control and/or process signals, data, or other information from the at least one sensor 102 and/or the radio interface 106. The radio interface 106 can be configured to transmit the signals, data, or other information from the at least one sensor 102. In some embodiments, the radio interface 106 can include a cellular antenna and/or an RFID antenna. The memory 108 can be configured to store the signals, data, or other information from at least one sensor 102 and/or the circuit 104. In some embodiments, the tracking device 100 can include a counter 111. The counter can be stored in the memory 108. The circuit 104 can increment the counter 111 when the at least one sensor 102 detects a location event. In some embodiments, the tracking device 100 can include a plurality of counters 111. In some embodiments, as further described below with reference to FIG. 5, the tracking device 100 can be configured to automatically determine a location of the tracking device 100 when the at least one sensor detects a location event, and the tracking device 100 can automatically transmit the location to a computer network on a data analytics platform, as described further below with reference to FIGS. 6-15.” (paragraph 0090). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the node sensor is operable to wirelessly communicate the node operational data to the data hub using a non-RFID wireless communication protocol and the data hub is operable to wirelessly communicate the node operational data to a remote monitoring location as taught by Khalife in order to communicate information to an external computer or device.
Claim 10:
As per claim 10, Zmood and Khalife teach the medical instrument kit of claim 9 as described above and Zmood further teaches further comprising a sterilization tray sized to receive the one or more medical instruments during a sterilization procedure, wherein the data hub is affixed to the sterilization tray (page 9, lines 10-16 and page 11, lines 25-32).
Claims 3 and 11:
As per claims 3 and 11, Zmood and Khalife teach the system and medical instrument kit of claims 1 and 10 as described above and Zmood further teaches wherein the data hub and the node sensor are each configured to withstand external temperature of up to 125°C and steam pressures of up to 208 kPa during the steam autoclave sterilization cycle (page 16, lines 4-16 and page 17, lines 3-13).
Claim(s) 2, 4, 6, 12, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zmood and Khalife as applied to claims 1, 9, and 10 above, and further in view of Donati et al. US Publication 20060145871.
Claim 2:
As per claim 2, Zmood and Khalife teach the system of claim 1 as described above but do not teach wherein the medical instrument kit includes a plurality of medical instruments and the system includes a plurality of node sensors each configured to be received in one of the plurality of medical instruments and operable to communicate the node operational data from the node sensor of each of the plurality of medical instruments to the data hub. However, Donati teaches Radio Frequency Identification for Medical Devices and further teaches, “RFID tags 7 and 8 of certain embodiments of the invention, associated with medical instruments 6 and located inside the sterilization case 1, have the capability of transmitting or responding with encoded data or a signature when they are interrogated by a reader 2...An alternative embodiment of the present invention includes active RFID tags that contain an independent energy source, such as a battery or other means, so that the RFID tag can actively transmit a signal or information.” (paragraph 0036) and “In certain embodiments of the present invention, the type of data transmitted by the RFID tags 7 and 8 and case RFID tag 5 to the reader 2 may include the identification of the medical instruments 6 to which the RFID tags 7 and 8 are attached, the contents of the entire sterilization case 1, the surgical technique associated with a particular medical instrument 6 or group of medical instruments contained within the sterilization case 1, surgical implants with which the instrument 6 is to be used, the manufacturing history of a particular medical instrument 6, how many times the instrument 6 has been sterilized, or any other relevant data associated with the instruments, group of instruments, or case. Alternatively, the RFID tags 7 and 8 may respond with a signal or signature that keys or correlates to such information in a database in the computer system or on a network such as the Internet or a local network. One may see that a number of different types of data may be conveyed with or keyed to information conveyed using RFID tags 7 and 8 and case RFID tag 5. In the preferred embodiment, the RFID tags 7 and 8 transmit or respond with data that corresponds to the identification of a particular medical instrument 6 and the case RFID tag 5 transmits data corresponding to the identification and contents of a particular sterilization case 1.” (paragraph 0040). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the medical instrument kit includes a plurality of medical instruments and the system includes a plurality of node sensors each configured to be received in one of the plurality of medical instruments and operable to communicate the node operational data from the node sensor of each of the plurality of medical instruments to the data hub as taught by Donati in order to communicate data associated with the medical instruments.
