DETAILED ACTION
Notice of Pre-AIA or AIA Status
In the present application, filed on or after March 16, 2013, claims 1-3, 5-11, 13-19, 21-24, and 26-28 have been considered and examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/11/2023 are in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by Examiner.
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 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 effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A). The rejections in this instant application are based on the English translation of JP H0599759 A) publication by computer.
As to claim 1, Schaff discloses a cold chain monitor comprising:
the containing material being located proximate to a heat sensitive material to be maintained in a determined temperature range (Schaff: [0019], [0022]-[0023], [0025], [0028], and FIG. 1 the biological sample tube 113: In order to maintain the biological sample in the sample tube 113 within a desired temperature range, generally cooler than an ambient temperature, one or more active or passive thermal management elements are used. Such elements may connect with ambient air to remove heat. One embodiment uses an air channel 106 for this purpose);
a sensor for measuring the heat property (Schaff: [0027], [0035], and FIG. 1 the electronic controller 116 comprising a temperature sensor) of the containing material (Schaff: [0027], [0035], and FIG. 1 the electronic controller 116 comprising a temperature sensor: The phase change material may occupy most of the volume of the centrifuge housing that is not occupied by other components. The electronic controller 116 may comprise a temperature sensor configured to monitor a temperature of the phase change material); and
a signal generator that provides a signal reflective of the heat property of the containing material as measured by the sensor and an electronic indication for indicating when the temperature of the heat sensitive product falls outside the determined temperature range (Schaff: [0030] and FIG. 1: The circuit board may monitor temperature and report if a threshold temperature has been crossed during shipment. For instance, logic on the circuit board 116 may report whether a temperature of 32° C. was exceeded. The upper or lower end of any temperature range discussed herein, or an average temperature, may also be reported. Such reporting may be via an internal or external visible indicator such as an LED, LCD or a passive material such as a fuse temperature sensitive chemical. Such reporting may be via an audible alarm. Such reporting may be via a wireless interface, such as Bluetooth, Wi-Fi or cellular).
Schaff does not explicitly disclose a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon.
However, it has been known in the art of monitoring conditions of heat sensitive material to implement a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon, as suggested by Minami, which discloses a carbon or silicon containing material having a heat transfer property variable with temperature (Minami: Abstract, [0003]-[0006], and FIG. 1: the temperature was gradually lowered from 27 ° C. to 17 ° C. while controlling the temperature with ice water, and the generated photoelectric flow rate was measured. The result is shown as a graph in FIG. As is clear from this graph, the logarithmic value of photoelectric flow shows good linearity in relation to temperature. Therefore, it can be seen that highly accurate temperature measurement can be performed in the temperature range of at least 15 to 30 ° C. by reading the photoelectric flow rat), and a sensor for measuring the heat transfer property of the carbon or silicon (Minami: Abstract, [0003]-[0006], and FIG. 1, and FIG. 3 the electrode 2: As the Fullerene, one single form of C60 and/or C70 can be used independently and also mixture of the both compounds can be used, as well. On a base plate 1 on which electrodes 2 are provided, a layer 3 of the Fullerene is formed to produce a temperature sensor).
Therefore, in view of Schaff and Minami, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff to include a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon, as suggested by Minami. The motivation for this is to implement a known alternative method/sensor system design to detect conditions of “biological” material via temperature sensing material.
As to claim 2, Schaff and Minami disclose the limitations of claim 1 further comprising the cold chain monitor of claim 1, wherein the heat transfer property is thermal conductivity or thermal conductance (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 3, Schaff and Minami disclose the limitations of claim 2 further comprising the cold chain monitor of claim 2, wherein the material is a carbon containing material being a member of a fullerene family of molecules (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 5, Schaff and Minami disclose the limitations of claim 3 further comprising the cold chain monitor of claim 3, wherein the member of the fullerene family of molecules is selected from an endohedral fullerene selected from the group consisting of C20, C60 and C70 fullerenes (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 6, Schaff and Minami disclose the limitations of claim 5 further comprising the cold chain monitor of claim 5, wherein a mixture of fullerenes is contained within the carbon containing material (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 7, Schaff and Minami disclose the limitations of claim 6 further comprising the cold chain monitor of claim 6, wherein the mixture of fullerenes includes C60 and C70 fullerenes (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 8, Schaff and Minami disclose the limitations of claim 5 further comprising the cold chain monitor of claim 5, wherein the endohedral fullerene is supported on a solid substrate (Minami: Abstract, [0003]-[0006], and FIG. 1-5 the insulating substrate 1: In the present invention, these C .sub.60 and C .sub.70 may be used alone or as a mixture of both. To manufacture a temperature sensor using these fullerenes, for example, a comb-shaped electrode is formed on a substrate of an electrically insulating material such as quartz or glass with a conductive material such as gold, platinum or copper, 2-1 fullerene over the entire surface).
