Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims will be analyzed below according to MPEP 2106.
Inquiry 1: Is the claim directed to a statutory category of invention (process, machine, manufacture, or composition of matter)?
Yes, claims 1-18 are directed to a process.
Inquiry 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, claim 1 recites “normalizing the luminous intensity values” and “identifying peaks in the output signal of the sensor”, which are mental processes that can be performed in the human mind and/or with pen and paper. See MPEP 2106.04(a).
Inquiry 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, claims 1-18 do not integrate the judicial exception into a practical application.
Regarding claim 1, nothing happens after the judicial exception, so there is no practical application of it. The steps prior also amount to the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
Claims 2-8 and 11-18 are directed to the data collection steps that precede the judicial exceptions, so there is no practical application of the judicial exceptions. See MPEP 2106.05(g).
Claim 9 is directed to the “normalization” step of claim 1, but generally applies this judicial exception through instruction, which is not sufficient to amount to a practical application of the “normalization” judicial exception. See MPEP 2106.05(f). Furthermore, because the “normalization” step precedes the “identifying” step, there is no practical application of the “identifying” judicial exception.
Claim 10 is directed to the “identifying” step of claim 1, but reads as mere instructions to generally apply the judicial exception. See MPEP 2106.05(f).
Inquiry 2B: Does the claim recite additional limitations that amount to significantly more than the judicial exception?
No, they do not. Claims 1-18 will be further discussed below.
Regarding claim 1, as mentioned above, the steps prior to the judicial exceptions amount to the insignificant extra-solution activity of mere data-gathering. See MPEP 2106.05(g).
Claims 2-8 and 11-18 are directed to the data collection steps that precede the judicial exceptions, so the claims do not amount to significantly more than the judicial exceptions. See MPEP 2106.05(g).
Claim 9 is directed to the “normalization” step of claim 1, but generally applies this judicial exception through instruction, which is not sufficient to amount to significantly more than the judicial exceptions. See MPEP 2106.05(f).
Claim 10 is directed to the “identifying” step of claim 1, but reads as mere instructions to generally apply the judicial exception, which does not amount to significantly more than the judicial exception. See MPEP 2106.05(f).
Furthermore, regarding claims 1-18, the elements of these claims are well-understood, routine, and conventional in the arts and do not amount to significantly more than the judicial exception; Xie et al (US20110275162A1) teaches of using an automated reader with a photodiode sensor for a lateral flow assay to determine the concentration of an analyte based on emission of the length of the test strip, in which moving the cassette causes the reader to gather spectra while inserting/removing the cassette from the reader; Kazunori et al. (JP2002022743A) teaches of using a black cassette and a white test strip in a lateral flow assay; Geun et al. (KR20140042143A) teaches of measuring the emission spectra of both a sample testing zone and a sample holding assembly concurrently and using the spectra of the sample holding assembly to correct the spectra of the sample testing zone; Hou et al. (Non-Patent Literature, Nanoscale Research Letters, Vol. 12, 2017) teaches the use of UV and white (broad-band visible) light in later flow assays. See MPEP 2106.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 9, 11, and 16-18 are rejected under 35 USC 103 for being unpatentable over Xie et al. (US20110275162A1) in view of Geun et al. (KR20140042143A). Note that references to Geun et al. rely on the English translation that is provided (Non-Patent Literature, Machine translation of KR20140042143A).
