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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 26, 2025, has been entered.
DETAILED ACTION
The claims filed on September 26, 2025, have been acknowledged. Claims 1 and 15 were amended. Claims 1-20 are pending and examined on the merits.
Priority
The applicant claims domestic priority from U.S. provisional applications No. 63/339,091 and 63/339,087, filed on May 6, 2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-20 receive domestic benefit from U.S. provisional applications No. 63/339,091 and 63/339,087, filed on May 6, 2022.
Information Disclosure Statement
The information disclosure statement filed September 26, 2025, has been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially parallel” in claim 15 is a relative term which renders the claim indefinite. The term “substantially parallel” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what constitutes substantially parallel and what level of parallelness would fall within the limitations of the claim. For example, it is not clear whether 100% parallelness is required or whether 90% would be sufficient to fall within the claim limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the 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 1-8, 10, 12-13, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over LUNGguard Paragonix Brochure (2021, Provided in Applicant’s IDS as in public use, on sale, or otherwise available to the public before May 6, 2021) in view of United States Patent Application No. 2016/0347532 (McCormick), United States Patent Application No. 2016/0362240 (Ferracamo), United States Patent No. 8,152,367 (Roberts), and United States Patent No. 9,910,000 (Lynam), and United States Patent Application No. 2018/0352807 (Judson). This is a new rejection substantially similar to a previous rejection made in response to Applicant’s amendments to claims 1 and 15. Any aspect of Applicant’s traversal that is relevant to the rejection as newly written is addressed below.
LUNGguard teaches a method of cooling an organ (such as a lung) comprising an organ storage chamber with a floor and walls (page 7, whole device).
Positioning cooling media on the floor (page 7, packets below the lungs)
Positioning an organ support surface above the cooling media (page 7, support surface sitting on ridge of device between the lungs above and the cooling media below).
LUNGguard shows that the support surface has an insulating layer above the cooling media (page 8, device deconstruction).
LUNGguard teaches that there are 4 temperature probes recording the temperature of the lungs (page 10, temp data from 4 probes).
LUNGguard shows lungs positioned on the organ support surface (page 7, device).
LUNGguard shows temperature readings measured over 40 hours using 4 temperature probes (page 10, temp data from 4 probes).
LUNGguard is silent as to the steps of positioning each layer in the device.
However, McCormick teaches a 10 step process for preparing a cold storage device to cool a payload. The relevant steps are steps 5-9:
Step 5-Place the payload into the volume of the payload container;
Step 6-Remove the top and bottom cold packs from the freezer;
Step 7-Place the bottom cold pack into the insulated storage container;
Step 8-Place the payload container into the insulated storage container on top of the bottom cold pack;
Step 9-Place the top cold pack into the insulated storage container on top of the payload container (paragraphs 0033-0043).
As such, it would have been obvious that one of ordinary skill in the art would have to position each component into the device before cooling of the tissue can occur.
Specifically, since the lower cooling media is below the organ, it would have been obvious to place this first; and since the upper cooling media is above the organ, it would have been obvious to place this last.
LUNGguard teaches that the temperature probe is in the insulating layer (page 8, deconstruction, line from temperature probe information is directed to the insulating layer). LUNGguard does not teach wherein there is a core layer above the insulating layer and wherein the core layer comprises a recess.
However, Ferracamo teaches an assembly for holding PCM materials. Each assembly 202, 204 may include a center piece 220, 230 having an inner face and an outer face, a front panel 222, 232 configured to cover the inner face, and a back panel 224, 234 configured to cover the outer face. The center piece 220, 230 may include a plurality of spacers and/or dividers that extend outwards from the surface of the center piece 220, 230. As shown in FIGS. 2B-C, a plurality of spacers and/or dividers can serve to create vertical and/or horizontal channels on the surface of the center piece 220, 230. A channel may be a recessed portion of the surface of a piece or panel that may be capable of receiving an object or providing a space for air to freely pass. The assemblies 202, 204 are capable of receiving PCM containers (such as sleeves or bottles) in a space between the surface of a center piece 220, 230 and the respective panel 222, 224, 232, 234 (paragraph 0044). As can be seen I figures 2B-C, the panels include openings (the recess of claim 1 is considered to include cutouts/openings as Figure 3 of the instant application identifies layer 403 as including a recess or cutout for the insulator plug 407 to go through as shown by the line from 407 to layer 405 in Figure 3). The core layer (the panels of Ferracamo) would be above and below the insulation layer (the center piece of Ferracamo).