As to claim 13, Schaff and Minami disclose the limitations of claim 7 further comprising the cold chain monitor of claim 7, wherein the carbon containing material is also used as a tracking indicator for the heat sensitive material (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A) and further in view of Yakura et al. (Yakura – US 5,466,614).
As to claim 9, Schaff and Minami disclose the limitations of claim 1 except for the claimed limitations of the cold chain monitor of claim 1, wherein the silicon containing material is a silica wafer.
However, it has been known in the art of temperature measurements to implement wherein the silicon containing material is a silica wafer, as suggested by Yakura, which discloses wherein the silicon containing material is a silica wafer (Yakura: Abstract, column 2 lines 10-22, column 2 lines 45-50, column 3 lines 25-56, and FIG. 3: One such application is in the periodic determination of temperature of a group or batch of silicon wafers which are being processed in the course of manufacture of semiconductor devices. In such a process, it is desirable to avoid actual contact with the silicon wafers in order to avoid possible contamination.).
Therefore, in view of teachings by Schaff, Minami, and Yakura, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the temperature sensing system of Schaff and Minami to include wherein the silicon containing material is a silica wafer, as suggested by Yakura. The motivation for this is to implement a known alternative method for remotely sensing temperature information and avoid contaminations of a material.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A) and further in view of Kun Xu (Xu – CN 109886381 A). The rejections in this instant application are based on the English translation of CN 109886381 A publication by computer.
As to claim 10, Schaff and Minami disclose the limitations of claim 2 further comprising the cold chain monitor of claim 2, wherein the heat sensitive material requiring to be stored and/or transported within the determined temperature range (Schaff: [0019], [0022]-[0023], [0025], [0028], and FIG. 1 the biological sample tube 113: In order to maintain the biological sample in the sample tube 113 within a desired temperature range, generally cooler than an ambient temperature, one or more active or passive thermal management elements are used. Such elements may connect with ambient air to remove heat. One embodiment uses an air channel 106 for this purpose), except for the claimed limitations of wherein the heat sensitive material includes a vaccine or other medicament requiring to be stored and/or transported within the determined temperature range.
However, it has been known in the art of handling biological material transportation to implement wherein the heat sensitive material includes a vaccine or other medicament requiring to be stored and/or transported within the determined temperature range, as suggested by Xu, which discloses wherein the heat sensitive material includes a vaccine or other medicament requiring to be stored and/or transported within the determined temperature range (Xu: Abstract, page 4 lines8-22, lines 31-37, page 5 lines 2-page 6 lines 13 and FIG. 1: It should be noted that, the RFID tags use the embodiment widely, not only can be applied to vaccine storage, transportation and storage and safe guarantee vaccine, further can be used for food, equipment, chemical industry, biological pharmacy industry, the application method is provided to the user in the form of product label use. The RFID tag of the embodiment, solves the problem in the existing technology cannot monitor temperature data in real time, has good temperature detecting function and adopts the ultrahigh frequency FRID technique. greatly increasing the reading distance warning reaction time, timely and accurately determine whether the temperature is within a predetermined range to ensure real-time adjusting transport environment, its cost is lower than other temperature label, can on the basis of realizing more functions avoid transportation process and environment caused by storage loss ).
Therefore, in view of teachings by Schaff, Minami, and Xu it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff and Minami to include wherein the heat sensitive material includes a vaccine or other medicament requiring to be stored and/or transported within the determined temperature range, as suggested by Xu. The motivation for this is to implement a known alternative method/sensor design to detect conditions of vaccine during transportation.
