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.
(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 1-2, 4, 6, 9-11, 14-15, 17-18, & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Chen, Yu-Shih, et al. "A review on microfluidics-based impedance biosensors." Biosensors 13.1 (2023): 83.).
Regarding Independent claim 1, Chen teaches:
A micro-electrical impedance-based assay system (µZAS) for real-time monitoring of cellular response to an environmental condition, the µZAS comprising:
at least one microfluidic device comprising (See Fig. 5a-d.):
a cell channel configured to receive a sample substance (Fig. 5d Element Sample. See associated text.);
at least one gas channel operatively coupled to the cell channel defining a controlled testing environment of the at least one microfluidic device (Fig. 5d Element Gas. See associated text.); and
a plurality of microfluidic impedance sensors (Fig. 5d Elements Electrodes and HF2TA. See associated text.) configured to obtain, via one or more detection electrodes (Fig. 5d Elements Electrodes. See associated text.), electrical impedance-based measurement values with respect to the sample substance (Fig. 5d Elements Electrodes, HF2TA, & HF2IS. See associated text.), wherein the at least one microfluidic device is operatively coupled to a gravity driven flow module configured to generate a gravity-driven hydrostatic pressure difference to drive a flow of the sample substance through the at least one microfluidic device (See Fig. 5a-d.); and
a measurement instrument operatively coupled to the at least one microfluidic device that is configured to control a testing environment of the at least one microfluidic device (See Fig. 5a-d Element the Impedance chip. See page 10 third to last line wherein “an electrical impedance microflow cytometer that can control oxygen flow for the analysis of sickle blood cells” is depicted.).
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Regarding claim 2, Chen teaches all elements of claim 1, upon which this claim depends.
Chen teaches a controller operatively coupled to the measurement instrument that is configured to determine and output at least one measurement value in relation to the sample substance to provide quantitative assessment of a hematological condition or outcome (See Fig. 5a-d Element the Impedance chip. See page 10 third to last line wherein “an electrical impedance microflow cytometer that can control oxygen flow for the analysis of sickle blood cells” is depicted.).
Regarding claim 4, Chen teaches all elements of claim 2, upon which this claim depends.
Chen teaches the controller is configured to detect a change in electrical impedance above a predetermined threshold that is indicative of an abnormal blood flow (See pages 2-4 comprising section 2. Silicon-Based Impedance Biosensors.).
Regarding claim 6, Chen teaches all elements of claim 2, upon which this claim depends.
Chen teaches a display device or monitor operatively coupled to the µZAS and the controller configured to output at least a portion of the electrical impedance-based measurement values (Fig. 5d Element HF2SI, the spectroscope.).
Regarding claim 9, Chen teaches all elements of claim 1, upon which this claim depends.
Chen teaches the at least one microfluidic device and the measurement instrument are operatively coupled to one another via a magnetic, force, or snap-fit connection (Fig. 5d Elements Impedance chip and Microfluidic system that are connected through a wire. That would be a connection of force.).
Regarding claim 10, Chen teaches all elements of claim 1, upon which this claim depends.
Chen teaches the at least one microfluidic device further comprises at least one microstructure for measuring a flow condition (See Abstract wherein it discloses sheath flow focusing.) or obstruction.
Regarding claim 11, Chen teaches all elements of claim 1, upon which this claim depends.
Chen teaches the at least one gas channel comprises or defines a gas channel network (Fig. 5d Element Gas wherein there is a network of channels depicted. See associated text.).
Regarding claim 14, Chen teaches all elements of claim 11, upon which this claim depends.
Chen teaches the gas channel network comprises a single inlet and a single outlet (Fig. 5d Element Gas wherein there is an input and output depicted. See associated text.).
Regarding claim 15, Chen teaches all elements of claim 11, upon which this claim depends.
Chen teaches the plurality of microfluidic impedance sensors is positioned within the gas channel network (Fig. 5d Elements Electrodes nested in the serpentine network of gas channels. See associated text.).
Regarding claim 17, Chen teaches all elements of claim 11, upon which this claim depends.
Chen teaches the µZAS is configured for blood testing under a plurality of controlled O2 conditions (Pages 10-11 section 5.2, Detection of Blood Samples.) or PaO2 conditions.
Regarding claim 18, Chen teaches all elements of claim 1, upon which this claim depends.
Chen teaches the at least one microfluidic device comprises at least one disposable chip (Fig. 5a-d wherein all elements can be thrown out.).
Regarding Independent claim 20, Chen teaches:
A micro-electrical impedance-based assay system (µZAS) for real-time monitoring of cellular response to an environmental condition comprising a plurality of microfluidic devices (See Fig. 5a-d.), each microfluidic device comprising:
a cell channel configured to receive a sample substance (Fig. 5d Element Sample. See associated text.);
at least one gas channel operatively coupled to the cell channel defining a controlled testing environment of each of the plurality of microfluidic devices (Fig. 5d Element Gas. See associated text.); and
a plurality of microfluidic impedance sensors (Fig. 5d Elements Electrodes and HF2TA. See associated text.) configured to obtain electrical impedance-based measurements with respect to the sample substance (Fig. 5d Elements Electrodes. See associated text.), wherein:
each microfluidic device is operatively coupled to a gravity driven flow module configured to generate a gravity-driven hydrostatic pressure difference to drive a flow of the sample substance through each respective microfluidic device (See Fig. 5a-d.), and
the plurality of microfluidic devices is operatively coupled to a measurement instrument that is configured to control a testing environment of each microfluidic device (See Fig. 5a-d Element the Impedance chip. See page 10 third to last line wherein “an electrical impedance microflow cytometer that can control oxygen flow for the analysis of sickle blood cells” is depicted.).
