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 .
Specification
The disclosure is objected to because of the following informalities: the specification and claim 24 recite a “90:1 ratio”, this should read a 90:10 ratio.
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.
As to claim 9, the claim recites the limitation "the first set of settings". Claim 9 depends on claim 6 which depends on claim 1. There is no mention of “a first set of settings” in claims 6 or 1.
As to claim 12, the claim recites the limitation "the [second/first] set of settings". Claim 12 depends on claim 8 which depends on claim 4 which depends on claim 1. There is no mention of “a first set of settings” in claims 8, 4 or 1.
As to claims 9, 12 there is insufficient antecedent basis for the limitations in the claims.
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.
Claim(s) 1, 6-7, 16, 19, 26-27, 30-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US-20070121110-A1 (Kralik).
As to claim 1, Kralik teaches an apparatus (10, Fig. 1) for conducting an assay based on an electrochemical process [0002][0157][0013], comprising:
a first detector (18, Fig. 1) configured to capture data associated with the electrochemical process (Fig. 1, [0105]);
a second detector (20) configured to capture data associated with the electrochemical process ([0105], Fig. 1); and
a beam splitting device (12)
configured to split emitted light from the electrochemical process into a first light beam (14) directed at the first detector (18) and a second light beam (16) directed at the second detector (20).
As to claim 6, Kralik teaches the apparatus of claim 1, wherein the one or more detectors includes a photo-detector ([0111] teaches PMT, photodiode etc…).
As to claim 7, Kralik teaches the apparatus of claim 6, wherein the photo-detector includes at least one of a CCD, CMOS device, scientific CMOS device, EMCCD device, SiPM device, APD, photodiode, and 2-layer transistor pixel stacked CMOS ([0111]).
As to claim 16, Kralik teaches apparatus of claim 1, wherein the first detector occupies a first portion of a single sensor and the second detector occupies a second portion of the single sensor (Fig. 1 with detectors 18 and 20 is being interpreted as a single sensor, Fig. 5 with detectors 150a,b).
As to claim 19, Kralik teaches the apparatus of claim 1, wherein the beam splitting device includes at least one of a fiber optic splitter, a beam splitting device cube, a plate beam splitting device, and a pellicle beam splitting device ([0092] teaches beam splitter, Fig. 1 and Fig. 5 show as plate).
As to claim 26, Kralik teaches the apparatus of claim 1, further comprising a reference light source (100a Fig. 5), wherein the beam splitting device (158) is configured to split reference light emitted from the reference light source into a first reference light beam [0141] directed at the first detector (150a) and a second reference light beam directed at the second detector (150b).
As to claim 27, Kralik teaches the apparatus of claim 26, wherein the reference light source is configured for selective activation ([0113] teaches emitting light of predetermined wavelength, controlled by CU 180 [0139] therefore can be selectively activated).
As to claim 29, Kralik teaches theapparatus of claim 1, further comprising one or more filters configured to permit selected wavelengths of light through (Fig. 3 shows filter 26, [0127]).
As to claim 30, Kralik teaches an apparatus (10, Fig. 1) for conducting an assay based on a light-emitting process [0002], comprising: a first detector (18, Fig. 1) configured to capture data associated with the emitted light (Fig. 1, [105]);
a second detector (20) configured to capture data associated with the emitted light (Fig. 1); and a beam splitting device (12) configured to split the emitted light into a first light beam directed at the first detector and a second light beam directed at the second detector (Fig. 1, [105]).
As to claim 31, Kralik teaches the apparatus of claim 30, wherein the emitted light is emitted from a luminescence-based assay [0157].
As to claim 32, Kralik teaches the apparatus of claim 30, wherein the emitted light is emitted from a chemiluminescence-based assay [0157].
As to claim 33, Kralik teaches the apparatus of claim 30, wherein the emitted light is emitted from an electrochemiluminescence-based assay [0157].
As to claim 32, Kralik teaches the apparatus of claim 31, wherein the emitted light is emitted from a fluorescence-based assay [0002][0046].
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.
Claim(s) 2-3, 9, 16, 28 are rejected under 35 U.S.C. 103 as being unpatentable
over US-20070121110-A1 (Kralik) in light of US-20210016288-A1 (Krivoy).
As to claim 2, Kralik teaches an apparatus of claim 1, further comprising a housing ([0052] teaches housing, [0146] teaches housing 164, Fig. 5).
Kralik is silent to: plate electrical connector.
However, Krivoy teaches a method and apparatus for conducting assays [0006] with a multi-well plate (426) and plate carriage (404) with a conductive bottom surface (536, Fig. 5n) for initiating ECL measurements [0070].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art of Kralik to include the plate electrical connector of Krivoy in order to easily induce ECL [0040 of Krivoy].