As to claim 11, Schaff, Minami, and Xu disclose the limitations of claim 10 further comprising the cold chain monitor of claim 10, configured to send a signal reflective of whether temperature of the heat sensitive material is within the determined temperature range (Schaff: [0030] and FIG. 1: The circuit board may monitor temperature and report if a threshold temperature has been crossed during shipment. For instance, logic on the circuit board 116 may report whether a temperature of 32° C. was exceeded. The upper or lower end of any temperature range discussed herein, or an average temperature, may also be reported. Such reporting may be via an internal or external visible indicator such as an LED, LCD or a passive material such as a fuse temperature sensitive chemical. Such reporting may be via an audible alarm. Such reporting may be via a wireless interface, such as Bluetooth, Wi-Fi or cellular and Xu: Abstract, page 2 lines 29-35, page 4 lines8-22, lines 31-37, page 5 lines 2-page 6 lines 13 and FIG. 1: In the embodiment of the invention, by using RFID wireless radio frequency technology, set a predetermined time interval periodically recording the measured temperature of the vaccine, and the temperature data is transmitted to the warehouse, distribution center, storage chamber and each node of the reader-writer, reader-writer sends the data set uploaded to a data center storing and processing to realize the whole temperature of the vaccine, real-time monitoring and early warning, while providing convenient inquiry means, to the consumer publishes safety traceability information of the product to the society).
Claims 14-18, 24, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A) and further in view of David Wearne (Wearne – WO 2019/157554 A1).
As to claim 14, Schaff and Minami disclose the limitations of claim 7 further comprising the cold chain monitor of claim 7, wherein the heat sensitive material is a biological material included within a portable therapeutic platform (Schaff: Abstract, [0019], [0022]-[0023], [0025], [0028], and FIG. 1 the biological sample tube 113: Embodiments for a portable and compact centrifugation and thermal management system capable of separating and transporting biological samples while maintaining sample quality for periods of shipment time are described) except for the claimed limitations of the heat sensitive material is a therapeutic item within a portable therapeutic platform comprising:
at least one therapeutic item required to conduct a therapeutic procedure; and
an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform.
However, it has been known in the art of handling biological material transportation to implement the heat sensitive material is a therapeutic item within a portable therapeutic platform comprising:
at least one therapeutic item required to conduct a therapeutic procedure; and
an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform, as suggested by Wearne, which discloses the heat sensitive material is a therapeutic item within a portable therapeutic platform (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], FIG. 1-3, and FIG. 5-8: a therapeutic procedural pack 10 for use in a therapeutic procedure suitable for administration of an injectable medicament or vaccine. The medicament could, for example, be insulin, for administration to insulin dependent diabetics. Procedural pack 10 includes the medical items necessary to conduct this therapeutic procedure ) comprising:
at least one therapeutic item required to conduct a therapeutic procedure (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025], FIG. 1-3, and FIG. 5-8: a therapeutic procedural pack 10 for use in a therapeutic procedure suitable for administration of an injectable medicament or vaccine. The medicament could, for example, be insulin, for administration to insulin dependent diabetics. Procedural pack 10 includes the medical items necessary to conduct this therapeutic procedure); and
an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform (Wearne: Abstract, [0008]-[0009], [0011], [0014], and FIG. 1-9: the platform, conveniently in the form of packs as alluded to above, may also include one, or a plurality of, analytic devices - such as microfluidic devices and associated integrated circuits - which allow analysis of items included within the pack or analysis of the environment surrounding and including the pack).
Therefore, in view of teachings by Schaff, Minami, and Wearne it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff and Minami to include the heat sensitive material is a therapeutic item within a portable therapeutic platform comprising:
at least one therapeutic item required to conduct a therapeutic procedure; and
an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform, as suggested by Wearne. The motivation for this is to implement a known alternative method/sensor design to detect conditions of a therapeutic item during transportation.