Regarding claim 1, Xie teaches a method of reading a lateral flow test ([0063]) (test readers of the present disclosure include lateral flow assay test), the method comprising:
using a cassette that has a window through which a test strip arranged in the cassette is observed, the test strip having a reactive zone with at least one test line and a control line (paragraph [0008] and [0096]) (positioned adjacent to a position associated with a control line and a test line and an assay test strip 102 is encased in a housing, casing, or shell);
manually moving the cassette in a housing of a reader that includes therein an optical unit that includes a light emitter and a sensor located inside the housing, the method including illuminating the cassette and the test strip inside and outside the reactive zone and receiving in the sensor light reflected, or emitted, by the cassette and test strip in response to being illuminated by the light emitter (paragraph [11]) (By affixing one or more detectors to the body of the reader, and by thereafter relying on the relative motion between the assay test strip (such as during insertion and/or removal));
obtaining with the sensor an output signal comprising luminous intensity values of the light reflected, or emitted, by the cassette and the test strip during the time that the cassette moves (paragraph [11]) (such that an assay test strip being examined moves relative to the at least one detector… thereafter relying on the relative motion between the assay test strip)
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identifying peaks in the output signal of the sensor, the peaks corresponding with the at least one test line and the control line (See figure 4 below, and paragraph [108]) (the disclosed reader is configured to make a qualitative determination about the outcome of a test (e.g., at "positive" or "negative" outcome) based on the existence of a signal sensed by a sensor).
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Xie teaches of relying on the detectors close proximity to the sample to ensure accuracy (paragraph [0102]) (by affixing the detector to the body, the disclosed reader relies on the motion of the test strip relative to the body/detector combination to enable the detector to accurately detect the results of the test).
Xie does not explicitly teach normalizing the luminous intensity values of the output signal of the sensor in a range defined between a lower value and a higher value, the lower value and the higher value are established between the light reflected, or emitted, by the cassette outside the window, and the light reflected, or emitted, by the test strip outside the reactive zone.
In the analogous art of immunoassay diagnostic apparatuses, Geun teaches a method of using the emission of a portion of a sample holding assembly to normalize the emission of a sample (paragraph [0054]) (the reflected light reflected by the internal reference portion 117 of the tray 115 is used to correct the value of the reflected light by the sensing unit of the microfluidic chip). Geun teaches that this approach improves the accuracy of analysis for infectious diseases (paragraph [0040]) (As a result, the accuracy of analysis for infectious diseases contained in biological samples can be improved).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reliance of the location of the detector to ensure accuracy as disclosed by Xie by instead normalizing the sample spectra by reading the emission of the sample holding assembly as disclosed by Geun because doing so would lead to the predictable outcome of improving the accuracy of analysis for infectious diseases with a reasonable expectation of success (see [102] of Xie and [40] of Geun). See MPEP 2143(I)(G).
Regarding claim 2, modified Xie teaches the method of claim 1 as rejected above. Xie teaches of relying on the detectors close proximity to the sample to ensure accuracy (paragraph [0102]) (by affixing the detector to the body, the disclosed reader relies on the motion of the test strip relative to the body/detector combination to enable the detector to accurately detect the results of the test).
Xie does not teach wherein the lower value corresponds with the light reflected, or emitted, by the cassette outside the window, and the higher value corresponds with the light reflected, or emitted, by the test strip outside the reactive zone.
In the analogous art of immunoassay diagnostic apparatuses, Geun teaches a method of normalizing the absorption reading of a sample using the values obtained from the test strip and the values obtained from the sample holding assembly (paragraph [0054]) (the reflected light reflected by the internal reference portion 117 of the tray 115 is used to correct the value of the reflected light by the sensing unit of the microfluidic chip). Geun teaches that this approach improves the accuracy of analysis for infectious diseases (paragraph [0040]) (As a result, the accuracy of analysis for infectious diseases contained in biological samples can be improved).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reliance of the location of the detector to ensure accuracy as disclosed by Xie by normalizing the sample spectra by reading the emission of the sample holding assembly as disclosed by Geun because doing so would lead to the predictable outcome of improving the accuracy of analysis for infectious diseases with a reasonable expectation of success (see [102] of Xie and [40] of Geun). See MPEP 2143(I)(G).
Regarding claim 9, modified Xie teaches the method of claim 1 as rejected above. Xie teaches of relying on the detectors close proximity to the sample to ensure accuracy (paragraph [0102]) (by affixing the detector to the body, the disclosed reader relies on the motion of the test strip relative to the body/detector combination to enable the detector to accurately detect the results of the test).