Roberts teaches an insulated container having a temperature monitoring device comprising a temperature sensor (abstract). The temperature sensor 28 is positioned in a temperature monitoring relationship with the interior space 18 of the container so that the storage temperature of object 36 can be measured (column 5, lines 15-36). The sensor is accommodated in the interior space through an opening in a housing member (see Figures 1-5 and column 6, lines 46-64). In some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored (column 5, lines 37-51).
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 method for cooling a biological material of LUNGguard and McCormick by using the PCM assembly that comprises recesses, as identified by Ferracamo, to accommodate a temperature probe in the payload volume, as identified by Roberts, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because LUNGguard is silent on how the temperature probe is accommodated to measure the temperature of the payload volume. In order for the probe to enter the payload volume, it would have to enter through some part of the housing of the container. Ferracamo teaches an assembly for holding PCM materials comprising a plurality of spacers and/or dividers that extend outwards from the surface of the center piece to create vertical and/or horizontal channels on the surface of the center piece that may be capable of receiving an object. As such, it would have been obvious that this design could be used to insert a thermal probe into the payload volume for measuring the temperature in the payload container/the biological sample. As further evidence, Roberts reduces to practice that temperature sensors can be accommodated in housing members to examine the temperature in the payload volume. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
LUNGguard teaches that the temperature probe is in the insulating layer (page 8, deconstruction, line from temperature probe information is directed to the insulating layer) but is silent as to how the temperature probes for the lungs are situated in the device.
Roberts teaches an insulated container having a temperature monitoring device comprising a temperature sensor (abstract). The temperature sensor 28 is positioned in a temperature monitoring relationship with the interior space 18 of the container so that the storage temperature of object 36 can be measured (column 5, lines 15-36). The sensor is accommodated in the interior space through an opening in a housing member (see Figures 1-5 and column 6, lines 46-64). In some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored (column 5, lines 37-51). The recess of claim 1 is considered to include cutouts/openings as Figure 3 of the instant application identifies layer 403 as including a recess or cutout for the insulator plug 407 to go through as shown by the line from 407 to layer 405 in Figure 3.
Lynam teaches that using a thermally insulating body for a thermistor (a temperature sensor) and a plug of thermally insulating material that is in contact with the thermistor leads at its base, see column 7, line 40-column, line 17, & Fig. 8, #122) that prevents the temperature reading from being affected by external factors. Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly (column 7, lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen to include a recess for a temperature probe with an insulator plug, as identified by Roberts and Lynam, in the method for cooling a lung of LUNGguard to accommodate a temperature probe in the payload volume to measure the temperature of the lung to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to choose this method with a reasonable expectation of success because Roberts has successfully reduced to practice that a temperature probe can be positioned within a recess to measure the temperature of an object within an insulated container. Furthermore, Lynam teaches that using the thermally insulating body and plug prevents the temperature reading from being affected by external factors (such as the PCM of McCormick). Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly.
Furthermore, Lynam teaches that their temperature sensor assembly can be placed within a hollow sensor housing assembly (column 3, lines 62-66 and column 7, lines 40-50). As the thermally insulating body would be going through the recess with the temperature sensor, it would act as an insulator plug within the recess. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
LUNGguard does not teach a cushion layer.
However, Judson teaches that contoured storage and transport chambers that can replicate the in vivo anatomical orientation and geometry for a given organ avoid damaging the organ which can result in decreased organ viability and decreased survival rates for transplant recipients. For example, a pair of donor lungs may be placed against a smooth, raised, central saddle (a cushion layer) designed to replicate the spine that the lungs would be resting against in vivo (paragraph 0038 and Figure 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the thermal storage container and temperature probe of McCormick, Ferracamo, Roberts, and Lynam with the contoured layer to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Judson teaches that contoured layers help avoid tissue damage which can decrease tissue viability and survival rates for transplant recipients. Furthermore, the cushion layer would include a opening for the temperature probe in the insulating body (an insulator plug) as Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored. As such, the probe would need to be close to the temperature sensitive tissue to ensure it gets accurate temperature readings of the tissue (i.e. it would need to go through the cushion layer to ensure it is near the tissue and to get accurate readings of the tissue). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
As stated supra, the temperature probe of the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson would be within the opening of the cushion layer on the insulator plug.
Regarding wherein the opening is aligned with a center axis of the cushion layer, Roberts, as stated supra, teaches that the sensor is accommodated in the interior space through an opening in a housing member (see Figure 5 and column 6, lines 46-64). As can be seen in figure 5 (shown below), the opening can be aligned along an axis of a layer of the housing above the temperature sensor.
