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 47 is objected to because of the following informalities: Claim 47 is objected to as containing a minor informal preamble/dependency error. The preamble currently recites “The method of The method of wherein the first electric-field-generating structure…,” which is improper. The preamble should be amended to recite “The method of claim 39, wherein the first electric-field-generating structure…,” to correctly identify the base claim and conform to proper dependent claim form. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) -706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 39–56 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,031,896 B2, in view of Kongsuphol et al. (U.S. 2015/0268195 A1).
Regarding claims 39–56, US Patent No. 12,031,896 B2 (July 9, 2024) teaches the claimed limitations as mapped in the chart below, in which the highlighted sections indicate the differences relative to the US Patent 12,031,896 B2:
Instant Application
US Patent No. 12,031,896 B2
Claim 39: A method comprising:
providing a microfluidic chip, the microfluidic chip comprising a microfluidic channel, and one or more electric-field-generating structures configured to generate an electric-field from outside the microfluidic channel that selectively polarizes or manipulates biologic or particle components flowing within the microfluidic channel;
measuring, via an on-chip impedance sensing element, impedance spectra associated with at least one internal capacitive structure of a first electric-field-generating structure or characteristic of the biologic or particle components; and
determining, via a processor or logic circuit, one or more parameters associated with the at least one internal capacitive structure, wherein the one or more parameters is selected from the group consisting of: an associated thickness of the at least one capacitive structure; a surface area size of the at least one internal capacitive structure; a surface charge property of the at least one internal capacitive structure; an architecture feature of the at least one internal capacitive structure; and a size of a portion of microfluidic channel to which the first electric-field- generating structure is located; wherein the measured impedance spectra is used at least for one of
i) control of the polarization or manipulation of the biologic or particle components when flowing through the microfluidic channel and
ii) geometric or functional quantification of the at least one internal capacitive structure or of the microfluidic chip.
Claim 1: A method comprising:
providing a microfluidic chip, the microfluidic chip comprising a microfluidic channel with one or more electric-field-generating structures located therein, including a first electric- field-generating structure, wherein the one or more electric-field-generating structures is configured to selectively polarize or manipulate biologic or particle components flowing within the microfluidic channel; and
measuring, via an on-chip impedance sensing element, impedance spectra associated with at least one internal capacitive structure of the first electric-field-generating structure or characteristic of the biologic or particle components, and
determining, via a processor or logic circuit, one or more parameters associated with the at least one internal capacitive structure, wherein the one or more parameters is selected from the group consisting of: an associated thickness of the at least one capacitive structure; a surface area size of the at least one internal capacitive structure; a surface charge property of the at least one internal capacitive structure; an architecture feature of the at least one internal capacitive structure; and a size of a portion of microfluidic channel to which the first electric-field- generating structure is located; wherein the measured impedance spectra is used at least for one of
i) control of the polarization or manipulation of the biologic or particle components when flowing through the microfluidic channel and
ii) geometric or functional quantification of the at least one internal capacitive structure or of the microfluidic chip.
Claim 40: The method of claim 39, further comprising:
triggering, by a processor or control circuit, controls of media conditions, polarization, or manipulation of the biologic or particle components when flowing through the microfluidic channel based on the measured impedance spectra.
Claim 2: The method of claim 1, further comprising:
triggering, by a processor or control circuit, controls of media conditions, polarization, or manipulation of the biologic or particle components when flowing through the microfluidic channel based on the measured impedance spectra.
Claim 41: The method of claim 39, further comprising:
determining, via a processor or logic circuit, one or more parameters associated with the at least one internal capacitive structure or the characteristic of the biologic or particle components, wherein the determination is performed by a fitting operation, performed via the processor or logic circuit, of the measured impedance spectra to an equivalent circuit model that at least include the first electric-field-generating structure or a portion thereof.
Claim 3: The method of claim 2, further comprising:
determining, via a processor or logic circuit, one or more parameters associated with the at least one internal capacitive structure or the characteristic of the biologic or particle components, wherein the determination is performed by a fitting operation, performed via the processor or logic circuit, of the measured impedance spectra to an equivalent circuit model that at least include the first electric-field-generating structure or a portion thereof.