As to claim 15, Schaff discloses a system for managing use of a portable therapeutic platform for a therapeutic procedure comprising the steps of:
wherein a heat sensitive material is to be maintained in a determined temperature range and a temperature of the heat sensitive item is detected by a temperature detector (Schaff: [0027], [0035], and FIG. 1 the electronic controller 116 comprising a temperature sensor) for a heat sensitive product (Schaff: [0019], [0022]-[0023], [0025], [0028], and FIG. 1 the biological sample tube 113: In order to maintain the biological sample in the sample tube 113 within a desired temperature range, generally cooler than an ambient temperature, one or more active or passive thermal management elements are used. Such elements may connect with ambient air to remove heat. One embodiment uses an air channel 106 for this purpose) comprising:
the containing material being located proximate to the heat sensitive item ([0019], [0022]-[0023], [0025], [0028], and FIG. 1 the biological sample tube 113: In order to maintain the biological sample in the sample tube 113 within a desired temperature range, generally cooler than an ambient temperature, one or more active or passive thermal management elements are used. Such elements may connect with ambient air to remove heat. One embodiment uses an air channel 106 for this purpose);
a sensor for measuring the heat property (Schaff: [0027], [0035], and FIG. 1 the electronic controller 116 comprising a temperature sensor) of the carbon or silicon containing material (Schaff: [0027], [0035], and FIG. 1 the electronic controller 116 comprising a temperature sensor: The phase change material may occupy most of the volume of the centrifuge housing that is not occupied by other components. The electronic controller 116 may comprise a temperature sensor configured to monitor a temperature of the phase change material); and
a signal generator that provides a signal reflective of the measured heat property of the containing material as measured by the sensor and an electronic temperature indication for indicating when the heat sensitive therapeutic item falls outside the determined temperature range ([0030] and FIG. 1: The circuit board may monitor temperature and report if a threshold temperature has been crossed during shipment. For instance, logic on the circuit board 116 may report whether a temperature of 32° C. was exceeded. The upper or lower end of any temperature range discussed herein, or an average temperature, may also be reported. Such reporting may be via an internal or external visible indicator such as an LED, LCD or a passive material such as a fuse temperature sensitive chemical. Such reporting may be via an audible alarm. Such reporting may be via a wireless interface, such as Bluetooth, Wi-Fi or cellular).
Schaff does not explicitly disclose
the steps of:
providing at least one platform comprising at least one heat sensitive therapeutic item required to conduct the therapeutic procedure and an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform;
transferring information, including temperature information, about the environment surrounding and including at least one platform between the electronic communications device and a computer system including a processor which processes the information; and
initiating a control response to the processed information,
a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon.
However, it has been known in the art of monitoring conditions of heat sensitive material to implement a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon, as suggested by Minami, which discloses a carbon or silicon containing material having a heat transfer property variable with temperature (Minami: Abstract, [0003]-[0006], and FIG. 1: the temperature was gradually lowered from 27 ° C. to 17 ° C. while controlling the temperature with ice water, and the generated photoelectric flow rate was measured. The result is shown as a graph in FIG. As is clear from this graph, the logarithmic value of photoelectric flow shows good linearity in relation to temperature. Therefore, it can be seen that highly accurate temperature measurement can be performed in the temperature range of at least 15 to 30 ° C. by reading the photoelectric flow rat), and a sensor for measuring the heat transfer property of the carbon or silicon (Minami: Abstract, [0003]-[0006], and FIG. 1, and FIG. 3 the electrode 2: As the Fullerene, one single form of C60 and/or C70 can be used independently and also mixture of the both compounds can be used, as well. On a base plate 1 on which electrodes 2 are provided, a layer 3 of the Fullerene is formed to produce a temperature sensor).
Therefore, in view of Schaff and Minami, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff to include a carbon or silicon containing material having a heat transfer property variable with temperature, and a sensor for measuring the heat transfer property of the carbon or silicon, as suggested by Minami. The motivation for this is to implement a known alternative method/sensor design to detect conditions of “biological” material via temperature sensing material.
The combination of Schaff and Minami does not explicitly disclose the steps of:
providing at least one platform comprising at least one heat sensitive therapeutic item required to conduct the therapeutic procedure and an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform;
transferring information, including temperature information, about the environment surrounding and including at least one platform between the electronic communications device and a computer system including a processor which processes the information; and
initiating a control response to the processed information.