Xie does not teach the lower curve is defined with at least one first point and one second point, the first point corresponding with the light reflected, or emitted, by the cassette at the start of the window and the second point corresponding with the light reflected, or emitted, by the cassette at the end of the window, and the upper curve is defined with at least one third point and one fourth point, the third point corresponding with the light reflected, or emitted, by the test strip at the start of the window and the fourth point corresponding with the light reflected, or emitted, by the test strip at the end of the window.
In the analogous art of immunoassay diagnostic apparatuses, Geun teaches a method of normalizing the absorption reading of a sample using the values obtained from the test strip and the values obtained from the sample holding assembly (paragraph [0054]) (the reflected light reflected by the internal reference portion 117 of the tray 115 is used to correct the value of the reflected light by the sensing unit of the microfluidic chip). Geun teaches that this approach improves the accuracy of analysis for infectious diseases (paragraph [0040]) (As a result, the accuracy of analysis for infectious diseases contained in biological samples can be improved).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reliance of the location of the detector to ensure accuracy as disclosed by Xie by normalizing the sample spectra by reading the emission of the sample holding assembly as disclosed by Geun because doing so would lead to the predictable outcome of improving the accuracy of analysis for infectious diseases with a reasonable expectation of success (see [102] of Xie and [40] of Geun). See MPEP 2143(I)(G).
Regarding claim 11, modified Xie teaches the method of claim 1 as rejected above. Xie teaches the use of a photodiode detector (paragraph [0023]) (In an embodiment, the at least one detector includes a photodiode detector).
Regarding claim 16, modified Xie teaches the method of claim 1 as rejected above. Xie teaches wherein the output signal is obtained during a removal of the cassette from the housing (paragraph [11]) (By affixing one or more detectors to the body of the reader, and by thereafter relying on the relative motion between the assay test strip (such as during insertion and/or removal)).
Regarding claim 17, modified Xie teaches the method of claim 1 as rejected above. Xie teaches wherein the output signal is obtained during an introduction of the cassette into the housing (paragraph [11]) (By affixing one or more detectors to the body of the reader, and by thereafter relying on the relative motion between the assay test strip (such as during insertion and/or removal)).
Regarding claim 18, modified Xie teaches the method of claim 1 as rejected above. Xie teaches wherein a first output signal is obtained during an introduction of the cassette into the housing and a second output signal is obtained during a removal of the cassette from the housing (paragraph [11]) (By affixing one or more detectors to the body of the reader, and by thereafter relying on the relative motion between the assay test strip (such as during insertion and/or removal)).
Claims 3-6, 10, and 12-15 are rejected under 35 USC 103 for being unpatentable over Xie et al. (US 20110275162A1) in view of Geun et al. (KR20140042143A) further in view of Kazunori et al. (JP2002022743A). Note that references to Kazunori rely on the English translation that is provided (Non-Patent Literature, Machine Translation of JP2002022743A).
Regarding claim 3, modified Xie teaches the method of claim 1 as rejected above. Xie teaches the use of cassettes (item 208) and test strips (item 102) that match in color; see figure 2 below:
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Xie does not explicitly teach wherein the cassette has a different color than the test strip which causes a luminous intensity of the light reflected, or emitted, by the cassette outside the window to be different from a luminous intensity of the light reflected, or emitted, by the test strip outside the reactive zone.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches of a sample holding assembly that is at least peripherally black in contrast to the white test strip (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black)). Kazunori teaches that this provides light-shielding properties, such as minimizing light scattering (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black) to provide light-shielding properties).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the cassette/test strip that are matching in color as disclosed by Xie with the black sample holder and white test strip of Kazunori because doing so would lead to the predictable outcome of providing light-shielding properties with a reasonable expectation of success (see paragraph [41] of Kazunori and Figure 2 of Xie). See MPEP 2143(I)(G).
Regarding claim 4, modified Xie teaches the method of claim 2 as rejected above. Xie teaches the use of cassettes (item 208) and test strips (item 102) that match in color; see modified figure 2 below:
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Xie does not teach wherein the cassette has a different color than the test strip which causes a luminous intensity of the light reflected, or emitted, by the cassette outside the window to be different from a luminous intensity of the light reflected, or emitted, by the test strip outside the reactive zone.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches of a sample holding assembly that is at least peripherally black (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black)). Kazunori teaches that this provides light-shielding properties, such as minimizing light scattering (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black) to provide light-shielding properties).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the cassette/test strip that are matching in color as disclosed by Xie with the black sample holder and white test strip of Kazunori because doing so would lead to the predictable outcome of providing light-shielding properties with a reasonable expectation of success (see paragraph [41] of Kazunori and Figure 2 of Xie). See MPEP 2143(I)(G).
