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, and 13-14 have been considered and examined under the first inventor to file provisions of the AIA .
Respond to Applicant’s Arguments/Remarks
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the rejection(s) of claims 1-3, 5-11, 13-19, 21-24, and 26-28 has been fully considered and the results as followings:
On page 5 of Applicant’s remarks, Applicant argues that the combination of Schaff and Minami does not teach the claimed invention because Minami discloses the temperature range of at least 15-30° C while the claimed invention the temperature range of lower than 8° C.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, as discussed in the Non-Final rejection mailed on 10/28/2025, the rejection relied upon Schaff to already disclose an apparatus to maintain temperature ranges of various materials during shipping including the temperature range of lower than 8° C (Schaff: [0002], [0018], [0030]-[0031], [0044], and FIG. 1: the embodiments described herein may include elements to provide thermal protection to a biological specimen for shipment. For example, an embodiment may be used to maintain a temperature range of between 2° C. to 8° C., between 15° C. to 30° C., between 11° C. to 32° C., between 15° C. to 8° C. and 32° C., below 0° C., and below −10° C., in a biological, regardless of external temperature and other conditions. Embodiments may be configured to provide thermal protection of samples for specific periods of time. For example, maximum time periods in the range of 12 to 36 hours, 24 to 72 hours, 24 hours or less, 48 hours or less, or one week or less… The circuit board may monitor temperature and report if a threshold temperature has been crossed during shipment).
Thus, the combination of Schaff and Minami reads on the limitations of the temperature range of lower than 8° C.
On page 5 of Applicant’s remarks, Applicant argues that Minami does not teach the limitations of thermal conductivity or thermal conductance because photocurrent generation is not the same as “thermal conductivity or thermal conductance.”
Examiner respectfully disagrees with Applicant because as in Minami explicitly disclose a correlation between the photoelectric flow rate and the temperature of the temperature sensing material (Minami: Abstract, [0003]-[0006], and FIG. 1, FIG. 3 the electrode 2 and FIG. 5: The present invention provides a temperature measuring method, characterized in that a required temperature is obtained by comparing the above-mentioned correlation data with a correlation data between a photoelectric flow rate and temperature). Thus, Minami’s teachings read on of the limitations of thermal conductivity or thermal conductance.
As a result, Applicant arguments are not deemed persuasive, and the previous rejections pertaining to the previous set of claims are sustained. Therefore, due to the claimed amendments, upon further consideration, a new ground of rejections necessitated by amendments is made in view of following reference/combinations.
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 and 5-8 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) lower than 8℃ (Schaff: [0002], [0018], [0030]-[0031], [0044], and FIG. 1: the embodiments described herein may include elements to provide thermal protection to a biological specimen for shipment. For example, an embodiment may be used to maintain a temperature range of between 2° C. to 8° C., between 15° C. to 30° C., between 11° C. to 32° C., between 15° C. to 8° C. and 32° C., below 0° C., and below −10° C., in a biological, regardless of external temperature and other conditions. Embodiments may be configured to provide thermal protection of samples for specific periods of time. For example, maximum time periods in the range of 12 to 36 hours, 24 to 72 hours, 24 hours or less, 48 hours or less, or one week or less);
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) lower than 8℃ (Schaff: [0002], [0018], [0030]-[0031], [0044], and FIG. 1: the embodiments described herein may include elements to provide thermal protection to a biological specimen for shipment. For example, an embodiment may be used to maintain a temperature range of between 2° C. to 8° C., between 15° C. to 30° C., between 11° C. to 32° C., between 15° C. to 8° C. and 32° C., below 0° C., and below −10° C., in a biological, regardless of external temperature and other conditions. Embodiments may be configured to provide thermal protection of samples for specific periods of time. For example, maximum time periods in the range of 12 to 36 hours, 24 to 72 hours, 24 hours or less, 48 hours or less, or one week or less… The circuit board may monitor temperature and report if a threshold temperature has been crossed during shipment).
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).
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 includes a vaccine or other medicament 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).
Claim 13 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 Meadow (Meadow – US 2018/0052218 A1).
As to claim 13, Schaff and Minami disclose the limitations of claim 7 except for the claimed limitations of the cold chain monitor of claim 7, wherein the carbon containing material is also used as a location tracking indicator for the heat sensitive material.
However, it has been known of sensing devices to implement wherein the carbon containing material is also used as a location tracking indicator for the heat sensitive material, as suggested by Meadow, which discloses wherein the carbon containing material is also used as a location tracking indicator for the heat sensitive material (Meadow: Abstract, [0107], [0109]-[0110], [0135], [0144], [0212], [0217]-[0218], and FIG. 5: The storage may include a list of known reference points that may be used in trilateration. Reference Points that may be utilized by logic being executed by the GRL Device 100 may include one or more generally fixed locations, such as, by way of example: cellular service tower, FM Broadcast Tower, Wi-Fi Hotspot with fixed location, Repeaters or GRLEAS Broadcasters. In addition, in some implementations, a GRL System will determine a location based upon relative location to generally non-fixed location devices, such as, for example, one or more of: a Wi-Fi Hotspot with non-fixed locations, GRLE Smartphones, GRLE Wi-Fi Routers, GRLE Near Field Communications devices etc. In some aspects, a GRL Device may comprise full bi-directional communication components, such as a Transmitter 106 in addition to the Receiver 105. In some embodiments, intercommunication may occur between multiple GRL Devices and act as relays of data contained in their respective Data Storage 108 capacities).
Therefore, in view of teachings by Schaff, Minami, 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 and Minami, to include wherein the carbon containing material is also used as a location tracking indicator for the heat sensitive material, as suggested by Meadow. The motivation for this is to implement a known alternative method for providing information for location tracking.
Claim 14 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 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 a therapeutic item 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.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Castonzo, US 2019/0364398 A1, discloses vaccine monitoring system.
Brynjulfsson et al., US 2016/0116310 A1, discloses smart wireless loggers.
Teixeira, US 2014/0275886 A1, discloses sensor fusion and probabilistic parameter estimation method and apparatus.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. 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 extension fee 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 QUANG PHAM whose telephone number is (571)-270-3668. The examiner can normally be reached 09:00 AM - 05:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, QUAN-ZHEN WANG can be reached at (571)-272-3114. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUANG PHAM/Primary Examiner, Art Unit 2685
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