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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/2/2026 was considered by the examiner.
Response to Arguments
Applicant's arguments filed 10/22/2025 have been fully considered are addressed below:
Applicant’s amendments overcome the objection to the speciation. The objection has been withdrawn.
Applicant’s amendments overcome the objection to claim 24. The objection to claim 24 has been withdrawn.
Applicant’s amendments overcome the 112b rejections of claim 9 and 12. The 112b rejections of claims 9 and 12 have been withdrawn.
Applicant' s arguments with respect to the 102 and 103 of claims 1-4, 6-10, and 12-34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 30 objected to because of the following informalities:
Regarding claims 1 and 30, the claims recite "a first detector configured to perform low light level detection" and "a second detector configured to measure high light levels". The examiner is unsure why these two similar limitations use different terminology and suggests amending the phrases to use the same language when referring to the function of the detectors.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “beam splitting device” in claims 1, 4-5, 26 and 30; imaging device in claim 15
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 1, the claim recites “beam splitting device” which uses the generic placeholder “device” that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Accordingly, the limitation on “beam splitting device” is interpreted under 35 U.S.C. 112(f) as corresponding to at least one of a fiber optic splitter, a beam splitting device cube, a plate beam splitting device, and a pellicle beam splitting device ([0025]).
Regarding claim 15, the claim recites “imaging device” which uses the generic placeholder “device” that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Accordingly, the limitation on “imaging device” is interpreted under 35 U.S.C. 112(f) as corresponding to imaging sensor, for example a CCD ([0046]).
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 30-34 are 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 30, the claim recites "for conducting an assay based on a light-emitting process" in line 1 and "the electrochemical process" in lines 7 and 12. There is insufficient antecedent basis for "the electrochemical process" in the claim. Further, claims 31-34 would not make sense if the light-emitting process was limited to an electrochemical process. The examiner believes that "the electrochemical process" was intended to read "the light-emitting process" and will be interpreting the claim as such for the purposes of examination. Appropriate correction is required.
Claims 31-34 are rejected based on their dependencies.
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.
(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 30- 21 and 34 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US20210080368 by Sharpe et al. (newly cited; hereinafter Sharpe).
Regarding claim 30, Sharpe teaches an apparatus (at least Fig.1 ) for conducting an assay based on a light-emitting process ([0052] light 102), comprising:
a first detector (first detector element 110; [0026]) configured to perform low light level detection of emitted light associated with the emitted light ([0026] the detector system 100 can provide rapid detection of intermixed high-intensity and low-intensity signals; Fig. 2 shows first detector sensitive to dim light);
a second detector (second detector element 120; [0026]) configured to measure high light levels of the emitted light associated with the emitted light ([0026]; Fig. 2 shows second detector sensitive to bright light); and
a beam splitting device ([0026] beam splitter 105) configured to split the emitted light from the light-emitting process into a first light beam directed at the first detector ([0026] first portion 115) and a second light beam directed at the second detector ([0026] second portion 125), wherein the first light beam includes a first percentage of the emitted light that is larger than a second percentage of the emitted light that is included in the second light beam ([0035] the first detector element 110 receives the first portion 115 that comprises 99.9% of the total light 102 while the second optical detector element 120 receives the second portion 125 that comprises 0.1% of the total light 102); and at least one processor ([0026] signal combiner) configured to make a measurement of the light-emitting process based on the first percentage and the second percentage ([0036] signal combiner 140 can process the first detector output or the second detector output; [0043]-[0044] calibration module 159 can update the multiplication factor prior. The multiplication factor can make the first detector output and the second detector output span the same range of voltage or intensity values to ease combination of the two outputs and reduce discontinuity in the combined signal. The multiplication factor can be approximately equal to the ratio of the intensities detected at the first optical detector element 110 and the second optical detector element 120).
Regarding claim 31, Sharpe teaches the apparatus of claim 30, and further teaches wherein the emitted light is emitted from a luminescence-based assay ([0052] light 102 by the detector system 100 can identify one or more particle characteristics associated with the particles 201 including, but not limited to, optical characteristics (fluorescence, scatter, absorbance, extinction, reflection, refraction, polarization, luminescence, chemiluminescence, phosphorescence, spectral/color).
