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 Objections
Claim 1 is objected to. It is suggested that “case housing the peristaltic pump” be amended to “a case housing the peristaltic pump” in order to enhance the clarity of the claim.
Claim 18 is objected to. It is suggested that “case housing the peristaltic pump” be amended to “a case housing the peristaltic pump” in order to enhance the clarity of the claim.
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.
Claim 19 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Brown (U.S. Publication 2017/0354941).
Regarding claim 19, Brown teaches A replaceable subsystem of a liquid handling system (items 20, 2011, 2021 are considered reading on the replaceable subsystem), the replaceable subsystem being configured to engage with a reusable subsystem comprising a peristaltic pump (this is considered intended use of the replaceable subsystem), a valve assembly comprising a plurality of valves (this is considered intended use of the replaceable subsystem), two or more bubble sensors each arranged to detect bubbles in a fluid path, a system controller configured to receive input from the bubble sensors (the bubble sensors are considered intended use of the replaceable subsystem),control operation of the peristaltic pump, and control operation of the valve assembly in accordance with a programmed processing protocol; and a case housing the peristaltic pump (the controller is also considered intended use of the replaceable subsystem), and valve operation assembly (the valve operation assembly is considered intended use of the replaceable subsystem), the replaceable subsystem comprising: replaceable subsystem comprising: a fluid path manifold comprising one or more fixed geometry fluid paths (item 20 is considered comprising at least one fixed geometry fluid path for material to flow through), at least one of the fluid paths being configured for engagement with the valve assembly whereby fluid paths can be selectively opened or closed by operation of the valve assembly (paragraph 69 teaches the valves are used with manifold 20), the fixed geometry of at least one fluid path being arranged to sit proximate the bubble sensors when secured in the housing such that the bubble sensors can identify bubbles within the fluid path (item 20 has an internal fixed path and is proximate item 33b housed in item 33 as taught in paragraph 61); a pump tube configured to enable operable engagement between the peristaltic pump and the fluid paths to cause fluid flow within the manifold by operation of the peristaltic pump (item 221 which causes fluid flow within the manifold 20 by operation of item 40); a plurality of a plurality of liquid input ports each configured for connection to respective liquid supply components for delivery of respective liquids to the one or more fluid paths (see fluid lines feeding upstream and into item 20); at least one gas inlet connected to at least one of the one or more fluid paths to enable gas to enter the fluid path (the gas is considered intended use, paragraph 2 teaches the feeding of fluids which is considered capable of feeding a gas); and at least one outlet port in fluid communication with the one or more fluid paths to dispense fluid (opening in item 20 through which lines feed material through item 33), the replaceable subsystem providing a closed environment for mixing and dispensing liquid formulations (the lines and manifold are not in fluid communication with the atmosphere and considered a closed environment for mixing and dispensing), wherein the controller determines a volume of liquid in one of the fluid paths based on action of the peristaltic pump and inputs from at least one bubble sensor associated with the respective fluid path (paragraph 69 item 2900 teaches using the rotors, stepper motors and valves, paragraph 98 teaches using the control panel and bubble sensor for checking the leakage in the tube, and is considered capable of determining the volume of liquid in the fluid path based on the action of the pump and bubble sensor).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 2, 3, 4, 5, 6, 7, 8, and 18, are rejected under 35 U.S.C. 103 as being unpatentable over Brown (U.S. Publication 2017/0354941).
Regarding claim 1, Brown teaches a liquid handling system (figure 1, 2A-B, 3A-H) comprising: a reusable subsystem (item 40, 21a, 21b, 33b, item 2900, and items 10f and 10g are considered reading on the reusable subsystem); and a replaceable subsystem (items 20, 2011, 2021 are considered reading on the replaceable subsystem ), the reusable subsystem comprising: a peristaltic pump (item 40); a valve assembly comprising a plurality of valves (items 21a and 21b); a bubble sensor arranged to detect bubbles in a fluid path (item 33b); a system controller configured to receive input from the bubble sensors (item 2900), control operation of the peristaltic pump, and control operation of the valve assembly in accordance with a programmed processing protocol (paragraph 69 teaches using item 2900 to rotate valves 21a, 21b and rotors 41 and 42 to obtain a predetermined timing of material flow); and case housing the peristaltic pump, and valve operation assembly (items 10g and 10f, paragraph 77 teaches a housing for valves 21a and 21b), and the single use, replaceable subsystem comprising: a fluid path manifold comprising one or more fixed geometry fluid paths (item 20 is considered comprising at least one fixed geometry fluid path for material to flow through), at least one of the fluid paths being configured for engagement with the valve assembly whereby fluid paths can be selectively opened or closed by operation of the valve assembly (paragraph 69 teaches the valves are used with manifold 20), the fixed geometry of at least one fluid path being arranged to sit proximate the bubble sensors when secured in the housing such that the bubble sensors can identify bubbles within the fluid path (item 20 has an internal fixed path and is proximate item 33b housed in item 33 as taught in paragraph 61); a pump tube configured to enable operable engagement between the peristaltic pump and the fluid paths to cause fluid flow within the manifold by operation of the peristaltic pump (item 221 which causes fluid flow within the manifold 20 by operation of item 40); a plurality of a plurality of liquid input ports each configured for connection to respective liquid supply components for delivery of respective liquids to the one or more fluid paths (see fluid lines feeding upstream and into item 20); at least one gas inlet connected to at least one of the one or more fluid paths to enable gas to enter the fluid path (the gas is considered intended use, paragraph 2 teaches the feeding of fluids which is considered capable of feeding a gas); and at least one outlet port in fluid communication with the one or more fluid paths to dispense fluid (opening in item 20 through which lines feed material through item 33), the replaceable subsystem providing a closed environment for mixing and dispensing liquid formulations (the lines and manifold are not in fluid communication with the atmosphere and considered a closed environment for mixing and dispensing), wherein the controller determines a volume of liquid in one of the fluid paths based on action of the peristaltic pump and inputs from at least one bubble sensor associated with the respective fluid path (paragraph 69 item 2900 teaches using the rotors, stepper motors and valves, paragraph 98 teaches using the control panel and bubble sensor for checking the leakage in the tube, and is considered capable of determining the volume of liquid in the fluid path based on the action of the pump and bubble sensor). Regarding claim 1, Brown is silent to two bubble sensors. Regarding claim 1, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to duplicate the number of bubble sensors to better detect potential leaks since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 2, Brown teaches wherein the combination of fixed geometry fluid manifold and bubble sensor arrangements enable measurement of a known volume in at least one region within the fluid paths and the controller utilizes the known volume measurement to calibrate the peristaltic pump (items 20, 33b and 2900 are considered capable of calibrating item 40).
