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 .
Response to Amendment
The 112(b) rejections of claims 38, 41 are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 4/1/2026, with respect to the rejection of claim 25 have been fully considered and are persuasive as the existing rejection does not address all the limitations of the amended claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of existing references Seibel (20090208072), Govyadinov (20180043687), Sabounchi (20170016060) & Wentz (20190239753), and new reference Zhang et al (“Surface acoustic waves enable rotational manipulation of Caenorhabditis elegans”, Lab Chip. 2019 March 13; 19(6): 984–992. doi:10.1039/c8lc01012a).
Applicant argues on pages 7-8 that Ahmed does not teach rotation while a cell is flowing.
Examiner’s position is that new art Zhang teaches rotation while flowing (Abstract “We present an acoustofluidic chip capable of rotating Caenorhabditis elegans (C. elegans) in both static and continuous flow in a controllable manner.”).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 25-31, 35-36, 38-39, 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Seibel (United States Patent Application Publication 20090208072) in view of Govyadinov et al (United States Patent Application Publication 20180043687) in view of Zhang et al (“Surface acoustic waves enable rotational manipulation of Caenorhabditis elegans”, Lab Chip. 2019 March 13; 19(6): 984–992. doi:10.1039/c8lc01012a) in view of Sabounchi et al (United States Patent Application Publication 20170016060) in view of Wentz (United States Patent Application Publication 20190239753), the combination of which is hereafter referred to as “SGZSW”.
As to claim 25, Seibel teaches a method for determining a location, a density, or a classification of a cell surface marker on a surface of a cell (paragraph 0004 “The 3D reconstruction then remains available for analysis in order to enable the quantification and the determination of the location of structures, molecules or molecular probes of interest. An object such as a biological cell may be labeled with at least one stain or tagged molecular probe, and the measured amount and location of this biomarker may yield important information about the disease state of the cell”), the method comprising:
(a) subjecting the cell to flow through a channel (Figure 1, paragraph 0029 “tube 22 including a biological object 1 held therein”);
(b) while the cell is flowing through the channel, exposing the cell to a beam generated by one or more excitation sources using a light system (Figure 1, paragraph 0029 “computer-controlled light source and condenser lens assembly 56”, also see Figure 6 where the object 1 is imaged multiple times at multiple places using different wavelengths),
wherein upon an exposure of the cell to the plurality of beams, a plurality of photons is emitted from the cell (Figure 6, paragraph 0064 “visible light diffraction analysis and cell counting 602 may be done at a first stage 611, followed by visible light imaging 604 at a second stage 612. In the case of imaging using live stains, 280 nm absorption imaging 606 may be conducted at a next stage 613, followed by 260 nm absorption imaging 608 at a fourth stage 614”),
wherein the light system exciting the cell M times in one pass through the channel (Figure 6, the object is imaged multiple times),
wherein the plurality of spatially separate locations along the channel comprises an array of detectors (Figure 6, paragraph 0064 “Separate imaging stages may be processed along the same pathway” indicates each station has its own light source & detector), and
wherein M is at least two (Figure 6, there are four imaging stations);
(d) using the array of detectors, generating data for the cell; and (e) processing the data for the cell detected in (d) to determine the location, the density, or the classification of the cell surface marker (paragraph 0001 teaches taking images and reconstructing a 3D image (“The present invention relates to optical tomographic imaging systems in general, and, more particularly, to optical projection tomography for 3D microscopy, in which a small object, such as a biological cell, is illuminated with ultraviolet radiation for pseudoprojection imaging and reconstruction into a 3D image.”), and paragraph 0052 teaches imaging cells comprising biomarkers (“The expression and display of cell surface biomarkers … could be examined”)).
