DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8, 9, 11-18, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biswal (US2023/0084738).
Biswal teaches a container (Fig. 1B) for preserving a biological material (the container can function as such), comprising a phase change material (106) enclosed between a first layer (104) and a second layer (110) which form a wall of the container configured to receive and hold the biological material therein (the container can function as such). Biswal DIFFERS in that it does not disclose wherein the con wherein the container is configured to maintain a preservation temperature of the biological material above 6°C and below 12°C for at least 8 hours. Biswal teaches selecting phase change materials having desired phase-transition temperatures and selecting the quantity of phase change material to achieve desired storage temperatures and thermal characteristics for temperature-sensitive products (¶ 25). Because preservation requirements vary among biological materials, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature above 6°C and below 12°C for at least 8 hours.
The container of claim 1, further comprising an outer transport container wall (104).
Biswal teaches a container (Fig. 1B) for preserving a biological material (the container can function as such), comprising: a bowl (100) comprising a first layer (104) having a peripheral edge (upper edge) and a second layer (110) having a peripheral edge (108), the peripheral edge of the first layer adjoined to the peripheral edge of the second layer around a circumference (Figs 1A-1B); wherein said bowl is configured to receive and hold the biological material therein (the container can function as such); and a phase change material (106) between the first layer and the second layer (Fig. 1B). Biswal DIFFERS in that it does not disclose wherein the con wherein the container is configured to maintain a preservation temperature of the biological material above 6°C and below 12°C for at least 8 hours. Biswal teaches selecting phase change materials having desired phase-transition temperatures and selecting the quantity of phase change material to achieve desired storage temperatures and thermal characteristics for temperature-sensitive products (¶ 25). Because preservation requirements vary among biological materials, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature above 6°C and below 12°C for at least 8 hours.
The container of claim 1, wherein the container is capable of maintaining a temperature of at least 8°C to 12°C for at least 8 hours (the container is capable of such, especially if it’s used in a refrigerator).
The container of claim 1, wherein the container is capable of maintaining a temperature of about 10°C for at least 8 hours (the container is capable of such, especially if it’s used in a refrigerator).
The container of claim 1, wherein the biological material comprises an organ, a body fluid, a body tissue, cells or cell cultures (the container can be used with such a biological material).
The container of claim 1, wherein the biological material is an organ selected from the group consisting a lung, a heart, a kidney, a liver, a pancreas and a small intestine (the container can be used with such a biological material).
The container of claim 11, wherein the biological material comprises blood (the container can be used with such a biological material).
The container of claim 12, wherein the biological material is a lung (the container can be used with such a biological material).
The container of claim 11, wherein the biological material comprises one or more cells or cell cultures selected from the group consisting of reproductive cells, porcine cells, fetal cells, induced pluripotent stem cells (iPS cells) and embryonic stem cells (the container can be used with such a biological material).
The container of claim 1, wherein the container is further configured to receive and hold a volume of a physiological solution or supportive media therein (the container can be used with such).
A method of preserving a biological material, comprising providing the container of claim 1 for said biological material ( such as bioprosthetic heart valve, paragraph 0023), placing said biological material into said container, and preserving the biological material in the container for a period of time (Fig. 1B).
A method of transporting a biological material ( such as bioprosthetic heart valve, paragraph 0023), comprising providing the container of claim 1 for said biological material (Fig. 1B), placing said biological material into said container (Fig. 1B), and transporting said biological material within said container.
The method of claim 17, wherein the method does not comprise cooling the container prior to the placing said biological material into said container (Fig. 1B, where the outer walls of the container is not cooled).
The method of claim 17, wherein the method comprises cooling the container prior to the placing said biological material into said container (Fig. 1B, where the PCM is cooled).
Claim(s) 4-7, 10, 19-20 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biswal.