PNG
media_image1.png
378
394
media_image1.png
Greyscale
Annotated Figure 5 of Roberts
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed the opening aligned with a center along an axis of the cushion layer, as identified by Roberts, in the method for cooling a lung of LUNGguard to accommodate a temperature probe in the payload volume to measure the temperature of the lung to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to choose this method with a reasonable expectation of success because Roberts has successfully reduced to practice that a temperature probe can be positioned within an opening aligned with a center along an axis in their insulated device and Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored. Therefore, it would have been obvious to one of ordinary skill in the art that a different insulating container could also include an opening aligned with a center along an axis of the cushion layer to accommodate a temperature probe in the payload volume to directly measure the temperature of the lung to ensure an accurate temperature reading of the lung. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claims 2 and 17, LUNGguard shows a second set of cooling media on a support surface above the lungs (page 7, packets on a support surface above the lungs).
Regarding claim 3, LUNGguard teaches that lungs are in a bag (page 8)
Regarding claim 4, LUNGguard teaches that the organ support surface is suspended above the cooling media on the floor by sitting on a ridge of the storage chamber (page 7, device).
Regarding claims 5 and 18, LUNGguard teaches that the cooling media support surface is suspended above the lungs by sitting on a ridge of the storage chamber (page 7, device).
Regarding claim 6, LUNGguard shows that there is a movable lid coupled to the walls (pages 7-8).
Regarding claims 7-8 and 19, LUNGguard is silent as to what cooling media they used. McCormick teaches that they used phase change materials as a coolant and to maintain the temperature within the payload container (paragraphs 0028 and 0033-0043). As such, it would have been obvious that PCMs could be used as the cooling media in the LUNGguard method as it had been previously used for a similar method of cooling a payload, as recited by McCormick.
Regarding claim 10, LUNGguard shows that the cooling media is evenly distributed on the support surface (page 9, packets above lungs).
Regarding claims 12-13, the temperature probe readings show that the temperature stayed at ~6°C for greater than 25 hours (page 10).
Regarding claim 15, claim 15 has the additional limitation of positioning the insulator plug radially within the first recess of the insulating layer and the second layer of the core layer. Positioned radially is understood to mean that the insulator plug is positioned outwardly from a central point within the first recess.
As stated supra, Roberts has successfully reduced to practice that a temperature probe can be positioned within a recess to measure the temperature of an object within an insulated container. Furthermore, Lynam teaches that using the thermally insulating body and plug prevents the temperature reading from being affected by external factors (such as by PCM), see column 7, line 40-column , line 17, & Fig. 8, #122). Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly (column 7, lines 1-20). As claim 15 does not define the reference central point for the radial positioning of the insulator plug, any central point can be used. As stated above, the insulator plug would be going through the recess with the temperature sensor, and would therefore be extending from a central point within the first recess outwardly (i.e. radially). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Additionally claim 15 has the additional limitations of stacking the insulated layer with the core layer such that a surface of each layer is substantially parallel and in contact with a similar design for the core layer and cushion layer.
Roberts teaches that their temperature monitoring device 40 includes a first housing member 42 and a second housing member 44 that are attached together and can be configured to include additional layers between the attached housing members 48, 50 (Figure 3 and column 6, lines 31-45). Similarly, Figure 5 of Ferracamo shows that different layers of the housing can include surfaces that are parallel to each other and in direct contact (paragraphs 0043-0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for cooling a lung of LUNGguard, McCormick, Ferracamo, Roberts, Lynam, and Judson by stacking the cushion layer, core layer, and insulating layer so that a surface is in contact, as identified by Roberts and Ferracamo, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify the method with a reasonable expectation of success because Roberts and Ferracamo have successfully reduced to practice that different layers of the insulating container can be stacked on top of each other so that a surface of each layer is parallel and in contact. Furthermore, by stacking the layers so that they are parallel and in contact, this reduces the overall size of the device compared to if they were not in contact. Thus, this would reduce the overall cost of making the device and save time in preparing the device for cooling an organ as defined by the claimed method. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed September 26, 2025, are acknowledged.
Applicant argues that it would not have been obvious to include an opening in the center of the cushion layer as Judson teaches including a protrusion running along the center of the surface of the saddle (page 7, paragraph 5-page 9, paragraph 1).
Applicant's arguments have been fully considered but they are not persuasive.
