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 35 is objected to because of the following informalities:
In claim 35, the term "The fluid sensor cartridge of claim 34" should be "The fluid sensor cartridge of claim 3" because claim 34 is cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings fail to show “a first fluid inlet, a first valve, a second fluid inlet, and a second valve” (as recited in claims 1 and 3); “third valve configured to fluidly connect the fluid pathway to the plunger” (as recited in claim 8); “third valve comprises a second rotatable plug valve having a plurality of operating positions” (as recited in claim 9); “a third drain to convey fluid to the waste reservoir, wherein the plurality of openings comprises a valve drain opening, wherein in a valve flush mode of the fluid sensor cartridge, the valve drain opening at least partially overlaps the third drain, the third drain disposed below the first valve” (as recited in claim 18); “first plug valve; a second face valve” (as recited in claim 54); “first plug valve; a second face valve” (as recited in claims 55-58); “third plug valve” (as recited in claims 59-61); “second face valve and third plug valve” (as recited in claim 62); “one or more cavities” (as recited in claim 63) in a broadest sense. Does “plug valve 140” corresponds to “a first valve” and/or “a first plug valve”? Does “face valve 130” corresponds to “a second valve” and /or “a second face valve”? The drawings must show every feature of the invention specified in the claims. Therefore, limitations of “a first fluid inlet, a first valve, a second fluid inlet, and a second valve” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The disclosure is objected to because of the following informalities: Due to drawing objection, the instant specification is also objected because the instant specification does not consistently reflect what being claimed i.e. “a first fluid inlet, a first valve, a second fluid inlet, and a second valve” (as recited in claim 1); “third valve configured to fluidly connect the fluid pathway to the plunger” (as recited in claim 8); “third valve comprises a second rotatable plug valve having a plurality of operating positions” (as recited in claim 9); “a third drain to convey fluid to the waste reservoir, wherein the plurality of openings comprises a valve drain opening, wherein in a valve flush mode of the fluid sensor cartridge, the valve drain opening at least partially overlaps the third drain, the third drain disposed below the first valve” (as recited in claim 18); “first plug valve; a second face valve” (as recited in claim 54); “first plug valve; a second face valve” (as recited in claims 55-58); “third plug valve” (as recited in claims 59-61); “second face valve and third plug valve” (as recited in claim 62); “one or more cavities” (as recited in claim 63) in the instant specification.
Note that the instant specification must consistently reflect claimed limitations.
Para. 0129 of the instant specification is also objected because the drawings i.e. fig.3 does not show “a sample fluid inlet 129”.
Para. 0129 of the instant specification is also objected because “face valve 134” should be “face valve 130”.
Appropriate correction is required.
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 9-10 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
As to claim 9, limitations of “a second rotatable plug valve” render the claim indefinite because it is not clear if there is a first rotatable plug valve. Does the third valve comprise a first rotatable plug valve? Hence, it is unclear.
As to claims 10 and 18, claims 10 and 18 are also rejected because they are dependent on the rejected claim 9 as set forth above.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ponomarev – US 20230149608.
As to claim 1, Ponomarev teaches a fluid sensor cartridge 10 (fig.3 and [0028]) comprising:
a sensor assembly (sensor module/cartridge 10) comprising a fluid pathway 36 and one or more sensing elements 28 in fluid communication with the fluid pathway 36 ([0030]);
a first fluid inlet (see described fig.3) configured to provide a first sample fluid to the fluid pathway 36 ([0030, 0032]: fluid pathway 30 can extend and circulate over electrodes 28 to expose the electrodes 28 to the sample fluid; the sensor channel 36 is in a fluid pathway 30; hence, the sensor channel 36 is also a fluid pathway);
a first valve (see described fig.3) configured to selectively direct the first sample fluid to the fluid pathway (see described fig.3; abstract; [0009]: controller is configured to control valve to open or close; thus, “a first valve configured to selectively direct the first sample fluid to the fluid pathway”);
a second fluid inlet (see described fig.3) configured to provide a second fluid to the fluid pathway 36 ([0032]: calibration fluid in calibration reservoir 32 is a second fluid; the second fluid is used to flush the sensor assembly; thus “a second fluid inlet configured to provide a second fluid to the fluid pathway”); and
a second valve (see described fig.3) configured to selectively direct the second fluid to the fluid pathway ([0032-0034]: valves 22 can be controlled by controller 18 to open/close to allow calibration fluid (or second fluid) to flush out the sensing assembly i.e. including the fluid pathway; thus “a second valve configured to selectively direct the second fluid to the fluid pathway”).
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As to claim 2, Ponomarev teaches a first drain 38 in fluid communication with the fluid pathway (fig.3), the first drain 38 to convey fluid from the fluid pathway to a waste reservoir 40 (fig.3).
As to claim 3, Ponomarev teaches a fluid sensor cartridge 10 (fig.3 and [0028]) comprising: a container ([0031]: calibration fluid or liquid can be provided in a calibration reservoir 32 of the housing of the sensor module 10; hence, the housing corresponds to “a container”) comprising a calibration fluid reservoir 32 to hold a calibration fluid and a waste reservoir 40; a sensor assembly 10 comprising a fluid pathway 36 ([0030, 0032]: fluid pathway 30 can extend and circulate over electrodes 28 to expose the electrodes 28 to the sample fluid; the sensor channel 36 is in a fluid pathway 30; hence, the sensor channel 36 is also a fluid pathway) and one or more sensing elements 28 in fluid communication with the fluid pathway 36; a first fluid inlet configured to provide a first sample fluid to the fluid pathway 36 (see reasons stated in the rejection of claim 1); a second fluid inlet configured to provide at least a second fluid to the fluid pathway 36 (see reasons stated in the rejection of claim 1); and a first drain 38 in fluid communication with the fluid pathway 36 (see reasons stated in the rejection of claim 1), the first drain 38 to convey fluid from the fluid pathway 36 to the waste reservoir 40 (see reasons stated in the rejection of claim 1).