Seibel does not teach a plurality of diffracted beams generated by diffracting a light from one or more excitation sources using a light diffractive system and wherein upon an exposure of the cell to a beam of the plurality of diffracted beams, a plurality of photons is emitted from the cell. However, it is known in the art as taught by Govyadinov. Govyadinov teaches a microfluidic analyzer (Abstract “A light emitter on a second side of the microfluidic channel is to pass light across the microfluidic channel to the optical sensor.”) with a plurality of diffracted beams (Figure 7, .lambda.sub.1-5) generated by diffracting a light from one or more excitation sources using a light diffractive system (Figure 7, paragraph 0043 “Waveguide 640 transmits light from a light source 641 to grating 642. Grating 642 concurrently directs different wavelengths of light across microfluidic channel 24.”) and wherein upon an exposure of the cell to a beam of the plurality of diffracted beams, a plurality of photons is emitted from the cell (paragraph 0038 “different types of particles, cells are constituents expected to flow within the respective channels 24”, and Figure 7, paragraph“0043 “individual optical sensors 628” indicate that as a cell flows down channel 24, light from source 642 would hit it and be detected at the corresponding detector 628). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have a plurality of diffracted beams generated by diffracting a light from one or more excitation sources using a light diffractive system and wherein upon an exposure of the cell to a beam of the plurality of diffracted beams, a plurality of photons is emitted from the cell, in order to simplify the required hardware (i.e. Govyadinov improves the invention of Seibel by combining multiple imaging stations into a single light source & detector array).
Seibel as modified by Govyadinov above does not teach the light diffractive system comprises a diffractive photonic circuit that causes the light from the one or more excitation sources to diffract into the plurality of diffracted beams that exposes a plurality of spatially separate locations along the channel, thereby exciting the cell M times in one pass through the channel. However, it is known in the art as taught by Govyadinov. Govyadinov teaches the light diffractive system comprises a diffractive photonic circuit that causes the light from the one or more excitation sources to diffract into the plurality of diffracted beams that exposes a plurality of spatially separate locations along the channel (Figure 7, paragraph 0043 “Grating 642 concurrently directs different wavelengths of light across microfluidic channel 24.”), thereby exciting the cell M times in one pass through the channel (the invention of Seibel teaches multiple images of a cell along a flow path (Figure 6 has multiple imaging stations) and adding the teaching of Govyadinov’s light source would not change the process of taking multiple images). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the light diffractive system comprises a diffractive photonic circuit that causes the light from the one or more excitation sources to diffract into the plurality of diffracted beams that exposes a plurality of spatially separate locations along the channel, thereby exciting the cell M times in one pass through the channel, in order to simplify the required hardware while maintaining multiple-wavelength analysis.
Seibel as modified by Govyadinov above does not teach (c) while the cell is flowing through the channel, using an acoustic transducer to change an orientation of the cell through the channel. However, it is known in the art as taught by Zhang. Zhang teaches rotating a cell in a flow channel (Abstract “Rotational manipulation was achieved by exposing C. elegans to a surface acoustic wave (SAW) field that generated a vortex distribution inside a microchannel. By selectively activating interdigital transducers, we achieved bidirectional rotation of C. elegans”) including (c) while the cell is flowing through the channel, using an acoustic transducer to change an orientation of the cell through the channel (Abstract “We present an acoustofluidic chip capable of rotating Caenorhabditis elegans (C. elegans) in both static and continuous flow in a controllable manner.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have (c) while the cell is flowing through the channel, using an acoustic transducer to change an orientation of the cell through the channel, in order to better view the cell from a desired direction without affecting the health of the organism.
Seibel as modified by Govyadinov and Zhang above does not teach single-photon detectors. However, it is known in the art as taught by Sabounchi. Sabounchi teaches a microfluidic analyzer (Abstract “a microfluidic cartridge includes a stack of fluidics layers defining channels and valves for processing the nucleic acid sample to be sequenced, and a solid state CMOS biosensor integrated in the stack”) using single-photon detectors (paragraph 0079, “a CMOS imager having a single-photon avalanche diode (CMOS-SPAD)”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use single-photon detectors, in order to better detect certain types of light (e.g. fluorophores).