Applicant argues against the references individually (specifically Judson). However, 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).
Although Judson teaches that their saddle runs along the center of the insulated container to replicate the in vivo anatomical orientation and geometry for a given organ to avoid damaging the organ, such as a pair of donor lungs placed against a smooth, raised, central saddle designed to replicate the spine that the lungs would be resting against in vivo (as can be seen in Figure 9), this central saddle structure would not preclude an opening to accommodate a temperature sensor. As can be seen in Figure 9, although the lungs are resting one the central saddle, there is space between the saddle structure and the lungs that would allow for an opening and allow for accommodation of the temperature probe and insulator plug. Furthermore, as stated supra, Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored (column 5, lines 37-51). Therefore, it is important to accommodate the temperature probe near the lung to get the most accurate temperature reading. Furthermore, as shown above, Roberts has successfully reduced to practice that a temperature probe can be positioned within an opening aligned with a center along an axis in their insulated device. As the saddle is in the center and holding the lungs in an anatomically beneficial position, it would have been obvious that the temperature probe could be accommodated through an opening in the saddle to be near the lungs.
In response to Applicant’s arguments regarding claim 15, Applicant argues against the references individually (specifically Roberts). However, 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). As stated supra, the insulator plug would surround the temperature sensor as it goes through each layer before reaching the organ chamber for recording the temperature of the organ. As such, the temperature sensor would be aligned with the first and second recess to reach the organ for temperature recordings.
Regarding claim 15, Applicant argues that the amended claims overcome the prior rejection of record as it would not be obvious to modify LUNGguard to arrive at the specific arrangement in claim 15.
Applicant's arguments have been fully considered but they are not persuasive.
As stated in the rejection above, it would have been obvious to stack the cushion layer, core layer, and insulating layer so that a surface is in contact between the layers based on the disclosures of Roberts and Ferracamo. Therefore, Applicant’s arguments are considered unpersuasive.
Claims 1-3 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 2016/0347532 (McCormick) in view of United States Patent Application No. 2016/0362240 (Ferracamo), United States Patent No. 8,152,367 (Roberts), United States Patent No. 9,910,000 (Lynam), and United States Patent Application No. 2018/0352807 (Judson). This is a new rejection substantially similar to a previous rejection made in response to Applicant’s amendments to claims 1 and 15. Applicant’s traversal has been considered and addressed above.
Regarding claim 1, McCormick teaches a method for transporting temperature sensitive biological material comprising a thermally insulated storage container and a payload container adapted to retrievably house a temperature sensitive payload (such as a biological sample) (abstract).
McCormick teaches a 10 step process for preparing a cold storage device to cool a payload. The relevant steps are steps 5-9:
Step 5-Place the payload into the volume of the payload container;
Step 6-Remove the top and bottom cold packs from the freezer;
Step 7-Place the bottom cold pack into the insulated storage container;
Step 8-Place the payload container into the insulated storage container on top of the bottom cold pack;
Step 9-Place the top cold pack into the insulated storage container on top of the payload container (paragraphs 0033-0043).
In regard to the insulated storage container, McCormick teaches it comprises:
one or more walls 14 (a floor), 16 (walls), and 18 (a lid wall) that together define an enclosed volume 20 (an organ storage chamber). The thermal storage system 10 includes a payload container 22 sized to fit within the enclosed volume 20. The payload container 22 includes a payload volume 24 adapted to retrievably house (e.g., via a closure that can be opened and closed) a temperature sensitive payload having a target temperature range (i.e. an organ) (paragraphs 0011-0012 and Figure 1). As such, the enclosed volume 20 is configured to receive an organ;
The storage chamber includes a first phase change pack 34, such as a cold pack, comprising a hollow shell 36 and the layers 26, 30 of first and second phase change materials inside the hollow shell near the floor of the storage chamber (paragraph 0014 and Figure 1).
The illustrated payload container 22 (organ support surface) of Figure 1 is above the cooling phase change pack 34.
includes built-in thermal buffers at its top and bottom in the form of the layers 54 (an insulating layer) of the third phase change material. The thermal buffers at the opposite sides of the payload container 22 are in direct physical contact with the bottom of the top cold pack 40 and the top of the bottom cold pack 34.
