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 .
Status of Claims
This office action is responsive to the amendment filed 11 December 2025.
Claim 1 is amended.
Claims 4, 5, 11-20, 23, and 25 are canceled.
Claims 1-3, 6-10, 21, 22, and 24 are presently pending in this application.
Drawings
The drawings are objected to for the following reasons:
The figures are pixelated and blurry. All lines should be solid, dark, and continuous.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-3, 6-10, 21, 22, and 24 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.
Claim 1 recites the limitation “the face plate remains exposed from the cassette bay” in line 26-27 of the claim. It is unclear how the term “exposed” is to be interpreted, as there is no claim language that clarifies what the face plate is exposed to. For the purposes of examination, examiner interprets “the face plate remains exposed from the cassette bay” to mean -- the face plate remains visible from the cassette bay--.
The other claims cited above are rejected as they depend from independent 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 1-3, 6-10, 21, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Busby et al. (US Patent Publication No. 20030220598 A1), hereinafter Busby, in view of Wright et al. (Foreign Patent No. EP 3831481 A1), hereinafter Wright, in further view of Suzuki et al. (US Patent Publication No. 20020045851 A1), hereinafter Suzuki.
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Regarding claim 1, Busby discloses a fluid management system (Fig. 1, system 10), comprising: a control console (Figs. 3A-4B, hardware unit 110), including: a housing (Figs. 3A-4B, housing 112); a cassette bay (Fig. 3A above, cassette bay A) defined within the housing (Figs. 3A-4B, housing 112); and an actuation mechanism (Fig. 15, valve actuator 26) disposed within the housing (Figs. 3A-4B, housing 112; valve actuator 26 is included as part of system 10, which is disposed within the housing 112; para. 0082 and 0111), the actuation mechanism (Fig. 15, valve actuator 26) including a plurality of actuators (Fig. 15, pistons 204), wherein the actuation mechanism (Fig. 15, valve actuator 26) includes a cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202) configured to rotate to a plurality of different orientations (Fig. 16A, cam profile 370) corresponding to a plurality of different actuation combinations (Fig. 15, cams 202 are shaped to provide a unique combination of bumps and valleys for every flow situation; para. 0192) of the plurality of actuators (Fig. 15, 16A, and 16B, pistons 204 are actuated by cams 202a-202c, in which a protrusion of cams 202a-202c results in an actuated piston 204; para. 0197 and 0200-0205) including at least one combination wherein at least one of the plurality of actuators (Fig. 15, pistons 204) is actuated (Fig. 16A and 16B, cams 202a-202c are shaped to provide a unique combination of bumps and valleys for every flow situation. Examiner interprets that cams 202a-202c are shaped to provide any unique permutation of bumps and valleys to result in any piston 204 to be opened or closed; para. 0195), at least one combination wherein at least one actuator (Fig. 15, pistons 204) of the plurality of actuators (Fig. 15, pistons 204) is unactuated (para. 0195); and a cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160) insertable into a cassette bay (Fig. 3A above, cassette bay A) of the control console (Figs. 3A-4B, hardware unit 110), the cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160) including: a chassis (Fig. 3A, 4A, and 5, frame 186) supporting a plurality of fluid flow paths (Fig. 4A above, fluid flow paths B) through the cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160); and an outer housing (Figs. 5 and 6, formed by membranes 162 and 164) defining a plurality of access openings (Fig. 5, fluid inlets/outlets 196) providing access to the plurality of fluid flow paths (Fig. 4A above, fluid flow paths B); and a pump (Fig. 5, receptacle 172) disposed within the outer housing (Figs. 5 and 6, formed by membranes 162 and 164) of the cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160) and coupled to at least first and second flow paths of the plurality of flow paths (Fig. 4A above, receptacle 172 fluidly connected to each of the fluid paths B), and the third flow path (Fig. 4A above, one of fluid paths B) defining an input (Fig. 4A, one