Seibel as modified by Govyadinov and Zhang and Sabounchi above does not teach (d) using the array of detectors, recording for at least a portion of the plurality of photons a duration of time between the exposure of the cell to the beam and a detection of a photon of the plurality of photons by a single-photon detector of the array of single-photon detectors, thereby generating an array of Time of Flight (TOF) data for the cell. However, it is known in the art as taught by Wentz. Wentz teaches a time-of-flight sensor (paragraph 0043 “Two or more photon sources emitting at these different wavelengths or with distributions overlapping these wavelengths may be utilized as sources in the time of flight imaging”) including an array of detectors (Figure 1A, paragraph 0020 “plurality of photon detectors 104a-b”), and (d) using the array of detectors, recording for at least a portion of the plurality of photons (from light source Figure 1A, paragraph 0044 “emission source 128”) a duration of time between the exposure of the cell to the beam and a detection of a photon of the plurality of photons by a single-photon detector of the array of single-photon detectors, thereby generating an array of Time of Flight (TOF) data for the cell (paragraph 0050 “fluorescence may be excited repetitively by short laser pulses”, “the time difference between excitation and emission may be measured” and “a SPAD-based time of flight system”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be (d) using the array of detectors, recording for at least a portion of the plurality of photons a duration of time between the exposure of the cell to the beam and a detection of a photon of the plurality of photons by a single-photon detector of the array of single-photon detectors, thereby generating an array of Time of Flight (TOF) data for the cell, in order to obtain more accurate measurements of the analyte being studied.
Seibel as modified by Govyadinov and Zhang and Sabounchi and Wentz above does not explicitly teach (d) processing the array of TOF data for the cell detected to determine the location, the density, or the classification of the cell surface marker. However, Seibel teaches taking multiple images of a cell (Figure 6 has multiple imaging stations using different wavelengths) and to use image data in the 3D reconstruction (paragraph 0010 “A plurality of pseudoprojection images of the biological object from the sensed radiation is formed and the plurality of pseudoprojections is reconstructed to form a 3D image of the cell.”), and it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use all available data, including the TOF data from Wentz, in the reconstruction process, in order to create a more accurate model of the cell.
As to claim 26, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches the array of single-photon detectors comprises 2 to 1,000,000 single-photon avalanche diodes (SPAD) (in the invention of Seibel as modified above, Seibel Figure 6 teaches four imaging stations, and using the teachings of Sabounchi above to modify the invention of Seibel to use SMOS-SPAD detectors would not change the number of detectors).
As to claim 27, SGZSW teaches everything claimed, as applied above in claim 25, in addition Zhang teaches the channel is configured to rotate the cell on an axis of the cell (Abstract “We present an acoustofluidic chip capable of rotating Caenorhabditis elegans (C. elegans) in both static and continuous flow in a controllable manner.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to rotate the cell on an axis of the cell, in order to better view the cell from a desired direction.
As to claim 28, SGZSW teaches everything claimed, as applied above in claim 25, in addition Zhang teaches the orientation of the cell changes during an iteration through the channel (Abstract “We present an acoustofluidic chip capable of rotating Caenorhabditis elegans (C. elegans) in both static and continuous flow in a controllable manner.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the orientation of the cell change during an iteration through the channel, in order to better image the cell from all directions.
As to claim 29, SGZSW teaches everything claimed, as applied above in claim 28, in addition Zhang teaches using the acoustic transducer to change the orientation of the cell in the iteration through the channel (Abstract “We present an acoustofluidic chip capable of rotating Caenorhabditis elegans (C. elegans) in both static and continuous flow in a controllable manner.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be using the acoustic transducer to change the orientation of the cell in the iteration through the, in order to better view the cell from a desired direction.
As to claim 30, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches generating a topographic map of the surface of the cell based on (e) (paragraph 0003 “The set of pseudoprojection images can be reconstructed using backprojection and filtering techniques to yield a 3D reconstruction of a cell of interest.” and while Seibel does not explicitly teach a “topographic map”, examiner’s position is that a 3D reconstruction contains all the information of a topographic map and is therefore not patentably different from such a map, see MPEP 2144.06(II) “Substituting Equivalents”).
As to claim 31, SGZSW teaches everything claimed, as applied above in claim 30, in addition Seibel teaches the topographic map comprises a location map comprising the cell surface marker (paragraph 0004 “The 3D reconstruction then remains available for analysis in order to enable the quantification and the determination of the location of structures, molecules or molecular probes of interest. An object such as a biological cell may be labeled with at least one stain or tagged molecular probe, and the measured amount and location of this biomarker may yield important information about the disease state of the cell”), an intensity map comprising the cell surface marker, a density map comprising the cell surface marker, or any combination thereof.
