DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/3/25 has been entered.
Claim Status
Claims 17, 18, 19, 21, 22, 24, 25, 26, 27, 37, 38, 39, 40, and 41 are pending and are examined. Claims 28, 29, 30, 31, 32, 33, 34, 35, and 36 are withdrawn and are not examined. Claims 1-16, 20, and 23 are cancelled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17, 18, 19, 21, 24, 25, 26, 27, 37, 38, 39, 40, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Norman (US Pub 2008/0093357; previously cited), in view of Ang (US Pub 2012/0063973).
Regarding Claim 17, Norman teaches an overwrap bag to be placed in a thawing system to monitor the temperature of a biological substance in a container during a thawing process of the biological substance by the thawing system, (see Fig. 13, bag 16 which is wrapped over a container 18. ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula. The examiner notes a temperature sensor with a RFID tag which would be used for monitoring during a thawing process since the temperature would be changing during a thawing process. The examiner also notes that “the limitation in the preamble beginning with “to be placed in a thawing system…. by the thawing system” is directed to intended use of the device),
the overwrap bag comprising:
a soft body (bag 16 has a soft body) defining an interior volume (there is an interior volume where the container 18 is held) configured to receive a container enclosing the biological substance to be thawed (“configured to” is a capability. The bag would be capable of receiving a container enclosing a biological substance to be thawed);
an opening (opening is at the top of the bag and the ziplock would be in the opened state.) configured to allow transfer of the container enclosing the biological substance to and from the interior volume (contents would be capable of being transferred when the bag is opened);
an RFID tag communicatively coupled to the sensor to communicate data associated with the temperature of the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula.).
Although Norman teaches RFID device 130 and [0049] One such RFID tag or RFID device 130 for inclusion with the breast milk or formula or for attachment to the wall of the container 18 is the Log-ice Temperature Tracker which is produced by Intelligent Devices, Inc., of Suwanee, Ga. The Log-ic device allows temperature monitoring over time and weighs less than 1 oz. The size of the Log-ic device is approximately 2 inches square with a thickness of about 0.1 inches. The Log-ic is a flexible RFID sensor tag capable of processing up to 64,000 temperature readings. It can be calibrated for a temperature sensitivity of from .+-.0.1 to .+-.1.degree. Celsius. The device is available both as single use disposable device as well as re-usable versions, Norman is silent to a temperature sensor coupled to an interior facing wall of the soft bag body and configured to be in direct contact with an exterior surface of the container within the interior volume, to measure the temperature of the exterior surface of the container through the direct contact with the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system.
Regarding the arrangement of the sensor coupled to an interior facing wall of the soft bag body, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04VIC.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have re-arranged the temperature sensor in the device of Norman to be coupled to an interior facing wall of the soft bag body to allow for the sensor to be reusable when it is arranged on the bag instead of when it is on the sample container.
Modified Norman is silent to a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor coupled to and disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer.
Ang teaches in the related art of a fluid bag. [0171] The electrical heating layer arrangement 122 may further include a thermal insulation and electrical insulation layer 144 arranged in contact with the layer of the electrically conductive strip 124 and the exterior surface 150 of one of the two flexible main walls 106 of the bag 102. [0176] FIG. 10E shows an electrical heating layer arrangement 122 attached on a flexible fluid storage and warming bag 102. The electrical heating layer arrangement 122 as shown in may include a thermal conduction and electrical insulation layer 148 arranged in contact with the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 and the layer of the electrically conductive strip 124 arranged on the thermal conduction and electrical insulation layer 148. The electrical heating layer arrangement 122 may further include a thermal insulation layer 172 arranged on a side of the layer of the electrically conductive strip 124 being remote from the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 to which the electrical heating layer arrangement 122 is attached.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor coupled to disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer, as taught by Ang, in the device of modified Norman, to avoid too much heat.
Regarding Claim 18, modified Norman teaches the overwrap bag of claim 17, wherein the RFID tag is facing in a direction opposite to the sensor ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula. [0048] Referring to FIG. 13, a radio frequency identification device (RFID) 130 having a temperature tracking or monitoring capability is shown included within the breast milk or formula in container 18.).
Regarding Claim 19, modified Norman teaches the overwrap bag of claim 17, wherein the sensor and the RFID tag are integrated into an electronic device, and the electronic device is coupled to the interior facing wall of the soft body ([0049] One such RFID tag or RFID device 130).
