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 .
DETAILED ACTION
The claims filed on April 24, 2025, have been acknowledged. Claims 1 and 6 were amended. Claims 17-18 are new. Claims 1-18 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 1-18 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 (IDS) filed on April 24, 2025, has been considered.
Claim Rejections - 35 USC § 112
Claim 6 is 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.
Claim 6 recites the limitation "the first cooling media" in line 6 There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “a first cooling media” of claim 6 is the same as the “cooling media” of claim 1 configured to be positioned within the cooling media pocket.
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 1-15 and 18 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), United States Patent Application No. 2018/0352807 (Judson), and Naoum (Xometry: Everything You Need to Know About Acrylic and Its Uses, Published May 4, 2022).
Regarding claim 1, McCormick teaches a thermal storage system comprising a thermally insulated storage container and a payload container adapted to retrievably house a temperature sensitive payload (such as a biological sample) (abstract), comprising:
one or more walls 14 (a floor), 16 (walls), and 18 (a lid wall) that together define an enclosed volume 20 (a sample 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. a biological sample) (paragraphs 0011-0012 and Figure 1). As such, the enclosed volume 20 is configured to receive a biological sample;
The payload container 22 (i.e. a sample support surface) may be shaped and sized to fill the portion of the enclosed volume 20 (i.e. configured to be positioned within the chamber to support a biological sample) of the storage container 12 between the top and bottom phase change packs 40, 34 (i.e. a cooling media pocket between the floor 14 and the sample support surface 22) (paragraph 0032 and Figure 1);
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 (i.e. configured to insulate the cooling media from the biological sample) (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).
McCormick does not teach wherein there is a core layer configured to provide rigidity to support the biological sample 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 panels are solid structures and as such would provide rigidity to support the biological sample. 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 thermal storage container 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 114 (a temperature sensor) and a plug of thermally insulating material 122, see column 7, line 40-column 8, line 17, & Fig. 8) 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.
Regarding the positioning of the temperature probe within the insulator plug, Figure 8 of Lynam shows that the temperature sensor 114 passes through the insulator plug 122 and the top of the temperature sensor is above the insulator plug where it makes contact with the copper plate 110 for measuring temperature. As such, based on Lynam, the temperature probe would be on and above an upper surface of the insulator plug. Regarding the positioning of the temperature probe within the core layer, as identified by Roberts above, 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). As such, it would be obvious to put the temperature probe near the tissue in the container to ensure accurate temperature readings of the tissue. Under this configuration, the temperature probe would be above the recess of the core layer in order to be near the tissue and achieve accurate temperature recordings of the tissue.
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 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 claim 2, McCormick teaches that the system 10 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. The hollow shell of each phase change pack may be constructed of a durable plastic or metal material (paragraphs 0014 and 0028 and Figure 1). As such, the hollow shell of the bottom phase change pack would include a rigid layer beneath the insulating layer.
Regarding claim 3, McCormick teaches that the phase change packs 34, 40 include phase change material in each pack (paragraph 0028).
Regarding claim 4, McCormick teaches that the top pack 40 has a 5° C phase change material at its bottom and the bottom pack 34 having a 5° C. phase change material at its top, thereby sandwiching the payload container 22 between layers of 5° C phase change materials (paragraph 0029).
Regarding claim 5, the system 10 also includes a second phase change pack 40, such as a second cold pack 40, comprising a hollow shell 42 (a cooling media support surface), a layer 44 of the first phase change material, and a layer 46 of the second phase change material inside the hollow shell 42 above the payload container. The hollow shell of each phase change pack may be constructed of a durable plastic or metal material (paragraphs 0015 and 0028 and Figure 1).
Regarding claim 6, McCormick teaches that a first phase change material is in a cooling media pocket below the payload container and a second phase change material is in a cooling media support surface above the payload container (Figure 1 and paragraphs 0013-0015 and 0022). As arranged in FIG. 1, the first phase change pack 34 is a small phase change pack and is configured to fit at a first or bottom end of the enclosed volume 20 of the thermally insulated container 12. The second phase change pack 40 is a large phase change pack and is configured to fit at a second or top end of the enclosed volume 20 of the thermally insulated container 12 on the opposite side of the payload container 22 from the small phase change pack 34.
Regarding claim 7, 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 (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.
