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 Interpretation
Applicant has amended claim 1 to state “a single shut-off element actively associated with the connection tube”. Due to the phrasing “actively associated with”, this is interpreted to mean that there may be more than one shut-off element comprised within the device, but only one shut-off element associated with the function of the connection tube.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valerievich et al. (As cited on the IDS)
Regarding claim 1: Valerievich discloses a closed system method of thawing and resuspending human platelets which comprises a closed multi-chamber set up connected with tubing (abstract) with flow directed by roller clamps and a speed regulator. (22, 24) Specifically, the system comprises of a chamber intended for storing thawed platelets, a chamber intended for thawed plasma to resuspend said platelets in, and a chamber in which the two components are mixed. (25) Importantly, all containers intended for use in the disclosed system are either bags intended for cryopreservation or flasks intended for cryopreservation. (35-38) This reads on the claimed method of resuspending a cryopreserved body fluid comprising a cryopreservation container comprising the body fluid in a cryopreservation liquid, a resuspension container comprising a resuspension solution, a connection tube with at least one shut-off element which sterilely connects the chambers, and adding the resuspension solution to the cryopreservation container to create a resuspended body fluid product.
Regarding claim 2: Valerievich discloses the first container of the claimed invention which is designated for the thawing of cryopreserved platelets and plasma at 37°C for 5-10 minutes in separate containers followed by transferring to containers 1 and 3 of the claimed invention respectively. The resuspended platelets, no longer at 37°C, can then sit in container 1 while being mixed for 10-15 minutes. (41-57) In addition to this, Valerievich discloses that the resuspension of the cryopreserved platelets is carried out at a temperature of 20-24°C. (15) This reads on the method of claim 2 of resting the resuspended platelets of claim 1 for up to 30 minutes.
Regarding claims 3, 4, 8, and 9: Valerievich discloses that the purpose of the first chamber is to be used for the storage of defrosted platelets that are to be mixed with the defrosted plasma housed in the second chamber. (13-14) This reads on claims 3 and 4 due to the body fluid being cryopreserved platelets and claims 8-9 due to the resuspension solution being human plasma. One skilled in the art would know that plasma is a transfusable solution.
Regarding claim 5: Valerievich discloses that the objective of the multi chamber model is to prepare cryopreserved platelets for transfusion. (10) In addition, the device is designed to facilitate transfusion in the way that the first chamber is intended for placing and storing defrosted platelets, the second for placing defrosted plasma, and the third for the resuspension of cryopreserved platelets. (22)
Regarding claims 6 and 7: Valerievich discloses that the defrosted platelets may be stored in container 1 for up to 24 hours(13) and that the resuspension of cryopreserved platelets is at as temperature of 20-24°C (15), which reads on the claimed range of being shelf stable for up to 24h.
Regarding claim 10: Valerievich discloses that the claimed invention is a closed system in order to “achieve high quality of thawed platelets and eliminate the possibility of microbial contamination” (60), which reads on use of a closed and sterile system.
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive. Applicant has amended claim 1 to state use of “a single shut-off element actively associated with the connection tube”, and argues that Valerievich discloses thawing cryopreserved platelets and frozen plasma in separate containers then transferring said containers to the system of Valerievich. This is true for the protocol taught by Valerievich, but not the example taught by Valerievich. The example describes the process as follows: the thawing of more than 130 doses of cryopreserved platelets were thawed and resuspended in a device consisting of 3 containers and a speed regulator, connected with tubes containing clamps and was done on a way that resulted in the entire process being carried out in a closed circuit. (60) This clearly demonstrates the closed system process of Valerievich.
Furthermore, Applicant’s use of wording of a single shut-off element actively associated with the connection tube does not render the teachings of Valerievich obsolete. While it is true that Valerievich makes use of four clamps, each one is associated with a different tube (24), making each connection tube associated with a single shut-off element.
As such, the 35 U.S.C. 102(a)(1) rejection over claims 1-10 is maintained.
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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/HANNA MARIE THUESON/Examiner, Art Unit 1638
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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