Regarding Claim 21, modified Norman teaches the overwrap bag of claim 17.
Norman is silent to wherein the heat-nonconductive layer configured to inhibit thermal communication between the temperature sensor and an exterior surface of the overwrap bag.
Ang teaches [0031] In an embodiment, the flexible fluid storage and warming bag may be a bag for storing blood, for example, a so-called blood bag. The bag may also be used for storing any other fluids, for example, saline solution, dialysis solution, bone marrow or any other suitable bodily fluids. The fluid may be stored in a liquid state or in a solid state (for example frozen blood) in the bag. [0170] FIG. 10A shows an electrical heating layer arrangement 122 attached on a flexible fluid storage and warming bag 102. The direction of the heat from the electrically conductive strip 124 onto the bag 102 may be as shown by the arrow. The electrical heating layer arrangement 122 includes a layer of electrically conductive strip 124 attached on an exterior surface 150 of one of the two flexible main walls 106 of the bag 102. The layer of the electrically conductive strip 124 may be printed directly on the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 or may be deposited or disposed on the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 by other suitable means. The layer of the electrically conductive strip 124 may include a material selected from a group consisting of a silver-based conductive ink, copper-based conductive ink, conductive polymer ink, and carbon-based resistive ink for example. [0171] The electrical heating layer arrangement 122 may further include a thermal insulation and electrical insulation layer 144 arranged in contact with the layer of the electrically conductive strip 124 and the exterior surface 150 of one of the two flexible main walls 106 of the bag 102.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a non-conductive layer (insulation layer), as taught by Ang, to the bag of Norman, in order to minimize thermal leakage to the environment and to improve heating rate. The electrical insulation layer is to prevent electrical short circuit, as taught by Ang, in [0053].
Regarding Claim 22, modified Norman teaches the overwrap bag of claim 17, wherein the container enclosing the biological substance is a bag (the examiner notes that the container is not positively recited in claim 17. The container would be capable of being a bag).
Regarding Claim 24, modified Norman teaches the overwrap bag of claim 17.
Norman is silent to the soft body is composed of a material having high thermal conductivity.
Ang teaches [0031] In an embodiment, the flexible fluid storage and warming bag may be a bag for storing blood, for example, a so-called blood bag. The bag may also be used for storing any other fluids, for example, saline solution, dialysis solution, bone marrow or any other suitable bodily fluids. The fluid may be stored in a liquid state or in a solid state (for example frozen blood) in the bag. [0170] FIG. 10A shows an electrical heating layer arrangement 122 attached on a flexible fluid storage and warming bag 102. The direction of the heat from the electrically conductive strip 124 onto the bag 102 may be as shown by the arrow. The electrical heating layer arrangement 122 includes a layer of electrically conductive strip 124 attached on an exterior surface 150 of one of the two flexible main walls 106 of the bag 102. The layer of the electrically conductive strip 124 may be printed directly on the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 or may be deposited or disposed on the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 by other suitable means. The layer of the electrically conductive strip 124 may include a material selected from a group consisting of a silver-based conductive ink, copper-based conductive ink, conductive polymer ink, and carbon-based resistive ink for example. [0171] The electrical heating layer arrangement 122 may further include a thermal insulation and electrical insulation layer 144 arranged in contact with the layer of the electrically conductive strip 124 and the exterior surface 150 of one of the two flexible main walls 106 of the bag 102.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bag of Norman by adding a material having high thermal conductivity, as taught by Ang, in order to allow for an electrical heating layer for thawing, [0168].
Regarding Claim 25, modified Norman teaches the overwrap bag of claim 17, wherein the interior volume is sized to receive a container having a volume of 250 milliliters to 500 milliliters (the interior volume is capable of receiving a volume of 250ml-500ml).
Regarding Claim 26, modified Norman teaches the overwrap bag of claim 17, wherein the opening of the overwrap bag is reversibly sealable (see Fig. 13 for ziplock for the bag, and a ziplock is reversibly sealable).
Regarding Claim 27, modified Norman teaches the overwrap bag of claim 17 further comprising an engaging mechanism at the opening (see Fig. 13 for ziplock for the bag).
Regarding Claim 37, modified Norman teaches the overwrap bag of claim 24, wherein the material of the soft body is for monitoring the biological substance in ambient temperatures between -196°C and 40° C (the material would be capable of monitoring the biological substance at ambient temperatures between -196°C and 40° C).
