Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-47 of U.S. Application 18/715,240 filed on May 31, 2024 are presented for examination.
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
Claims 4, objected to because of the following informalities: Since claim 1 gives a option of different limitations the phrase:” wherein the set and reset module or capability is integrated with the magnetic sensor.” Should be “wherein a set and reset module or capability is integrated with the magnetic sensor” because it lacks anteceded basis. 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.
Claim 10 is 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.
Regarding claim 10, the phrase “comprising a magnetic or electric field generator, wherein the magnetic field or electric generator is provided on a surface of the circuit board at a location corresponding to the sensing zone on the upper surface of the circuit board” is indefinite for the reason below. The Examiner cannot interpret if the term” a magnetic or electric field generator” is the same field generator from claim 1 or another generator. The Examiner will interpret the phrase as the same magnetic or electric generator. Appropriate correction is required.
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 of this title, 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.
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.
Claims 1,2, 9, 10, 11, 18, 19, 24-26, 28, 30, 35-39, 41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlan et al (WO2005116661) in view of Schroeders et al (WO2009024922).
Regarding claim 1, Kahlan discloses an apparatus (shown in figs 1-18) for sensing of a sample comprising particles (46) bound and unbound to an analyte (abstract discloses sensing samples), the apparatus comprising: a sensing zone (zone of 43 and 62) comprising at least an array of magnetic and/or electric field sensors (magnetoresistive sensor elements 42),
a sample introduction device (using 61) configured to introduce the sample to the sensing zone (claim 9 discloses supplying fluid to medium 62),a field generator (41), provided the magnetisable particles do not have an aligned dipole moment, the field generator optimised for magnetic field generation if a magnetic field sensor is present and/or electrical field generator if an electric field sensor is present, the electrical field generator generating a current having a standard sine wave pattern (known that the generator would be able to perform this), provided that when a magnetic field sensor is present, the particles comprise magnetisable particles (magnetic particle) and the magnetisable particles are in a magnetised state when at the sensing zone (claim 1 discloses magnetic particles in the vicinity of the sensor). Kahlam does not fully disclose a controller connected to receive signals from the array of magnetic and/or electric field, the controller configured to determine an amount of analyte in the sample based on the signals received from the array of magnetic and/or electric field sensors, provided that when a magnetic sensor is present the apparatus further comprises: i) a set and reset module or capability for performing a set/reset of the magnetic sensors, or ii) a data transmission layer, that is configured to shield the signals being transmitted from the one or more magnetic sensors, or iii) a plurality of magnetic field transmission zones corresponding to an area below each magnetic sensor, or iv) a printed circuit board comprising one or more vias connecting to the magnetic field sensors, or v) any combination of two or more of (i) to (iv).
However, Schroeders discloses a controller (30) connected to receive signals from the array of magnetic and/or electric field, the controller configured to determine an amount of analyte in the sample based on the signals received from the array of magnetic and/or electric field sensors (pg 3 lines 1-25 discloses determining detecting analytes in fluids), provided that when a magnetic sensor is present the apparatus further comprises: ii) a data transmission layer, that is configured to shield the signals being transmitted from the one or more magnetic sensors (pg 12-13 line 25 discloses wires are used to transmit data), or iii) a plurality of magnetic field transmission zones corresponding to an area below each magnetic sensor (using 260 located adjacent to sensors 250).It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to determine particles in a sample using electromagnetic means.
Regarding claim 2, Kahlan discloses wherein the magnetisable particles may be magnetised before binding to the analyte, or before or during introduction of the sample to the magnetic sensing zone (pg 9 lines 10-22 discloses magnetization during introduction. Therefore, occurs in-situ).
Regarding claim 9, Kahlan discloses wherein at least the sensing zone is provided on an upper surface of a circuit board (pg 3 lines 25-35 332 can be on top of 330. Therefore, the sensing zone is on the upper surface).
Regarding claim 10, Kahlan discloses a magnetic or electric field generator, wherein the magnetic field or electric generator is provided on a surface of the circuit board at a location corresponding to the sensing zone on the upper surface of the circuit board (pg 13 lines 1-34 discloses having field generations means near magnetic sensor elements. Therefore, is provided at a location according to a sensing zone).
Regarding claim 11, Kahlan discloses wherein the circuit board comprises a plurality of layers (pg 5 lines 1-15 discloses having at least a cover layer and sensitive layer. Therefore, there are multiple layers).
Regarding claim 18, Kahlan discloses wherein the array of magnetic sensors are closely packed (shown in fig 16 as being tightly packed).
Regarding claim 19, Kahlan does not fully disclose an enclosure for housing at least one circuit board.
However, Schroeders discloses an enclosure for housing at least one circuit board (pg 8 lines 1-30 discloses insulating layer 70). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to protect the circuity from harm.
Regarding claim 24, Kahlan does not fully disclose wherein the controller is configured to controllably bias one or more of the sample introduction device, field generators, array of sensors, amplifiers and/or filters.
