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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/26/2024 and 2/5/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 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.
Claims 1-8, 10, 11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Saito (JP 2020-204604 A) in view of Kawakita (JP 2012-88304 A) (pagination for both documents according to the translations provided in the IDS filed 8/26/2024).
Regarding claims 1, 15 and 16, Saito discloses a particle analyzing device, method of operation, and non-transitory computer readable storage medium storing the method thereon, (Fig.1), including:
a) a light irradiation unit 2 that irradiates a sample 1 emitting fluorescence of a plurality of colors with excitation light;
b) one or a plurality of filters 33 that transmits the fluorescence of the plurality of colors while cutting off the excitation light;
c) an imaging unit 31 for imaging fluorescence that has passed through the filter 33; and
d) an analysis unit 4 that obtains a diffusion rate due to Brownian motion of a particle included in the sample 1 from image data of fluorescence obtained by the imaging unit 31 and analyzes a physical property of the particle (see at least par.0008).
Further regarding claim 1, Saito does not specifically disclose that the imaging unit 31 has color identification ability. The spectral selectively is performed by the filter 33 (par.0027).
Kawakita teaches the practice of determining a physical property of biological particles in motion via a plurality of fluorescence colors (Figs.19-24) using a color CCD 80 paired with a filter 84 that removes the excitation wavelength L (either a long-pass wavelength filter or a notch filter, par.0081) that provides spectral analysis of the fluorescence emitted from the sample in order to determine a physical property of the particles (Figs.20, 21 and 24). In this manner, the capabilities are comparable to that of having spectrally dedicated image sensors and corresponding filters and optics while providing relatively inexpensive and compact arrangements with only one routine filter necessary (compare to Figs.1 and 6; also see pars.0082-0084 and 0100-0101).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to use an imaging unit having color identification, as taught by Kawakita, in order to dramatically simplify the fluorescence detection system while maintaining practical detection capabilities for analyzing the physical properties of biological particles, as taught by Kawakita, with a reasonable expectation of success and without undue experimentation.
With respect to claim 2, Saito and Kawakita both further disclose that the fluorescence of the plurality of colors is transmitted while the excitation light is cut off by a plurality of the filters (par.0027 of Saito; par.0081 of Kawakita).
With respect to claim 3, Saito further discloses that the light irradiation unit 2 irradiates the sample 5 with excitation light having excitation wavelengths different from each other (Fig.1).
Further with respect to claim 3, Saito does not specifically disclose that the one or a plurality of filters 33 are configured such that a wavelength region to be transmitted is wider than a wavelength region to be cut off, in a region of a wavelength longer than a shortest one of the excitation wavelengths. There are no details concerning the spectral transmission characteristics of the filter(s) 33 aside from passing the known fluorescence wavelengths (par.0027).
However, Saito does teach that the excitation wavelengths may be sequentially emitted or simultaneously emitted (par.0026).
Kawakita teaches the practice of providing a simple long-pass or notch filter 84 in order to cut off the excitation wavelength in order to take advantage of the color identification capabilities of the color CCD 80 (par.0081) for compact and efficient spectral analysis of the fluorescence (pars.0100-0101).
The skilled artisan readily recognizes that Saito would take advantage of the color identification capabilities of the color CCD 80 of Kawakita by sequentially providing long-pass filters 84 for sequential irradiation, or a stack of notch filters 84 for simultaneous irradiation, for simplified and comprehensive biological particle analysis. In either case, the one or a plurality of filters would be configured such that the wavelength region to be transmitted is wider than a wavelength region to be cut off, in a region of a wavelength longer than a shortest one of the excitation wavelengths.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to have the one or the plurality of filters be configured such that a wavelength region to be transmitted is wider than a wavelength region to be cut off, in a region of a wavelength longer than a shortest one of the excitation wavelengths, as suggested by Kawakita, in order to take advantage of the color identification capabilities of the color CCD, as taught by Kawakita, all with a reasonable expectation of success and without undue experimentation.
With respect to claim 4, Kawakita further teaches that the imaging unit is a color CCD (pars.0081 and 0100).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to use an imaging unit having a color CCD, as taught by Kawakita, in order to dramatically simplify the fluorescence detection system while maintaining practical detection capabilities for analyzing the physical properties of biological particles, as taught by Kawakita, with a reasonable expectation of success and without undue experimentation.
With respect to claim 5, Saito further discloses that the light irradiation unit 2 sequentially changes the excitation light having an excitation wavelength for generating the fluorescence of the plurality of colors and irradiates the sample with the excitation light (par.0026).
With respect to claim 6, Saito further discloses:
e) a particle identification unit that identifies a particle emitting fluorescence from the image data of fluorescence obtained by the imaging unit 3 (par.0008);
f) a fluorescence identification unit that identifies fluorescence information related to fluorescence emitted by a particle identified by the particle identification unit (par.0009); and
g) the analysis unit analyzing a physical property of a particle for each piece of the fluorescence information identified by the fluorescence identification unit (pars.0008-0009).
With respect to claim 7, Saito does not specifically disclose that the fluorescence identification unit identifies, as the fluorescence information, hue obtained by converting an output value from the imaging unit. This is due to the lack of color identification by the imaging unit.