However, it has been known in the art of handling biological material transportation to implement the steps of:
providing at least one platform comprising at least one heat sensitive therapeutic item required to conduct the therapeutic procedure and an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform;
transferring information, including temperature information, about the environment surrounding and including at least one platform between the electronic communications device and a computer system including a processor which processes the information; and
initiating a control response to the processed information, as suggested by Wearne, which discloses the steps of:
providing at least one platform comprising at least one heat sensitive therapeutic item required to conduct the therapeutic procedure (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], FIG. 1-3, and FIG. 5-8: a therapeutic procedural pack 10 for use in a therapeutic procedure suitable for administration of an injectable medicament or vaccine. The medicament could, for example, be insulin, for administration to insulin dependent diabetics. Procedural pack 10 includes the medical items necessary to conduct this therapeutic procedure ) and an electronic communications device (Wearne: [0046] and FIG. 9: System 200 may involve use of a wireless communications network where the therapeutic procedural packs 10 include suitable electronic communications devices, such as included, for example, in laptops, smart devices or cell phones) for receiving and transmitting information about an environment surrounding and including the platform (Wearne: Abstract, [0008]-[0009], [0011], [0014], and FIG. 1-9: the platform, conveniently in the form of packs as alluded to above, may also include one, or a plurality of, analytic devices - such as microfluidic devices and associated integrated circuits - which allow analysis of items included within the pack or analysis of the environment surrounding and including the pack);
transferring information, including temperature information, about the environment surrounding and including at least one platform between the electronic communications device (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], [0042]-[0049], and FIG. 1-9: RFID tracking information providing locations of the therapeutic packs 10 may be communicated, in a manner known in the art of RFID systems, to a computer system 200 which controls the operation of system 100 through wireless communication channels 104. Computer system 200 may include a mainframe computer or system of mainframe computers as well as personal computing devices where needed. Other forms of computer may also be used, with parallel processing being adopted where required by the amount of data and processing required by the application for therapeutic packs 10. Multiple applications may be controlled by computer system 200) and a computer system including a processor which processes the information (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], [0042]-[0049], and FIG. 1-9: Where the procedural packs 10 include sensors, of the "lab on a chip" nature or microfluidic sensors, such sensors may identify possible threats and such information may also be conveyed through communication channels 104 to the computer system 200 and processed by processor 21 0 to develop a control response. One control response may involve modifying the production rate (indicated by arrow 310) of procedural packs 10 by manufacturing plant 300 producing procedural packs 1 0 by an injection moulding process in response to processor 210 analysis of the received sensor signals. Alternatively, where there are a number of manufacturing plants 300 in different geographical locations, production rate may be modified according to demand assigned to each of the manufacturing plants 300. Such control may be completely automated. Such statistical process control may be supplemented by use of machine learning techniques by processing of information by the processor to improve the manufacture and/or efficacy of deployment of therapeutic packs as described herein while minimising costs, however measured, of such deployment or, indeed, non-deployment); and
initiating a control response to the processed information (Wearne: [0011]-[0012], [0015], [0043]-[0044], [0048], and FIG. 1-9: The computer system may also initiate a control response in terms of modifying a step in a pack manufacturing process, as described below, so that packs include the necessary therapeutically effective item(s) to counter the threat. In one embodiment, the computer system could control a machine or manufacturing plant to produce packs customized to the identified threat.).
Therefore, in view of teachings by Schaff, Minami, and Wearne it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff and Minami to include the steps of:
providing at least one platform comprising at least one heat sensitive therapeutic item required to conduct the therapeutic procedure and an electronic communications device for receiving and transmitting information about an environment surrounding and including the platform;
transferring information, including temperature information, about the environment surrounding and including at least one platform between the electronic communications device and a computer system including a processor which processes the information; and
initiating a control response to the processed information, as suggested by Wearne. The motivation for this is to implement a known alternative method for managing supply of therapeutic items as needed.
As to claim 16, Schaff, Minami, and Wearne disclose the limitations of claim 15 further comprising the system of claim 15, wherein the platform comprises a therapeutic pack (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], FIG. 1-3, and FIG. 5-8: a therapeutic procedural pack 10 for use in a therapeutic procedure suitable for administration of an injectable medicament or vaccine. The medicament could, for example, be insulin, for administration to insulin dependent diabetics. Procedural pack 10 includes the medical items necessary to conduct this therapeutic procedure).