Regarding claim 5, modified Xie teaches the method of claim 3 as rejected above. Xie teaches the use of a white test strip (item 102, see also paragraph [0109]) (counting the number of detected lines and white spaces between lines). Xie teaches the use of a white sample cassette (item 208); see modified figure 2:
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Xie does not teach wherein the cassette has a black color and the test strip has a white color.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches of a sample holding assembly that is at least peripherally black (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black)). Kazunori teaches that this provides light-shielding properties, such as minimizing light scattering (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black) to provide light-shielding properties).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the white sample cassette of Xie with the black sample cassette of Kazunori because doing so would lead to the predictable outcome of providing light-shielding properties with a reasonable expectation of success (see paragraph [0041] of Kazunori and paragraph [109] and Figure 2 of Xie). See MPEP 2143(I)(G).
Regarding claim 6, modified Xie teaches the method of claim 4 as rejected above. Xie teaches the use of a white test strip (item 102, see also paragraph [0109]) (counting the number of detected lines and white spaces between lines). Xie teaches the use of a white sample cassette (item 208); see modified figure 2:
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Xie does not teach wherein the cassette has a black color and the test strip has a white color.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches of a sample holding assembly that is at least peripherally black (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black)). Kazunori teaches that this provides light-shielding properties, such as minimizing light scattering (paragraph [0041]) (The peripheral portion… is coated or printed with a coloring agent (such as black) to provide light-shielding properties).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the white sample cassette of Xie with the black sample cassette of Kazunori because doing so would lead to the predictable outcome of providing light-shielding properties with a reasonable expectation of success (see paragraph [0041] of Kazunori and paragraph [109] and Figure 2 of Xie). See MPEP 2143(I)(G).
Regarding claim 10, modified Xie teaches the method of claim 1 as rejected above. Xie teaches of using the output signal from the test strip to determine the concentration of an analyte such as glucose (paragraph [108]) (a quantitative determination as to the blood-glucose concentration of a subject may be made by the disclosed reader based on a magnitude of a signal generated by a sensor).
Regarding claim 12, modified Xie teaches the method of claim 1 as rejected above. Xie teaches the use of light sources in general (paragraph [0090]) (light sources may be utilized in conjunction with the one or more detectors).
Xie does not teach wherein the sensor is a spectrometric sensor which obtains an output signal in a plurality of channels, each of the plurality of channels corresponding with the light reflected, or emitted, by the cassette at different wavelengths.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches of using a plurality of light sources with different wavelengths and collecting the emission of the sample after excitation (paragraph [0069] and [0075) (The light-emitting element 61 includes a plurality of LEDs with different emission wavelengths and an absorbance profile of the transmitted light from the immunochromatographic specimen 10 is created based on the output signal intensity). Kazunori teaches that this leads to less light attenuation and a smooth/even spectrum (paragraph [75]) (As a result, the measurement light is not attenuated, and no unevenness occurs in the absorbance profile).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light source of Xie with the multichannel/multiwavelength light-emitting element of Kazunori because doing so would lead to the predictable outcome of minimizing light attenuation with a reasonable expectation of success (see paragraph [75] of Kazunori). See MPEP 2143(I)(G).
Regarding claim 13, modified Xie teaches the method of claim 12 as rejected above. Xie teaches of using an encoder to process the raw spectral data (paragraph [0125]) (encoder such as described above to linearize the motion of the assay test strip within the reader).
Xie does not teach wherein a lower curve and an upper curve are obtained for each of the plurality of channels, the lower curves of the plurality of channels are superimposed on a main lower curve, and the upper curves of the plurality of channels are superimposed on a main upper curve, with the range being defined between the main lower curve and the main upper curve, with the luminous intensity values of the light of each of the plurality of channels being established proportionally between the main lower curve and the main upper curve.