Regarding Claim 38, modified Norman teaches the overwrap of claim 27, wherein the engaging mechanism is a ziplock (see Fig. 13 for ziplock for the bag).
Regarding Claim 39, modified Norman teaches the overwrap bag of claim 24, wherein the material comprises plastic (Fig, 13, the bag is plastic).
Regarding Claim 40, modified Norman teaches an overwrap bag to be placed in a thawing system to monitor the temperature of a biological substance in a container during a thawing process of the biological substance by the thawing system, (see Fig. 13, bag 16 which is wrapped over a container 18. ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula. The examiner notes a temperature sensor with a RFID tag which would be used for monitoring during a thawing process since the temperature would be changing during a thawing process. The examiner also notes that “the limitation in the preamble beginning with “to be placed in a thawing system…. by the thawing system” is directed to intended use of the device),
the overwrap bag comprising:
a soft body (bag 16 has a soft body) defining an interior volume (there is an interior volume where the container 18 is held) configured to receive a container enclosing the biological substance to be thawed (“configured to” is a capability. The bag would be capable of receiving a container enclosing a biological substance to be thawed);
an opening (opening is at the top of the bag and the ziplock would be in the opened state.) configured to allow transfer of the container enclosing the biological substance to and from the interior volume (contents would be capable of being transferred when the bag is opened);
an RFID tag communicatively coupled to the sensor to communicate data associated with the temperature of the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula.).
wherein the thawing system is to thaw the biological substance by heating the temperature of the biological substance from -40° C based on the temperature measured by the temperature sensor (the examiner notes the thawing system is directed to intended use of the device. The thawing system is disclosed in the preamble and as in “to be placed in a thawing system” and therefore the thawing system is not required as part of the claimed overwrap bag. Further, the overwrap bag is capable of being placed in a thawing system.).
Although Norman teaches RFID device 130 and [0049] One such RFID tag or RFID device 130 for inclusion with the breast milk or formula or for attachment to the wall of the container 18 is the Log-ice Temperature Tracker which is produced by Intelligent Devices, Inc., of Suwanee, Ga. The Log-ic device allows temperature monitoring over time and weighs less than 1 oz. The size of the Log-ic device is approximately 2 inches square with a thickness of about 0.1 inches. The Log-ic is a flexible RFID sensor tag capable of processing up to 64,000 temperature readings. It can be calibrated for a temperature sensitivity of from .+-.0.1 to .+-.1.degree. Celsius. The device is available both as single use disposable device as well as re-usable versions, Norman is silent to a temperature sensor coupled to an interior facing wall of the soft bag body and configured to be in direct contact with an exterior surface of the container within the interior volume, to measure the temperature of the exterior surface of the container through the direct contact with the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system.
Regarding the arrangement of the sensor coupled to an interior facing wall of the soft bag body, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04VIC.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have re-arranged the temperature sensor in the device of Norman to be coupled to an interior facing wall of the soft bag body to allow for the sensor to be reusable when it is arranged on the bag instead of when it is on the sample container.
Modified Norman is silent to a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor coupled to disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer within the portion.
Ang teaches in the related art of a fluid bag. [0171] The electrical heating layer arrangement 122 may further include a thermal insulation and electrical insulation layer 144 arranged in contact with the layer of the electrically conductive strip 124 and the exterior surface 150 of one of the two flexible main walls 106 of the bag 102. [0176] FIG. 10E shows an electrical heating layer arrangement 122 attached on a flexible fluid storage and warming bag 102. The electrical heating layer arrangement 122 as shown in may include a thermal conduction and electrical insulation layer 148 arranged in contact with the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 and the layer of the electrically conductive strip 124 arranged on the thermal conduction and electrical insulation layer 148. The electrical heating layer arrangement 122 may further include a thermal insulation layer 172 arranged on a side of the layer of the electrically conductive strip 124 being remote from the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 to which the electrical heating layer arrangement 122 is attached.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor coupled to disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer, as taught by Ang, in the device of modified Norman, to avoid too much heat.