As to claim 35, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches detecting or generating a plurality of two-dimensional images of the cell and using the plurality of two-dimensional images to construct a three-dimensional morphology of the cell (paragraph 0033 “A computer 41 includes an image processor 40 coupled to receive data from the first and second light detectors 10, 14. A reconstruction module 42 is coupled to the image processor 40, where the reconstruction module processes the data to form a 3D image of the cell”).
As to claim 36, SGZSW teaches everything claimed, as applied above in claim 35, in addition Seibel teaches the plurality of photons generates the plurality of two-dimensional images at the plurality of spatially separate locations along the channel (paragraph 0003 teaches multiple images are taken at each imaging station (“The resultant images comprise a set of extended depth of field images from differing perspectives called "pseudoprojection images." The set of pseudoprojection images can be reconstructed using backprojection and filtering techniques to yield a 3D reconstruction of a cell of interest.”) and Figure 6 shows separate imaging stations, and using the teachings of Govyadinov to have a single light source with separated wavelengths in the same flow channel (Figure 7) on the invention of Seibel would have multiple stations each taking multiple images, reading on the claimed limitation).
As to claim 38, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches (d) comprises detection of the [at least two] M excitations (paragraph 0003 teaches multiple images are taken at each imaging station (“The resultant images comprise a set of extended depth of field images from differing perspectives called "pseudoprojection images." The set of pseudoprojection images can be reconstructed using backprojection and filtering techniques to yield a 3D reconstruction of a cell of interest.”) and Figure 6 shows separate imaging stations each of which would obviously take multiple images).
As to claim 39, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches taking multiple data points (images) at each of multiple stations (paragraph 0003 “The resultant images comprise a set of extended depth of field images from differing perspectives called "pseudoprojection images." The set of pseudoprojection images can be reconstructed using backprojection and filtering techniques to yield a 3D reconstruction of a cell of interest.” and Figure 6 shows separate imaging stations), and applying the teachings of Wentz of taking TOF data would make it obvious to one of ordinary skill in the art before applicant’s effective filing date to take TOF data at each of the imaging stations and have the array of TOF data comprise TOF data for the cell generated by the at least two M excitations, in order to more completely characterize the cell.
As to claim 41, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches the plurality of photons comprises photons derived from fluorescence and detection of the plurality of photons of the plurality of photons comprises fluorescent detection (paragraph 0031 “The optical tomographic imaging system 11 may advantageously employ illumination radiation having a frequency that stimulates native fluorescence from the biological object, where the light detectors and image processor further include modules for measuring the stimulated fluorescence.”).
As to claim 42, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches the channel comprises a width of at least 10 μm (paragraph 0022 “"Capillary tube" has its generally accepted meaning and is intended to include transparent microcapillary tubes and equivalent items with an inside diameter generally of 500 microns or less.”).
As to claim 43, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches the channel comprises a space-constrained tube (Figure 1, paragraph 0029 “A tube 22, such as a capillary tube, microcapillary tube or equivalent, is positioned to be viewed by a microscope 16”).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over SGZSW, and further in view of Cao (United States Patent Application Publication 20230169662).
As to claim 32, SGZSW teaches everything claimed, as applied above in claim 30, with the exception of the topographic map comprises an atlas of cellular expression comprising the cell surface marker. However, it is known in the art as taught by Cao. Cao teaches taking multiple images and reconstructing a 3D image of a cell (Abstract “A method for generating a morphological atlas of an embryo including the steps of receiving a plurality of 3D images”) the topographic map comprises an atlas of cellular expression comprising the cell surface marker (paragraph 0005 “there is provided a system for generating a morphological atlas of an embryo including a cell imaging unit arranged to receive a plurality of 3D images of the embryo”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the topographic map comprise an atlas of cellular expression comprising the cell surface marker, in order to create a more reliable model of the object under study.
Claims 33, 44 are rejected under 35 U.S.C. 103 as being unpatentable over SGZSW, and further in view of Hu et al (CN 104266955).
As to claim 33, SGZSW teaches everything claimed, as applied above in claim 25, in addition Seibel teaches the cell is part of a population of cells (Figures 4 & 5 show multiple cells).
