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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 August 2025 has been entered.
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 Claims 12-17 remain withdrawn.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The rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over Argento, in view of Faust et al., is withdrawn.
Maintenance/Modification of Rejections:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 includes the limitation of a “post-cryopreservation platelet storage additive solution,” indicating that support can be found is paragraph [0034] of the published Application. This paragraph recites:
[ 0034 ] After the desired freezing period, storage units 90 and/or 100 may be removed from the freezer and thawed in a warm bath or other thermally controlled environment. Once the platelets in sub-chamber 59 and additive solution in container 64 have thawed, platelets may be expressed from sub-chamber 59 to platelet storage container 62. After breakage of frangible container 72, platelet additive solution or a portion thereof from container 64 may be expressed to platelet storage container 62. Some or all of the platelet additive solution may also be used to rinse sub-chamber 59 to ensure maximum platelet recovery. If only a portion of the additive solution is used to rinse sub-chamber 59, the remainder of the platelet additive solution from container 64 may then be added to platelet storage container 62.
This passage only recites the presence of a platelet additive solution in the system. The platelet additive solution is present in the system and frozen and may be used to rinse the sub-chamber and added to the platelet storage container. There is not a “post-cryopreservation platelet storage additive solution” present in this passage or in the application overall. Only a platelet additive solution is recited. There is no definition indicating what is included in the post-cryopreservation platelet storage additive solution, or how it differs from the platelet additive solution. As such, a “post-cryopreservation platelet storage additive solution” appears to be new matter.
Claims 2-11 are included in this rejection as these claims depend from above rejected claim 1, and fail to remedy the noted deficiencies.
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.
Claims 1-11 are 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.
With regard to claim 1, the term “post-cryopreservation platelet storage additive solution” is indefinite, because it is unclear how this solution differs from “platelet additive solution” as recited in the specification. Further, it is unclear what components are intended to be included in, or excluded from, this solution. No definition of a post-cryopreservation platelet storage additive solution is provided, and there does not appear to be any examples of this solution in the specification. For the purposes of examination, any solution suitable for being added to platelets is deemed to be encompassed within the term “post-cryopreservation platelet storage additive solution.”
Claims 2-11 are included in this rejection as these claims depend from above rejected claim 1, and fail to remedy the noted deficiencies.
Response to Arguments
With regard to the 112(a) written description rejection, Applicant urges that a post-cryopreservation platelet storage additive solution would be understood by one of ordinary skill in the art to be an additive solution that is added to platelets after cryopreservation, referring to para. 34 of the specification. The platelet additive solution is added only after the platelets have been cryopreserved and thawed, thereby describing a post-cryopreservation platelet storage additive solution.
With regard to the 112(b) indefiniteness rejection, Applicant urges that the element of a post-cryopreservation platelet storage additive solution is sufficiently described in the specification so that an ordinary artisan would understand the claims.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument about the 112(a) written description rejection; while paragraph 34 of the specification indicates that the platelet additive solution may be used, for example, to rinse platelets following cryopreservation, there is nothing in this paragraph, or in the specification as originally filed, that describes both a platelet additive solution and a “post-cryopreservation platelet storage additive solution.” There is no recitation of a “post-cryopreservation platelet storage additive solution,” or a recitation of how this solution differs in structure from the platelet additive solution that is recited throughout the specification. As such, a post-cryopreservation platelet storage additive solution is still deemed to be new matter.
With regard to Applicant’s argument about the 112(b) indefiniteness rejection; the make-up of the “post-cryopreservation platelet storage additive solution” is unclear, as this term is not recited in the specification. Additionally, this is not a known solution in the art that has specific components necessarily present. The original term of “platelet additive solution” has been changed to “post-cryopreservation platelet storage additive solution” in the claims, which appears to suggest that the solutions are different in composition. However, there is no indication in the specification or in the claims that there is any structural difference between the “platelet additive solution” and “post-cryopreservation platelet storage additive solution.” As such, it is still unclear what components are intended to be included in, or excluded from, the post-cryopreservation platelet storage additive solution as claimed.
New Rejections:
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).
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 deemed to be capable of being a post-cryopreservation platelet storage 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 freezing, 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 freezable 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 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 freezing and storage results in a higher viable cell count than a vertical configuration (see Fig. 1). The housing can be made of metal, wood, composite material, ceramic, or fiber reinforced materials (Para. 13); thus, the housing includes waterproof material that allows frozen platelets to thaw.
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 cryopreservation of biomaterials including of blood products, including platelets. A cryopreservation system that includes a freezable storage unit 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 the 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 cryopreserved, 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 for freezing 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
In view of Applicant’s amendments, the previous rejection of Argento in view of Faust has been withdrawn. Applicant’s arguments relating to Faust, and to the combination of Argento with Faust, are therefore moot. New Rejections have been set forth above. Applicant’s arguments relating to Argento as applicable to the current rejection will be addressed.
Applicant again urges that Argento does not teach a container of a post-cryopreservation platelet storage additive solution, instead teaching a freezing solution.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Argento, it is noted that the limitation of “post-cryopreservation platelet storage additive solution” is still indefinite, as discussed in the indefiniteness rejection presented above. Argeto teaches, referring to Fig. 1, a platelet freezing system comprising a container (8) of freezing solution (Abs.; Fig. 1; claim 1). Applicant has not provided any further limitations such as components included in the claimed “post-cryopreservation platelet storage additive solution” that would structurally distinguish this solution from that taught. As such, the freezing solution as taught by Argeto, which is a platelet additive solution, is deemed to be a post-cryopreservation platelet storage additive solution.
It is noted that the claims are directed to a kit and not to a method of using the kit. Applicant appears to be trying to indicate that the solutions are different because the claimed solution is added after cryopreservation and not before. However, the components of the solution are not claimed, and there does not appear to be any difference in structure of “platelet additive solution” and “post-cryopreservation platelet storage additive solution.” The only difference appears to be in the timing of how the solution is intended to be used, which does not alter the structure of the solution as present in the kit.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653