Claim 42: The method of claim 39, wherein the impedance spectra is measured by:
applying an impedance interrogating signal having a power level and a frequency range corresponding to those associated with the control of the media condition, polarization, or manipulation of the biologic or particle components; and measuring a resulting voltage resulting from the applied impedance interrogating signal, wherein the measured resulting voltage has an amplitude and phase properties that defines the impedance spectra.
Claim 4: The method of claim 1, wherein the impedance spectra is measured by:
applying an impedance interrogating signal having a power level and a frequency range corresponding to those associated with the control of the media condition, polarization, or manipulation of the biologic or particle components; and measuring a resulting voltage resulting from the applied impedance interrogating signal, wherein the measured resulting voltage has an amplitude and phase properties that defines the impedance spectra.
Claim 43: The method of claim 39, wherein the first electric-field-generating structure comprises
an electrode portion and an insulating barrier, wherein the insulating barrier corresponds to the at least one internal capacitive structure.
Claim 5: The method of claim 1, wherein the first electric-field-generating structure comprises
an electrode portion and an insulating barrier, wherein the insulating barrier corresponds to the at least one internal capacitive structure.
Claim 44: The method of claim 43, wherein the electrode portion is configured as at least one of:
a contactless dielectrophoresis electrode; a bi-polar dielectrophoresis electrode; a passivated dielectrophoresis electrode; an electrowetting on dielectric electrode; and a droplet manipulating system electrode.
Claim 6: The method of claim 6, wherein the electrode portion is configured as at least one of:
a contactless dielectrophoresis electrode; a bi-polar dielectrophoresis electrode; a passivated dielectrophoresis electrode; an electrowetting on dielectric electrode; and a droplet manipulating system electrode.
Claim 45: The method of claim 39,
wherein the impedance spectra is measured when the biologic or particle components are flowing within the microfluidic channel.
Claim 7: The method of claim 1,
wherein the impedance spectra is measured when the biologic or particle components are flowing within the microfluidic channel.
Claim 46: The method of claim 39,
wherein the impedance spectra is measured when the microfluidic channel is filled with a test media that does not have present biologic or particle components of interest.
Claim 8: The method of claim 1,
wherein the impedance spectra is measured when the microfluidic channel is filled with a test media that does not have present biologic or particle components of interest.
Claim 47: The method of claim 39 wherein
the first electric-field-generating structure is used for electrokinetic trapping, acoustic trapping, or dielectrophoresis operation, and
wherein the functional quantification of at least one internal capacitive structure or the characteristic of the biologic or particle component comprises at least one of: a quantification associated with efficacy of the electrokinetic trapping, acoustic trapping, or dielectrophoresis operation; a quantification associated with a frequency response of the electrokinetic trapping, acoustic trapping, or dielectrophoresis operation;
a quantification of parasitic voltage drops of the first electric-field-generating structure; a quantification associated with identifying a particle type and its position in the microfluidic channel; and a quantification associated with sample transport post-trapping operation.
Claim 9: The method of claim 1 wherein
the first electric-field-generating structure is used for electrokinetic trapping, acoustic trapping, or dielectrophoresis operation, and
wherein the functional quantification of at least one internal capacitive structure or the characteristic of the biologic or particle component comprises at least one of: a quantification associated with efficacy of the electrokinetic trapping, acoustic trapping, or dielectrophoresis operation; a quantification associated with a frequency response of the electrokinetic trapping, acoustic trapping, or dielectrophoresis operation;
a quantification of parasitic voltage drops of the first electric-field-generating structure; a quantification associated with identifying a particle type and its position in the microfluidic channel; and a quantification associated with sample transport post-trapping operation.
Claim 48: The method of claim 39, wherein the first electric-field-generating structure and corresponding controls are configured for a target cell type selected from the group consisting of tumor cells, immune cells, and stem cells.
Claim 10: The method of claim 1, wherein the first electric-field-generating structure and corresponding controls are configured for a target cell type selected from the group consisting of tumor cells, immune cells, and stem cells.
Claim 49: The method of claim 39, wherein the first electric-field-generating structure and corresponding controls are configured for dielectrophoresis operation having a wide frequency range of at least 1 MHz.
Claim 11: The method of claim 1, wherein the first electric-field-generating structure and corresponding controls are configured for dielectrophoresis operation having a wide frequency range of at least 1 MHz.