Seibel as modified by Govyadinov and Zhang and Sabounchi and Wentz does not teach generating a distribution for the population of cells. However, it is known in the art as taught by Hu. Hu teaches the analysis of cells (Abstract “The invention combines the flow cytometry and fluorescence microscopy imaging, which has a plurality of detection channels, can be collected by cell of the flow chamber of the cell image, and using the analysis software to each cell image to carry out quantification analysis so as to provide information of statistical data and cell morphology, cell structure and subcellular distribution of the cell population.”) including generating a distribution for the population of cells (paragraph 0018 “using the analysis software to each cell image to carry out quantification analysis so as to provide information of statistical data and cell morphology, cell structure and subcellular distribution of the cell population.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be generating a distribution for the population of cells, in order to better understand the cell characteristics & behavior.
While Hu does not explicitly teach using TOF data when generating the population distribution, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date for one operating the invention of Seibel (who teaches taking multiple sets of data at multiple wavelengths) as modified by the teachings of Govyadinov and Zhang and Sabounchi and Wentz (who teaches taking TOF data) to take advantage of all available data when making calculations, in order to obtain a more accurate result.
As to claim 44, SGZSW teaches everything claimed, as applied above in claim 25, with the exception of recording intensity and spectral information of the plurality of photons. However, it is known in the art as taught by Hu. Hu teaches recording intensity (paragraph 0045 “these parameters include not only the scattered light and fluorescence signal intensity of the whole cell”) and spectral information of the plurality of photons (paragraph 0013 “the multi-spectral PMT light signal and the fluorescent image of the multi-spectral fluorescence intensity of the image”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be recording intensity and spectral information of the plurality of photons, in order to better identify characteristics that appear stronger in certain wavelengths.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over SGZSW in view of Hu, and further in view of Xu et al (United States Patent Application Publication 20170102310).
As to claim 34, SGZSW in view of Hu teaches everything claimed, as applied above in claim 33, with the exception of classifying the population of cells based at least in part on the distribution for the population of cells. However, it is known in the art as taught by Xu. Xu teaches a flow cytometer and classification method (Abstract “The present disclosure provides a flow cytometer and a multidimensional data automatic classification method and apparatus thereof.”) and classifying the population of cells based at least in part on the distribution for the population of cells (paragraph 0033 “it is possible to first classify some cell populations in the statistics result according to the auxiliary parameter, and then the cell population meeting the specificity may be determined as the cell population of interest based on the test item and a distribution feature of the cell population of interest on the auxiliary parameter.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be classifying the population of cells based at least in part on the distribution for the population of cells, in order to better determine a cell population of interest.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over SGZSW, and further in view of Roche et al (United States Patent Application Publication 20030030783).
As to claim 37, SGZSW teaches everything claimed, as applied above in claim 25, with the exception of classifying the cell using the array of TOF data. However, it is known in the art as taught by Roche. Roche teaches a flow cytometry & classification system (Abstract “The present invention is a flow cytometry-based hematology system useful in the analysis of biological samples”) including classifying the cell using the array of TOF data (paragraph 0054 “measuring at least one parameter from the group consisting of … time-of-flight for each cell in the sample, to produce a measurement value for each parameter; and analyzing the measurement values to classify each cell”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have classifying the cell using the array of TOF data, in order to more accurately classify the cell.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over SGZSW, and further in view of Meng et al (United States Patent Application Publication 20210331161).
As to claim 40, SGZSW teaches everything claimed, as applied above in claim 25, with the exception of performing (a)-(e) simultaneously in parallel in a plurality of channels. However, it is known in the art as taught by Meng. Meng teaches performing (a)-(e) simultaneously in parallel in a plurality of channels (Figure 4B, channels 10 are parallel, see paragraph 0106 “Optionally, the microfluidic channels in a respective one of the plurality of regions 15 having a same fluid flow direction.”) It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be performing (a)-(e) simultaneously in parallel in a plurality of channels, in order to perform more detections at the same time.
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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/J.C.U/Examiner, Art Unit 2877
/Michael A Lyons/Primary Examiner, Art Unit 2877
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