Regarding claim 32, Sharpe teaches the apparatus of claim 30, and further teaches wherein the emitted light is emitted from a chemiluminescence-based assay ([0052] light 102 by the detector system 100 can identify one or more particle characteristics associated with the particles 201 including, but not limited to, optical characteristics (fluorescence, scatter, absorbance, extinction, reflection, refraction, polarization, luminescence, chemiluminescence, phosphorescence, spectral/color).
Regarding claim 34, Sharpe teaches the apparatus of claim 30, and further teaches wherein the emitted light is emitted from a fluorescence-based assay ([0052] light 102 by the detector system 100 can identify one or more particle characteristics associated with the particles 201 including, but not limited to, optical characteristics (fluorescence, scatter, absorbance, extinction, reflection, refraction, polarization, luminescence, chemiluminescence, phosphorescence, spectral/color).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-10, 12-19, 28-29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe in view of US20210016288A1 by Krivoy (previously cited).
Regarding claim 1, Sharpe teaches An apparatus (at least Fig.1 ) for conducting an assay based on a light-emitting process ([0052] light 102), comprising:
a first detector (first detector element 110; [0026]) configured to perform low light level detection of emitted light associated with the light-emitting process ([0052] light 102 [0026] the detector system 100 can provide rapid detection of intermixed high-intensity and low-intensity signals; Fig. 2 shows first detector sensitive to dim light);
a second detector (second detector element 120; [0026]) configured to measure high light levels of the emitted light associated with the light-emitting process ([0026]; Fig. 2 shows second detector sensitive to bright light) ; and
a beam splitting device ([0026] beam splitter 105) configured to split emitted light from the light-emitting process into a first light beam ([0026] first portion 115) directed at the first detector and a second light beam directed at the second detector ([0026] second portion 125), wherein the first light beam includes a first percentage of the emitted light that is larger than a second percentage of the emitted light that is included in the second light beam ([0035] the first detector element 110 receives the first portion 115 that comprises 99.9% of the total light 102 while the second optical detector element 120 receives the second portion 125 that comprises 0.1% of the total light 102) ; and at least one processor ([0026] signal combiner) configured to make a measurement of the light-emitting process based on the first percentage and the second percentage ([0036] signal combiner 140 can process the first detector output or the second detector output; [0043]-[0044] calibration module 159 can update the multiplication factor prior. The multiplication factor can make the first detector output and the second detector output span the same range of voltage or intensity values to ease combination of the two outputs and reduce discontinuity in the combined signal The multiplication factor can be approximately equal to the ratio of the intensities detected at the first optical detector element 110 and the second optical detector element 120).
Sharpe does not explicitly teach the apparatus is used for conducting an assay based on an electrochemical process, the emitted light is associated with the electrochemical process, or the at least one processor configured to make a measurement of the electrochemical process.
However, Sharpe does teach analysis of the light 102 by the detector system 100 can identify one or more particle characteristics associated with the particles 201 including, but not limited to, optical characteristics (fluorescence, scatter, absorbance, extinction, reflection, refraction, polarization, luminescence, chemiluminescence, phosphorescence, spectral/color) and electromagnetic characteristics ([0052]).
Further, Krivoy does address this limitation. Krivoy and Sharpe are considered to be analogous to the present invention as they are in the same field of optical detection.
Krivoy teaches an apparatus used for conducting an assay based on an electrochemical process ([0154] electrochemiluminescence-based assay formats) and that emitted light associated with the electrochemical process can be measured with optical detectors ([0052] optical sensor 902 is capable of capturing light or ECL emission), or the at least one processor configured to make a measurement of the electrochemical process ([0040] imaging system can report luminescence values for luminescence emitted from individual elements of the arrays).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to conduct an assay based on an electrochemical process. Therefore, it would have been obvious to modify Sharpe use the apparatus for conducting an assay based on an electrochemical process, wherein the emitted light is associated with the electrochemical process, and the at least one processor configured to make a measurement of the electrochemical process as suggested by Krivoy in order to perform a known type of measurement with a known apparatus to identify particle characteristics with improved detection.
Regarding claim 2, Sharpe modified by Krivoy teaches the apparatus of claim 1, but Sharpe does not explicitly teach further comprising a housing and plate electrical connector.
However, Krivoy does address this limitation.
Krivoy teaches a housing ([0040]-[0041] 321 housing) and plate electrical connector ([0070] electrically conductive bottom surface 536 disposed on a bottom surface of plate carriage 404; contact members and can be raised to contact a multi-well plate 426's bottom surface, e.g., to initiate an ECL measurement).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a housing and plate electrical connector in an assay apparatus. Therefore, it would have been obvious to modify Sharpe to include a housing and plate electrical connector as suggested by Krivoy in order to isolate the measurement and efficiently induce ECL ([0040] housing is light sealed).
