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 amended claims filed on November 21, 2025, have been acknowledged. Claims 14-20 were cancelled. Claims 1, 3-5, 21, and 23-25 were amended. Claims 1-13 and 21-27 are pending and examined on the merits.
Priority
The applicant claims domestic priority from U.S. provisional application No. 63/631,946, filed on April 9, 2024. 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 1-13 and 21-27 receive domestic benefit from U.S. provisional application No. 63/631,946, filed on April 9, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) filed on November 21, 2025, has been considered.
Withdrawn Claim Rejections - 35 USC § 112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.
The prior rejection of claims 3-5 and 23-25 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s amendments to claims 1, 3-5, 21, and 23-25 to clarify that it is the canister wall.
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 1-13 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 2022/0007638 (Judson; referenced in IDS), United States Patent Application No. 2016/0362240 (Ferracamo; referenced in IDS), Ma et al. (Biomater. Sci. 9: 5762-5780. 2021), and United States Patent Application No. 2008/0145919 (Franklin; referenced in IDS).
Regarding claims 1, 6 and 21, Judson teaches a method for cooling a biological sample (abstract and paragraphs 0012-0026) comprising:
An insulated transport container 1000 containing an intermediate sterile canister 1100 for organ transport and wherein the canister comprises a sterile lid 1110 and a wall. A preservation apparatus 10 can be placed in the sterile canister 1110 after an organ is harvested, placed into the preservation apparatus 10 and the apparatus will be filled with preservation fluid, and the sterile canister 1110 is sealed and placed in the insulated transport container 1000;
Cooling media 1015 may be added to the insulated transport container 1000 to maintain temperature inside the container during transport. The cooling media 1015 may comprise eutectic cooling blocks with a stable temperature of 2-8°C. The cooling media can be arranged in recess 1010 in the interior of the insulated vessel 1002. As can be seen in Figures 34 and 37, the cooling media 1015 is adjacent to the wall of the canister (Figures 34 and 37 and paragraphs 0228-0239).
Judson does not teach wherein a second cooling block is adjacent to the canister lid.
However, Ferracamo teaches a method of cooling a payload using a passive temperature-controlled container for regulating a payload's temperature (paragraphs 0003-0006). As part of this container, Ferracamo teaches that phase change material (PCM) 302 and 304 can be placed adjacent to the top of the payload 310 on a tray portion 252 of the top wall assembly 208 (paragraphs 0050-0053 and Figure 3).
Ma teaches that a numerical simulation of putting cold storage material in different positions in a cold storage showed that the most suitable method is to place the cold storage plate on the top and on the vertical side. When the cold storage plate was on the top it gave the largest effective temperature area and the most uniform temperature distribution. Moreover, when the cold storage plate was on the edge it gave the worst insulation effect and could not meet the insulation requirements (page 5766, column 1, paragraph 3 and Figure 3).
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 of cooling a biological sample of Judson by including a cooling block adjacent to the canister lid, as identified by Ferracamo and Ma, 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 Ferracamo successfully reduces to practice that PCM materials can be placed above the top of a sample payload (i.e. adjacent to the top of the sample payload) and Ma teaches that a numerical simulation of putting cold storage material in different positions in a cold storage showed that the most suitable method is to place the cold storage plate on the top and on the vertical side. When the cold storage plate was on the top it gave the largest effective temperature area and the most uniform temperature distribution. Moreover, when the cold storage plate was on the edge it gave the worst insulation effect and could not meet the insulation requirements. The design of Judson most closely resembles the on the edge position. Therefore, it would have been obvious to modify the method of cooling a biological sample of Judson by also including a cooling block adjacent to the canister lid to generate the most effective temperature distribution as an even temperature distribution is important for maintaining an organ at a safe temperature during transportation. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
The combined teachings of Judson, Ferracamo, and Ma do not teach wherein the first cooling block is at least 1°C higher than the temperature of the second cooling block.
However, Franklin teaches a method of cooling an organ wherein a chamber containing a liquid dialysate wherein the temperature can be controlled through the use of cooling blocks and the dialysate is circulated through convection (paragraphs 0039-0040).
Ferracamo teaches that convection occurs when there is a temperature differential between PCM materials and that convection evenly distributes the temperature within the container to maintain a constant temperature on all parts of the container. Ferracamo also teaches that PCM material on the tray portion above the sample payload can take part in convection (paragraphs 0038-0056).
