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 .
Election/Restrictions
Applicant’s election without traverse of Group I: claims 21-33 in the reply filed on 01/08/2026 is acknowledged.
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: “imaging system” in claims 21-33.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,668,641 (Patent claim) in view of US 20170268981 A1 (Diebold). Patent claim does not recite, “the imaging system is configured to obtain the optical signal data at a sampling rate of no less than 200 kHz”. Diebold teaches these limitations (Diebold: See corresponding citations and arguments provided in showing teaching for the corresponding limitations in the 35 USC § 102 rejection section below). One of ordinary skill in the art would have recognized the advantage of enabling high-throughput and high-resolution and imaging capabilities in flow cytometry.
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)(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.
Claim(s) 21, 22, 24, 25, 27-29, 32, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20170268981 A1 (Diebold).
As per claim 21, Diebold teaches an image-based flow cytometry system, comprising:
a particle flow device structured to include a substrate comprising a channel, the particle flow device operable to flow cells along a flow direction to a first region of the channel; an imaging system configured to obtain optical signal data associated with a cell when the cell is in the first region (Diebold:
abstract: “sorting cells in a flow cytometry system”;
“[0003] The present invention relates generally to devices and methods for determining characteristics of particles flowing through a flow cytometer, e.g., via fluorescence analysis of samples, and more particularly to devices and methods for sorting particles, e.g., sorting cells in a flow cytometer based, for example, on their characteristics.”;
Para 6: “a method of determining a characteristic of a particle is disclosed, which includes illuminating a particle as it flows through a flow cytometry system with a radiofrequency-modulated optical beam so as to elicit at least one radiative response from the particle, detecting the radiative response emanating from the particle to generate temporal waveform data associated with the radiative response”;
“[0036] In another aspect, a method of sorting cells in a flow cytometry system is disclosed, which includes introducing a plurality of cells, each of which is associated with at least one fluorophore, into an optical interrogating region one at a time at a rate greater than about 1000 cells per second to illuminate each of the cells with radiofrequency-modulated optical radiation so as to elicit fluorescent radiation from the fluorophore(s). For each cell, the fluorescent radiation emitted from the cell is detected to generate a time-frequency waveform, and the waveform is processed to arrive at a sorting decision regarding the cell.”;
“[0087] The terms “cytometry” and “flow cytometry” are also used consistent with their customary meanings in the art. In particular, the term “cytometry” can refer to a technique for identifying and/or sorting or otherwise analyzing cells. The term “flow cytometry” can refer to a cytometric technique in which cells present in a fluid flow can be identified, and/or sorted, or otherwise analyzed, e.g., by labeling them with fluorescent markers and detecting the fluorescent markers via radiative excitation.”;
“[0114] Referring again to FIG. 1, a positive lens 50 (200-mm lens in this embodiment) and an objective lens 52, mounted in this embodiment on an adjustable post holder mount C, form a telescope for relaying the image at the intermediate plane 48 onto a sample flowing through a flow cell 54.”;
“[0115] As shown schematically in FIG. 6, the combined beam 49 concurrently illuminates a plurality of spatial locations 60 of a sample 62 flowing through the flow cell 54. Thus, each location 60 is illuminated by the overlap of one of the RF comb beams with a portion of the top-hat shaped LO laser beam.”;
“[0175] FIG. 16B schematically depicts a system 3000 according to an embodiment for estimating at least one characteristic of a particle, such as a cell. The exemplary system 3000 includes an illuminating system 3002 for illuminating one or more particles flowing through a cell of a flow cytometry system with a radiofrequency-modulated optical laser beam. A detector 3004 can detect a radiative response of the particle, e.g., fluorescent and/or scattered radiation, in response to its illumination, and generate one or more signals indicative of the radiative response.”;
Fig. 1 (shown below);
Figs. 9A-10); and
a data processing and control unit comprising a processor, the data processing and control unit in communication with the imaging system and configured to (Diebold:
para 24: “processor”;
para 86: “In embodiments discussed below, the methods employ computer processors for their implementation.”;
para 97: “controller 21”;
para 109: “imaging system… controller 21”;
para 128: “the photodetector may include… active-pixel sensors (APSs), quadrant photodiodes, image sensors, change-coupled devices (CCDs), intensified charge-coupled devices (ICCDs)”;
para 130: “photodetector 64”;
paras 143, 148, 155, 178, 216, 218: controller and/or processor;
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(i) process the optical signal data into a two-dimensional image of the cell (Diebold:
Para 89: “The fluorescence emission can be detected and its frequency components can be analyzed to construct a fluorescence image of the sample.”;
Para 147: “As each frequency component corresponds to one of the beat frequencies employed to elicit the fluorescence radiation from a particular location of the sample, the measure of the amplitude of the frequency component can provide a pixel value for a location associated with that frequency component along a horizontal row of the sample. In this manner, pixel values for an image of a horizontal row of the sample can be determined. The above steps can be repeated for fluorescence data obtained for each horizontal row of the sample as the sample flows through the flow cell in a vertical direction. The pixels values can be used to construct a fluorescence image (step 5).”;
Para 151: “The above steps can be repeated for fluorescence data obtained for each horizontal row of the sample as the sample flows through the flow cell in a vertical direction. The pixels values can be used to construct a fluorescence image (step 5).”;
“[0154] An envelope detector at each beat frequency is employed to estimate, for each horizontal line, the amplitude of each pixel corresponding to that frequency (step 4). In some cases, a plurality of pixel values corresponding to a pixel, obtained by processing multiple fluorescent signals corresponding to a sample location associated with that pixel, is averaged to obtain an average pixel value. The above steps can be repeated for fluorescence data obtained for each horizontal row of the sample as the sample flows through the flow cell in a vertical direction. The pixels values can be used to construct a one-dimensional or a two-dimensional fluorescence image of the sample (step 5).”
Para 161: “an image can be digitally reconstructed using the time values of the detected fluorescence signal as the horizontal pixel coordinate, and the digitized voltage values of the fluorescence signal as the pixel values (brightness). Each scan of the drive frequencies applied to the AOD produces one horizontal line (row) of the image. The image reconstruction is achieved via consecutive scans as the sample flows through the illumination area (point).”;
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),
(ii) extract one or more parameters from the two-dimensional image of the cell, wherein the one or more parameters are associated with one or more spatial features of the cell (Diebold:
Para 156: “The fluorescence image can also be analyzed to determine the location of fluorescent probe giving rise to that image (e.g., it can be determined whether the probe is the nucleus, cytoplasm, localized to organelles, or on the outside of the cell membrane). Further, in some applications, multiple fluorescent images obtained by detecting different fluorescent bands, all of which taken from the same cell, can be used to determine the degree of co-localization of multiple fluorescent probes within a cell. Additionally, the analysis of cell morphology, cell signaling, internalization, cell-cell interaction, cell death, cell cycle, and spot counting (e.g., FISH), among others, are possible using multi-color fluorescence, brightfield, and darkfield images”;
Para 166: “the output of the detector detecting the brightfield image of the sample/flow cell can be used to obtain reference phases with which the phases of the fluorescence beat frequencies can be compared.”),
wherein the imaging system is configured to obtain the optical signal data at a sampling rate of no less than 200 kHz and the cell is flowed through the channel at a speed of no less than 0.08 m/s (Diebold:
para 146: “data acquisition… a 256 MHz sampling rate”
para 159: “a sample flow speed of 0.1 meters per second”;
para 169: “The flow rate of particles in the flow stream may be… such as 0.1 m/s or more, such as 0.5 m/s or more, such as 1 m/s or more, such as 2 m/s or more, such as 3 m/s or more, such as 4 m/s or more, such as 5 m/s or more, such as 6 m/s or more, such as 7 m/s or more, such as 8 m/s or more, such as 9 m/s or more, such 10 m/s or more, such as 15 m/s or more and including 25 m/s or more”).