Claim 4:
As per claim 4, Zmood and Khalife teach the system of claim 1 as described above but do not teach wherein the node electronics module is operable to obtain the node operational data that includes one or more of temperature and motion. However, Donati teaches Radio Frequency Identification for Medical Devices and further teaches, “In certain embodiments of the present invention, the type of data transmitted by the RFID tags 7 and 8 and case RFID tag 5 to the reader 2 may include the identification of the medical instruments 6 to which the RFID tags 7 and 8 are attached, the contents of the entire sterilization case 1, the surgical technique associated with a particular medical instrument 6 or group of medical instruments contained within the sterilization case 1, surgical implants with which the instrument 6 is to be used, the manufacturing history of a particular medical instrument 6, how many times the instrument 6 has been sterilized, or any other relevant data associated with the instruments, group of instruments, or case. Alternatively, the RFID tags 7 and 8 may respond with a signal or signature that keys or correlates to such information in a database in the computer system or on a network such as the Internet or a local network. One may see that a number of different types of data may be conveyed with or keyed to information conveyed using RFID tags 7 and 8 and case RFID tag 5. In the preferred embodiment, the RFID tags 7 and 8 transmit or respond with data that corresponds to the identification of a particular medical instrument 6 and the case RFID tag 5 transmits data corresponding to the identification and contents of a particular sterilization case 1.” (paragraph 0040). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the node electronics module is operable to obtain the node operational data that includes one or more of temperature and motion as taught by Donati in order to provide status data associated with the medical instrument.
Claims 6 and 14:
As per claims 6 and 14, Zmood and Khalife teach the system and medical instrument kit of claims 1 and 9 as described above but do not teach wherein the data hub electronics module is operable to obtain data hub operational data that includes temperature and motion. However, Donati teaches Radio Frequency Identification for Medical Devices and further teaches, “In certain embodiments of the present invention, the type of data transmitted by the RFID tags 7 and 8 and case RFID tag 5 to the reader 2 may include the identification of the medical instruments 6 to which the RFID tags 7 and 8 are attached, the contents of the entire sterilization case 1, the surgical technique associated with a particular medical instrument 6 or group of medical instruments contained within the sterilization case 1, surgical implants with which the instrument 6 is to be used, the manufacturing history of a particular medical instrument 6, how many times the instrument 6 has been sterilized, or any other relevant data associated with the instruments, group of instruments, or case. Alternatively, the RFID tags 7 and 8 may respond with a signal or signature that keys or correlates to such information in a database in the computer system or on a network such as the Internet or a local network. One may see that a number of different types of data may be conveyed with or keyed to information conveyed using RFID tags 7 and 8 and case RFID tag 5. In the preferred embodiment, the RFID tags 7 and 8 transmit or respond with data that corresponds to the identification of a particular medical instrument 6 and the case RFID tag 5 transmits data corresponding to the identification and contents of a particular sterilization case 1.” (paragraph 0040). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the data hub electronics module is operable to obtain data hub operational data that includes temperature and motion as taught by Donati in order to receive status data associated with the medical instrument.
Claim 12:
As per claim 12, Zmood and Khalife teach the medical instrument kit of claim 9 as described above but do not teach wherein the node electronics module is operable to obtain the node operational data that includes temperature and motion. However, Donati teaches Radio Frequency Identification for Medical Devices and further teaches, “In certain embodiments of the present invention, the type of data transmitted by the RFID tags 7 and 8 and case RFID tag 5 to the reader 2 may include the identification of the medical instruments 6 to which the RFID tags 7 and 8 are attached, the contents of the entire sterilization case 1, the surgical technique associated with a particular medical instrument 6 or group of medical instruments contained within the sterilization case 1, surgical implants with which the instrument 6 is to be used, the manufacturing history of a particular medical instrument 6, how many times the instrument 6 has been sterilized, or any other relevant data associated with the instruments, group of instruments, or case. Alternatively, the RFID tags 7 and 8 may respond with a signal or signature that keys or correlates to such information in a database in the computer system or on a network such as the Internet or a local network. One may see that a number of different types of data may be conveyed with or keyed to information conveyed using RFID tags 7 and 8 and case RFID tag 5. In the preferred embodiment, the RFID tags 7 and 8 transmit or respond with data that corresponds to the identification of a particular medical instrument 6 and the case RFID tag 5 transmits data corresponding to the identification and contents of a particular sterilization case 1.” (paragraph 0040). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the node electronics module is operable to obtain the node operational data that includes temperature and motion as taught by Donati in order to provide status data associated with the medical instrument.
Claim 16:
As per claim 16, Zmood, Khalife, and Donati teach the medical instrument of claim 14 as described above and Zmood further teaches wherein the data hub communicates the node operational data to the remote monitoring location when the sensed temperature indicates a steam autoclave cycle (page 16, lines 4-32 and page 17, lines 3-13).