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 of cooling a biological sample of Judson, Ferracamo, and Ma by including maintaining the side cooling block at least 1°C higher than the temperature of the cooling block adjacent to the canister lid, as identified by Franklin 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 Franklin successfully reduces to practice that convection can be used to circulate a liquid dialysate for cooling an organ and Ferracamo teaches that convection occurs when there is a temperature differential between PCM materials and that convection evenly distributes the temperature within the container to maintain a constant temperature on all parts of the container. As stated supra, Judson teaches that the cooling blocks can be 2-8°C Celsius, allowing for there to be differences in temperature between blocks of at least 1°C or 2°C. Therefore, it would have been obvious to maintain the two cooling blocks at different temperatures to ensure convection of the preservation solution so that the temperature of the preservation solution is constant at all regions within the container. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding the limitation, wherein the at least one first cooling block is engineered to a temperature that is at least 1°C higher than the temperature of the at least one second cooling block, the ordinary artisan would have recognized that there are a finite number of identified, predictable potential solutions (i.e. the ordinary artisan would reasonably understand that there are only two options for which cooling block has the higher temperature, either the first of the second cooling block). Thus, it is considered that there is no great intellectual leap to conceive of and/or arrive at instantly claimed combination(s). It would have been obvious to one of ordinary skill in the art to choose from a finite number of identified, predictable options because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.” "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at ___, 82 USPQ2d at 1396.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding the limitation, wherein the at least one first cooling block and the at least one second cooling block are positioned adjacent to different surfaces of the canister to promote convection between a top portion of the preservation solution and a bottom portion of the preservation solution, as identified by the combined teachings of Judson, Ferracamo, Ma, and Franklin, the first cooling block can be the side cooling block maintained at least 1°C higher than the temperature of the cooling block adjacent to the canister lid. As such, the side cooling block would be adjacent to the surface of the side wall and the cooling block adjacent to the canister lid would be adjacent to the top surface of the lid. Therefore, these cooling blocks would be adjacent to different surfaces of the canister.
Regarding claims 2 and 22, Judson teaches that four canine kidneys were attached via aortic catheter to an adapter coupled to the lid of a self-purging preservation apparatus. The organs were immersed into cold (4°C) freshly prepared University of Wisconsin Solution (preservation solution). The self-purging preservation apparatus was then placed into an insulated transport case into which eutectic cold packs had been previously placed. Temperature was continuously monitored during 24 hours of storage. The average temperature during storage was 4.5° C (Example 1).
Regarding claims 3-5 and 23-25, Judson teaches an example of the canister 790 with a lid 710 and wherein the combined canister and lid assembly is a self-purging preservation apparatus 700 housed within the insulated transport container 1000 (Figure 36). Judson teaches that the canister has a height of about 5.91 inches and the overall apparatus can have a height of about 8.77 inches (paragraphs 205-212). Judson teaches that the system may use any of a number of cooling media 1015 to maintain the temperature inside the insulated transport container 1000 during transport. As shown in FIG. 34, the cooling media 1015 may comprise eutectic cooling blocks. The cooling media 1015 will be arranged in recess 1010 in the interior of the insulated vessel 1002. The recess 1010 may be a slot, such as shown in FIG. 35, or the recess may be a press-fit, or the cooling media 1015 may be coupled to the walls of the insulated vessel 1002 using a snap, screw, hook and loop, or another suitable connecter (paragraph 232).
Judson does not specifically identify positioning of the cooling blocks in relation to the canister wall.
However, Figure 3 of Ma shows that in their simulation of on the top, some of the side blocks are only half way to the top of the box (i.e. adjacent to the wall of the canister) and are in contact with the floor of the container (page 5766, column 1, paragraph 3 and Figure 3) and this configuration was the best performing with the most uniform temperature distribution (page 5766, column 1, paragraph 3 and Figure 3).
As this was the best performing configuration in their simulation, it would have been obvious to use a similar formation in the transport container of the combined teachings of Judson, Ferracamo, Ma, and Franklin as this would ensure the most uniform temperature distribution.
Therefore, the blocks that only cover half the height would fall within the limitations of claims 3, 5, 23, and 25 as they would only cover the lower 50% of the canister wall as the canister rests on the floor of the container. Furthermore, based on the height measurements of Judson, a cooling block that only covers half the height of the apparatus would be ~4.385 inches tall, leaving ~4.385 inches of open space between the end of the block and the top of the canister wall, falling within the limitations of claims 4 and 24.