Regarding claim 8, McCormick, as stated supra, teaches that the system 10 also includes a second phase change pack 40, such as a second cold pack 40, comprising a hollow shell 42 (a cooling media support surface), a layer 44 of the first phase change material, and a layer 46 of the second phase change material inside the hollow shell 42 above the payload container. The hollow shell of each phase change pack may be constructed of a durable plastic or metal material (paragraphs 0015 and 0028 and Figure 1). As such, the hollow shell (as can be seen in Figure 1) comprises a lower surface, upper surface, and side surfaces that define the slot for receiving the second cooling media.
Regarding claim 9, as stated supra, 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 raised, central saddle (i.e. a textured surface to interact with the biological sample) designed to replicate the spine that the lungs would be resting against in vivo (paragraph 0038). The contoured central saddle would increase the coefficient of friction, holding the tissue in place during transport and preventing lateral motion.
Regarding claim 10, Ferracamo teaches that the material for the center pieces 220, 230 can be a material with a high insulation value such as Polystyrene (a closed cell foam).
It would have been obvious to use polystyrene as it was known to have a high insulation value. As this is the insulation layer between the phase change material and the payload volume, it would have been obvious to use a high insulation value material.
Regarding claims 11-13, as there is no definition for aperture, aperture is interpreted to mean a hole (or a slit). 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). 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. 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). As such, the insulating layer would need a hole to accommodate the temperature probe so that it can be near the biological sample to accurately measure its temperature.
Coaxial is not defined by the claims, as such its common meaning is used (sharing an axis (i.e. a central point). 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) and that the thermistor leads 118 extend downwardly through the lower housing part 106. A plug 122 of thermally insulating material is provided, in order to close the lower end of the housing part 106, the leads then passing through the plug 122 (column 8, lines 3-12). As the temperature probe must reach the payload volume to measure the temperature of the sample, the probe would have to be inserted through the recess of the core layer and the aperture in the insulating layer at the same point. As Lynam already teaches that the temperature sensor can be placed within a hollow sensor housing assembly, it would have been obvious that it could be inserted through an aperture to reach the sample chamber to directly measure the temperature of the sample.
Regarding claim 14, McCormick, as stated supra, teaches that the hollow shell of each phase change pack may be constructed of a durable plastic or metal material (paragraphs 0014 and 0028 and Figure 1). Naoum teaches that acrylic is a known hard plastic (page 7, paragraph 3). As such, although McCormick is silent as to which durable plastics could be used, acrylic, as a known hard plastic woul;d have been an obvious one to choose,
Regarding claim 15, Ferracamo teaches that Expanded Polystyrene has high insulation value.
It would have been obvious to use expanded polystyrene for the insulation plug on the temperature as it was known to have a high insulation value. As the thermal insulation around the temperature probe is meant to limit the effects of external temperature, such as PCMs, it would have been obvious to use a high insulation value material surrounding the temperature probe to ensure that the temperature readings accurately represent the temperature of the biological sample and not the PCM.
Regarding claim 18, as the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson teach that the sample tissue would rest on the cushion layer above the core and insulating layers, the sample support surface. As such, the sample support surface would be configured to be positioned entirely beneath the biological sample.
Response to Arguments
Applicant's arguments filed April 24, 2025, are acknowledged.
First, Applicant argues that Lynam is non-analogous art and that the Office Action failed to show that Lynam is either from the same field of endeavor or reasonably pertinent to the present application. Applicant argues that the mere fact Lynam teaches measuring temperature is insufficient to prove that Lynam is “reasonably pertinent” to the problems faced by the inventor of the present application (page 6, paragraphs 1-3).
Second, Applicant argues that it would not be obvious to modify the arrangement of Lynam to have the temperature sensor on the upper surface of the insulator plug as this would not allow air gaps between the plug and temperature sensor (page 7, paragraphs 1-2).
Applicant's arguments have been fully considered but they are not persuasive.
In response to applicant's argument that Lynam is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Lynam is “reasonably pertinent” art because Lynam is focused on solving the problem of accurately measuring temperature from a surface while preventing external factors from impacting the temperature reading. Organ transportation also has the issue of accurately measuring temperature in a system where external factors could impact the temperature reading. The organ cooling system includes PCM cooling (i.e. external factors that could impact the temperature reading) which would be in close contact with the temperature probe in the recess. As such, finding a way to insulate the temperature probe from the surrounding cooling material is the main problem to be solved and Lynam teaches a way is resolving this problem. As such, it is considered “reasonably pertinent” art. See also MPEP2141.01(a), section IV, Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 227 USPQ 766 (Fed. Cir. 1985), where the claims at issue were directed to an instrument marker pen body, the improvement comprising a pen arm holding means having an integrally molded hinged member for folding over against the pen body. Although the patent owners argued the hinge and fastener art was nonanalogous, the court held that the problem confronting the inventor was the need for a simple holding means to enable frequent, secure attachment and easy removal of a marker pen to and from a pen arm, and one skilled in the pen art trying to solve that problem would have looked to the fastener and hinge art. In instant case, the inventors from McCormick et al. would have turned to the temperature sensor systems of Lynam in order to solve the problems associated with temperature probes.