Regarding claim 3, Sharpe modified by Krivoy teaches the apparatus of claim 2, but Sharpe does not explicitly teach further comprising a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector.
However, Krivoy does address this limitation.
Krivoy teaches further comprising a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector ([0016] voltage source to conduct a voltage to the at least a pair of electrical contact probes; [0070] initiate an ECL measurement).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a voltage source or current source to initiate the electrochemical process via the plate electrical connector. Therefore, it would have been obvious to modify Sharpe to include a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector as suggested by Krivoy in order to efficiently control the initiation of the electrochemical process ([0075]).
Regarding claim 4, Sharpe modified by Krivoy teaches the apparatus of claim 1, and Sharpe further teaches wherein the beam splitting device is configured to transmit the first light beam and to reflect the second light beam ([0026]; Fig. 1), and
the beam splitting device is configured with a transmission percentage of at least 90%, at least 95%, or at least 99% ([0035] the first detector element 110 receives the first portion 115 that comprises 99.9% of the total light 102 while the second optical detector element 120 receives the second portion 125 that comprises 0.1% of the total light 102).
Regarding claim 6, Sharpe modified by Krivoy teaches the apparatus of claim 1, and Sharpe further teaches wherein the first detector or the second detector includes a photo-detector ([0029] the first detector includes PMT, SiPM, photodiode).
Regarding claim 7, Sharpe modified by Krivoy teaches the apparatus of claim 6, and Sharpe further teaches 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 ([0029] PMT, SiPM, photodiode; [0031] CCD).
Regarding claim 8, Sharpe modified by Krivoy teaches the apparatus of claim 4, and Sharpe further teaches wherein
the first detector and the second detector are of a same device type ([0029]; [0031]),
the first detector is configured with a first set of settings to decrease read noise and increase low light sensitivity ([0035] the first optical detector element 110 having a relatively smaller sensing area but relatively larger pixel dimension), and
the second detector is configured with a second set of settings to increase high-end dynamic range ([0035] second optical detector element 120 having a relatively larger sensing area but relatively smaller pixel dimension).
Regarding claim 9, Sharpe modified by Krivoy teaches the apparatus of claim 8, and although Sharpe teaches that the first set of settings have larger pixel dimensions ([0035]), Sharpe does not explicitly teach wherein the first set of settings include binning settings combining multiple photo-detector pixels.
However, Krivoy does address this limitation.
Krivoy teaches that binning is a process in which charges accumulated in adjacent pixels in a CCD are combined to create a super-pixel, which effectively reduces the electronic read noise per unit area. Binning may depend on the field of view, demagnification, and size of the CCD pixels ([0143]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to using binning settings to create larger pixels. Therefore, it would have been obvious to modify Sharpe to include wherein the first set of settings include binning settings combining multiple photo-detector pixels as suggested by Krivoy in order to improve the sensitivity of the measurement.
Regarding claim 10, Sharpe modified by Krivoy teaches the apparatus of claim 4, and Sharpe further teaches 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 ([0023] Systems and devices taught herein provide large effective dynamic ranges (e.g., 10^7, 10^8, or more); [0026] greater effective dynamic range than either detector element could achieve alone, i.e., greater than the first dynamic range or the second dynamic range; [0032]).
Regarding claim 12, Sharpe modified by Krivoy teaches the apparatus of claim 8, and although Sharpe teaches the second set of settings use smaller pixel dimensions than the first set of settings ([0035]), Sharpe does not explicitly teach wherein the second set of settings include finer binning settings than the first set of settings to capture higher light levels.
However, Krivoy does address this limitation.
Krivoy teaches that binning is a process in which charges accumulated in adjacent pixels in a CCD are combined to create a super-pixel, which effectively reduces the electronic read noise per unit area. Binning may depend on the field of view, demagnification, and size of the CCD pixels ([0143]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to using binning settings to create smaller pixel or larger pixels. Therefore, it would have been obvious to modify Sharpe to include wherein the second set of settings include finer binning settings than the first set of settings to capture higher light levels as suggested by Krivoy in order to improve the sensitivity of the measurement.
Regarding claim 13, Sharpe modified by Krivoy teaches the apparatus of claim 4, and Sharpe further teaches wherein the first detector is a higher sensitivity device than the second detector ([0035]).