Regarding claim 3, Brown teaches wherein the peristaltic pump is automatically calibrated by the controller (paragraph 69, item 2900 controls rotors of pump and is considered capable of automatically controlling the rotors of the pump 40).
Regarding claim 4, Brown teaches wherein the peristatic pump is dynamically calibrated during execution of the one or more processing protocols (items 20, 33b and 2900 are considered capable of calibrating item 40, the processing protocols are considered intended use).
Regarding claim 5, Brown teaches wherein based on bubble sensor input, the controller utilizes the measurement of known volume to verify the volume of dispensed products (items 20, 33b and 2900 are considered capable measuring a known volume to verify the volume of dispensed products).
Regarding claim 6, Brown teaches wherein bubbles in fluid lines are used to separate small volumes of liquid and volume of each small volume of liquid is verified in at one region in the flow paths using bubble sensor data from each respective region (item 33b measures the presence of a bubble of material flowing proximate item 33). Regarding claim 6, Brown is silent to a second bubble sensor at a second region. Regarding claim 6, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to duplicate the number of bubble sensors to better detect potential leaks since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 7, Brown teaches wherein the verified volume data includes dispensed volume data (item 33 b along with item 2900 are considered capable of measuring volume at a region).
Regarding claim 8, Brown teaches wherein the gas inlet is an air inlet (the gas is considered intended use, paragraph 2 teaches the feeding of fluids which is considered capable of feeding a gas including air).
Regarding claim 18, Brown teaches reusable subsystem of a liquid handling system, the reusable subsystem comprising: a peristaltic pump (item 40); a valve assembly comprising a plurality of valves (items 21a and 21b); a bubble sensor arranged to detect bubbles in a fluid path (item 33b); a system controller configured to receive input from the bubble sensors (item 2900), control operation of the peristaltic pump, and control operation of the valve assembly in accordance with a programmed processing protocol (paragraph 69 teaches using item 2900 to rotate valves 21a, 21b and rotors 41 and 42 to obtain a predetermined timing of material flow); and case housing the peristaltic pump, and valve operation assembly (items 10g and 10f, paragraph 77 teaches a housing for valves 21a and 21b), wherein the pump, valve assembly and bubble sensors are arranged to engage with a fluid path manifold comprising one or more fixed geometry fluid paths (item 20 is in communication with items 40 and items 21a and 21b, see paragraph 69), whereby fluid paths can be selectively opened or closed by operation of the valve assembly (paragraph 69 teaches the valves are used with manifold 20), at least one fluid sits proximate each of the bubble sensor when secured in the housing such that the bubble sensor can identify bubbles within the fluid path (item 33b can detect bubbles within the fluid path extending through item 33), and the pump engage with a pump tube configured to enable operable engagement between the peristaltic pump and the fluid paths to cause fluid flow within the manifold by operation of the peristaltic pump (item 221 which causes fluid flow within the manifold 20 by operation of item 40), wherein the controller determines a volume of liquid in one of the fluid paths based on action of the peristaltic pump and inputs from at least one bubble sensor associated with the respective fluid path (paragraph 69 item 2900 teaches using the rotors, stepper motors and valves, paragraph 98 teaches using the control panel and bubble sensor for checking the leakage in the tube, and is considered capable of determining the volume of liquid in the fluid path based on the action of the pump and bubble sensor). Regarding claim 18, Brown is silent to two bubble sensors. Regarding claim 18, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to duplicate the number of bubble sensors to better detect potential leaks since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Allowable Subject Matter
Claims 10, 11, 12, 13, 14, 15, 16, and 17 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.
Regarding claim 10, the prior art does not teach or fairly suggest the system in combination with the controller configured to dispense the determined number of doses based on the particle count in a liquid sample being processed.
Regarding claim 12, the prior art does not teach or fairly suggest the method of calibrating the peristaltic pump with the combination of the reusable subsystem and replaceable subsystem.
Regarding claim 14, the prior art does not teach or fairly suggest a method with the combination of the reusable subsystem, replaceable subsystem with the controller configuration controlling the steps of the mixing operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774
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