However, Schroeders discloses wherein the controller is configured to controllably bias one or more of the sample introduction device, field generators, array of sensors, amplifiers and/or filters (controller would be able to at least control the array of sensors). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to determine particles in a sample using electromagnetic means.
Regarding claim 25, Kahlan discloses wherein the controller is configured to control the bias of the sample introduction device (using the system of 60 to control multiple elements within the system).
Regarding claim 26, Kahlan discloses wherein the magnetisable particles have a particles size of about 1 nm to about 100 nm (pg 10 lines 10-15 discloses about 130nm).
Regarding claim 28, Kahlan does not fully disclose wherein the controller biases the particles through the generation of an external force, the external force works to augment any inter-particle, particle-to-solvent or bonding forces.
However, Schroeders discloses wherein the controller biases the particles through the generation of an external force, the external force works to augment any inter-particle, particle-to-solvent or bonding forces (controller would be able to at least control the generation of an external force). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to determine particles in a sample using electromagnetic means.
Regarding claim 30, Kahlan discloses wherein the sample introduction device biases the particles relative to the sensors (as shown in figs 1-16 as being relative to the sensors).
Regarding claim 35, Kahlan does not fully disclose wherein the one or more magnetic sensors are analog sensors.
However, Schroeders discloses wherein the one or more magnetic sensors are analog sensors (pg 8 lines 10-15 discloses electronics being digital or analog. Therefore, the sensors can be analog). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to keep electromagnetic interference from the sensor.
Regarding claim 36, Kahlan discloses wherein the one or more magnetic sensors comprise one or more of magneto-resistive, hall effect, and fluxgate sensors (pg 13 lines 20-25 discloses being Hall sensors).
Regarding claim 37, Kahlan discloses comprising a signal processing module, wherein the signal processing module comprises one or more of: an amplifier for amplifying the signal from the one or more magnetic sensors, an analog to digital converter, and a power supply (pg 20 lines 8-15 discloses amplification. Therefore, signal processing an amplifier).
Regarding claim 38, Kahlan discloses wherein when the sample introduction device is removable (shown in figs 1-10 as removable based on intended need).
Regarding claim 39, Kahlan discloses wherein when the sample introduction device is integrated with the apparatus (shown in figs 1-10 as being integrated based on intended need).
Regarding claim 41, Kahlan discloses wherein as a multiplex design (pg 18 lines 5-10 discloses the sensors can be multiplex).
Regarding claim 43, Kahlan discloses wherein as a parallel simplex design (pg 18 lines 5-10 discloses the sensors can be parallel).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlan et al (WO2005116661) in view of Schroeders et al (WO2009024922) in further view of Wright et al (USPGPub 20050150295).
Regarding claim 3, Kahlan in view of Schroeders does not fully disclose wherein the array of magnetic sensors comprises a set and reset coil/strap for performing set/reset of the magnetic sensors.
However, Wright discloses wherein the array of magnetic sensors comprises a set and reset coil/strap for performing set/reset of the magnetic sensors (par 7 discloses set/reset). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in further view of Wright in order to determine values when the sensors are energized.
Regarding claim 4, Kahlan in view of Schroeders does not fully disclose wherein the set and reset module or capability is integrated with the magnetic sensor.
However, Wright discloses the set and reset module or capability is integrated with the magnetic sensor (par 7 discloses set/reset circuitry. Therefore, would be integrated based on intended need). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in further view of Wright in order to determine values when the sensors are energized.
Regarding claim 5, Kahlan in view of Schroeders does not fully disclose wherein the magnetic sensors are set/reset between readings.
However, Wright discloses wherein the magnetic sensors are set/reset between readings (par 7 discloses set/reset circuitry for the sensors. Therefore, would be set/reset based on intended need). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in further view of Wright in order to determine values when the sensors are energized.
Claims7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlan et al (WO2005116661) in view of Schroeders et al (WO2009024922) in further view of King et al (USPGPub 20220003758).
Regarding claim 7, Kahlan in view of Schroeders does not fully disclose wherein the magnetic sensors have a sampling rate of about 0.05, 0.1, 0.5, 1, 5, 10, 15 or 20 KHz.
However, King discloses herein the magnetic sensors have a sampling rate of about 0.05, 0.1, 0.5, 1, 5, 10, 15 or 20 KHz (par 91 discloses between 50-5000,000hz). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in further view of King in order to sample to determine analyte information.
Regarding claim 8, Kahlan in view of Schroeders does not fully disclose wherein the magnetic sensors have a sampling rate of about 100 kHz to about 200 kHz.
However, King discloses wherein the magnetic sensors have a sampling rate of about 100 kHz to about 200 kHz (par 91 discloses between 50-5000,000hz). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in further view of King in order to sample to determine analyte information.
Claims 16, 17, 27, 29, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlan et al (WO2005116661) in view of Schroeders et al (WO2009024922).