Claim 17:
As per claim 17, Zmood and Khalife teach the medical instrument of claim 10 as described above but do not teach wherein the node sensor communicates with the data hub when the medical instrument including the node sensor is placed in the sterilization tray. However, Donati teaches Radio Frequency Identification for Medical Devices and further teaches, “RFID tags 7 and 8 of certain embodiments of the invention, associated with medical instruments 6 and located inside the sterilization case 1, have the capability of transmitting or responding with encoded data or a signature when they are interrogated by a reader 2...An alternative embodiment of the present invention includes active RFID tags that contain an independent energy source, such as a battery or other means, so that the RFID tag can actively transmit a signal or information.” (paragraph 0036) and “In certain embodiments of the present invention, the type of data transmitted by the RFID tags 7 and 8 and case RFID tag 5 to the reader 2 may include the identification of the medical instruments 6 to which the RFID tags 7 and 8 are attached, the contents of the entire sterilization case 1, the surgical technique associated with a particular medical instrument 6 or group of medical instruments contained within the sterilization case 1, surgical implants with which the instrument 6 is to be used, the manufacturing history of a particular medical instrument 6, how many times the instrument 6 has been sterilized, or any other relevant data associated with the instruments, group of instruments, or case. Alternatively, the RFID tags 7 and 8 may respond with a signal or signature that keys or correlates to such information in a database in the computer system or on a network such as the Internet or a local network. One may see that a number of different types of data may be conveyed with or keyed to information conveyed using RFID tags 7 and 8 and case RFID tag 5. In the preferred embodiment, the RFID tags 7 and 8 transmit or respond with data that corresponds to the identification of a particular medical instrument 6 and the case RFID tag 5 transmits data corresponding to the identification and contents of a particular sterilization case 1.” (paragraph 0040). Therefore, it would have been obvious to one ordinary skilled in the art at the time of filing to modify Zmood to include wherein the node sensor communicates with the data hub when the medical instrument including the node sensor is placed in the sterilization tray as taught by Donati in order to communicate the status of the medical device while inside the sterilization tray.
Claim(s) 5, 7, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zmood, Khalife, and Donati as applied to claims 4, 6, 12, and 14 above, and further in view of Beck et al. US Publication 20200261183 A1.
Claims 5 and 13:
As per claims 5 and 13, Zmood, Khalife, and Donati teach the system and medical instrument kit of claims 4 and 12 as described above but do not teach wherein the control unit of the node electronics module is operable to disconnect the node power supply from the node electronics module when an external temperature is above a temperature threshold. However, Beck teaches a Medical Asset Tracking Methods and Apparatus and further teaches, “As previously described in conjunction with FIG. 1, the tracking apparatus 401 includes a power supply 408, which in a portable application typically comprises batteries, coupled with the processor 402 and other circuitry in the tracking apparatus via a thermally-responsive (thermal) switch 410. The thermal switch 410 functions to physically disconnect the power supply 408 from the entirety of the circuitry in the tracking apparatus 401 when a temperature in the tracking apparatus exceeds a prescribed threshold. In one or more embodiments, the prescribed temperature threshold is designed to be slightly less than a sterilization temperature, which is generally about 130° C. or higher.” (paragraph 0060). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the control unit of the node electronics module is operable to disconnect the node power supply from the node electronics module when an external temperature is above a temperature threshold is above a temperature threshold as taught by Beck in order to prevent any damage to the device.
Claims 7 and 15:
As per claims 7 and 15, Zmood, Khalife, and Donati teach the system and medical instrument kit of claims 6 and 14 as described above but do not teach wherein the data hub electronics module is operable to disconnect the data hub power supply from the data hub electronics module when an external temperature is above a temperature threshold. However, Beck teaches a Medical Asset Tracking Methods and Apparatus and further teaches, “As previously described in conjunction with FIG. 1, the tracking apparatus 401 includes a power supply 408, which in a portable application typically comprises batteries, coupled with the processor 402 and other circuitry in the tracking apparatus via a thermally-responsive (thermal) switch 410. The thermal switch 410 functions to physically disconnect the power supply 408 from the entirety of the circuitry in the tracking apparatus 401 when a temperature in the tracking apparatus exceeds a prescribed threshold. In one or more embodiments, the prescribed temperature threshold is designed to be slightly less than a sterilization temperature, which is generally about 130° C. or higher.” (paragraph 0060). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the data hub electronics module is operable to disconnect the data hub power supply from the data hub electronics module when an external temperature is above a temperature threshold as taught by Beck in order to prevent any damage to the device.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zmood and Khalife as applied to claim 1 above, and further in view of Lentvorski et al. US Publication 20220023463 A1.