In response to applicant's argument that it would not be obvious to modify the arrangement of Lynam, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Lynam makes obvious that an insulator plug can be used with a temperature probe to insulate it from external temperature factors. Furthermore, as the housing assembly is related to using a temperature probe to read the temperature of the windshield of a car, it would be well understood by one of ordinary skill in the art that there would be differences in how the teachings of Lynam would be incorporated into a cooling device for transporting organs. Additionally, as the insulator plug is at the base of the assembly housing, the temperature probe would extend from the upper surface of the insulator plug and would therefore also be on an upper surface of the insulator plug.
Claims 1 and 16 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) as applied to claim 1 above, and further in view of World Intellectual Property Organization Patent Application No. 2020/061202 (Mazor).
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 temperature sensor is within a blunt jacket.
However, Mazor teaches that they used a temperature probe with a blunt tip to prevent the probe from puncturing tissue (paragraph 0071).
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 temperature probe of the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson with the blunt tip probe of Mazor 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 Mazor teaches that a blunt tip prevents the probe from puncturing tissue. As this is a transport container for the biological sample, it is possible that the tissue could get jostled. As such, it would be obvious to use a blunt tip to ensure that the temperature sensor does not cause puncture wounds in the tissue. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 17 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) as applied to claim 1 above, and further in view of United States Patent No. 5586438 (Fahy).
The teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson are as discussed above.
The combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson are silent as to the material of the cushion layer.
However, Fahy teaches that the container 12 includes a pad 13 for receiving an organ. The pad 13 consists of a soft sterile foam material. This foam material may be similar to the soft foam inserts normally used to package non-living materials for shipment. Pad 13 is sufficiently soft such that it conforms to the contour of the organ transported thereon. The pad 13, however, is sufficiently firm to support the weight of the organ and to prevent lateral motion of the organ on the pad. Pad 13 is tapered having a taller section adjacent a back wall 197 of the container 11. The center of the pad 13 contains a depression 17 for cradling the organ. Alternatively, pad 13 may be inflatable and the depression 17 in pad 13 for cradling the organ may be formed largely during inflation of the pad (column 4, lines 7-20).
It would have been obvious to a person skilled in the art to use foam as the material for the cushion layer of the combined teachings of McCormick, Ferracamo, Roberts, Lynam, and Judson since one skilled in the art would recognize that foam was a suitable material for supporting an organ for transportation and to prevent lateral motion, as taught by Fahy. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1, 3-9, 11-13, and 18 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 No. 8,152,367 (Roberts), and United States Patent No. 9,910,000 (Lynam), United States Patent Application No. 2018/0352807 (Judson), and United States Patent Application No. 2016/0347532 (McCormick).
LUNGguard teaches a container for an organ (such as a lung) comprising an organ storage chamber with a floor and walls (page 7, whole device).
LUNGguard teaches that the sample support surface is above a cooling media pocket wherein cooling media is on the floor (page 7, support surface sitting on ridge of device between the lungs above and the cooling media below).
Positioning an organ support surface above the cooling media (page 7, packets below the lungs).
LUNGguard shows that the support surface has two surfaces (a core layer and an insulating layer) (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 teaches that the temperature probe is in the core layer (page 8, deconstruction, line from temperature probe information is directed to the core layer) 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, 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 device 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. Furthermopre, 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.
Regarding the positioning of the temperature probe within the insulator plug, Figure 8 of Lynam shows that the temperature sensor 114 passes through the insulator plug 122 and the top of the temperature sensor is above the insulator plug where it makes contact with the copper plate 110 for measuring temperature. As such, based on Lynam, the temperature probe with be on and above an upper surface of the insulator plug. Regarding the positioning of the temperature probe within the core layer, as identified by Roberts above, 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). As such, it would be obvious to put the temperature probe near the tissue in the container to ensure accurate temperature readings of the tissue. Under this configuration, the temperature probe would be above the recess of the core layer in order to be near the tissue and achieve accurate temperature recordings of the tissue.
LUNGguard does not teach a cushion layer above the core 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.
The temperature probe would be within the opening of the cushion layer on the insulator plug.