Regarding claim 14, Sharpe modified by Krivoy teaches the apparatus of claim 13, and Sharpe further teaches wherein the first detector is a first CCD or CMOS device and the second detector is a second CCD or CMOS device ([0031] the first or second optical elements can be CCD)
Regarding claim 15, Sharpe modified by Krivoy teaches the apparatus of claim 13, and Sharpe further teaches wherein the first detector is a SiPM ([0031] Si photomultiplier) device and the second detector is an imaging device ([0031] CCD is an imaging device).
Regarding claim 16, Sharpe modified by Krivoy teaches the apparatus of claim 1, and although Sharpe does not explicitly teach wherein the first detector occupies a first portion of a single sensor and the second detector occupies a second portion of the single sensor in the embodiment of Fig. 1, Sharpe does address this limitation in an alternative embodiment.
Sharpe teaches in Fig. 3 wherein the first detector occupies a first portion of a single sensor and the second detector occupies a second portion of the single sensor ([0049] the first optical detector element 110 and the second optical detector element 120 are part of a single detector).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention use two portions of a single sensor as individual detectors. Therefore, it would have been obvious to modify the first embodiment of Sharpe to include wherein the first detector occupies a first portion of a single sensor and the second detector occupies a second portion of the single sensor as suggested the by alternative embodiment in order to make the device more compact.
Regarding claim 17, Sharpe modified by Krivoy teaches the apparatus of claim 16, and although Sharpe does not explicitly teach wherein the single sensor is an imaging sensor in the embodiment of Fig. 1, Sharpe does address this limitation in an alternative embodiment.
Sharpe teaches wherein the single sensor is an imaging sensor ([0049] or example, the first optical detector element 110 and second optical detector element 120 can be different pixels or groups of pixels on a single CCD camera.)
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention that an imaging device such as a CCD can be portioned. Therefore, it would have been obvious to modify the first embodiment of Sharpe to include wherein the single sensor is an imaging sensor as suggested the by alternative embodiment in order to efficiently divide the pixels into portions for detection.
Regarding claim 18, Sharpe modified by Krivoy teaches the apparatus of claim 1, and but Sharpe does not explicitly teach 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 does address this limitation.
Krivoy teaches further comprising a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector ([0016] voltage source to conduct a voltage to the at least a pair of electrical contact probes; [0070] initiate an ECL measurement) configured to initiate individual electrochemical processes in sequence to minimize optical crosstalk ([0112] sequentially apply a voltage to each well in the matrix of a single well addressable plate; [0144] imaging light from a single well at a time obviates the need to correct for optical cross-talk among the wells).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a voltage source or current source to initiate the electrochemical process via the plate electrical connector. Therefore, it would have been obvious to modify Sharpe to include a voltage source or current source configured to initiate the electrochemical process via the plate electrical connector configured to initiate individual electrochemical processes in sequence to minimize optical crosstalk as suggested by Krivoy in order to efficiently control the initiation of the electrochemical process ([0075]).
Regarding claim 19, Sharpe modified by Krivoy teaches the apparatus of claim 1, and Sharpe further teaches 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 ([0046] beam splitter 105 can include any suitable beam-splitting or beam dividing technology including plate or cube beamsplitters).
Regarding claim 28, Sharpe modified by Krivoy teaches the apparatus of claim 1, and Sharpe further teaches wherein at least one of the first detector and the second detector include a sensor array ([0029] first optical detector element 110 can include a photomultiplier tube or an array of photomultiplier tubes).
Regarding claim 29, Sharpe modified by Krivoy teaches the apparatus of claim 1, and Sharpe further teaches comprising one or more filters configured to permit selected wavelengths of light through ([0047] light beam selection elements 116 and 126 can include spectral selection elements such as spectral filters).
Regarding claim 33, Sharpe teaches the apparatus of claim 30, but Sharpe does not explicitly teach wherein the emitted light is emitted from an electrochemiluminescence-based assay.
However, Sharpe does teach analysis of the light 102 by the detector system 100 can identify one or more particle characteristics associated with the particles 201 including, but not limited to, optical characteristics (fluorescence, scatter, absorbance, extinction, reflection, refraction, polarization, luminescence, chemiluminescence, phosphorescence, spectral/color) and electromagnetic characteristics ([0052]).
Further, Krivoy does address this limitation. Krivoy and Sharpe are considered to be analogous to the present invention as they are in the same field of optical detection.