Regarding Claim 41, modified Norman teaches an overwrap bag to be placed in a thawing system to monitor the temperature of a biological substance in a container during a thawing process of the biological substance by the thawing system, (see Fig. 13, bag 16 which is wrapped over a container 18. ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula. The examiner notes a temperature sensor with a RFID tag which would be used for monitoring during a thawing process since the temperature would be changing during a thawing process. The examiner also notes that “the limitation in the preamble beginning with “to be placed in a thawing system…. by the thawing system” is directed to intended use of the device),
the overwrap bag comprising:
a soft body (bag 16 has a soft body) defining an interior volume (there is an interior volume where the container 18 is held) configured to receive a container enclosing the biological substance to be thawed (“configured to” is a capability. The bag would be capable of receiving a container enclosing a biological substance to be thawed);
an opening (opening is at the top of the bag and the ziplock would be in the opened state.) configured to allow transfer of the container enclosing the biological substance to and from the interior volume (contents would be capable of being transferred when the bag is opened);
an RFID tag communicatively coupled to the sensor to communicate data associated with the temperature of the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system ([0026] Fig. 13 shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula.).
wherein the thawing system is to thaw the biological substance by heating the temperature of the biological substance from -40° C to 36.6oC within 10 minutes based on the temperature measured by the temperature sensor (the examiner notes the thawing system is directed to intended use of the device. The thawing system is disclosed in the preamble in “to be placed in a thawing system” and therefore the thawing system is not required as part of the claimed overwrap bag. Further, the overwrap bag is capable of being placed in a thawing system.).
Although Norman teaches RFID device 130 and [0049] One such RFID tag or RFID device 130 for inclusion with the breast milk or formula or for attachment to the wall of the container 18 is the Log-ice Temperature Tracker which is produced by Intelligent Devices, Inc., of Suwanee, Ga. The Log-ic device allows temperature monitoring over time and weighs less than 1 oz. The size of the Log-ic device is approximately 2 inches square with a thickness of about 0.1 inches. The Log-ic is a flexible RFID sensor tag capable of processing up to 64,000 temperature readings. It can be calibrated for a temperature sensitivity of from .+-.0.1 to .+-.1.degree. Celsius. The device is available both as single use disposable device as well as re-usable versions, Norman is silent to a temperature sensor coupled to an interior facing wall of the soft bag body and configured to be in direct contact with an exterior surface of the container within the interior volume, to measure the temperature of the exterior surface of the container through the direct contact with the exterior surface for a period of time during the thawing process of the biological substance being thawed by the thawing system.
Regarding the arrangement of the sensor coupled to an interior facing wall of the soft bag body, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04VIC.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have re-arranged the temperature sensor in the modified device of Norman to be coupled to an interior facing wall of the soft bag body to allow for the sensor to be reusable when it is arranged on the bag instead of when it is on the sample container.
Ang teaches in the related art of a fluid bag. [0171] The electrical heating layer arrangement 122 may further include a thermal insulation and electrical insulation layer 144 arranged in contact with the layer of the electrically conductive strip 124 and the exterior surface 150 of one of the two flexible main walls 106 of the bag 102. [0176] FIG. 10E shows an electrical heating layer arrangement 122 attached on a flexible fluid storage and warming bag 102. The electrical heating layer arrangement 122 as shown in may include a thermal conduction and electrical insulation layer 148 arranged in contact with the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 and the layer of the electrically conductive strip 124 arranged on the thermal conduction and electrical insulation layer 148. The electrical heating layer arrangement 122 may further include a thermal insulation layer 172 arranged on a side of the layer of the electrically conductive strip 124 being remote from the exterior surface 150 of one of the two flexible main walls 106 of the bag 102 to which the electrical heating layer arrangement 122 is attached.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor coupled to disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer, as taught by Ang, in the device of modified Norman, to avoid too much heat.
Response to Arguments
Applicant's arguments filed 9/3/25 have been fully considered but they are not persuasive.
First, Applicant argues on pages 7 and 8 that the prior art of Norman and Ang does not teach or suggest the amended claim “a heat-nonconductive layer disposed within an area of the soft body; a temperature sensor disposed on an interior facing wall of the soft bag body and on the heat-nonconductive layer.”
In response, the examiner notes that the prior art of Ang teaches an insulating layer. The insulation layer meets the limitation of a heat-nonconductive layer. [0176] In Fig. 10E, the electrical heating layer arrangement 122 as shown in may include a thermal conduction and electrical insulation layer 148 arranged in contact with the exterior surface 150 of one of the two flexible main walls 106 of the bag 102. Therefore, the prior art is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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/JB/
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798