of fluid inlets 196) on a face plate (Fig. 3A, side of disposable unit 160 projecting the fluid inlets/outlets 196) and an output (Fig. 4A, one of fluid outlets 196) on the face plate (side of 160), wherein, with the cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160) positioned within the cassette bay (Fig. 3A above, cassette bay A), each actuator of the plurality of actuators (Fig. 15, pistons 204) is aligned with an access opening of a plurality of access openings (Fig. 5, fluid inlets/outlets 196) to enable each actuator (Fig. 15, pistons 204), upon actuation thereof, to close a corresponding fluid flow path of the plurality of fluid flow paths (Fig. 4A above, fluid flow paths B; para. 0195), and wherein, with the cassette (Figs. 3A, 4A, 5, and 6, disposable unit 160) position within the cassette bay (Fig. 3A above, cassette bay A), the control console (Figs. 3A-4B, hardware unit 110) is configured to drive the pump of the cassette (Fig. 4B, pump 20 drives pumping of receptacle 172), and, wherein, with the cassette (Fig. 3A, disposable unit 160) positioned within the cassette bay (Fig. 3A above, cassette bay A), the face plate (side of 160) remains visible from the cassette bay (Fig. 3A above, while lid 116 is open, the side of unit 160 would still be visible while positioned in cassette bay A).
Busby does not expressly disclose the at least a third fluid flow path of the plurality of flow paths that is independent of the pump.
Wright teaches an at least a third fluid flow path (Wright: Fig. 19, sixth fluid channel 164) of the plurality of flow paths (Fig. 19 shows a plurality of fluid flow paths) that is independent of the pump (Fig. 19, sixth fluid channel 164 is independent of pump port 104, which is coupled to a pneumatic pump; para. 0298).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid flow paths of Busby in view of Suzuki such that an at least a third fluid flow path of the plurality of flow paths that is independent of the pump as taught by Wright in order to allow for a separate fluid port to direct fluid contents for sample preparation (Wright: para. 0298).
Busby in view of Wright does not expressly disclose the first and second flow paths sharing a common input on a face plate of the cassette and having separate outputs on the face plate.
Suzuki teaches a first (Suzuki: Fig. 2, fluid draining circuit 824) and second flow paths (Fig. 2, fluid infusing circuit 823) sharing a common input (Fig. 2, connection tube 85c can be an input) on a face plate of the cassette (Fig. 1, section of cassette 8 where connection tubes 85 project from) and having separate outputs (Fig. 2, connection tube 85c and 85d can be outputs) on the face plate (section of 8).
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Regarding claim 2, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein each actuator of a plurality of actuators (Busby: Fig. 15, pistons 204) is a plunger (Fig. 15 above, pistons 204 comprise of plungers C).
Regarding claim 3, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein each plunger (Busby: Fig. 15 above, pistons 204 comprise of plungers C) is biased towards an un-actuated position (Fig. 15, pistons 204 require to be pushed up by cams 202 in order to actuate, therefore, through gravity, are biased towards an un-actuated position; para. 0190-0191).
Regarding claim 6, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein each orientation of a plurality of different orientations (Busby: Fig. 16A, composite cam profile 370 shows a combination of each cam 202a-202f shown in Fig. 16B with different orientations; para. 0193) of the cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202) corresponds to a different combination of closed and open fluid flow paths of the plurality of fluid flow paths (Fig. 4A above, fluid flow paths B; para. 0194-0195).
Regarding claim 7, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein a plurality of fluid flow paths (Busby: Fig. 4A above, fluid flow paths B; para. 0195) includes the first and second fluid flow paths (Fig. 4A above, fluid flow paths B includes a first and second flow paths among the plurality of flow paths; para. 0195), wherein a plurality of actuators (Fig. 15, pistons 204) includes first, second, and third actuators (Fig. 15, pistons 204 includes first, second, and third pistons among the plurality of pistons).
Busby does not expressly disclose the third fluid flow path.