Claim 50: The method of claim 39, wherein the measured impedance spectra is used for the control of the selective polarization or manipulation of the biologic or particle components when flowing through the microfluidic channel.
Claim 12: The method of claim 1, wherein the measured impedance spectra is used for the control of the selective polarization or manipulation of the biologic or particle components when flowing through the microfluidic channel.
Claim 51: The method of claim 39, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or of the microfluidic chip.
Claim 13: The method of claim 1, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or of the microfluidic chip.
Claim 52: The method of claim 51, wherein the geometric or functional quantification is used to determine an initialized control setting value used in the control of the microfluidic chip.
Claim 14: The method of claim 14, wherein the geometric or functional quantification is used to determine an initialized control setting value used in the control of the microfluidic chip.
Claim 53: The method of claim 39, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or the microfluidic chip as part of a quality control assessment operation of the microfluidic chip.
Claim 15: The method of claim 1, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or the microfluidic chip as part of a quality control assessment operation of the microfluidic chip.
Claim 54: The method of claim 39, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or the microfluidic chip to determine a geometry or functional feature of the first electric-field-generating structure that is optimized for maximum trapping operation.
Claim 16: The method of claim 1, wherein the measured impedance spectra is used for the geometric or functional quantification of at least one internal capacitive structure of the first electric-field-generating structure or the microfluidic chip to determine a geometry or functional feature of the first electric-field-generating structure that is optimized for maximum trapping operation.
Claim 55: The method of claim 39, wherein the microfluidic chip comprises a channeled structure made of a material selected from the group consisting of a polymer and a glass.
Claim 17: The method of claim 1, wherein the microfluidic chip comprises a channeled structure made of a material selected from the group consisting of a polymer and a glass.
Claim 56: The method of claim 39, wherein the impedance spectra is measured via active electronic components located on an electronic board that is electrically coupled to the on-chip impedance sensing elements.
Claim 18: The method of claim 1, wherein the impedance spectra is measured via active electronic components located on an electronic board that is electrically coupled to the on-chip impedance sensing elements.
Regarding independent claim 39, reference claim 1 recites a microfluidic chip with a microfluidic channel and one or more electric field generating structures located therein, including a first electric field generating structure, configured to selectively polarize or manipulate biologic or particle components, with on chip impedance measurement of spectra associated with at least one internal capacitive structure and determination of parameters from the same recited group for control and/or geometric or functional quantification.
U.S. Patent No. 12,031,896 B2 is not understood to explicitly disclose “one or more electric-field-generating structures configured to generate an electric-field from outside the microfluidic channel that selectively polarizes” as recited in the instant claims.
Kongsuphol et al. (U.S. 2015/0268195 A1) disclose microfluidic sensor devices employing electric field generators and electrodes arranged with respect to microfluidic channels to carry out electrophoresis and manipulate target molecules. In particular, paragraph [0077] describes one or more electric-field-generating structures configured to generate an electric-field from outside the microfluidic channel that selectively polarizes (see [0077], wherein a sensor device that includes a separation reservoir, first and second electric field generators, a plurality of channels, and sensing elements that are moveable between a first position inside the channel and a second position outside the channel, and that may be located outside the channel during operation of one of the electric field generators. This teaching demonstrates that it was known in the art to configure field-generating/electrode structures and sensing structures relative to the microfluidic channel such that electric fields used for electrophoresis and manipulation of target molecules are applied from structures arranged outside of the main flow path, to protect sensitive sensing surfaces while still achieving effective field-based manipulation).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the microfluidic chip of U.S. Patent No. 12,031,896 B2 to incorporate electric-field-generating structures configured relative to the microfluidic channel so as to generate an electric field from outside the microfluidic channel that selectively polarizes or manipulates biologic or particle components, in view of the teachings of Kongsuphol et al. One of ordinary skill would have been motivated to adopt such an arrangement to achieve effective electric-field-driven manipulation and separation of target molecules while reducing adverse effects on sensing surfaces and improving suitability for point-of-care operation (e.g., by reducing background interference and protecting surface chemistry during high-field electrophoresis), as emphasized by Kongsuphol et al. in their discussion of microfluidic electrophoresis devices and sensor positioning in paragraph and related passages.