The illustrated payload container 22 includes built-in thermal buffers at its top and bottom in the form of the layers 54 (an insulating layer) of the third phase change material. The thermal buffers at the opposite sides of the payload container 22 are in direct physical contact with the bottom of the top cold pack 40 and the top of the bottom cold pack 34. This arrangement effectively manages heat flow between the payload container 22 and the cold packs 34, 40 (paragraph 0032);
McCormick teaches that the illustrated payload container 22 comprises a housing 52 that defines the payload volume 24 and one or more cavities 54 in which each layer of the third phase change material is contained (paragraph 0019). McCormick teaches that the payload container 22 may also include an opening (not shown in FIG. 1) adapted to accommodate a temperature probe for measuring the temperature inside the payload volume where the temperature sensitive contents are stored (paragraph 0020). Thus, McCormick reasonably suggests the step of measuring a temperature of the organ with the temperature probe.
McCormick does not teach wherein there is a core layer above the insulating layer and wherein the core layer comprises a recess.
However, Ferracamo teaches an assembly for holding PCM materials. Each assembly 202, 204 may include a center piece 220, 230 having an inner face and an outer face, a front panel 222, 232 configured to cover the inner face, and a back panel 224, 234 configured to cover the outer face. The center piece 220, 230 may include a plurality of spacers and/or dividers that extend outwards from the surface of the center piece 220, 230. As shown in FIGS. 2B-C, a plurality of spacers and/or dividers can serve to create vertical and/or horizontal channels on the surface of the center piece 220, 230. A channel may be a recessed portion of the surface of a piece or panel that may be capable of receiving an object or providing a space for air to freely pass. The assemblies 202, 204 are capable of receiving PCM containers (such as sleeves or bottles) in a space between the surface of a center piece 220, 230 and the respective panel 222, 224, 232, 234 (paragraph 0044). As can be seen I figures 2B-C, the panels include openings (the recess of claim 1 is considered to include cutouts/openings as Figure 3 of the instant application identifies layer 403 as including a recess or cutout for the insulator plug 407 to go through as shown by the line from 407 to layer 405 in Figure 3). The core layer (the panels of Ferracamo) would be above and below the insulation layer (the center piece of Ferracamo).
Roberts teaches an insulated container having a temperature monitoring device comprising a temperature sensor (abstract). The temperature sensor 28 is positioned in a temperature monitoring relationship with the interior space 18 of the container so that the storage temperature of object 36 can be measured (column 5, lines 15-36). The sensor is accommodated in the interior space through an opening in a housing member (see Figures 1-5 and column 6, lines 46-64). In some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored (column 5, lines 37-51).
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 method for cooling a biological material of McCormick by using the PCM assembly that comprises recesses, as identified by Ferracamo, to accommodate a temperature probe in the payload volume, as identified by Roberts, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because McCormick is silent on how the temperature probe is accommodated to measure the temperature of the payload volume outside of identifying that an opening would be required for the probe to access the payload volume. In order for the probe to enter the payload volume, it would have to enter through some part of the housing of the payload container. As the top and bottom include thermal buffers while the side walls do not, it would make most sense to accommodate the temperature probe through one of the thermal buffers as this would limit any temperature loss. Ferracamo teaches an assembly for holding PCM materials comprising a plurality of spacers and/or dividers that extend outwards from the surface of the center piece to create vertical and/or horizontal channels on the surface of the center piece that may be capable of receiving an object. As such, it would have been obvious that this design could be used to insert a thermal probe into the payload volume for measuring the temperature in the payload container/the biological sample. As further evidence, Roberts reduces to practice that temperature sensors can be accommodated in housing members to examine the temperature in the payload volume. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
The teachings of McCormick, Ferracamo, and Roberts are as discussed above.
The combined teachings of McCormick, Ferracamo, and Roberts do not teach wherein an insulator plug is positioned in the recess.
However, Lynam teaches that using a thermally insulating body for a thermistor (a temperature sensor) and a plug of thermally insulating material, see column 7, line 40-column , line 17, & Fig. 8, #122) that prevents the temperature reading from being affected by external factors. Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly (column 7, lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the thermal storage container and temperature probe of McCormick, Ferracamo, and Roberts with the thermally insulating body and a plug of thermally insulating material of the thermistor of Lynam to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Lynam teaches that using the thermally insulating body and plug prevents the temperature reading from being affected by external factors (such as the PCM of McCormick). Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly.
Furthermore, Lynam teaches that their temperature sensor assembly can be placed within a hollow sensor housing assembly (column 3, lines 62-66 and column 7, lines 40-50). As the thermally insulating body and would be going through the recess with the temperature sensor, it would act as an insulator plug within the recess. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
The teachings of McCormick, Ferracamo, Roberts, and Lynam are as discussed above. As stated supra, Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored (column 5, lines 37-51).
