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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional Application 63/351825, filed on 06/14/2022.
Information Disclosure Statement
The IDS filed 10/29/2025 has been considered by the Examiner.
Status of Claims
Claims 1-27 are under examination.
Claim Rejections - 35 USC § 112
Rejection to claims 1-2 and 20-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been withdrawn in view of the applicant’s amendments filed on 04/27/2026.
Claim Rejections - 35 USC § 102
Claims 1-18, 20-24, and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Powell-Palm (WO 2021/146122 Al).
Regarding claim 1, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach within the primary container, preserved biologics may be stored in an inner container, such as a bag, balloon, covered vial or tube, or other vessel with a flexible surface. Powell-Palm teach the inner container may also be filled with an aqueous solution, be free of air and sealed. Powell-Palm teaches the inner containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024).
(b) Powell-Palm teach an inner container for the preserved biologic which is filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the controller will continuously monitor the pressure and tum off the energy delivery module (heating) when the pressure returns to beneath the threshold value, indicating that all or most ice has melted and that the state of stable supercooling may be resumed. Powell-Palm teach that the temperature in the system is elevated only to just above the melting point of the medium and the stored biologic remains cold (page 3, paragraph 012). Therefore, the storage temperature will normally be below the melting point of the medium except in cases where it is slightly elevated to melt ice.
(c, d) The inner container is completely free of air and sealed (page 4, paragraph 024).
Powell-Palm teach supercooling of aqueous media, the method comprising: providing a rigid container containing the aqueous media, ensuring the removal of all or most bulk gas phase from the contained aqueous media, sealing the container with a rigid air-tight closure; and cooling the aqueous media to a temperature below 0°C. (page 5, paragraph 029).
(e) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution. Powell-Palm teach the aqueous solution in the outer container may have different freezing point than the inner container and biological matter which could be lower or higher (page 30, paragraph 0275).
(f) Powell-Palm teach a rigid outer container containing the aqueous media (page 33, claim 1).
(g, h) Powell-Palm teach sealing the container with a rigid air-tight closure, ensuring the removal of essentially all bulk gas phase from the contained aqueous media (page 33, claim 1).
(i) Powell-Palm teach the container can be cooled and the housing a supercooled media and preserved biologic can be stored at any temperature between 0°C and -273°C (page 4, paragraph 019).
(j) Powell-Palm teach the stored biologic may be preserved within the container for any length of time, including but not limited to 6 hours to 20 years. (page 4, paragraph 020).
(k) Powell-Palm teach the container may feature on-board or off-board control capabilities, which employ a microprocessor, computer, or other programmable processing device to monitor the pressure reading from the pressure transducer and activate the energy delivery module (heating) (page 3, paragraph 012).
(l,m) Powell-Palm does not explicitly teach the unsealing and removing of the biological sample after freezing. Powell-Palm teach effective preservation of complex organ and tissue systems is essential medical and research efforts, including expanding access to lifesaving organ transplantations, enabling the storage and transportation of engineered tissues for drug-testing, etc. (page 12, paragraph 0137). Organ transplantation includes preservation and further unsealing and removing the organ in order to perform the transplant. Therefore, it is inherent that the biological sample is unsealed and removed from the container.
Regarding claim 2, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach within the primary container, preserved biologics may be stored in a secondary container, such as a bag, balloon, covered vial or tube, or other vessel with a flexible surface. Powell-Palm teach the secondary container may also be filled with an aqueous solution, be completely or mostly free of air, and sealed. Powell-Palm teaches secondary containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024).
(b) Powell-Palm teach a secondary container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the controller will continuously monitor the pressure and tum off the energy delivery module (heating) when the pressure returns to beneath the threshold value, indicating that all or most ice has melted and that the state of stable supercooling may be resumed. This ensures that the temperature in the system is elevated only to just above the melting point of the medium and the stored biologic remains cold (page 3, paragraph 012). Therefore, the storage temperature will normally be below the melting point of the medium except in cases where it is slightly elevated to melt ice.
(c) This secondary container is completely free of air and sealed (page 4, paragraph 024).
(d, e) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution. Powell-Palm teach a rigid outer container containing the aqueous media (page 33, claim 1).
(f, g) Powell-Palm teach sealing the container with a rigid air-tight closure, ensuring the removal of essentially all bulk gas phase from the contained aqueous media (page 33, claim 1). (h) Powell-Palm teach the container can be cooled and the housing a supercooled media and preserved biologic can be stored at any temperature between 0°C and -273°C (page 4, paragraph 019). (i) Powell-Palm teach the stored biologic may be preserved within the container for any length of time, including but not limited to 6 hours to 20 years (page 4, paragraph 020). (j) Powell-Palm teach the container may feature on-board or off-board control capabilities, which employ a microprocessor, computer, or other programmable processing device to monitor the pressure reading from the pressure transducer and activate the energy delivery module (heating) (page 3, paragraph 012).
