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 § 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.
Claim 16 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 16 recites the limitation " the bag member ". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8, 9, 11-18, 25 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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).
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).
The container of claim 1, wherein the container is capable of maintaining a temperature of at least about 8°C to about 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 bag member or the bowl 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 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) 4-7, 10 and 19-24 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.
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.
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.
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.
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.
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.
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 5 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.
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.
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.
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.
Conclusion
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