As to claim 17, Schaff, Minami, and Wearne discloses the limitations of claim 15 further comprising the system of claim 15, wherein the information about the environment, including temperature data is transferred directly or through an interface including an app (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], [0042]-[0049], and FIG. 1-9: RFID tracking information providing locations of the therapeutic packs 10 may be communicated, in a manner known in the art of RFID systems, to a computer system 200 which controls the operation of system 100 through wireless communication channels 104. Computer system 200 may include a mainframe computer or system of mainframe computers as well as personal computing devices where needed. Other forms of computer may also be used, with parallel processing being adopted where required by the amount of data and processing required by the application for therapeutic packs 10. Multiple applications may be controlled by computer system 200).
As to claim 18, Schaff, Minami, and Wearne discloses the limitations of claim 17 further comprising the system of claim 17, wherein the system enables tracking using a tracking indicator in a form of a member of an endohedral fullerene family of molecules (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 24, Schaff, Minami, and Wearne disclose the limitations of claim 15 further comprising the system of claim 15, wherein the information is processed by the processor and used to build a virtual or remote stockpile of therapeutic items (Wearne: Abstract, [0008]-[0009], [0014]-[0020], [0025]-[0026], [0042]-[0049], and FIG. 1-9: Where the procedural packs 10 include sensors, of the "lab on a chip" nature or microfluidic sensors, such sensors may identify possible threats and such information may also be conveyed through communication channels 104 to the computer system 200 and processed by processor 21 0 to develop a control response. One control response may involve modifying the production rate (indicated by arrow 310) of procedural packs 10 by manufacturing plant 300 producing procedural packs 1 0 by an injection moulding process in response to processor 210 analysis of the received sensor signals. Alternatively, where there are a number of manufacturing plants 300 in different geographical locations, production rate may be modified according to demand assigned to each of the manufacturing plants 300. Such control may be completely automated. Such statistical process control may be supplemented by use of machine learning techniques by processing of information by the processor to improve the manufacture and/or efficacy of deployment of therapeutic packs as described herein while minimising costs, however measured, of such deployment or, indeed, non-deployment).
As to claim 27, Schaff, Minami, and Wearne disclose the limitations of claim 15 further comprising the system of claim 15, comprising monitoring of temperature of a food or beverage during transport (Schaff: [0003], [0028], [0034], and [0040], Thermal moderating material 111 may comprise a phase change material. The phase change material may comprise water, an aqueous solution of hydrated salts, paraffins, vegetable oils, or blends of fatty acids. Phase change materials may absorb a heat of fusion when transitioning from a solid phase to a liquid phase at a melting point temperature, thereby providing a means of stabilizing ambient temperature in the vicinity of the melting point temperature. The phase change material will be selected such that the melting point temperature of the phase change material is near the upper value of an intended temperature range for the sample tube.).
As to claim 28, Schaff, Minami, and Wearne disclose the limitations of claim 27 further comprising the system of claim 27, wherein the food is olive oil and temperature information is used to control heating or cooling of olive oil to a predetermined temperature during transport (Schaff: [0003], [0028], [0034], and [0040]: in these cases, phase change material (PCM) such as water/ice, hydrated salts, paraffin waxes, and biological oils may be used to provide cooling or heating energy by the release or absorption of the thermal heat of fusion as appropriate in the vicinity of the temperature of the melting point of the PCM. Phase change materials may provide a thermal reserve against temperature change greater than passive materials relying solely on the thermal heat capacity, However, phase change materials may require active refrigeration or heating to achieve the desired phase state at the initial condition. For instance, a typical cold pack may require freezing by conventional refrigeration prior to its use in thermal regulation of packaged materials).
Claims 19 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A) and David Wearne (Wearne – WO 2019/157554 A1) and further in view of Meadow (Meadow – US 2018/0052218 A1).
As to claim 19, Schaff, Minami, and Wearne disclose the limitations of claim 18 except for the claimed limitations of the system of claim 18, wherein the endohedral fullerene is in a form of an atomic clock.