(k, l) Powell-Palm teach a secondary container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the controller will continuously monitor the pressure and tum off the energy delivery module (heating) when the pressure returns to beneath the threshold value, indicating that all or most ice has melted and that the state of stable supercooling may be resumed. This ensures that the temperature in the system is elevated only to just above the melting point of the medium and the stored biologic remains cold (page 3, paragraph 012). Therefore, the storage temperature will normally be below the melting point of the medium except in cases where it is slightly elevated to melt ice.
Regarding claim 3, Powell-Palm teach the container can be cooled and the housing a supercooled media and preserved biologic can be stored at any temperature between 0°C and -273°C (page 4, paragraph 019).
Regarding claims 4 and 5, Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution. Powell-Palm teach the aqueous solution in the outer container may have different freezing point than the inner container and biological matter which could be lower or higher (page 30, paragraph 0275).
Regarding claims 6 and 7, Powell-Palm teach maintaining supercooling until the glass transition temperature of the aqueous media (page 18, paragraph 0173). Powell-Palm teach providing aqueous environments that remain liquid at sub-zero centigrade temperatures (page 18, paragraph 0174). Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution. Powell-Palm teach the aqueous solution in the outer container may have different freezing point than the inner container and biological matter which could be lower or higher (page 30, paragraph 0275).
Regarding claim 8, Powell-Palm teach the inner container is comprised of hydrophobic polymeric substances which can be polytetrafluoroethylene-based and perfluorocarbon-based substances.
Regarding claim 9, Powell-Palm teach the aqueous medium within the container may contain organic molecules (page 2, paragraph 009).
Regarding claim 10, Powell-Palm teach the aqueous medium within the container may contain chemical cryoprotectants (page 2, paragraph 009).
Regarding claims 11 and 12, Powell-Palm teach supercooling to enhance the duration and quality of bio-preservation while minimizing cryoprotectant concentrations (page 12, paragraph 0137). It would have been obvious to one of ordinary skill in the art to reduce the concentration of the cryoprotectants in the inner container because they are in contact with the biological sample. There would have been a reasonable expectation of success because Powell-Palm teach decreasing cryoprotectant concentrations increases the quality of bio-preservation.
Regarding claim 13, Powell-Palm teach the biological matter is perfused with the aqueous media (page 8, claim 54).
Regarding claims 15 and 17, Powell-Palm teach the container may also be cooled at various rates including <1 ºC per minute to <1000 ºC per minute (page 4, paragraph 019) which fall between the range of 1 ºC to 1000 ºC per minute.
Regarding claims 14 and 16, Powell-Palm teach the container may also be cooled at various rates including <1 ºC per minute, <5 ºC per minute, <10 ºC per minute (page 4, paragraph 019) which fall between the range of <.01 ºC to <10 ºC per minute.
Regarding claim 18, Powell-Palm a sealed secondary flexible container which can be a bag or balloon (page 4, paragraph 024).The sealed container would not allow transmission of mass. Regarding claim 20, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach an apparatus for supercooling of aqueous media, the method comprising: providing a rigid container containing the aqueous media, ensuring the removal of all or most bulk gas phase from the contained aqueous media, sealing the container with a rigid air-tight closure; and cooling the aqueous media to a temperature below 0°C. (page 5, paragraph 029).
(b) Powell-Palm teach within the container, preserved biologics may be stored in an inner container, such as a bag, balloon, covered vial or tube, or other vessel with a flexible surface. Powell-Palm teach the inner container may also be filled with an aqueous solution, be completely free of air, and sealed. Powell-Palm teaches secondary containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024). The sealed container would prevent transmission of mass.
(c) Powell-Palm teach an inner container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
(d) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution (page 33, claim 1). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
Regarding claim 21, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach an apparatus for supercooling of aqueous media, the method comprising: providing a rigid container containing the aqueous media, ensuring the removal of all or most bulk gas phase from the contained aqueous media, sealing the container with a rigid air-tight closure; and cooling the aqueous media to a temperature below 0°C. (page 5, paragraph 029).
(b) Powell-Palm teach within the container, preserved biologics may be stored in an inner flexible container. Powell-Palm teach the inner container may also be filled with an aqueous solution, be completely free of air, and sealed. Powell-Palm teaches inner containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024). The sealed container would prevent transmission of mass.
(c) Powell-Palm teach an inner container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
(d) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution (page 33, claim 1). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
Regarding claim 22, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach an apparatus for supercooling of aqueous media, the method comprising: providing a rigid container containing the aqueous media, ensuring the removal of all or most bulk gas phase from the contained aqueous media, sealing the container with a rigid air-tight closure; and cooling the aqueous media to a temperature below 0°C. (page 5, paragraph 029).
