DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 27 May 2026. Claims 1 and 2 have been amended. Claims 12-17 remain withdrawn. Claims 1-11 are currently pending and under examination.
This application claims benefit of priority to U.S. Provisional Patent Application No. 62/784045, filed December 21, 2018.
Withdrawal of Rejections:
The rejection of claims 1-11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn.
The rejection of claims 1-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification of Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 103
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Argento (IDS; WO 2008/035240; Published 2008), in view of Ilyin et al. (US 2015/0305324; Published 2015 – Previously Presented).
With regard to claim 1, Argeto teaches, referring to Fig. 1, a platelet freezing system comprising: a fluid circuit including a container (8) of freezing solution, which is a platelet additive solution, a platelet storage container (1), and tubing (2, 5) interconnecting the platelet storage container (1), and the additive solution (8), and establishing a flow path therebetween (Abs.; Fig. 1; claim 1). The system further comprising a platelet concentrate container (9), which is a container of platelets configured to be joined to the circuit (Fig. 1).
Argeto further teaches that the system allows for freezing and thawing of the platelet units contained in the system (claim 1). However, Argeto does not specifically teach a freezable storage unit comprising a housing defining a plurality of insets/compartments within the housing for holding the platelet storage container and/or platelet concentrate container, the housing comprising a waterproof material that allows frozen platelets to thaw.
Ilyin et al. teach a system for cooling, storing, and transporting blood products, including platelets and platelet concentrate, contained in bags in a housing held in a horizontal position (Abs.). The system includes a storage unit that has casings, which are housing, providing a plurality of compartments for holding the bags containing the blood products, including the platelet concentrate, wherein that plurality of compartments are stacked and fluidly connected together (Fig. 12, Para. 49, 80). The stacked casings together are a housing defining a plurality of compartments, and make up the storage unit. The housing can be made of metal, wood, composite material, ceramic, or fiber reinforced materials (Para. 13); thus, the storage unit/housing includes material that is both freezable and waterproof, which would necessarily allow for freezing and thawing of platelets contained within. The bags containing the blood products are placed in the housing in a horizontal configuration, which is holding the bags in a lay-flat configuration (Fig. 12). The horizontal configuration for cooling and storage results in a higher viable cell count than a vertical configuration (see Fig. 1).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Argeto and Ilyin et al., because both teach a system for preservation of biomaterials including of blood products, including platelets. A preservation system that includes a storage unit made of freezable materials comprising a housing including a plurality of compartments within the housing for holding a bag of platelets, the housing comprising a waterproof material that allows frozen platelets to thaw, where the bags in the system are held in a horizontal, which is a lay-flat, configuration, is known in the art as taught by Ilyin et al. One would have been motivated to utilize the system of Ilyin et al. et al., in the cryopreservation kit of Argeto, as Argeto teaches that the kit is a platelet freezing system, but does not teach an overall housing for the taught components that is used for the freezing/thawing. The inclusion of a freezable storage unit including a plurality of compartments within the housing for holding containers of platelets, as taught by Ilyin et al., would have been expected to predictably and successfully provide a means by which the platelets in the cryopreservation kit of Argeto may be frozen, thawed, and transported, that advantageously will also provide a higher viable cell count due to the horizontal configuration. Wherein, the container of platelets as taught by Ilyin et al. are a sample of platelets intended to be preserved, and thus may be used as the platelets in the fluid circuit of Argeto.
With regard to claim 2, as Ilyin et al. teach that multiple platelet-filled containers may be included in one system (see Fig. 12), it would have been obvious to one of ordinary skill in the art to store multiple platelet containers in the system along with the platelet additive solution, wherein each housing in the system is a compartment for holding a container of platelets and a platelet storage container. The rationale for combining Argeto with Ilyin et al. has been set forth previously.
With regard to claims 3-5, Argeto teaches that the kit includes a sterile docking site (7, 4) for the container of cryopreservation solution (8) and a container of platelet concentrate/storage (1, 9) (see Fig. 1; p. 5, Para. 3 to p. 6, Para. 1).
With regard to claim 6, Ilyin et al. teach that the housing includes a casing (30), wherein when the casing is open, the housing includes and open top, and the casing is the lid (see Fig. 3). As such, the housing comprises an open top and a lid. The rationale for combining Argeto with Ilyin et al. has been set forth previously.
With regard to claims 7-9, Argeto teaches that the tubes connecting the components of the kit can be held in place with clamps and “Y” connectors (p. 2, Platelet Freezing System, Para. 10-11), both of which are tubing guides, and compartments for accommodating the tubing. Further, a clamp is deemed to comprise two, which is a plurality, of upstanding members, around which the tube is threaded.
With regard to claims 10 and 11, Ilyin et al. teach that the housing can be made of metal (Para. 13), which is a material capable of allowing a cryopreserved platelet product to thaw in approximately 5 minutes or less at a temperature of approximately 37°C (see Spec., para. 29). Additionally, the housing includes components made of plastic (Para. 12), wherein plastic is a polymeric material, and thus is suitable for exposure to temperatures up to about -80°C without damage. The rationale for combining Argeto with Ilyin et al. has been set forth previously.
Response to Arguments
Applicant urges that Ilyin does not cure the deficiencies of Argento, because Ilyin does not disclose a storage unit having a housing that defines a plurality of insets/compartments within the housing. Instead, Ilyin’s device includes multiple casings, including high-strength casings including first and second pockets, that can be stacked, where each casing is designed to hold a bag of blood products. Thus, Ilyin does not describe or suggest a housing that defines a plurality of insets or compartments. Additionally, an ordinary artisan would not combine Ilyin with Argento, because doing so would render Argento inoperable for its intended purpose, as Ilyin teaches that the platelet concentrate is at least partially saturated with xenon gas, and cooled, but not frozen.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument that Ilyin does not disclose a storage unit having a housing that defines a plurality of insets/compartments within the housing; Ilyin teaches that the system includes a storage unit that has casings, which are housing, providing a plurality of compartments for holding the bags containing the blood products, including the platelet concentrate, wherein that plurality of compartments are stacked and fluidly connected together (Fig. 12, Para. 49, 80). It is noted the stacked casings together are a housing defining a plurality of compartments and making up the freezable storage unit (i.e. each casing is a separate compartment contained within the overall housing/storage unit).
With regard to Applicant’s argument that an ordinary artisan would not combine Ilyin with Argento, because doing so would render Argento inoperable for its intended purpose, as Ilyin teaches that the platelet concentrate is not frozen; it is noted that the materials used in the storage unit of Ilyin et al. cannot be separated from their properties. Ilyin et al. teach that the housing can be made of metal or plastic (Para. 12-13), which are materials capable of being frozen and that are waterproof (see for example Spec., para. 29). The inclusion of a freezable storage unit including a plurality of compartments within the housing for holding containers of platelets, as taught by Ilyin et al., would have been expected to predictably and successfully provide a means by which the platelets in the cryopreservation kit of Argeto may be frozen, thawed, and transported, that advantageously will also provide a higher viable cell count due to the horizontal configuration.
Conclusion
No claims are allowable.
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.
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/JENNIFER M.H. TICHY/
Primary Examiner, Art Unit 1653
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