Kawakita teaches the practice of using the hue of the fluorescence as the fluorescence information in order to efficiently identify the expected fluorescence emitted by the sample (R/G and/or B/G ratios with 256 gradations due to conversion by 8-bit ADC: pars.0082-0084 and Figs.20 and 21).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to use hue as the fluorescence information in order to efficiently identify the fluorescence of the plurality of colors using the simplified detection arrangement with the color CCD camera, as taught by Kawakita, with a reasonable expectation of success and without undue experimentation.
With respect to claim 8, Saito does not specifically disclose that the display unit displays a graph in which one axis is set to the fluorescence information and another axis is set to a physical property of a particle, and displays plots indicating particles on the graph.
Kawakita teaches the practice of displaying a graph in which one axis is set to the fluorescence information and another axis is set to a physical property of a particle, and displays plots indicating particles on the graph (particle type and hue intensity, Figs.20 and 21). In this manner, the various particles are efficiently identified based on the hue of the plurality of colors of the emitted fluorescence from the sample as detected by the color CCD (par.0100).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to display a graph in which one axis is set to the fluorescence information and another axis is set to a physical property of a particle, and displays plots indicating particles on the graph in order to efficiently identify the particles, as taught by Kawakita, with a reasonable expectation of success and without undue experimentation.
With respect to claim 10, Kawakita further teaches that the display unit displays each of the plots in a selectable manner, and in a case where one or a plurality of the plots are selected, displays an analysis result of the analysis unit for particles indicated by the plots (plots of Figs.20 and 21 are displayed based on the collected data (R, G and B)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to display the plots in a selectable manner and to display the analysis results with either or both of the plots in order to efficiently identify the particles, as taught by Kawakita, with a reasonable expectation of success and without undue experimentation.
With respect to claim 11, while neither Saito nor Kawakita specifically disclose displaying an enlarged portion of a plot, it is routine in the art of graphical user interfaces to display portions of graphs, or graphs with or without all of the data points, enlarged or thumbnail, as desired for convenient and intuitive assessment of the analysis results and management of the display space.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to display an enlarged image obtained by cutting out particles indicated by the plots from the image data, as desired for convenient display of the analysis results, as recognized by one of ordinary skill in the art, with a reasonable expectation of success and without undue experimentation.
With respect to claim 14, Saito further discloses that a plurality of types of fluorescent markers are added to at least one type of particles included in the sample (par.0033).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Saito and Kawakita, as applied to claim 6 above, in view of Nagai (WO 2021/157710 A1).
With respect to claim 9, neither Saito nor Kawakita specifically disclose displaying a graph where one axis is set to fluorescence information with respect to illumination with a first excitation wavelength, and another axis is set to fluorescence information with respect to illumination with a second excitation wavelength and displays plots indicating particles on the graph.
Nagai teaches the common practice of displaying graphs having one axis represent fluorescence information corresponding to illumination with a first wavelength, and having another axis represent fluorescence information corresponding to illumination with a second wavelength, and displaying the plots indicating particles on the graph (Figs.10A, 11A, 12A, etc.). In this manner, the particles are unambiguously determined in a visually intuitive manner.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to display a graph in which one axis is set to the fluorescence information obtained by irradiating the sample with excitation light having a first excitation wavelength and another axis set to the fluorescence information obtained by irradiating the sample with excitation light having a second excitation wavelength, and displays plots indicating particles on the graph for clear and intuitive communication of the analysis results, as taught by Nagai.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Saito and Kawakita, as applied to claim 6 above, in view of Geddes (US 2010/0209937 A1).
With respect to claim 12, neither Saito nor Kawakita specifically disclose calculating the average of color information of a plurality of pixels representing one particle included in the image data, as fluorescence information of a fluorescent marker added to the particle. Kawakita teaches summing the color information of the pixels representing the fluorescent marker added to the particle, after subtracting the background (Fig.9 and par.0064).
Geddes teaches the routine practice of calculating an average fluorescence for a given particle within the image (Fig.5, par.0094). The skilled artisan appreciates the fact that averaging improves the statistics of the results, where the inherent noise in individual pixel values are essentially smoothed to an overall value that provides a more precise comparison to the other particles.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Saito to have the fluorescence identification unit calculate an average of color information of a plurality of pixels representing one particle included in the image data, as fluorescence information of a fluorescent marker added to the particle, as taught by Geddes, in order to improve the fluorescence intensity statistics for a higher confidence in detection results, as understood by one of ordinary skill in the art.
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art neither teaches nor reasonably suggests the additional limitation that the color information to be averaged is that of pixels excluding at least a pixel located in a central portion among a plurality of pixels representing the one particle, as required by the combination as claimed. As noted above, Kawakita teaches a summation of all pixels above background, and US patent documents to Yamaguchi exclude the peripheral pixels when calculating the average (par.0070 of US 2005/0089191 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892 unless otherwise noted):
US patent documents to Orwar disclose another example of having a color imaging camera for detecting fluorescence from a sample of particles for subsequent analysis (in addition to the various prior art documents cited in the IDSes and highlighted in the foreign search reports and opinions); and
US patent documents to Ozasa, to Werner, and to Stramski all teach various modern GUI for selective display of all available data and analytical results (particularly Ozasa, Fig.14).
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THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884
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