The container of claim 1, Biswal DIFFERS in that it does not disclose the phase change material is an organic phase change material. Biswal does disclose that any latent heat storage PCM can be used (paragraph 0025). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use such a PCM, in order to use an alternative PCM to suit the desired temperature and delivery time. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The container of claim 4, Biswal DIFFERS in that it does not disclose the phase change material is an octyl laurate. Biswal does disclose that any latent heat storage PCM can be used (paragraph 0025). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use such a PCM, in order to use an alternative PCM to suit the desired temperature and delivery time. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality (different material) of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The container of claim 1, Biswal DIFFERS in that it does not disclose the phase change material is an inorganic phase change material. Biswal does disclose that any latent heat storage PCM can be used (paragraph 0025). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use such a PCM, in order to use an alternative PCM to suit the desired temperature and delivery time. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality (inorganic phase change material) of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The container of claim 6, Biswal DIFFERS in that it does not disclose the phase change material is a salt hydrate. Biswal does disclose that any latent heat storage PCM can be used (paragraph 0025). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use such a PCM, in order to use an alternative PCM to suit the desired temperature and delivery time. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality (different material) of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The container of claim 1, Biswal DIFFERS in that it does not disclose the phase change material has a melting point of about 9.5 °C. Biswal does disclose that any latent heat storage PCM can be used (paragraph 0025). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use such a PCM, in order to use an alternative PCM to suit the desired temperature and delivery time. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The method of claim 17, Biswal DIFFERS in that it does not disclose the biological material organ is an ex vivo organ. Biswal does disclose the container can hold various temperature sensitive contents (paragraph 0029). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use the container to hold the above-mentioned material, in order to use a material needed by a user. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality (different material) of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The method of claim 19, Biswal DIFFERS in that it does not disclose the organ is a lung. Biswal does disclose the container can hold various temperature sensitive contents (paragraph 0029). Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to use the container to hold the above-mentioned material, in order to use a material needed by a user.
The method of claim 17, wherein the container preserves a temperature of the biological material at a temperature of 0°C to 12°C (paragraph 0023) for at least 10 hours. Biswal DIFFERS in that it does not disclose the container preserves the biological material for the above disclosed hours. However, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to modify Biswal, to allow the container to keep contents cold for the above disclosed hours, in order to allow enough time for the biological material to reach its destination. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The method of claim 17, wherein the container preserves a temperature of the biological material at a temperature of 0°C to 12°C (paragraph 0023) for at least 15 hours. Biswal DIFFERS in that it does not disclose the container preserves the biological material for the above disclosed hours. However, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to modify Biswal, to allow the container to keep contents cold for the above disclosed hours, in order to allow enough time for the biological material to reach its destination. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
The method of claim 17, wherein the container preserves a temperature of the biological material at a temperature of 0°C to 12°C (paragraph 0023) for at least 20 hours. Biswal DIFFERS in that it does not disclose the container preserves the biological material for the above disclosed hours. However, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to modify Biswal, to allow the container to keep contents cold for the above disclosed hours, in order to allow enough time for the biological material to reach its destination. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize these known parameters, including the phase-transition temperature and quantity or quality (different material) of the phase change material, to achieve a temperature profile appropriate for the particular biological material being preserved, including maintaining the biological material at a preservation temperature.
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive. Applicant’s arguments are not persuasive. While Biswal may not expressly disclose maintaining a biological material above 6°C and below 12°C for at least 8 hours, Biswal teaches selecting latent heat storage phase change materials and configuring the phase change material package to achieve desired storage temperatures and thermal characteristics for temperature-sensitive products (e.g., ¶¶ 25-26). Because preservation requirements vary among biological materials, one of ordinary skill in the art would have recognized that the phase-transition temperature and quantity of PCM are result-effective variables that may be selected and optimized to achieve a desired preservation temperature profile for a particular biological material. Therefore, it would have been obvious to optimize the known PCM parameters taught by Biswal to maintain the biological material within the claimed temperature range of above 6°C and below 12°C for the desired period of time, including at least 8 hours. Applicant has not identified evidence demonstrating that the claimed temperature range and duration are critical or produce unexpected results relative to the optimization of the thermal-storage characteristics taught by Biswal.
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 KAREEN KAY THOMAS whose telephone number is (571)270-5611. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREEN K THOMAS/Primary Examiner, Art Unit 3736
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