As to claim 3, the combination teaches the apparatus of claim 2.
The combination is silent to: further comprising a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector.
However, Krivoy teaches a multi-well plate (426) and plate carriage (404) with a conductive bottom surface (536, Fig. 5n) for initiating ECL measurements [0070][0040] and a voltage source [0075]([0016] teaches applying voltage from voltage source to one or more wells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the voltage source in order to be able to easily induce ECL [0040 of Krivoy].
As to claim 9, Kralik teaches the apparatus of claim 6.
Kralik is silent to: wherein the first set of settings include binning settings combining multiple photo-detector pixels.
However, Krivoy teaches binning [0143].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kralik to include the binning settings of Krivoy in order to improve the sensitivity of measurement during image collection [0143 of Krivoy].
As to claim 16, Kralik teaches the apparatus of claim 1.
Kralik is silent to: wherein a voltage source or current source configured to initiate the electrochemical process via a plate electrical connector is configured to initiate individual electrochemical processes in sequence to minimize optical crosstalk.
However, Krivoy teaches a multi-well plate (426) and plate carriage (404) with a conductive bottom surface (536, Fig. 5n) for initiating ECL measurements [0070][0040] and a voltage source [0075]([0016] teaches applying voltage from voltage source to one or more wells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art of Kralik to include the plate electrical connector and the voltage source of Krivoy in order to easily induce ECL [0040 of Krivoy].
As to claim 28, Kralik teaches the apparatus of claim 1.
Kralik is silent to: wherein at least one of the first detector and the second detector include a sensor array.
However, Krivoy teaches arrays of light detectors [0040].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kralik to include a sensory array for at least one of the first detector and second detector in order to improve accuracy and minimize errors from individual sensor units.
Claim(s) 4-5, 10, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US-20070121110-A1 (Kralik) in light of US-20130088719-A1 (Sugiyama).
As to claim 4, Kralik teaches the apparatus of claim 1.
Kralik is silent to: wherein the beam splitting device is configured to transmit the first light beam and to reflect the second light beam, and the beam splitting device is configured with a transmission percentage of at least 90%, at least 95%, or at least 99%.
However, Sugiyama generally teaches adjusting a reflection:transmission ratio of a beam splitter to a 5:95 reflection:transmission ratio [0069].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art of Kralik to include a beam splitter of ratio 5:95 R:T in order to provide less light to one detector of higher sensitivity in order to avoid over saturation.
As to claim 5, Kralik teaches the apparatus of claim 1.
Kralik is silent to: wherein the beam splitting device is configured to transmit the first light beam and to reflect the second light beam, and the beam splitting device is configured with a reflection percentage of at least 90%, at least 95%, or at least 99%.
However, as explained in the rejection of claim 4, Sugiyama teaches a beam splitter of 5:95 R:T.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the beam splitter to have a 95:5 R:T ratio in order to allow for the optimization of the device set up and allow for different locations of detectors.
As to claim 10, the combination teaches apparatus of claim 4, wherein a combined dynamic range of the first detector and the second detector is at least a magnitude of 10x, at least 20x, or at least 100x greater than an individual dynamic range of the first detector and the second detector [0108-112 of Kralik].
As to claim 13, the combination teaches the apparatus of claim 4, wherein the first detector is a higher sensitivity device than the second detector [0110 of Kralik].
As to claim 14, the combination teaches the apparatus of claim 13, wherein the first detector is a first CCD or CMOS device and the second detector is a second CCD or CMOS device ([0111] of Kralik teaches CMOS or CCD).
Claims 8, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US-20070121110-A1 (Kralik) in light of US-20130088719-A1 (Sugiyama) and US-20210016288-A1 (Krivoy).
As to claims 8 and 11, the combination teaches the apparatus of claim 4, wherein the first detector and the second detector are of a same device type [0108-109 of Kralik].
As to claim 12, the combination teaches the apparatus of claim 8.
As to claim 8, the combination is silent to: the first detector is configured with a first set of settings to decrease read noise and increase low light sensitivity, and the second detector is configured with a second set of settings equal to the first set of settings.
As to claim 11, the combination is silent to: the first detector is configured with a first set of settings to decrease read noise and increase low light sensitivity, and the second detector is configured with a second set of settings to increase high-end dynamic range.
As to claim 12, the combination is silent to: wherein the second setting include finer binning settings than the first set of settings to capture higher light levels.