Regarding claim 3, the device on page 7 shows cooling media on the floor. 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 4, LUNGguard is silent as to the phase change temperature of the cooling media. LUNGguard does show that they maintained temperatures in the device at ~6° C for over 24 hours (page 10). McCormick teaches that the top pack 40 has a 5° C phase change material at its bottom and the bottom pack 34 having a 5° C. phase change material at its top, thereby sandwiching the payload container 22 between layers of 5° C phase change materials to generate a desired payload temperature of 5° C (paragraphs 0029 and 0031). As such, it would have been obvious that one could use PCM with a phase change temperature of ~6° C to achieve the results found in LUNGguard.
Regarding claim 5, the device of LUNGguard on page 7 comprises a cooling media support surface for a second cooling media above the organ.
Regarding claim 6, the device on page 7 shows cooling media on the floor and at the top of the device. 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.
LUNGguard does not teach wherein the second cooling media (top cooling media region) comprises more PCM by volume than the first cooling media (bottom cooling media region)
McCormick teaches that a first phase change material is in a cooling media pocket below the payload container and a second phase change material is in a cooling media support surface above the payload container (Figure 1 and paragraphs 0013-0015 and 0022). As arranged in FIG. 1, the first phase change pack 34 is a small phase change pack and is configured to fit at a first or bottom end of the enclosed volume 20 of the thermally insulated container 12. The second phase change pack 40 is a large phase change pack and is configured to fit at a second or top end of the enclosed volume 20 of the thermally insulated container 12 on the opposite side of the payload container 22 from the small phase change pack 34.
As the device of LUNGguard clearly shows additional space in the upper cooling media region, it would have been obvious that one could add additional PCM to the upper PCM region as was done by McCormick as this would allow more PCM material to be added to the device, and would also cause the temperature in the device to stay at the preferred temperature for longer as a result of the additional PCM being added. As the bottom is already at max capacity based on the device on page 7, PCM could only be added to the top cooling media region.
Regarding claim 7, as can be seen in the device on page 7, the sample support surface and the cooling media support surface use ridges to the surfaces in place.
Regarding claim 8, as can be seen in the device on page 7, the cooling media support surface comprises a lower surface, an upper surface, and a side surface that defines a slot for receiving the second cooling media.
Regarding claim 9, as can be seen in the device on page 7, the samples are in a bag.
Regarding claims 11-13, as there is no definition for aperture, aperture is interpreted to mean a hole (or a slit). As stated supra, 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). As such, the insulating layer would need a hole to accommodate the temperature probe so that it can be near the biological sample to accurately measure its temperature.
Coaxial is not defined by the claims, as such its common meaning is used (sharing an axis (i.e. a central point). 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) and that the thermistor leads 118 extend downwardly through the lower housing part 106. A plug 122 of thermally insulating material is provided, in order to close the lower end of the housing part 106, the leads then passing through the plug 122 (column 8, lines 3-12). As the temperature probe must reach the payload volume to measure the temperature of the sample, the probe would have to be inserted through the recess of the core layer and the aperture in the insulating layer at the same point. As Lynam already teaches that the temperature sensor can be placed within a hollow sensor housing assembly, it would have been obvious that it could be inserted through an aperture to reach the sample chamber to directly measure the temperature of the sample.
Regarding claim 18, as the combined teachings of LUNGguard, Roberts, Lynam, Judson, and McCormick teach that the sample tissue would rest on the cushion layer above the core and insulating layers, the sample support surface. As such, the sample support surface would be configured to be positioned entirely beneath the biological sample.
Claims 2, 10, and 14-15 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 No. 8,152,367 (Roberts), and United States Patent No. 9,910,000 (Lynam), United States Patent Application No. 2018/0352807 (Judson), and United States Patent Application No. 2016/0347532 (McCormick) as applied to claim 1 above, and further in view of United States Patent Application No. 2016/0362240 (Ferracamo).
The teachings of LUNGguard, Roberts, Lynam, Judson, and McCormick are as discussed above.
The combined teachings of LUNGguard, Roberts, Lynam, Judson, and McCormick do not teach wherein the sample support surface further comprises a rigid layer.
However, Ferracamo teaches an assembly with recesses. 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. As can be seen in 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 panels are solid structures and as such would provide rigidity to support the biological sample. The core layer (the upper panels of Ferracamo) would be above the insulation layer (the center piece of Ferracamo) and a rigid layer (the lower panels) would be below the insulation layer.
As LUNGguard is silent as to how the temperature probe inserts into the sample support surface, it would have been obvious that one could use the assembly of Ferracamo as the samp