As per claim 22, Diebold teaches the system of claim 21, wherein the imaging system includes one or more light sources to provide an input light to the cell at the first region of the particle flow device, and an optical imager configured to receive optical image data from the cells in the first region (Diebold: See arguments and citations offered in rejecting claim 21 above: light source illuminates cell at first region for image capture).
As per claim 24, Diebold teaches the system of claim 21, wherein the optical signal data comprises a first optical signal and a second optical signal, the first optical signal comprising a first fluorescent signal, and the second optical signal comprising a second fluorescent signal (Diebold: See arguments and citations offered in rejecting claim 21 above;
“[0013] In some embodiments, the particle can be stained with at least two fluorescence markers, where each marker is configured to emit fluorescent radiation in response to illumination by radiation having one of the optical frequencies. In such embodiments, the method can further include collecting and digitizing fluorescence signals emanated from these markers to generate temporal fluorescence waveforms each corresponding to one of the markers.”;
“[0030] In some embodiments, the cell can be stained with at least two fluorescence markers and the optical radiation is configured to elicit fluorescent radiation from those markers. The fluorescent radiation can be collected and digitized to generate temporal fluorescence waveforms (i.e., waveforms indicating fluorescence intensity as a function of time) each corresponding to one of the markers.”;
“[0032] In some embodiments, a cell is labeled with two fluorescence markers one of which is coupled to the cell's membrane and the other to the cell's nucleus. The optical radiation applied to the cell is configured to elicit fluorescence from both markers. The fluorescence signals emitted by both markers are detected in two different channels and analyzed to obtain an estimate of a ratio of the size of the cytoplasm relative to that of the nucleus.”;
“[0133] In many cases, the excitation radiation illuminating the sample excites multiple fluorophores (e.g., organic fluorophores) that can have broad enough radiation absorption spectra such that the excitation frequencies fall within the absorption spectra of multiple fluorophores in the sample. Each fluorophore would then emit fluorescence radiation at a different frequency.”;
“[0134] A plurality of bandpass filters 120, 122, 124, and 126, each centered at one of the four fluorescence frequencies, are placed in front of the photomultiplier tubes 106, 108, 110, and 112, respectively.”;
Para 154: “a plurality of pixel values corresponding to a pixel, obtained by processing multiple fluorescent signals corresponding to a sample location associated with that pixel, is averaged to obtain an average pixel value.”;
Paras 156, 176, 182, 183, 185, 188, 197, 202, 203, 208: multiple fluorescent signals;
: uses 2 different fluorescent signals).
As per claim 25, Diebold teaches the system of claim 21, wherein the optical signal data comprises a first optical signal and a second optical signal, the first optical signal comprising a first fluorescent signal, and the second optical signal comprises a visible light signal (See arguments and citations offered in rejecting claim 24 above: 2 different fluorescent signals are recited above.
: uses fluorescent and visible light signals. Note that fluorescence is visible light.).
As per claim 27, Diebold teaches the system of claim 21, wherein the data processing and control unit is configured to determine, from the two-dimensional image of the cell, (only one of the following listed items is required due to the use of the conjunction “or”) one or more of an amount or a size of a feature of or on the cell, one or more particles attached to the cell, or a particular morphology of the cell or portion of the cell (Diebold:
Para 156: “The fluorescence image can also be analyzed to determine the location of fluorescent probe giving rise to that image (e.g., it can be determined whether the probe is the nucleus, cytoplasm, localized to organelles, or on the outside of the cell membrane). Further, in some applications, multiple fluorescent images obtained by detecting different fluorescent bands, all of which taken from the same cell, can be used to determine the degree of co-localization of multiple fluorescent probes within a cell. Additionally, the analysis of cell morphology, cell signaling, internalization, cell-cell interaction, cell death, cell cycle, and spot counting (e.g., FISH), among others, are possible using multi-color fluorescence, brightfield, and darkfield images”;
Para 166: “the output of the detector detecting the brightfield image of the sample/flow cell can be used to obtain reference phases with which the phases of the fluorescence beat frequencies can be compared.”
: cell parameters or features can include cell feature size or amount, cell-attached particle presence, or cell or cell-portion morphology (e.g. shape)).
As per claim 28, Diebold teaches the system of claim 21, wherein the one or more parameters from the two-dimensional image of the cell comprise at least one of (only one of the following listed items is required due to the use of the conjunction “or”) fluorescence area, bright field area, fluorescence perimeter, or bright field perimeter (Diebold: See arguments and citations offered in rejecting claim 21 above: fluorescence, brightfield areas of image(s)).
As per claim 29, Diebold teaches the system of claim 21, wherein the data processing and control unit is operable to analyze the cell including analysis criteria, and wherein the analysis criteria include (only one of the following listed items is required due to the use of the conjunction “or”) a cell contour, a cell size, a cell shape, a nucleus size, a nucleus shape, a fluorescent pattern, or a fluorescent color distribution (Diebold: See arguments and citations offered in rejecting claim 21 above;
Para 156: “The fluorescence image can also be analyzed to determine the location of fluorescent probe giving rise to that image (e.g., it can be determined whether the probe is the nucleus, cytoplasm, localized to organelles, or on the outside of the cell membrane). Further, in some applications, multiple fluorescent images obtained by detecting different fluorescent bands, all of which taken from the same cell, can be used to determine the degree of co-localization of multiple fluorescent probes within a cell. Additionally, the analysis of cell morphology, cell signaling, internalization, cell-cell interaction, cell death, cell cycle, and spot counting (e.g., FISH), among others, are possible using multi-color fluorescence, brightfield, and darkfield images”).
As per claim 32, Diebold teaches the system of claim 21, wherein the one or more parameters from the two-dimensional image of the cell are associated with a physiological property of the cell including (only one of the following listed items is required due to the use of the conjunction “or”) a cell life cycle phase, an expression or localization of a protein by the cell, an expression or localization of a gene by the cell, a damage to the cell, or an engulfment of a substance or a particle by the cell (Diebold: See arguments and citations offered in rejecting claim 21 above;
Para 156: “The fluorescence image can also be analyzed to determine the location of fluorescent probe giving rise to that image (e.g., it can be determined whether the probe is the nucleus, cytoplasm, localized to organelles, or on the outside of the cell membrane). Further, in some applications, multiple fluorescent images obtained by detecting different fluorescent bands, all of which taken from the same cell, can be used to determine the degree of co-localization of multiple fluorescent probes within a cell. Additionally, the analysis of cell morphology, cell signaling, internalization, cell-cell interaction, cell death, cell cycle, and spot counting (e.g., FISH), among others, are possible using multi-color fluorescence, brightfield, and darkfield images”).
As per claim 33, Diebold teaches the system of claim 32, wherein the damage to the cell includes DNA damage (Diebold: See arguments and citations offered in rejecting claim 32 above. These alternative limitations are not required because “damage to the cell” is recited as an alternative listed item in claim 32 above, and a teaching was provided for a different listed item).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diebold as applied to claim 21 above, and further in view of WO 2015200857 (Di Carlo).
As per claim 26, Diebold teaches the system of claim 21, wherein the data processing and control unit is configured to process the image data to produce the image data set by filtering the image data, reconstructing a first image based on the filtered data, (Diebold:
“[0144] As discussed in more detail below, the analysis method determines the frequency components of the time-varying photodetector's output and constructs a fluorescence image of the sample based on those frequency components. A variety of methods for determining the frequency content of the photodetector's output can be employed. Some examples of such suitable methods include, without limitation, Fourier transform, lock-in detection, filtering, FQ demodulation, homodyne detection, and heterodyne detection.”;
Para 147: “Some examples of such suitable methods include, without limitation, Fourier transform, lock-in detection, filtering, FQ demodulation, homodyne detection, and heterodyne detection.”;
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: first filter (e.g. signal before reconstructing optical signal to 2D image), then reconstruct).