However, Krivoy teaches binning [0143].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the binning settings of Krivoy to improve the sensitivity of measurements during image collection [0143 of Krivoy]. It would have further been obvious to try adjusting the binning settings to capture different light levels depending on which type of detectors are being used.
Claim(s) 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over US-20070121110-A1 (Kralik) in light of US-20200225158-A1 (Booker).
As to claim 15, Kralik teaches the apparatus of claim 1, wherein the second detector is an imaging device ([0111] of Kralik teaches CCD or CMOS).
Kralik is silent to: wherein the first detector is a SiPM device.
However, Booker teaches an analyzer that can be used in point-of-care settings to measure the absorbance and fluorescence of a sample [0031] with a silicon photomultiplier detector as a light detector [0059].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kralik to include a SiPM as a light detector it offers high gain, low voltage, fast response, and compact size [0059 of Booker].
As to claim 17, the combination teaches the apparatus of claim 15, wherein the single sensor is an imaging sensor (Fig. 1 with detectors 18 and 20 is being interpreted as a single sensor, [0111 of Kralik] teaches CMOS or CCD), [0140] teaches 150a,b form pixels in image).
As to claim 20, Kralik teaches the apparatus of claim 19.
Kralik is silent to: wherein the beam splitting device includes a fiber optic splitter, the apparatus further comprising: light collection optics configured to receive the emitted light;
a fiber connector configured to interface with the light collection optics; a first fiber collimator configured to direct the first light beam at the first detector; and a second fiber collimator configured to direct the second light beam at the second detector.
(Fig. 3 shows collimating lens 36, [1059] teaches one or more fibers, collimating lenses, filters to upgrade an existing device
As to claim 21, The apparatus of claim 20, wherein the fiber optic splitter is configured to split the emitted light into the first light beam and the second light beam.
As to claim 22, The apparatus of claim 20, wherein the light collection optics include at least one of a GRIN lens, fiber optic taper, discrete lens, combination of lenses, or Ball lens (Fig. 3 of Kralik has coupling lens 32 which is shown as rounded).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over US-20070121110-A1 (Kralik) in light of US-20210016288-A1 (Krivoy) and US-20100267049-A1 (Rutter).
As to claim 23, Kralik teaches the apparatus of claim 1, the apparatus further comprising: a reference light source ([0113][0139] of Kralik teaches emitting light of predetermined wavelength, Fig. 3 shows laser 100).
Kralik is silent to: wherein the beam splitting device includes a 2x2 fiber optic coupler-splitter with a split ratio, the apparatus further comprising: wherein the 2x2 fiber optic coupler-splitter is configured to selectively direct reference light from the reference light source or the emitted light from the electrochemical process to the first detector and the second detector.
However, Rutter teaches a device, system, and method for evaluating the presence of analytes in samples [0008] with a light source (1630) applies the light onto a fiber hub (1634) which distributes the light via optical fibers [0251] to the cartridges with detector modules [0250].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kralik to use the fiber hub of and distribution method of Rutter to direct the light to each director in order to prevent loss of signal and reduce the complexity of the assembly as it would not require movement of the components [0251 of Rutter].
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over US-20070121110-A1 (Kralik) in light of US-20210016288-A1 (Krivoy), US-20100267049-A1 (Rutter) and US-20130088719-A1 (Sugiyama).
As to claim 24, the combination teaches the apparatus of claim 23.
The combination is silent to wherein the split ratio is selected from a 99:1 ratio and a 90:1 ratio. (As stated in the objection above, the Examiner believes this should read “a 90:10 ratio”, and is being interpreted as such.)
However, Sugiyama generally teaches adjusting the reflection transmission ratio of a beamsplitter in order to control how much light is reflected from or transmitted through the splitter [0069]. This teaching would be applicable to any beamsplitting device which is directing light to two different positions.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art of Kralik adjust the split ratio of a beam splitter, as taught by Sugiyama, in order to control how much light each detector receives. Further, selecting the split ratio to be 99:1 or 90:10 is a result effective variable (one that would adjust how much light is sent to each detector) and would be a matter of routine optimization, in order to yield the predictable result of transmitting less light to one detector over the other in order to allow for differing detector sensitivities and to avoid saturation. "[W]here 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).
As to claim 25, the combination teaches the apparatus of claim 23, wherein the reference light source is configured for selective activation ([0113] of Kralik teaches emitting light of predetermined wavelength, controlled by CU 180 [0139] therefore can be selectively activated).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Maya Hendija whose telephone number is (571)272-0269. The examiner can normally be reached M-F 08:00-16:00 (MST).
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/MAYA HENDIJA/ Examiner, Art Unit 2877
/Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877
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