Wright teaches an at least a third fluid flow path (Wright: Fig. 19, sixth fluid channel 164) of the plurality of flow paths (Fig. 19 shows a plurality of fluid flow paths) that is independent of the pump (Fig. 19, sixth fluid channel 164 is independent of pump port 104, which is coupled to a pneumatic pump; para. 0298).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid flow paths of Busby in view of Suzuki such that an at least a third fluid flow path of the plurality of flow paths that is independent of the pump as taught by Wright in order to allow for a separate fluid port to direct fluid contents for sample preparation (Wright: para. 0298).
Regarding claim 8, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein a cam roller (Busby: Fig. 15 and 16B, formed by camshaft 200 and cams 202) includes first, second, and third sections along a length thereof (Fig. 15 and 16B, formed by camshaft 200 and cams 202, there are first, second, and third cams, 202a-202c, among the plurality of cams along the length of the camshaft 200), each of a first, second, and third sections (Fig. 16B, cams 202a-202c) including a different pattern of protrusions and no protrusions (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204; para. 0197, 0200-0205) radially disposed around a circumference thereof (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f which are radially disposed from cams 202a-202c) such that each orientation of a cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202) provides a different combination of protrusions and no protrusions along a first, second, and third sections (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204; para.0197, 0200-0205).
Regarding claim 9, Busby in view of Wright and Suzuki discloses teaches the fluid management system above, wherein a first, second, and third sections (Busby: Fig. 16B, cams 202a-202c) are positioned adjacent a first, second, and third actuators (Fig. 15 and 16B, cams 202a-202c are positioned in-line with pistons 204) and wherein, for each orientation of a plurality of different orientations (Fig. 16A, cam profile 370) of a cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202), the presence of a protrusion in one of a first, second, or third section (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f; para. 0197, 0200-0205) actuates the respective first, second, or third actuator (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204, in which a protrusion results in an actuated piston 204; para. 0197, 0200-0205), and no protrusion in a first, second, or third section (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f; para. 0197, 0200-0205) does not actuate a respective first, second, or third actuator (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204, in which an occlusion results in an unactuated piston 204; para. 0197, 0200- 0205).
Regarding claim 10, Busby in view of Wright and Suzuki discloses the fluid management system above, wherein a control console (Busby: Figs. 3A-4B, hardware unit 110) includes a rotary motor (Fig. 1, valve motor 28) configured to drive rotation of a cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202, valve motor 28 drives rotation of camshaft 200; para. 0195).
Regarding claim 21, Busby teaches the fluid management system above, wherein each rotation orientation (Busby: Fig. 16A, cam profile 370) of the cam roller (Fig. 15 and 16B, formed by camshaft 200 and cams 202) corresponds to a unique combination of the plurality of different combinations (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204; para. 0197 and 0200-0205).
Regarding claim 22, Busby teaches the fluid management system above, wherein the plurality of different combinations (Busby: Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204; para. 0197 and 0200-0205) includes plural combinations (Fig. 16A and 16B, cams 202a-202c have protrusions/occlusions 372-386f, corresponding to different patterns of opened and closed pistons 204; para. 0197 and 0200-0205) wherein multiple actuators of the plurality of actuators are actuated (Fig. 16A and 16B, cams 202a-202c are shaped to provide a unique combination of bumps and valleys for every flow situation. Examiner interprets that cams 202a-202c are shaped to provide any unique permutation of bumps and valleys to result in any piston 204 to be opened or closed; para. 0195).
Regarding claim 24, Busby teaches the fluid management system above, wherein the plurality of actuators includes at least three actuators (Busby: Fig. 15, pistons 204 includes first, second, and third pistons among the plurality of pistons).
Response to Arguments
Applicant’s arguments, see page 5-6, filed 11 December 2025, with respect to the rejections of claims 1-3, 6-10, 21, 22, and 24 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Busby in view of Wright and Suzuki cited above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783