Krivoy teaches an apparatus wherein the emitted light is emitted from an electrochemiluminescence-based assay ([0154] electrochemiluminescence-based assay formats).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to conduct an assay based on electrochemiluminescence. Therefore, it would have been obvious to modify Sharpe to include wherein the emitted light is emitted from an electrochemiluminescence-based assay as suggested by Krivoy in order to perform a known type of measurement with a known apparatus to identify particle characteristics with improved detection.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe in view Krivoy as applied to claim 19 above and in further view of US20030081220A1 by Ostrovsky et al. (newly cited; hereinafter "Ostrovsky").
Regarding claim 20, Sharpe modified by Krivoy teaches the apparatus of claim 19, but Sharpe does not explicitly teach 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.
However, Sharpe does address some of these limitations in a separate embodiment.
Sharpe teaches the apparatus (Fig. 5) further comprising light collection optics configured to receive the emitted light ([0051] optical elements 106 collect light from particles 201);
a first fiber collimator configured to direct the first light beam at the first detector ([0051] first fiber optic 114 delivers the first portion 115 of the light to the first optical detector element 110); and
a second fiber collimator configured to direct the second light beam at the second detector ([0051] second fiber optic 124 delivers the second portion 125 of the light to the second optical detector element 120).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use light collection optics and fiber collimators to direct emitted light to the detectors. Therefore, it would have been obvious to modify the first embodiment of Sharpe to include light collection optics configured to receive the emitted light 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 as suggested by the alternate embodiment in order to enable the location of the detectors at longer distances or closely packed arrangements compared to free-space optical elements ([0055]).
Sharpe is still silent as to wherein the beam splitting device includes a fiber optic splitter, the apparatus further comprising: a fiber connector configured to interface with the light collection optics.
However, Ostrovsky does address this limitation. Ostrovsky and Sharpe are considered to be analogous to the present invention as they are in the same field of optical detection.
Ostrovsky teaches wherein the beam splitting device includes a fiber optic splitter (Fig. 3a; [0039] fiber optic beam splitter 104) , the apparatus further comprising:
light collection optics configured to receive the emitted light ([0039] light source 102 optically coupled to a fiber optic beam splitter 104 by an optical fiber 106; Fig. 3a shows collection optics as part of light source 102);
a fiber connector configured to interface with the light collection optics ([0039] light source 102 optically coupled to a fiber optic beam splitter 104 by an optical fiber 106);
a fiber collimators configured to direct the light beams a first detector ([0040] first collimator 112; second collimator 116; [0043] detector 122).
Further, Sharpe teaches beam splitter 105 can include any suitable beam-splitting or beam dividing technology ([0046]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a fiber optic splitter and fiber connector to direct light toward detectors. Therefore, it would have been obvious to modify Sharpe to include wherein the beam splitting device includes a fiber optic splitter instead of plate or cube splitter, the apparatus further comprising: a fiber connector configured to interface with the light collection optics as suggested by Ostrovsky as fiber optic elements allow for more flexible arrangements than free-space optical elements (Sharpe [0055]).
Regarding claim 21, Sharpe modified by Krivoy and Ostrovsky teaches the apparatus of claim 20, and Sharpe further teaches wherein the fiber optic splitter is configured to split the emitted light into the first light beam and the second light beam ([0026] first portion 115, second portion 125).
Regarding claim 22, Sharpe modified by Krivoy and Ostrovsky teaches the apparatus of claim 20, and Sharpe further teaches wherein the light collection optics include at least one of a GRIN lens, fiber optic taper, discrete lens, combination of lenses, or Ball lens (light beam shaping elements can include spherical lenses, achromatic lenses, discrete or arrayed microlenses, meniscus lenses, projection lenses, objective lenses, any other suitable lens configuration, or fiber optics.).
Claims 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe in view Krivoy as applied to claim 19 above and in further view of US 6328932 by Carter et al. (hereinafter "Carter").
Regarding claim 23, Sharpe modified by Krivoy teaches the apparatus of claim 1, but Sharpe does not teach wherein the beam splitting device includes a 2×2 fiber optic coupler-splitter with a split ratio, the apparatus further comprising: a reference light source, wherein the 2×2 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, Carter does address this limitation. Carter and Sharpe are considered to be analogous to the present invention as they are in the same field of optical detection.