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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.
Claims 3, 7-8, & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chen, Yu-Shih, et al. "A review on microfluidics-based impedance biosensors." Biosensors 13.1 (2023): 83.) in view of Liu et al (Liu, Jia, et al. "Electrical impedance microflow cytometry with oxygen control for detection of sickle cells." Sensors and Actuators B: Chemical 255 (2018): 2392-2398.).
Regarding claim 3, Chen teaches all elements of claim 2, upon which this claim depends.
Chen does not explicitly teach the controller is configured to determine at least one of a sickling index and/or sickle cell rheology.
Liu teaches the controller is configured to determine at least one of a sickling index and/or sickle cell rheology (Page 2393 column 1 Section 2.1 wherein it states that “the microfluidic device (Fig. 1) consists of a triple Ti/Au electrode set for electrical impedance measurement and a double-layer microfluidic channel for microflow with oxygen control, adapted from our previous design for the study of sickle cell morphology and rheology.”).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to apply the teachings of Liu to the teachings of Chen such that the controller is configured to determine at least one of a sickling index and/or sickle cell rheology because this is an important, well-known area of study that addresses the problems associated with sickle cell anemia.
Regarding claim 7, Chen teaches all elements of claim 1, upon which this claim depends.
Chen does not explicitly teach at least one of the electrical impedance-based measurement values is used to evaluate treatment efficacy for sickle cell disease, determine a biophysical marker of diabetes, assess whether blood flow is normal under hypoxia, or to evaluate dosage-dependencies of blood flow on medications.
Liu teaches at least one of the electrical impedance-based measurement values is used to evaluate treatment efficacy for sickle cell disease, determine a biophysical marker of diabetes, assess whether blood flow is normal under hypoxia, or to evaluate dosage-dependencies of blood flow on medications (See Abstract and Sections 1 & 2 on pages 2392-2393 and elsewhere wherein flow due to hypoxia is disclosed.).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to apply the teachings of Liu to the teachings of Chen such that at least one of the electrical impedance-based measurement values is used to evaluate treatment efficacy for sickle cell disease, determine a biophysical marker of diabetes, assess whether blood flow is normal under hypoxia, or to evaluate dosage-dependencies of blood flow on medications because the state of flow of the sample is observed in flow cytometry techniques.
Regarding claim 8, Chen teaches all elements of claim 1, upon which this claim depends.
Chen does not explicitly teach the measurement instrument is configured to measure a rate of blood flow through the at least one microfluidic device.
Liu teaches the measurement instrument is configured to measure a rate of blood flow through the at least one microfluidic device (See Abstract and Sections 1 & 2 on pages 2392-2393 and elsewhere wherein flow due to hypoxia is disclosed which indicates a change in the flow rate.).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to apply the teachings of Liu to the teachings of Chen such that the measurement instrument is configured to measure a rate of blood flow through the at least one microfluidic device because the state of flow of the sample is observed in flow cytometry techniques.
Regarding claim 12, Chen teaches all elements of claim 11, upon which this claim depends.
Chen does not explicitly teach the at least one gas channel is configured to supply at least a first gaseous substance and a second gaseous substance.
Liu teaches the at least one gas channel is configured to supply at least a first gaseous substance and a second gaseous substance (See Section 2.2 page 2393 column 2.).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to apply the teachings of Liu to the teachings of Chen such that the at least one gas channel is configured to supply at least a first gaseous substance and a second gaseous substance because this allows one to create hypoxia in the cell channel. See page 2303 column 2 of Liu.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chen, Yu-Shih, et al. "A review on microfluidics-based impedance biosensors." Biosensors 13.1 (2023): 83.).
Regarding claim 19, Chen teaches all elements of claim 1, upon which this claim depends.
Chen & Liu do not explicitly teach the plurality of microfluidic impedance sensors comprises 16 microfluidic impedance sensors.
But it would have been obvious to one of ordinary skill in the art before the effective time of filing to have the plurality of microfluidic impedance sensors comprises 16 microfluidic impedance sensors because this is the mere duplication of parts that has no patentable significance unless a new and unexpected result is produced. In the instant case, the number of electrodes would simply appear to gather more information making the sensor more robust and dependable.
Allowable Subject Matter
Claims 5, 13, & 16 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art listed does not anticipate alone or combine in an obvious manner to teach the invention claimed by applicant. The requirements are highly specific and would require impermissible hindsight to make any combination obvious. The specific requirements have not been found.
Regarding claim 5, Chen teaches all elements of claim 11, upon which this claim depends.
Chen does not explicitly teach the controller is configured to detect a PaO2 transition resulting from resistance to electric currents associated with a corresponding sickling event.
Regarding claim 13, Chen teaches all elements of claim 11, upon which this claim depends.
Chen does not explicitly teach the gas channel network comprises at least one valve and at least one gas cartridge defining the controlled testing environment.
Regarding claim 16, Chen teaches all elements of claim 1, upon which this claim depends.
Chen does not explicitly teach the gravity driven flow module comprises a rocker module configured to facilitate programmable gravity-driven flow.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art listed but not cited represents the previous state of the art and analogous art that teaches some of the limitations claimed by applicant.
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/CHRISTOPHER P MCANDREW/Primary Examiner, Art Unit 2858