Regarding claim 16, Kahlan in view of Schroeders does not fully disclose comprising a detection surface area of about 1 cm2 to about 25 cm2.
However, It has been held where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention taught by Kahlan in view of Schroeders to be limited to 1 cm2 to about 25 cm2 in order to have enough surface to determine analyte data.
Regarding claim 17, Kahlan discloses wherein the detection surface comprises about 6 to about 24 magnetic sensors (shown in figs 10-16 as having around 25 magnetic sensors).
Regarding claim 27, Kahlan in view of Schroeders does not fully disclose wherein the magnetisable particles have a particles size of about 0.5 μm to 5 μm.
However, It has been held where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention taught by Kahlan in view of Schroeders to be limited to a particles size of about 0.5 μm to 5 μm in order to have enough surface to determine analyte data.
Regarding claim 29, Kahlan does not fully disclose wherein the controller biases the particles through the generation of an external force, the external force works to fully counteract any inter-particle, particle-to-solvent or bonding forces.
However, Schroeders discloses wherein the controller biases the particles through the generation of an external force, the external force works to fully counteract any inter-particle, particle-to-solvent or bonding forces (controller would be able to at least control the generation of an external force). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine Kahlan in view of Schroeders in order to determine particles in a sample using electromagnetic means.
Regarding claim 31, Kahlan in view of Schroeders does not fully disclose comprising a detection surface area of about 5 cm2 to about 100 cm2.
However, it has been held where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention taught by Kahlan in view of Schroeders to be limited to 5 cm2 to about 100 cm2 in order to have enough surface to determine analyte data.
Regarding claim 32, Kahlan in view of Schroeders does not fully disclose wherein a detection surface covers about 10% to about 50% of the circuit board surface.
However, it has been held where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention taught by Kahlan in view of Schroeders to be limited a detection surface covers about 10% to about 50% of the circuit board surface in order to have enough surface to determine analyte data based on the system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kahlan et al (WO2005116661) in view of Schroeders et al (WO2009024922) in further view of Zafer et al (USPGPub 20200150073).
Regarding claim 20, Kahlan in view of Schroeders does not fully disclose wherein the enclosure comprises an integrated display configured to render a diagnostic output obtained from the circuit board.
However, Zafer discloses wherein the enclosure comprises an integrated display configured to render a diagnostic output obtained from the circuit board (par 73 discloses a display that would be used to render diagnostic output).
Allowable Subject Matter
Claims 6, 12-15, 21-23, 33, 34, 40, 42, and 44-47 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 6, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the plurality of magnetic sensors are connected in series to a calibration port such that one calibration signal is used to set/reset of the plurality of magnetic sensors in combination with the other limitations of the claim.
Regarding claim 12, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the circuit board comprises at least one upper layer, a ground plane layer, and a lower layer and a plurality of circuit layers in combination with the other limitations of the claim.
Regarding claim 13, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the circuit board comprises a data transmission layer, that is configured to shield the signals being transmitted from the one or more magnetic sensor from electromagnetic interference generated by the other components of the circuit board, and/or a magnetic field generator in combination with the other limitations of the claim.
Regarding claim 14, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the data transmission layer is positioned between the upper and lower layer and upper and lower level ground planes in combination with the other limitations of the claim.
Regarding claim 15, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the circuit board comprises a plurality of magnetic field transmission windows, each transmission window defining a portion of the circuit board that is devoid of copper layers, and transmission window corresponding to an area of the circuit board below each magnetic sensor in combination with the other limitations of the claim.
Regarding claim 21, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the enclosure comprising the integrated display and at least one circuit board is configured to perform the operation of a lab-on-a-chip device in combination with the other limitations of the claim.
Regarding claim 22, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the enclosure comprising the integrated display and a plurality of circuit boards being arranged in parallel is configured to perform the operation of a lab-on-a-bench device in combination with the other limitations of the claim.
Regarding claim 23, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the enclosure is configured to be controlled by a user interface in the lab-on-a-chip and lab-on-a-bench device modes in combination with the other limitations of the claim.
Regarding claim 33, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: a sensor for detecting an orientation of the apparatus such that the apparatus is operable in any orientation in combination with the other limitations of the claim.
Claim 34 is also objected to as it depends on claim 33.
Regarding claim 40, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the sensing zone comprises a plurality of wells in combination with the other limitations of the claim.
Claims 45-47 are also objected to as they depend on claim 40.
Regarding claim 42, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the plurality of channels are arranged in a cross-hatched configuration in combination with the other limitations of the claim.
Regarding claim 44, the prior art of record taken alone or in combination fail to teach or suggest a sensor device for detection of the presence of at least one magnetic particle comprising: wherein the plurality of channels are arranged in a noncross-hatched configuration in combination with the other limitations of the claim.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu et al (USPGPub 20080160630): discloses detecting an analyte in a sample.
Conclusion
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/DOMINIC E HAWKINS/Primary Examiner, Art Unit 2858