(b) Powell-Palm teach within the container, preserved biologics may be stored in an inner flexible container. Powell-Palm teach the inner container may also be filled with an aqueous solution, be completely free of air, and sealed. Powell-Palm teaches inner containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024). The sealed container would prevent transmission of mass.
(c) Powell-Palm teach an inner container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
(d) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution (page 33, claim 1). Powell-Palm teach the aqueous environments that remains liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
Regarding claim 23, Powell-Palm teach methods and devices for high-stability and optionally transportable supercooling of aqueous solutions or suspensions, and the stable and long-term preservation of biological matter that may be stored therein. (page 1, abstract).
(a) Powell-Palm teach supercooling of aqueous media, the method comprising: providing a rigid container containing the aqueous media, ensuring the removal of all or most bulk gas phase from the contained aqueous media, sealing the container with a rigid air-tight closure; and cooling the aqueous media to a temperature below 0°C. (page 5, paragraph 029).
(b) Powell-Palm teach a secondary container may be used to house one or multiple primary isochoric containers (page 16, paragraph 0154). Powell-Palm teach within the container, preserved biologics may be stored in an inner flexible container. Powell-Palm teach the inner container may also be filled with an aqueous solution, be completely free of air, and sealed. Powell-Palm teaches inner containment will protect the biologics from osmotic damage in the event that ice forms in the principal supercooled media (page 4, paragraphs 023-024). The sealed container would prevent transmission of mass.
(c) Powell-Palm teach an inner container for the preserved biologic and filled with an aqueous solution (page 30, paragraph 0275). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
(d) Powell-Palm teach the environment surrounding the inner container may be filled with an aqueous solution (page 33, claim 1). Powell-Palm teach the aqueous environments that remain liquid at sub-zero centigrade temperatures and prevents ice nucleation (page 18, paragraph 0174).
Regarding claim 24, Powell-Palm teach monitoring capabilities, active control capabilities, (e) energy delivery capabilities, and cooling capabilities are incorporated (page 14, paragraph 0149).
(h) Powell-Palm teach the container may feature on-board or off-board control capabilities, which employ a microprocessor, computer, or other programmable processing device to (g) monitor the pressure reading and heating (page 3, paragraph 012). The controller may continuously monitor the pressure and tum off the energy delivery module (heating) when the pressure returns to beneath the threshold value. This ensures that the (f) temperature in the system is elevated only to just above the freezing point of the medium and the stored biologic remains cold and preserved. The container is then allowed to return to the desired preservation temperature and supercooling is resumed (page 15, paragraph 152).Regarding claim 26, Powell-Palm teach the outer container may be fabricated from a transparent rigid material (page 18, paragraph 0172).
Regarding claim 27, Powell-Palm teach a secondary container may be used to house one or multiple primary isochoric containers for the purposes of transportation. Powell Palm teach the container may include measures to protect the housed primary container from vibration (page 16, paragraph 0154).
Claim Rejections - 35 USC § 103
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Powell-Palm (WO 2021/146122 Al) as applied to claims 1, 2, 18 above, and further in view of and Zeng et al. (KeAi, 2021).
Regarding claim 19, Powell-Palm teach within the primary container, preserved biologics may be stored in an inner container, such as a bag, balloon, covered vial or tube, or other vessel with a flexible surface (page 4, paragraphs 023-024). Powell-Palm do not specifically teach the flexible inner container is a tissue adhesive.
Zeng et al. teach tissue adhesive for cryopreservation of tissue (page 229, Title).Zeng et al. teach tissue adhesive hydrogel has excellent cold-resistance and efficient recoverability at a low temperature (page 234, Conclusions).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Powell-Palm et al. for the flexible inner container with the teachings of Zeng et al. for tissue adhesive for cryopreservation of tissue. Zeng et al. provide motivation by teaching that the tissue adhesive hydrogel has excellent cold-resistance and efficient recoverability at a low temperature. One of skill in the art would have had a reasonable expectation of success at combining Powell-Palm et al. and Zeng et al. because both teach cryopreservation of a tissue.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Powell-Palm (WO 2021/146122 Al) as applied to claims 20, 21, 22, and 23 above, and further in view of Thomas Scientific (2016).
Regarding claim 25, Powell-Palm teach the inner container is a bag, balloon, covered tube, or covered vial. Powell-Palm do not specifically teach the container is low-density polyethylene.