The combined teachings of McCormick, Ferracamo, Roberts, and Lynam do not teach wherein the thermal storage system comprises a cushion layer.
However, Judson teaches that contoured storage and transport chambers that can replicate the in vivo anatomical orientation and geometry for a given organ avoid damaging the organ which can result in decreased organ viability and decreased survival rates for transplant recipients. For example, a pair of donor lungs may be placed against a smooth, raised, central saddle (a cushion layer) designed to replicate the spine that the lungs would be resting against in vivo (paragraph 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the thermal storage container and temperature probe of McCormick, Ferracamo, Roberts, and Lynam with the contoured layer to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Judson teaches that contoured layers help avoid tissue damage which can decrease tissue viability and survival rates for transplant recipients. Furthermore, the cushion layer would include a opening for the temperature probe in the insulating body (an insulator plug) as Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored. As such, the probe would need to be close to the temperature sensitive tissue to ensure it gets accurate temperature readings of the tissue (i.e. it would need to go through the cushion layer to ensure it is near the tissue and to get accurate readings of the tissue). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
As stated supra, the temperature probe of the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson would be within the opening of the cushion layer on the insulator plug.
Regarding wherein the opening is aligned with a center axis of the cushion layer, Roberts, as stated supra, teaches that the sensor is accommodated in the interior space through an opening in a housing member (see Figure 5 and column 6, lines 46-64). As can be seen in figure 5 (shown below), the opening can be aligned along an axis of a layer of the housing above the temperature sensor.
PNG
media_image1.png
378
394
media_image1.png
Greyscale
Annotated Figure 5 of Roberts
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed the opening aligned with a center along an axis of the cushion layer, as identified by Roberts, in the method for cooling a lung of McCormick, Ferracamo, Roberts, Lynam, and Judson to accommodate a temperature probe in the payload volume to measure the temperature of the payload to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to choose this method with a reasonable expectation of success because Roberts has successfully reduced to practice that a temperature probe can be positioned within an opening aligned with a center along an axis in their insulated device and Roberts teaches that in some environments the temperature may have some fluctuation from point-to-point within the container. To ensure uniformity in temperature exposure in this type of environment, it may be desirable to position the temperature sensor in close proximity to the object to be monitored. Therefore, it would have been obvious to one of ordinary skill in the art that a different insulating container could also include an opening aligned with a center along an axis of the cushion layer to accommodate a temperature probe in the payload volume to directly measure the temperature of the lung to ensure an accurate temperature reading of the lung. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
McCormick teaches that the payload (i.e. an organ) is placed within the payload container during the process of cooling the payload (paragraphs 0033-0043).
As stated supra, McCormick teaches that the payload container 22 may also include an opening (not shown in FIG. 1) adapted to accommodate a temperature probe for measuring the temperature inside the payload volume where the temperature sensitive contents are stored (paragraph 0020).
Regarding claims 2 and 17, as stated above in regard to step 9, McCormick teaches that their container illustrated in Figure 1 comprises a small cold pack 34 at the bottom, a large cold pack 40 at the top, and the payload container 22 between the two cold packs. Both cold packs are within hollow shells (a cooling media support surface) (paragraphs 0022-0023).
Regarding claim 3, as stated above in regard to step 5, Judson, as stated supra, teaches that contoured storage and transport chambers that can replicate the in vivo anatomical orientation and geometry for a given organ avoid damaging the organ which can result in decreased organ viability and decreased survival rates for transplant recipients. For example, a pair of donor lungs may be placed against a smooth, raised, central saddle (a cushion layer) designed to replicate the spine that the lungs would be resting against in vivo (paragraph 0038).
Regarding claims 5-6 and 18, as stated above in regard to step 9, McCormick teaches that the illustrated payload container 22 obtains its one-way configuration in part from the tapered side walls of the housing of the payload container. The illustrated phase change packs 34, 40 each have a flange or rim at the second larger end of the hollow shells to give that end its larger dimension with respect to the first smaller end.
Although McCormick teaches that their container configuration ensures the second phase change packs remain above the payload container, they do not teach wherein the walls have ridges.