However, it has been known of sensing devices to implement wherein the endohedral fullerene is in a form of an atomic clock, as suggested by Meadow, which discloses wherein the endohedral fullerene is in a form of an atomic clock (Meadow: Abstract, [0047], [0095], [0375], and FIG. 1 the atomic clock 101: Miniature Atomic Clocks may be based, for example, upon Fullerene technology, including Buckyballs or other technology that utilizes electronic transition frequency as a frequency standard. The electronic transition frequency may include, for example microwave, ultraviolet, infrared or visual light spectrum wavelengths).
Therefore, in view of teachings by Schaff, Minami, Wearne, and Meadow it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff, Minami, and Wearne to include wherein the endohedral fullerene is in a form of an atomic clock, as suggested by Meadow. The motivation for this is to implement a known alternative method for providing timing information for location tracking.
As to claim 21, Schaff, Minami, Wearne, and Meadow disclose the limitations of claim 19 further comprising the system of claim 19, wherein the member of the endohedral fullerene family is selected from an endohedral fullerene selected from the group consisting of C20, C60 and C70 fullerenes (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 22, Schaff, Minami, Wearne, and Meadow disclose the limitations of claim 21 further comprising the system of claim 21, wherein the carbon containing material contains a mixture of fullerenes (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
As to claim 23, Schaff, Minami, Wearne, and Meadow disclose the limitations of claim 22 further comprising the system of claim 22, wherein the mixture of fullerenes includes C60 and C70 fullerenes (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: the present inventor has found that a carbon five-membered ring and a carbon six-membered ring are soccer balls or The photocurrent generated when irradiating light on a cage compound of 60 or 70 carbons, so-called fullerenes, which is formed by combining in a rugby ball shape, changes depending on the temperature, and between the photoelectric flow rate and the temperature).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Schaff et al. (Schaff – US 2022/0022449 A1) in view of Shinji Minami (Minami – JP H0599759 A) and David Wearne (Wearne – WO 2019/157554 A1) and further in view of Kun Xu (Xu – CN 109886381 A).
As to claim 26, Schaff, Minami, and Wearne disclose the limitations of claim 15 except for the claimed limitations of the system of claim 15, comprising monitoring of cold chain performance of vaccines and medicaments.
However, it has been known in the art of handling biological material transportation to implement monitoring of cold chain performance of vaccines and medicaments, as suggested by Xu, which discloses monitoring of cold chain performance of vaccines and medicaments (Xu: Abstract, page 4 lines8-22, lines 31-37, page 5 lines 2-page 6 lines 13 and FIG. 1: It should be noted that, the RFID tags use the embodiment widely, not only can be applied to vaccine storage, transportation and storage and safe guarantee vaccine, further can be used for food, equipment, chemical industry, biological pharmacy industry, the application method is provided to the user in the form of product label use. The RFID tag of the embodiment, solves the problem in the existing technology cannot monitor temperature data in real time, has good temperature detecting function and adopts the ultrahigh frequency FRID technique. greatly increasing the reading distance warning reaction time, timely and accurately determine whether the temperature is within a predetermined range to ensure real-time adjusting transport environment, its cost is lower than other temperature label, can on the basis of realizing more functions avoid transportation process and environment caused by storage loss ).
Therefore, in view of teachings by Schaff, Minami, and Xu it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the biological material container of Schaff and Minami to include monitoring of cold chain performance of vaccines and medicaments, as suggested by Xu. The motivation for this is to implement a known alternative method/sensor design to detect conditions of vaccine during transportation.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Kasai, US 2020/0173942 A1, discloses test wafer and method for manufacturing same.
Teixeira, US 2014/0275886 A1, discloses sensor fusion and probabilistic parameter estimation method and apparatus.
Kobayashi, US 2011/0028005 A1, discloses vertical boat for heat treatment and method for heat treatment of silicon wafer using the same.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANG PHAM whose telephone number is (571)-270-3668. The examiner can normally be reached on Monday - Thursday 9:30 AM - 5:00 PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, QUAN-ZHEN WANG can be reached on (571)-272-3114. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANG PHAM/Primary Examiner, Art Unit 2685