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 .
Election/Restrictions
Applicant's election with traverse of Group I: Claims 1-7 and 13-20 in the reply filed on 6/8/2026 is acknowledged. The traversal is on the ground(s) that a search for the subject matter of Group I would overlap the search for Group I without serious burden. This is not found persuasive because Groups I and II are drawn to distinct systems that are part of a larger apheresis machine. A search for asystem for controlling a pump in response to a sensor does not overlap with a search for a system for controlling the brake of a centrifuge.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibbs (US 7,686,779).
With respect to Claim 1, Gibbs teaches a system for controlling a soft cassette assembly of an apheresis machine (Abstract and Column 10, Line 38 through Column 12, Line 14; the control system is capable of controlling an assembly wherein at least a portion of the cassette is soft), the system comprising:
at least one processor (Colum 6, Lines 52-54); and
at least one memory (the processor is configured to control the system, therefore the presence of memory containing an algorithm is implicit; Column 6, Lines 52-60) storing instructions that, when executed by the at least one processor, cause the system to:
receive at least one signal from at least one sensor of the soft cassette assembly;
actuate at least one valve (pump/valve/sensor assembly 1000 comprises divert valve assemblies 1100, 1110, 1120; Column 42, Lines 1-5) of the soft cassette assembly based on the at least one signal received from the at least one sensor; and
actuate at least one pump (pump/valve/sensor assembly 1000 comprises umps 1020, 1030, 1040, 1060, and 1090; Figure 3; Column 10, Lines 50-62; Column 11, Line 47 through Column 12, Line 14) based on the at least one signal received from the at least one sensor (Column 12, Lines 11-14).
With respect to Claim 2, Gibbs teaches that the at least one sensor comprises a pressure sensor and/or an ultrasonic fluid level sensor (the pressure/valve/sensor assembly comprises a plurality of pressure sensors (1200, 1260, 1224) and ultrasonic level sensors (1300, 1320)). See Column 11, Line 14 through Column 18, Line 54.
With respect to Claim 3, Gibbs teaches that the at least one valve comprises a plurality of fluid control valves configured to prevent fluid flow through the cassette assembly when closed and allow fluid flow through the cassette assembly when open (pump/valve/sensor assembly 1000 comprises divert valve assemblies 1100, 1110, and 1120; Column 42, Lines 1-5).
With respect to Claim 4, Gibbs teaches that the actuating of the at least one valve (1100, 1110, 1120) of the cassette assembly includes actuating the at least one valve to a closed position to redirect fluid from a first flowpath to a second fluid flowpath of the assembly. Specifically, blood separation control device 6 provides control signals to pump/valve/sensor assembly 1000 so that platelet divert valve assembly 1100 diverts the flow of separated platelets pumped through platelet outlet tubing 66 and platelet tubing loop 142 into platelet collection tubing 82 for collection in reservoir 84. If plasma collection is desired, blood component separation device 6 also provides control signals so that plasma divert valve assembly 1110 diverts the flow of separated plasma pumped through plasma outlet tubing 68 and plasma tubing loop 162 into plasma collector tubing 92 for collection in reservoir 94 (Column 41, Line 56 through Column 42, Line 17).
With respect to Claim 5, Gibbs teaches that the first fluid path is a direct flow lumen and the second flow path is a bypass path. The examiner notes that no structural specifics of the direct flow lumen and bypass path have been claimed. Therefore, one of Gibbs’ first and second lines discussed above with respect to Claim 4 have be interpreted as a bypass path.
With respect to Claim 6, Gibbs teaches that the at least one pump comprises a draw pump 1030, a return pump 1090, and an anticoagulant pump 1020 (Column 10, Lines 50-62; Column 12, Lines 11-14). See Figure 3.
Allowable Subject Matter
Claims 13-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art (Gibbs; cited above) does not teach or suggest that the apheresis machine comprises the system for controlling a soft cassette of Claim 1 is provided in combination with a centrifuge system including at least one second processor; and at least one second memory storing instructions that, when executed by the at least one processor, cause the centrifuge system to receive at least one signal from at least one centrifuge sensor, actuate a motor of the centrifuge to rotate the centrifuge at a desired speed setting, and actuate a brake of the centrifuge based on the at least one signal received from the at least one centrifuge sensor, and wherein the soft cassette assembly system and the centrifuge system are configured to communicate. While centrifuges with brakes are known in the art, it is unclear why one of ordinary skill would have provided a system with separate first and second controllers configured to operate and communicate as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bainbridge (US 2002/0033370) teaches an apheresis machine comprising a cassette and a plurality of pumps and valves for controlling fluid flow.
Flexman (US 2014/0100507) teaches an apheresis machine comprising an anticoagulant line with pumps and valves for controlling fluid flow.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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