Thomas Scientific teaches LDPE sample bags are ideal for samples (page 1, description and specification).Thomas Scientific teaches the bags are clear for easy identification of contents and waterproof to protect samples and keep them dry (page 1, description and specification).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Powell-Palm et al. for an inner container which is a bag, balloon, covered tube, or covered vial with the teachings of Thomas Scientific for LDPE sample bags for storage and preservation. Thomas Scientific provide motivation by teaching that the bags are waterproof to protect samples and clear for easy sample identification. One of skill in the art would have had a reasonable expectation of success at combining Powell-Palm et al. and Thomas Scientific because both teach bags for sample storage and preservation.
Response to Arguments
Applicant’s arguments, see pages 15-18, filed 04/27/2026, with respect to claims 1--27 have been fully considered and are not persuasive.
Applicant’s Arguments: Powell-Palm teach the aqueous solution employed in the primary container need not be the same as employed within the secondary container. In preferred embodiments, the solution employed within the secondary container may have a lower freezing point than that within the primary container.
Applicant argues Powell-Palm teaches that, in the preferred embodiment, the inner solution has a lower freezing point than the outer solution. Powell-Palm teaches that the lower freezing point of the inner solution is necessary for ensuring that ice nucleation will occur in the outer solution, and thus the biological material in the inner container will be protected from osmotic damage and damage from ice nucleation.
Examiner’s response: The applicant is pointing to an embodiment where the inner liquid has a lower freezing point than the outer solution, however that does not encompass the entire scope of the invention. However, there are various other embodiments taught by Powell-Palm. One embodiment teaches the primary outer container can contain alginate or hyaluronic acid to facilitate reactions at temperatures equal to or below 0ºC (column 34, claims 18-20). Powell-Palm teach the outer container may contain an aqueous medium which optionally features chemical cryoprotectants to modulate the range of temperatures in which the system is supercooled or an increase in the degree and stability of supercooling at a given preservation temperature. Powell-Palm teach the chemical cryoprotectants could be dimethyl sulfoxide, ethylene glycol, polyethylene glycol, 3-OMG, glycerol, antifreeze proteins etc. The aqueous medium may also include any other solute or combinations of solutes which reduce the freezing point of the solution, such as trehalose, glucose, fructose, mannitol, betaine, or glycine (column 4, lines 10-20). Therefore Powell-Palm describe embodiments where the freezing point of the outer solution would be lower than that of the inner solution. While Powell-Palm describes an embodiment where the solution employed within the secondary container may have a lower freezing point than that within the primary container (column 30, lines 20-25). Powell-Palm teach that this arrangement ensures that should the system destabilize, ice nucleation will occur in the primary container, and the biologic will thus be protected both from osmotic damage and ice damage, Powell-Palm does not require this arrangement nor claim it necessary to the invention described.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,270,601 although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method for decreasing ice nucleation during preservation of biological subject matter in isochoric systems and further the secondary container.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,270,601 although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method for decreasing ice nucleation during preservation of biological subject matter in isochoric systems.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12,270,601 Although the claims at issue are not identical, they are not patentably distinct from each other because both recite storage temperatures equal to or below 0° C.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant’s Argument: Claim 1 of U.S. Patent No. 12,270,601 does not teach or suggest at least the following features of Claim 1 of the present application: (a) an inner container; (b) adding an inner solution into the inner container; (c) removing bulk gas from the inner container, (d) sealing the inner container; and (e) placing the inner container in an outer container.
In addition, claim 1 of U.S. Patent No. 12,270,601 does not teach or suggest that the outer solution has a melting point that is lower than the equilibrium melting point of the biological matter and lower than the equilibrium melting point of the inner solution.
Examiner’s response: While claim 1 does not teach all limitations of claim 1 of the present application. Claim 17 of U.S. Patent No. 12,270,601 teaches all of the limitations of claim 1 and further teaches an inner container with an aqueous solution with an equilibrium freezing temperature lower than that of the surrounding aqueous media. The claims of U.S. Patent No. 12,270,601 make obvious the present invention.
Applicant’s Arguments: Applicant argues that claim 2 of U.S. Patent No. 12,270,601 does not teach or suggest at least the following features of Claim 2 of the present application: (a) an inner container; (b) removing bulk gas from the inner container, (c) sealing the inner container; and (d) placing the inner container in an outer container. In addition, for the same reasons discussed above, claim 1 of U.S. Patent No. 12,270,601 does not teach or suggest that the biological matter has a melting point, and the outer solution has a melting point that is lower than the melting point of the biological matter, as recited in Claim 2 of the presently claimed invention.
Examiner’s response: While claim 2 does not teach all limitations of claim 1 of the present application. Claim 17 of U.S. Patent No. 12,270,601 teaches all of the limitations of claim 1 and further teaches an inner container with an aqueous solution with an equilibrium freezing temperature lower than that of the surrounding aqueous media. The claims of U.S. Patent No. 12,270,601 make obvious the present invention.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights