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 .
Response to Amendments/Arguments
Applicant's amendments and arguments filed 22 September have been fully considered but they are not persuasive.
Applicant argues that Hardwick does not illustrate a single donation procedure, but rather a large-scale blood separation and separation program (Remarks at 12-13). While that may be the case, Applicant’s claims do are drawn to an apparatus, not a procedure, and do not reference a “single” donation procedure. Accordingly, Applicant’s arguments are narrower than the limitations of the claims.
Applicant concludes that since Hardwick does not disclose a blood processing procedure as desired by Applicant, it would not have been obvious to modify the controller of Min to arrive at the claimed configuration. However, Min discloses a blood processing apparatus with the claimed pump system, valve system, separator, and variable controller. Hardwick discloses an apparatus and procedure for separating blood into component parts, including plasma for collection and plasma for fractionation. Since Min discloses that the controller is programmable, and Hardwick discloses the various separated volumes claimed by Applicant, the references reasonably teach a blood processing device capable of performing a plasma collection step and a fraction plasma collection step.
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 US 8,075,468 to Min et al in view of Hardwick (as cited by Applicant).
In the specification and figures, Min discloses the apparatus substantially as claimed by Applicant. With regard to claims 1, 6, Min discloses a reusable centrifuge, pump, and valve assembly for use with a disposable fluid flow circuit (see FIG 2 and accompanying text, col 1 ln 22-26). The disposable circuit comprises a processing chamber 18, a blood supply container 312, a plasma collection container 304, a red blood cell container 308 (see col 7, ln 51-55; col 12, ln 18-32). A controller may be used to run various blood collection applications 254, which may vary (see col 18, ln 13-23). In a red blood cell and plasma collection procedure, the pump and valve system convey whole blood to a separation system, separating WB into plasma and red blood cells, collecting each in their respective containers (see col 34, ln 15-51). Min further discloses collection of a third component, the buffy coat, in a third container 376 (see col 59, ln 39-67). Min also discloses that the apparatus may be programmed in many different ways, including process to retain some of the plasma for storage or fractionation purposes (see col 61, ln 63 to col 62, ln 9). Min does not expressly disclose the step of separating the plasma into two separate containers.
However, Hardwick discloses that it is known in the art to process whole blood into various parts such that the components may be stored under ideal conditions, and maximizes the use of a single donation (see FIG 11-1, p 148). To that end, Hardwick illustrates a procedure wherein whole blood is separated into red cells, plasma, and platelets, wherein the plasma is further separated into a first portion of liquid plasma for therapeutic purposes, and a second portion for fractionation in order to maximize the use of excess plasma (see p163, 170-171). It would have been obvious to a person having ordinary skill in the art at the time of filing to program the Min apparatus to separate collected plasma into separate parts such as fresh plasma, and plasma for fractionation, in order to maximize a single donation, as taught by Hardwick.
With regard to claims 2, 7 and 8, Min discloses that fluid weight may be used to determine target collection volumes and control the system (see col 19, ln 9-20).
With regard to claims 3-4, 9-10, Min discloses that the system may be programmed to move the fluid in a manner consistent with the desired collection protocol (see col 98, ln 44-68).
With regard to claims 5, 11, Min discloses the use of an additive solution being combined with collected red blood cells (see col 91, ln 42-col 92, ln 34).
Allowable Subject Matter
Claims 12-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: While the prior art generally teaches an apparatus for separating and collecting two separate plasma products in an apheresis session, the prior art fails to teach the priming steps claimed by Applicant. While Min discloses a priming operation, Min does not teach an apparatus with a controller that is programmed to execute a priming stage in which a controller controls a centrifuge to rotate at a first and second target rate or first and second target orientation while pumping fluid, along with the other steps and limitations of the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 6 October 2026