Claim 8:
As per claim 8, Zmood and Khalife teach the system of claim 1 as described above but do not teach wherein the data hub electronics module can communicate to the remote monitoring location by both short-range radio and cellular connections. However, Lentvorski teaches an Automatic Sterilization and Charging of Wearable Device and further teaches, “The remote device 120 may be a personal device, such as a laptop, a tablet, a smartphone or another computing device, a server, a database and/or another storage device. The network 118 may be a Dedicated Short-Range Communication (DSRC) network, a local area network (LAN), a wide area network (WAN), a cellular network, the Internet, or combination thereof, that connects, couples and/or otherwise communicates among the sterilization and charging apparatus 122, the wearable device 116 and/or the remote device 120.” (paragraph 0024) and “The computing device 106 includes, a network access device 204. The network access device 204 may include a communication port or channel, such as one or more of a Dedicated Short-Range Communication (DSRC) unit, a Wi-Fi unit, a Bluetooth® unit, a radio frequency identification (RFID) tag or reader, or a cellular network unit for accessing a cellular network (such as 3G, 4G or 5G). The network access device 204 may transmit data to and receive data from the different components of the sterilization and charging system 100 including the platform 114 via the data/charging port 126, the wearable device 116 and/or the remote device 120. For example, the processor 202 may download data from the wearable device 116 either wirelessly or via the platform 114 and data/charging port 126 and may upload the downloaded data to the remote device 120 for storage. In another example, the computing device 106 may send commands to control the one or more light sources 124 and/or receive sensor data from the one or more sensors 212 to detect the wearable device 116.” (paragraph 0037). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Zmood to include wherein the data hub electronics module can communicate to the remote monitoring location by both short-range radio and cellular connections as taught by Lentvorski in order to facilitate communication in a variety of different formats.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed December 22, 2025 with respect to the rejection(s) of claim(s) 1-17 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zmood in view of Khalife.
According to applicant’s arguments on pages 7-9 disclose, “As amended, the data hub of claim 1 remains affixed to the medical instrument kit during the steam autoclave sterilization cycle. Thus, the data hub remains with the medical instrument kit and does not have to be separated and potentially misplaced. Thus, this feature of amended claim 1 is not shown in Zmood.” The examiner respectfully disagrees.
The examiner interprets the limitation, “…wherein the data hub remains affixed to the medical instrument kit during the steam autoclave sterilization cycle.” as a device attached to a container when the steam autoclave sterilization cycle is occurring or happening. This limitation is taught by Zmood by disclosing, “The cradle may be configured so that the cradle and mounted container will not fit inside an autoclave or other sterilization machine. This can help prevent the interrogator from being accidentally exposed to the rigours of a sterilization process. Other forms of removable interrogator may also be similarly configured, and where an inner holder is provided, the arrangement of the inner holder and interrogator may be such that the inner holder cannot be placed within the container with the interrogator attached. It may also, however be advantageous to provide systems that allow this so that items can be read through the inner holder interrogators whilst in the container. The container may include a closure element, such as a lid, and the container and interrogator may couple together such that the container may only be closed when the interrogator is detached from the tray e.g. by using a suitable mechanical interlock. For example, the lid may have a pin attached to it which prevents the lid from closing properly unless the interrogator is detached. This may help to prevent interrogators from being left on containers during their sterilization, as the container will generally be opened to check the contents prior to sterilization. The closing mechanism may be designed so that the lid can be removed whilst the interrogator is attached, but can then not be refitted. The mechanism may also be designed so that the interrogator may be attachable to the container when the lid is closed. The system may include sterilization apparatus, such as an autoclave or gamma irradiation equipment, and may include an interrogator associated with the apparatus, which monitors for the presence of a container interrogator prior to commencing a sterilization process…” Zmood discloses the interrogator (similar to the data hub) is attached to the surgical container (similar to the medical instrument kit) prior and during the autoclave. Therefore, the examiner maintains the rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lenzenhuber et al. US Publication 20240382269 A1 System and Method for Monitoring at Least One Medical Device
Lenzenhuber discloses a system and method are used for monitoring at least one medical device in a surgical environment. The system includes monitoring apparatuses that can be interconnected for data transmission in a monitoring network and that have a detection device designed to detect whether a transponder of a medical device is located in a detection region extending around the relevant monitoring apparatus. The monitoring apparatuses are arrangeable such that the detection regions overlap. The system also includes a data processing apparatus that is connectable via the monitoring network to the monitoring apparatuses for data transmission and that is designed to store points in time of detections of the transponder. The data processing apparatus can calculate time periods in which the transponder is located exclusively in one of the detection regions and/or to register sequences in which the monitoring apparatuses detect the transponder in the detection regions.
Humayun et al. US Publication 20100174415 A1 Sterile Surgical Tray
Humayun discloses a sterile surgical tray includes structure for receiving a plurality of surgical instruments. The sterile surgical tray also may include electrical input and output connectors attached to tray.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571)270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3682