In the analogous art of using an immunochromatographic testing device, Kazunori teaches a method of using an upper and lower curve to define minimum and maximum absorbance values for a plurality of channels ([0069] and [0075] and [0076]) (a plurality of LEDs and an absorbance profile of the transmitted light… is created based on the output signal intensity and using the output signal intensity T0 at the position corresponding to the uncolored portion… and the output signal intensity Ti at the position corresponding to the colored portion). Kazunori teaches that this method enables a quantitative measurement of antigen/antibody concentration (paragraph [78]) (the total amount (concentration) of antigens or antibodies contained in the sample can be accurately measured).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the encoder of Xie with the upper and lower curve of Kazunori because doing so would lead to the predictable outcome of quantifying antigen and antibody concentration with a reasonable expectation of success (see paragraph [76] and [78] of Kazunori). See MPEP 2143(I)(G).
Regarding claim 14, modified Xie teaches the method of claim 12 as rejected above. Xie teaches the identification of luminous intensity variations corresponding to at least a test region and control region (paragraph [0124] and [0125]) (enable the disclosed reader to accurately determine whether a signal is present at a designated location on an assay test strip and the encoder may… construct an accurate representation of the color properties of the assay test strip, including an accurate representation of the spacing of the detected regions).
Regarding claim 15, modified Xie teaches the method of claim 13 as rejected above. Xie teaches the identification of luminous intensity variations corresponding to at least a test region and control region (paragraph [0124] and [0125]) (enable the disclosed reader to accurately determine whether a signal is present at a designated location on an assay test strip and the encoder may… construct an accurate representation of the color properties of the assay test strip, including an accurate representation of the spacing of the detected regions).
Claims 7-8 are rejected under 35 USC 103 for being unpatentable over Xie et al. (US 20110275162A1) in view of Geun et al. (KR20140042143A) further in view of Hou et al. (Non-Patent Literature, Nanoscale Research Letters, Vol. 12, 2017).
Regarding claim 7, modified Xie teaches the method of claim 1 as rejected above. Xie teaches the use of a light source to irradiate the cassette and sample test strip (paragraph [0090]) (light sources may be utilized in conjunction with the one or more detectors).
Xie is silent to the wavelength(s) emitted by their light source.
In the analogous art of developing lateral flow assays, Hou et al teaches a method that uses white light to irradiate the test strip (Pg. 3 left column paragraph 1) (Dual-modality imaging (using white LED or UV LED) can be switched easily according to different kinds of strip (colloidal gold strip and fluorescence strips)). Hou teaches that white light may be used to enable the use of different kinds of indicators or test strips (pg. 2 left column paragraph 3) (the white and UC light of an optical system… could be changed to the different kinds of strips (color strip or fluorescence strip)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light source of Xie to emit white light as disclosed by Hou because doing so would lead to the predictable outcome of enabling the use of different kinds of indicators or test strips with a reasonable expectation of success (see pg. 2 left column paragraph 3 of Hou and [0090] of Xie). See MPEP 2143(I)(G).
Regarding claim 8, modified Xie teaches the method of claim 1 as rejected above. Xie teaches the use of a light source to irradiate the cassette and sample test strip (paragraph [0090]) (light sources may be utilized in conjunction with the one or more detectors).
Xie is silent to the wavelength(s) emitted by their light source.
In the analogous art of developing lateral flow assays, Hou et al teaches a method that uses white light to irradiate the test strip (Pg. 3 left column paragraph 1) (Dual-modality imaging (using white LED or UV LED) can be switched easily according to different kinds of strip (colloidal gold strip and fluorescence strips)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light source of Xie to emit UV light as disclosed by Hou because doing so would lead to the predictable outcome of enabling the use of different kinds of indicators or test strips with a reasonable expectation of success (see pg. 2 left column paragraph 3 of Hou and [0090] of Xie). See MPEP 2143(I)(G).
Conclusion
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/H.D.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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