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 Rejections - 35 USC § 112
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 1-14 and 16-21 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 respect to Claims 1 and 3-5, it is unclear what constitutes a “standard blood processing procedure” and a “non-standard blood processing procedure,” and the specification does not provide any clarification or special definition of either of these terms.
For examination purposes, the examiner has interpreted a standard blood processing procedure to be any procedure that is pre-programmed onto the controller, and a non-standard blood processing procedure to be any procedure that differs from the standard, pre-programmed procedure in any way (i.e. via manual edits to pump flow rates, etc.).
Claims 2-14 and 16-21 are rejected at least because they depend from rejected Claim 1.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2002/0179544) in view of Min (US 2019/0201916).
With respect to Claim 1, Johnson teaches a configurable automated blood component manufacturing system (see Abstract, Figures 1-19B, paragraphs [0040-0045] and [0064-0066]) comprising:
a durable hardware component comprising
a pump station 16 with plurality of pumps [0045],
a microprocessor-based controller (paragraphs [0040] and [0043]) including a touchscreen 12 (Figure 1, paragraph [0043]) for receiving operator input and displaying procedure parameters,
hangers for suspending containers,
a weight scale associated with each hanger configured to send a signal to the controller indicative of a weight of a container supported on an associated hanger (suspended from arm 24 and weight scale 26; paragraph [0048]),
a plurality of tubing clamps [0044], and
a cassette nesting module (the front surface of the device that receives the cassette, as shown in Figures 1 and 2A) including a plurality of valves (clamp module 14 comprises a plurality of clamps/valves; paragraph [0044]) and pressure sensors 18 (one or more pressure transducers; see paragraph [0046]); and
a single use fluid flow circuit comprising
a fluid flow control cassette 30 configured to be mounted in the cassette nesting module, the cassette having external tubing loops (Figure 2A) engageable with the pumps so that fluid flow through the cassette is controlled by actuation of the pumps and valves [0045-0049], and
a plurality of containers (34, 40, 42, 44, 46) in fluid communication with the cassette by a tubing segment associated with each container, with one or more
of the tubing segments configured to be received in one of the tubing clamps (see Figures 2A-2B), wherein
the controller is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by an operator by input to the touchscreen (paragraph [0064]; paragraph [0065] teaches default programming options), and
the controller is further configured to be programmed by the operator to perform additional blood processing procedures (paragraph [0064]; paragraph [0066 teaches additional programming options).
Johnson does not specifically teach a centrifuge mounting station and drive unit, an optical system associated with the centrifuge mounting station and drive unit, and a separation chamber configured to be received in the centrifuge mounting station and drive unit.
However, centrifugation is a well-known alternative to Johnson’s separation by a spinning membrane module. For example, Min teaches a centrifuge mounting station and corresponding separation chamber for separating blood into its components (Figure 1; paragraphs [0090-0091]). Min further discloses that the centrifuge is used in conjunction with an optical system for detecting the interface between separated blood components (paragraphs [0146-0151]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Johnson’s automated blood processing system to have a centrifuge mounting station and drive unit, an optical system associated with the centrifuge mounting station and drive unit, and a separation chamber configured to be received in the centrifuge mounting station and drive unit, as suggested by Min, in order to provide a well-known alternate means for separating blood components and to allow detection of the interface between the separated blood components.
With respect to Claim 2, Johnson teaches that the controller is programmed to perform at least one of processing blood cells and plasma, red cell washing, platelet washing, and pooling and separation into a platelet product. See entire disclosure, especially Abstract, paragraphs [0040-0045], [0064-0066, and [0289]).
With respect to Claim 3, Johnson teaches that the controller is configured to receive input from the operator through the touchscreen (paragraphs [0042-0043], [0056], and [0065]), thereby enabling operating of the system to perform edits/modifications to a procedure (i.e. perform a “non-standard procedure”; paragraphs [0014], [0043], [0056], [0066], [0071], and [0073]).
With respect to Claim 4, Johnson teaches that the controller is configured to receive input from the operator to control fluid flow rates and fluid paths of the system [0043].
With respect to Claim 5, Johnson’s pre-programmed system is configured to operate the system at pre-set settings for flow rates [0043], and is configured to receive input from the operator as to one or more flow rates to override the pre-programmed settings (i.e. the system is capable of receiving inputs from the user that edit the pre-programmed flow rates; paragraphs [0014], [0043], [0056], [0066], [0071], and [0073]).
When combined with Min as suggested above with respect to Claim 1the resultant system would be configured to control the flow rates and centrifugation forces of for pre-programmed and non-standard, edited system control settings.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson and Min as applied to claims 1 and 5 above, and further in view of Gibbs (US 2018/0154067).
With respect to Claim 6, Johnson and Min reasonably suggest the system of Claims 1 and 5, but do not specifically teach that the programmable controller is further configured to receive input from the operator to initially accelerate to a first centrifugal force and/or flow rate over a first period of time, and then to accelerate or decelerate to a second centrifugal force and/or flow rate over a second period of time.
Gibbs teaches a blood processing centrifuge system for separating blood into its components (Abstract), the system being configured to operate at a first speed for a predetermined period of time. Thereafter, the speed of the centrifuge may be increased from the current speed to a faster second speed that creates a second centripetal acceleration that results in additional separation of the components in the chambers of the system. This step results in additional plasma being separated from the white and red blood cells (paragraph [0104]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the blood processing system of Johnson and Gibbs to have the programmable controller further configured to initially accelerate to a first centrifugal force over a first period of time, and then to accelerate to a second centrifugal force and/or flow rate over a second period of time, as suggested by Gibbs, in order to provide a well-known means for providing additional separation of plasma from red and white blood cells, thereby improving the efficiency of the system.
Allowable Subject Matter
Claims 7-14 and 16-21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
The prior art does not teach or suggest an automated blood processing system comprising a controller that is configured to perform each of the steps in dependent claims 7, 9, 11, and 13.
Claims 8, 10, 12, 14, and 16-21 are allowable due to their dependency from claims 7, 9, 11, or 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hashimoto (US 2016/0199563) teaches an extracorporeal blood circuit with a touchscreen controller.
Min (US 8,075,468) teaches a blood processing apparatus comprising a controller and a plurality of bags and scales.
Brown (US 6,899,666) teaches a blood processing apparatus comprising a centrifuge for separating blood into its components.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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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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/PHILIP R WIEST/Primary Examiner, Art Unit 3781