Carter teaches wherein the beam splitting device includes a fiber optic coupler-splitter with a split ratio (Fig. 2 coupler 24; col 5 lines 60-65; col 20 lines 63 splitters have coupling ratios), the apparatus further comprising:
a reference light source (reference light 21; col 5 lines 50-60), wherein
the 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 (col 5 lines 50-67 fiber coupler sends light from reference light to detectors and light from analyte to detectors); detector may be selected to simultaneously or sequentially monitor the optical Signal reflected back from the sensor of both the detection and reference Source.)
Although Carter does not teach a 2×2 fiber optic coupler-splitter in this embodiment, Carter teaches the use of conventional fiber optic couplers or splitters (col 5 lines 60-65). It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that a 2×2 fiber optic coupler-splitter can be used instead a 1x4 coupler in order to perform the same function of splitting light in multiple directions. Further, Sharpe teaches beam splitter 105 can include any suitable beam-splitting or beam dividing technology ([0046]).
Thus, it would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a use a fiber coupler and reference light source to direct reference light to the detectors. Therefore, it would have been obvious to modify Sharpe to include wherein the beam splitting device includes a 2×2 fiber optic coupler-splitter with a split ratio, the apparatus further comprising: a reference light source, wherein the 2×2 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 as suggested by Carter in order to provide a separate reference light source to allow collection of independent reference data to improve measurement accuracy (col 5 lines 50-55; col 6 lines 15-18).
Regarding claim 24, Sharpe modified by Krivoy and Carter teaches the apparatus of claim 23, and Sharpe further teaches wherein the split ratio is selected from a 99:1 ratio and a 90:10 ratio ([0035] the first detector element 110 receives the first portion 115 that comprises 99.9% of the total light 102 while the second optical detector element 120 receives the second portion 125 that comprises 0.1% of the total light 102).
Regarding claim 25, Sharpe modified by Krivoy and Carter teaches the apparatus of claim 23, but Sharpe does not teach wherein the reference light source is configured for selective activation.
However, Carter does address this limitation.
Carter teaches wherein the reference light source is configured for selective activation (col 5 lines 50-67 detector may be selected to simultaneously or sequentially monitor the optical Signal reflected back from the sensor of both the detection and reference Source; col 6 lines 13-17 reference light can be pulsed).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to selectively activate the reference light source. Therefore, it would have been obvious to modify Sharpe to include wherein the reference light source is configured for selective activation in order to allow for the independent detection of the reference signal (col 6 lines 15-18).
Regarding claim 26, Sharpe modified by Krivoy teaches the apparatus of claim 1, but Sharpe does not teach further comprising a reference light source, wherein the beam splitting device is configured to split reference light emitted from the reference light source into a first reference light beam directed at the first detector and a second reference light beam directed at the second detector.
However, Carter does address this limitation. Carter and Sharpe are considered to be analogous to the present invention as they are in the same field of optical detection.
Carter teaches a reference light source (reference light 21; col 5 lines 50-60), wherein the beam splitting device is configured to split reference light emitted from the reference light source into a first reference light beam directed at the first detector and a second reference light beam directed at the second detector (col 5 lines 50-67 fiber coupler sends light from reference light to detectors and light from analyte to detectors); detector may be selected to simultaneously or sequentially monitor the optical Signal reflected back from the sensor of both the detection and reference Source).
Thus, it would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a reference light source coupled to the beam splitting device to direct reference light to the detectors. Therefore, it would have been obvious to modify Sharpe to include a reference light source, wherein the beam splitting device is configured to split reference light emitted from the reference light source into a first reference light beam directed at the first detector and a second reference light beam directed at the second detector as suggested by Carter in order to provide a separate reference light source to allow collection of independent reference data to improve measurement accuracy (col 5 lines 50-55; col 6 lines 15-18).
Regarding claim 27, Sharpe modified by Krivoy and Carter teaches the apparatus of claim 26, but Sharpe does not teach wherein the reference light source is configured for selective activation.
However, Carter does address this limitation.
Carter teaches wherein the reference light source is configured for selective activation (col 5 lines 50-67 detector may be selected to simultaneously or sequentially monitor the optical Signal reflected back from the sensor of both the detection and reference Source; col 6 lines 13-17 reference light can be pulsed).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to selectively activate the reference light source. Therefore, it would have been obvious to modify Sharpe to include wherein the reference light source is configured for selective activation in order to allow for the independent detection of the reference signal (col 6 lines 15-18).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAITLYN E KIDWELL/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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