Accordingly, each of the instant claims recites the above-discussed “electric-field-generating structures configured to generate an electric-field from outside the microfluidic channel that selectively polarizes or manipulates biologic or particle components” in combination with features that are fully met by corresponding claims or embodiments of U.S. Patent No. 12,031,896 B2 or represent obvious variations thereof in view of Kongsuphol et al., and therefore the claims do not define subject matter that is patentably distinct. For the foregoing reasons, claims 39–56 of the instant application are not patentably distinct from claims 1–18 of U.S. Patent No. 12,031,896 B2.
Examiner’s Note: The instant application is a continuation of parent US Application 17/425,414 (now U.S. Patent No. 12,031,896 B2). In the parent application, claim 1 was allowed with limitations including: measuring, via an on-chip impedance sensing element, impedance spectra associated with at least one internal capacitive structure of a first electric-field-generating structure or characteristic of the biologic or particle components; and determining, via a processor or logic circuit, one or more parameters associated with the at least one internal capacitive structure, wherein the one or more parameters is selected from the group consisting of: an associated thickness of the at least one capacitive structure; a surface area size of the at least one internal capacitive structure; a surface charge property of the at least one internal capacitive structure; an architecture feature of the at least one internal capacitive structure; and a size of a portion of the microfluidic channel to which the first electric-field-generating structure is located; wherein the measured impedance spectra is used at least for one of (i) control of the polarization or manipulation of the biologic or particle components when flowing through the microfluidic channel and (ii) geometric or functional quantification of the at least one internal capacitive structure or of the microfluidic chip. Claim 39 of the instant application recites substantially the same limitations as the allowed subject matter of claim 1 of the parent application and therefore lacks patentable distinction.
Further, the prior art applied in the parent application, including Sano et al. (U.S. 2012/0085649 A1) and Balijepalli et al. (U.S. 2019/0137443 A1), discloses microfluidic chip systems generally corresponding to the claimed environment. However, these references were previously found to fail to disclose the specific impedance-based measurement and parameter-determination limitations recited in the allowed claims.
Accordingly, while claims 40–56 may distinguish over Sano et al. and Balijepalli et al. for the reasons set forth in the Office Action mailed 10/04/2023, such distinctions do not overcome the present nonstatutory obviousness-type double patenting rejection, because the claims are not patentably distinct from the allowed claims of the parent application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. 11,973,503 B2 to Huang et al. an application specific integrated circuit (ASIC) chip is provided. Stress in various directions can be measured by disposing symmetrical “four-corner+middle” delay chain combinations in three dimensions inside the ASIC chip. Two sensors using the ASIC chip are further provided. In one sensor, a micro-electromechanical system (MEMS) chip is stacked with the ASIC chip. In the other sensor, the MEMS chip and the ASIC chip are symmetrically arranged. After being stacked and symmetrically arranged, the MEMS chip and the ASIC chip have highly consistent stress concentration characteristics, which can calibrate stress in various directions and effectively improve accuracy and temperature stability of the MEMS chip. In addition, an electric toothbrush using the ASIC chip is further provided, which can effectively improve consistency, stability, reliability, sensitivity, and linearity of stress detection, and can more accurately compensate for a temperature drift.
U.S. 2018/0093271 A1 to Fujii et al. disclose a microdevice for capturing particles from a sample, a method for capturing particles from a sample, and a method for concentrating or separating particles using the same.
U.S. 2003/0178310 A1 to Gawad et al. disclose Micro technologically prepared component as a flow cytometer. The component contains a preparation area to specifically influence and separate the particles, preferably by means of dielectrophoresis, a measuring channel area for characterizing the particles, and a sorting area for sorting the particles identified in the measuring channel area by means of dielectrophoresis. The sorting includes switching elements which permit active guidance of the particles into two or more subchannels corresponding to the criteria which have been registered in the measuring channel area. By means of a component configured in this way for the use of a flow cytometer, quick and precise sorting of particles, in particular biological cells in a suspension, can be implemented.
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Examiner: /Trung Q. Nguyen/- Art 2858
March 18, 2026
/HUY Q PHAN/ Supervisory Patent Examiner, Art Unit 2858