Regarding claims 7-8 and 26, as an initial matter, the specification discloses that the term “about” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. This is considered a non-limiting definition as it uses “may refer to”. Therefore, about is considered to be a magnitude change (e.g. about 1 ranges from .1-10). As stated supra, Judson teaches that as an example, the cooling blocks can range from 2-8°C. As such, cooling blocks with temperatures of 2°C (falls within range of “about 1”) for the cooling block adjacent to the lid and 3°C for the cooling block adjacent to the wall of the canister would fall within the limited number of known possible combinations of different temperatures for the cooling blocks and would, thus, be obvious.
Regarding claims 9 and 27, based on the configuration of cooling blocks identified by Ma as being the most efficient for producing uniform temperature distribution, the cooling block that only covers half the storage sample would cool that half of the preservation solution to its warmer temperature, while the cooling block adjacent to the lid which gave the largest effective temperature area would account for the temperature of roughly the other 50% of the preservation solution (page 5766, column 1, paragraph 3 and Figure 3).
Regarding claim 10, Judson teaches that the tissue for transport can be heart (paragraphs 0084 and 0228).
Regarding claim 11, As can be seen in figures 34-37, the cooling blocks would be in the same large cavity of the transport container wherein the preservation apparatus is housed.
Regarding claim 12, as stated supra, Judson teaches that the cooling media can be eutectic cooling blocks (paragraph 0232).
Regarding claim 13, Judson teaches that the cooling blocks can be arranged as multiple cooling blocks joined side to side to form a band of coupled cooling blocks (paragraph 0233).
Response to Arguments
Applicant's arguments filed November 21, 2025, are acknowledged.
Applicant argues that Franklin describes convection using a discharge vent, a circulation fan, and a warming fan. This differs significantly from convection caused by the placement of PCM with different temperatures along different surfaces of a canister as described with respect to amended claims 1 and 21.
Applicant argues that Ferracamo describes the convection occurs within an air chamber outside of the storage chamber 102, not within the storage chamber. Applicant argues that it would not have been obvious, based on the cooling material of Ferracamo causing convection in an air chamber outside of the storage container, to arrange cooling materials with different temperatures against different surfaces of the container (as recited in the amended claims 1 and 21) to promote convection therewithin. Rather, Ferracamo shows one cooling material around the entirety of the container and another cooling material around the entirety of the first cooling material.
Applicant argues that Judson does not remedy the defects of Franklin and Ferracamo as Judson is silent as to blocks that are used in the system having differences in temperature between them of at least 1 °C or 2 °C.
None of the cited portions of the references describe cooling blocks of different temperatures being positioned against different surfaces of the canister to promote convection, in combination with the other limitations recited in amended claims 1 and 21. Applicant submits that one of skill in the art would not have been motivated to include at least one first cooling block engineered to a temperature that is at least 1°C higher than the temperature of the at least one second cooling block, where the cooler block is positioned against the lid and the warmer is positioned against the wall, and both are in contact with different surfaces of the container, based on the discharge vent-circulation fan arrangement of Franklin, the outer air chamber of Ferracamo, and the 2-8°C Celsius range of Judson (page 5, paragraph 7-page 8, paragraph 2).
Applicant's arguments have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Franklin, as stated supra, discloses that convection can be used to circulate a solution in a method of cooling an organ. Therefore, Franklin identifies the scientific concept of using convection to circulate a solution for cooling an organ. Although Franklin uses other means to effectuate convection, as noted by the Applicant, Ferracamo, as stated supra, specifically identifies that convection can occur when there is a temperature differential between PCM materials. Therefore, Ferracamo identifies the scientific concept that temperature differentials between PCM materials can effectuate convection. Furthermore, Ferracamo provides motivation for using convection as convection evenly distributes the temperature within the container to maintain a constant temperature on all parts of the container which would also be true for the liquid solution. Although Ferracamo performs convection in an air chamber outside of the storage chamber, it would have been well understood that an air chamber outside of the storage chamber is not the only area in which convection can occur. On eof ordinary skill in the art would identify the scientific concepts of Franklin and Ferracamo and understand that they could be modified to occur in other systems, such as in the method of Judson, to evenly distribute the temperature within the container and fluid to maintain a constant temperature on all parts of the container and fluid. Therefore, the combined teachings of Judson, Ferracamo, Ma, and Franklin make obvious the method of the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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 at (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
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631