As to claim 4, claim 4 is rejected as reasons stated in the rejection of claim 1.
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.
Claims 54 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolognia – US 20220291165.
As to claim 54, Bolognia teaches a fluid sensing method ([0008-0009, 0017, 0022]) comprising:
opening a first plug valve to provide a first sample fluid to a fluid pathway to expose a sensor assembly to at least the first sample fluid; transducing at least one fluid property of the first sample fluid with the sensor assembly ([0008]: valve can have a sensing position in which the sample fluid is conveyed from the fluid inlet, along the fluid pathway, and through the outlet; [0009]: the fluid pathway passes over the functionalized electrode to provide fluid communication between the functionalized electrode and the sample fluid; wherein the functionalized electrode configured to, in response to interacting with the sample fluid, transmit a signal indicative of a constituent component of the sample fluid; thus “opening a first plug valve to provide a first sample fluid to a fluid pathway to expose a sensor assembly to at least the first sample fluid; transducing at least one fluid property of the first sample fluid with the sensor assembly”) and;
rotating a second face valve to provide a second fluid to the fluid pathway to flush the sensor assembly, the second fluid flowing along the fluid pathway through a first drain to a waste reservoir ([0017, 0022]: a method of sensing fluid can comprise rotating a valve body to switch between a plurality of operating modes, the plurality of operating modes comprising a sensing mode and a calibration mode, sensing one or more constituent component of a sample fluid in the sensing mode using one or more functionalized electrodes, and calibrating the one or more functionalized electrodes by driving a calibration fluid over the one or more functionalized electrodes in the calibration mode; [0072]: The calibration fluid and the calibration mode can serve to reset the sensor module by flushing the sensing assembly of older sample fluid and/or other debris. Thus, the calibration fluid may also be deemed a purge fluid (or “second fluid”); [0078]: the used calibration fluid can alternatively be routed upwardly by way of an internal channel (not shown) to waste container 310; valve 102 corresponds to “a first plug valve and a second face valve” because the instant specification does not differentiate between “a first plug valve and a second face valve”; thus “rotating a second face valve to provide a second fluid to the fluid pathway to flush the sensor assembly, the second fluid flowing along the fluid pathway through a first drain to a waste reservoir”).
As to claim 56, Bolognia teaches rotating the second face valve to provide a third fluid to the fluid pathway, the third fluid flowing along the fluid pathway through the first drain, the third fluid comprising a quality control (QC) fluid (see reasons stated in the rejection of claim 54 and [0071]: valve motor can place the valve 102 in the calibration position 502 as shown in FIGS. 5A-5B and 5D-5E. As shown in FIG. 5B, calibration fluid 52 (also referred to as a quality control fluid, or QC fluid; since the instant specification does not differentiate between second and third fluid, the calibration fluid corresponds to both second and third fluid; thus “rotating the second face valve to provide a third fluid to the fluid pathway, the third fluid flowing along the fluid pathway through the first drain, the third fluid comprising a quality control (QC) fluid”).
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 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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ponomarev and further in view of Hardeep – WO 2020/132146 A1.
As to claims 7-8, Ponomarev does not explicitly teach a plunger configured to control flow of fluid in the fluid pathway.
Hardeep teaches a concept of: integrated oral fluid collection device and cartridge for processing and testing the collected sample ([0026]), cartridge holder may include or may be coupled with one or more valves controlled by one or more valve controls 2161; the valves may be plunger (e.g., solenoid) and/or pinch valves that may interface valve openings on the cartridge to regulate fluid flow ([0192]).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify valving of Ponomarev with concept teachings of solenoid-operated plunger type valves of Hardeep to include a plunger configured to control flow of fluid in the fluid pathway (as recited in claim 7); a third valve configured to fluidly connect the fluid pathway to the plunger (as recited in claim 8), to regulate fluid flow ([0192]).
Allowable Subject Matter
Claims 10 and 18 and 35 are objected to as being dependent upon a rejected base claim, but would be allowable once drawing and claim objections and 112 issues are corrected and if rewritten in independent form including 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:
As to claim 10, claim 10 includes during a setup mode of the fluid sensor cartridge, the setup mode fluid inlet opening at least partially overlaps with the second fluid inlet, the setup mode drain opening at least partially overlaps with the second drain, and the first drain is occluded, when in combination with the remaining limitations of the claim 10 distinguish the present invention from the prior arts.
As to claim 18, claim 18 is also objected due to their dependency on the objected claim 10.
As to claim 35, claim 35 includes a calibration fluid inlet opening of a manifold attached on top of the container, when in combination with the remaining limitations of the claim 35 distinguish the present invention from the prior arts.
Conclusion
Due to drawing and specification objections and 112 issues presenting in claims 9-10, 18 and due to drawing and specification objections presenting in claims 54-63, a rejection under prior art could not reasonably be made, and that once drawing and specification objections and the 112 issues are absolved/corrected, another comparison with the prior art will again be made, based upon the Examiner's clearer understanding of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRUONG D PHAN whose telephone number is (571)272-8883. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Breene can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRUONG D PHAN/Examiner, Art Unit 2855
/JOHN E BREENE/ Supervisory Patent Examiner, Art Unit 2855