However, Ferracamo teaches that the wall assemblies may be designed to detachably attach without literally attaching to one another by having ridges that snuggly fit together. For example, the length and/or width of the front panels 222, 232 and cover panels 244, 254 may be shorter than the length and width of the respective center pieces 220, 230, base plate 242, and tray portion 252 that they are associated with, which may create ridges that allow the wall assemblies to fit together. Ferracamo teaches that the side wall assemblies, base wall assembly, and top wall assembly may be detachably attached together to form a storage chamber (i.e. coupling a movable lid with the walls) (paragraphs 0043 and 0047 and Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tapered wall of the thermal storage device of McCormick with the ridged side wall assembly of Ferracamo to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute with a reasonable expectation of success because the thermal storage designs of McCormick and Ferracamo ensure that different assemblies (the second phase change pack above the payload container of McCormick and the side wall, base wall, and top wall assemblies of Ferracamo) are placed in the correct positions, the assemblies of Ferracamo have the benefit of being detachable allowing for different configurations or replacing a damaged wall assembly without requiring a whole new container, as would be required if the tapered wall of McCormick was damaged. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Ferracamo teaches that the wall assemblies may be designed to detachably attach without literally attaching to one another by having ridges that snuggly fit together. For example, the length and/or width of the front panels 222, 232 and cover panels 244, 254 may be shorter than the length and width of the respective center pieces 220, 230, base plate 242, and tray portion 252 that they are associated with, which may create ridges that allow the wall assemblies to fit together. Ferracamo teaches that the side wall assemblies, base wall assembly, and top wall assembly may be detachably attached together to form a storage chamber (paragraphs 0043 and 0047 and Figure 2).
Regarding claim 7, as stated above in regard to step 7, McCormick, as stated above, teaches that the storage chamber includes a first phase change pack 34, such as a cold pack, comprising a hollow shell 36 and the layers 26, 30 of first and second phase change materials (PCM) inside the hollow shell near the floor of the storage chamber (paragraph 0014 and Figure 1).
Regarding claims 8 and 19, as stated above in regard to step 9,, McCormick teaches that a second phase change pack 40, such as a second cold pack 40, comprising a hollow shell 42, a layer 44 of the first phase change material, and a layer 46 of the second phase change material inside the hollow shell 42 (paragraph 0015).
Regarding claims 9 and 20, McCormick, as stated supra, teaches that their container illustrated in Figure 1 comprises a small cold pack 34 at the bottom, a large cold pack 40 at the top, and the payload container 22 between the two cold packs (paragraphs 0022-0023).
Regarding claim 10, McCormick teaches that their system includes the step of stacking a layer of the first phase change material 44 between the payload container 22 and a layer of the second phase change material 46 (paragraph 0024). As such, the PCMs in the hollow shell 42 are stacked on top of each other (i.e. evenly distributed).
Regarding claims 11 and 16, Ferracamo, as stated supra, teaches an assembly for holding PCM materials. Each assembly 202, 204 may include a center piece 220, 230 having an inner face and an outer face, a front panel 222, 232 configured to cover the inner face, and a back panel 224, 234 configured to cover the outer face. The panels are solid structures and as such would provide rigidity to support the biological sample. The rigid layer (the bottom panels of Ferracamo) would be below the insulation layer (the center piece of Ferracamo) (paragraph 0044).
Regarding claims 12-14, McCormick teaches that the method may further include the step of monitoring the temperature of the payload volume 24, after the step of stacking and during transport of the thermally insulated storage container 12 from one location to another location, such as during one or both of the aforementioned first (24-96 hours) or second transport segments (30 minutes-24 hours) (paragraphs 0004 and 0027). McCormick teaches that the objective is to continue to ensure maximum temperature stability of the payload during transport up until the time of use (paragraph 0059). Claim 5 of McCormick teaches that the target temperature range is between 2°C to 8°C. As such, the temperature would be maintained between 2°C to 8°C for at least 24.5 hours an up to 120 hours. Furthermore, Ferracamo teaches that the container is designed to maintain an internal temperature in the cargo region of the container of between 2°C to 8°C for up to 120 hours (paragraph 0036). Specifically in regard to claim 14, Ferracamo teaches that they maintained the temperature of the cargo around 5°C for greater than 70 hours (Figure 12). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to maintain the temperature of about 5°C for greater than 70 hours , since that is the desired temperature of McCormick (paragraphs 36-37), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 15, claim 15 has the additional limitation of positioning the insulator plug radially within the first recess of the insulating layer and the second layer of the core layer. Positioned radially is understood to mean that the insulator plug is positioned outwardly from a central point within the first recess. As stated supra, Roberts has successfully reduced to practice that a temperature probe can be positioned within a recess to measure the temperature of an object within an insulated container. Furthermore, Lynam teaches that using the thermally insulating body and plug prevents the temperature reading from being affected by external factors (such as by PCM), see column 7, line 40-column , line 17, & Fig. 8, #122). Therefore, the thermally insulating body improves the accuracy of the temperature sensor assembly (column 7, lines 1-20). As claim 15 does not define the reference central point for the radial positioning of the insulator plug, any central point can be used. As stated above, the insulator plug would be going through the recess with the temperature sensor, and would therefore be extending from a central point within the first recess outwardly (i.e. radially).
