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 § 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.
Claim(s) 1, 2, 13, 14 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kochar et al. (U.S. 2020/0105409, hereafter referred to as Kochar).
Regarding claims 1 and 13, Kochar teaches a method for performing a function check of a fluid handling system (see para. 0743, ‘The present invention also includes methods for qualifying the operation and performance of the assay systems’), the method comprising: dispensing a first reference dose of a fluid into a reference container using a first fluid dispenser (see para. 0747, ‘The washer dispenses a predetermined amount of wash buffer, into each well in an assay plate’); measuring a first fluid height of the first reference dose in the reference container with a fluid level sensing system of the fluid handling system (see para. 0747, ‘The pipettor using the capacitive liquid level sensing, discussed above, is used to gauge the liquid levels in the well’); changing a status of the fluid handling system based on the measured first fluid height (see para. 0748, ‘if one of the above qualification steps fails, the entire qualification process may stop to conserve qualification consumables’), determining a first volume of dispensed fluid of the first reference dose based on the measured first fluid height (see para. 0747, ‘Since the amount of wash buffer and the volume and shape of each well are known, the liquid level in each well should also be known’), wherein changing the status of the fluid handling system is based on the determined first volume: dispensing a second reference dose of the fluid measuring a second fluid height of the second reference dose with the fluid level sensing system of the fluid handling system (see para. 0747, ‘The washer dispenses a predetermined amount of wash buffer, into each well in an assay plate’; the phrase “each well” suggests there exists a second fluid, and a corresponding second fluid height/volume to be determined): and determining a second volume of dispensed fluid of the second reference dose based on the measured second fluid height (see para. 0747, ‘Since the amount of wash buffer and the volume and shape of each well are known, the liquid level in each well should also be known’; see para.0747, ‘In one example, an eight-pipette system can check the liquid level from one column to the next until all 12 columns in a 96-well assay plate are checked. Consistent reading of the liquid level in each well would qualify the plate washer's dispensing capability’), wherein changing the status of the fluid handling system is based on the determined first volume and the determined second volume (see para. 0748, ‘if one of the above qualification steps fails, the entire qualification process may stop to conserve qualification consumables’).
Regarding claim 2, Kochar further teaches wherein changing a status of the fluid handling system based on the first measured reference fluid height comprises toggling between a normal mode where user-initiated operation of the fluid handling system is enabled and an error mode where user-initiated operation of the fluid handling system is restricted (see para. 0748, ‘if one of the above qualification steps fails, the entire qualification process may stop to conserve qualification consumables. Also, preferably the above qualification process should be completed before the assay system (900, 1000) is first used...the operation and performance qualification can be automated and the user/technician can be guided or prompted by the user interface on the assay system to load the consumable, preferably from a qualification kit, and activate the qualification. Preferably, the operation and performance qualification of the system may be evaluated for PASS/FAIL criteria by the software running the assay system, without requiring user interaction’).
Regarding claim 14, Kochar further teaches wherein the functionality evaluation comprises determining acceptable functionality of the fluid handling system (see para. 0748, ‘Preferably, the operation and performance qualification of the system may be evaluated for PASS/FAIL criteria by the software running the assay system’).
Regarding claims 31 and 32, Kochar further teaches wherein the fluid transferer comprises a pipette system 1021.
Additionally, it has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer, 1962 C.D.408 (1961).
Regarding claim 33, Kochar teaches a robotic fluid handling system 1000 comprising: a controller (see para. 0237, ‘an electronic enclosure 1009 configured to house a system control computer’); a stationary deck 1012; a fluid reservoir positioned on the deck (see para. 0237, ‘one or more wells of a multi-well assay plate positioned on the preparation platform’); a transport device 1002 controlled by the controller to move in three-dimensional space; and a fluid dispenser 1021 configured to dispense fluid into the fluid reservoir, the fluid dispenser arranged and adapted to be moved in three-dimensional space by the transport device (see para. 0237, ‘a multi-channel pipetting tip head, which is used to dispense/draw fluids to/from wells of a multi-well plate. The pipetting subsystem is affixed to a gantry (1022) within the robotic system that enables the pipetting tip head to move throughout the assay system in the X, Y, and Z direction’), the fluid dispenser comprising a capacitance sensor (see para. 0747, ‘The pipettor using the capacitive liquid level sensing’), wherein the controller is configured to detect contact of the fluid dispenser with a liquid level disposed in the fluid reservoir based on the amount of capacitance sensed by the capacitance sensor, wherein the controller is further configured to determine operability of the robotic fluid handling system based on the sensed capacitance (see para. 0748, ‘Preferably, the operation and performance qualification of the system may be evaluated for PASS/FAIL criteria by the software running the assay system’); and wherein the controller is further configured to determine a volume of liquid dispensed from the fluid dispenser based on comparing sensed liquid levels to reference information accessible to the controller (see para. 0747, ‘The washer dispenses a predetermined amount of wash buffer, e.g., 300 μl, into each well in an assay plate. Since the amount of wash buffer and the volume and shape of each well are known, the liquid level in each well should also be known’).
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.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kochar in view of Elsenhans (U.S. 2010/0097231).
Regarding claim 10, Kochar teaches the claimed invention except wherein changing the status of the of the fluid handling system is based on whether the measured first fluid height is above or below the threshold height.
Elsenhans teaches a similar process and system wherein a method for monitoring a program controlled pipetting process comprising the steps of selecting a program for treating a fluid, the program identifying at least a first volume of the fluid, providing an instrument for automated pipetting of fluid, the instrument comprising a pipettor, a susceptibility measurement unit, a controller for controlling operation of the pipettor, and a controller for controlling the susceptibility measurement unit, the controller for controlling operation of the pipettor operating according to the selected program, pipetting with the pipettor a first volume of fluid into a container, the pipettor under control of the controller for controlling operation of the pipettor, conducting a non-contact capacitive susceptibility measurement of the container and the first volume of fluid therein, calculating a calculated volume in the container from the susceptibility measurement, comparing the calculated volume with the first volume of fluid, releasing a volume discrepancy indication if the calculated volume deviates from the first volume of fluid by more than a threshold volume (see claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Kochar with the teaching of Elsenhans in order to provide a threshold for a PASS/FAIL system.
Allowable Subject Matter
Claims 7, 9-12, 16, 18-20, 23, 24 and 26 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMEL E WILLIAMS whose telephone number is (571)270-7027. The examiner can normally be reached Monday-Thursday 10am-4pm.
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/JAMEL E WILLIAMS/ Primary Examiner, Art Unit 2855
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