Additionally claim 15 has the additional limitations of stacking the insulated layer with the core layer such that a surface of each layer is substantially parallel and in contact with a similar design for the core layer and cushion layer.
Roberts teaches that their temperature monitoring device 40 includes a first housing member 42 and a second housing member 44 that are attached together and can be configured to include additional layers between the attached housing members 48, 50 (Figure 3 and column 6, lines 31-45). Similarly, Figure 5 of Ferracamo shows that different layers of the housing can include surfaces that are parallel to each other and in direct contact (paragraphs 0043-0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for cooling a lung of LUNGguard, McCormick, Ferracamo, Roberts, Lynam, and Judson by stacking the cushion layer, core layer, and insulating layer so that a surface is in contact, as identified by Roberts and Ferracamo, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify the method with a reasonable expectation of success because Roberts and Ferracamo have successfully reduced to practice that different layers of the insulating container can be stacked on top of each other so that a surface of each layer is parallel and in contact. Furthermore, by stacking the layers so that they are parallel and in contact, this reduces the overall size of the device compared to if they were not in contact. Thus, this would reduce the overall cost of making the device and save time in preparing the device for cooling an organ as defined by the claimed method. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 2016/0347532 (McCormick) in view of United States Patent Application No. 2016/0362240 (Ferracamo), United States Patent No. 8,152,367 (Roberts), United States Patent No. 9,910,000 (Lynam), and United States Patent Application No. 2018/0352807 (Judson) and further in view of United States Patent Application No. 20110173023 (LeClair). This rejection is repeated in regards to the Final rejection mailed on June 26, 2025. Applicant’s traversal has been considered and addressed above.
The teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson are as discussed above.
The combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson do not teach wherein the organ storage chamber is suspended on a ridge of the organ storage chamber.
However, LeClair teaches a method for managing the transportation of high priority medical materials, such as harvested organs from the donor to the recipient, so as to ensure a secure, continuous and monitored transport of such materials (abstract). LeClair teaches a thermal storage container comprising a waterproof open well 40 may be made of PE plastic and surrounded by the insulating layer 37. The well 40 may be inserted in the outer case 11 to substantially engage the walls 39 of the insulating layer and bottom portion, so as to seal the insulated layer 37 to the outer case 11. The well 40 may be secured to the outer case 11 by anchor screws 45. It will be appreciated by those skilled in the art that other securing means may be applied to secure the well 40 to the outer case 11, or that the well 40 may be removable from the outer case.
Ferracamo, as stated supra, teaches that the wall assemblies may be designed to detachably attach without literally attaching to one another by having ridges that snuggly fit together. For example, the length and/or width of the front panels 222, 232 and cover panels 244, 254 may be shorter than the length and width of the respective center pieces 220, 230, base plate 242, and tray portion 252 that they are associated with, which may create ridges that allow the wall assemblies to fit together. Ferracamo teaches that the side wall assemblies, base wall assembly, and top wall assembly may be detachably attached together to form a storage chamber (paragraphs 0043 and 0047 and Figure 2).
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 payload container of the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson to include a ridge in the wall of the container to detachably attach the payload container to the storage chamber, as identified by LeCLair and Ferracamo, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because securing the payload container to the storage chamber reduces the risk of damage to the tissue during transportation. Transportation will involve significant vertical and horizontal forces on the storage container that could risk damaging the organ housed in the payload container. Although the payload container of McCormick helps with horizontal motion, vertical motion would be uninhibited as nothing is preventing the phase packs and payload container from bouncing up. However, sealing the payload container into the storage chamber would prevent this potential vertical movement. As LeClair contemplates a securable and removable storage container and Ferracamo teaches that ridges allow for parts of the container to detachably attach, it would have been obvious to incorporate a ridge into the payload container to increase its stability during transport while still allowing for it to be easily detached once it reaches its final destination. As such, it would have been obvious to include a ridge in the wall of the storage container to allow the payload container to be sealed in place during transport and detached once it reaches its destination. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEENAN A BATES/Examiner, Art Unit 1631