Diebold does not teach resizing the reconstructed first image to produce a second image, wherein the second image includes binary image data.
Di Carlo teaches resizing the reconstructed first image to produce a second image, wherein the second image includes binary image data (Di Carlo:
Di Carlo: Fig. 1C: mainly 40, 40c, 40d, 40e: paras 36 37: “FIG. 1C illustrates a background-subtracted image frame 40c that has been subject to the background image subtraction process. Next, the resulting image frames 40c are resized 3x to increase the accuracy of measurements to sub-micron resolution and noise is filtered out to produce an enlarged image frame 40d. After this step, the image frames 40d are converted to a binary format”; Fig. 1A: para 33: “FIG. 1A illustrates an embodiment of the system 10 that uses a high speed camera imaging system as the cell analysis device 14. The cell analysis device 14 includes a high speed camera 34 in conjunction with a lens 36 (or combination of lenses) that is used to image a portion of the outlet 26 of the purification device 12. A light source 38 is used to provide illumination of the field to image the passing cells. Cells traverse this region at speeds of 0.1-0.4 m/s, which depends on the time after release. The captured high-speed video, which is taken at a suitable frame rate to generate image frames 40 to either capture one or multiple measurements per cell”; Fig. 1D: paras 41-42: “FIG. ID illustrates an example of an embodiment where the imaging field-of-view 41 of, for example, a camera 34 encompasses the expansion regions 28… This embodiment may employ similar image processing techniques as those described above in the context of FIG. 1C… high-resolution images are reconstructed”
: reconstruct, then resize, then binarize).
Thus, it would have been obvious for one of ordinary skill in the art, prior to filing, to implement the teachings of Di Carlo into Diebold since both Diebold and Di Carlo suggest a practical solution and field of endeavor of laser excitation fluorescence microscopy flow cytometry involving reconstructing captured light into an image array in general and Di Carlo additionally provides teachings that can be incorporated into Diebold in that the reconstructed image array is resized and binarized so that “the cell traces are filled with morphological closing using an erosion process followed by dilation as seen in image frame 40e. This image frame 40e is then used for cell measurements” (Di Carlo: para 37). Furthermore, one of ordinary skill in the art could have combined the elements as claimed by known methods and, in combination, each component functions the same as it does separately. One of ordinary skill in the art would have recognized that the results of the combination would be predictable.
Claim(s) 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Diebold as applied to claim 29 above, and further in view of Official Notice.
As per claim 30, Diebold teaches the system of claim 29. Diebold does not teach the analysis comprises counting the absolute number of cells exhibiting specific analysis criteria.
Examiner provides Official Notice that these limitations were well known prior to filing.
One of ordinary skill in the art, prior to filing, would have recognized the advantage of high-speed, accurate, and multiparameter quantification of heterogeneous cell populations, allowing for precise identification of rare cell subsets, measurement of phenotypic markers, assessment of cell viability, and analysis of functional states. The teachings of the prior art could have been incorporated into Diebold in that analysis comprises counting the absolute number of cells exhibiting specific analysis criteria.
As per claim 31, Diebold teaches the system of claim 29. Diebold does not teach the analysis comprises counting the relative number of cells exhibiting specific analysis criteria as compared to the number of cells analyzed.
Examiner provides Official Notice that these limitations were well known prior to filing.
One of ordinary skill in the art, prior to filing, would have recognized the advantage of rapid, high-throughput characterization of specific cell subsets within heterogeneous populations. This method enables accurate, reproducible analysis of cell markers, health, or behavior (e.g., % apoptosis, % CD4+) even when total cell concentration varies. The teachings of the prior art could have been incorporated into Diebold in that analysis comprises counting the relative number of cells exhibiting specific analysis criteria as compared to the number of cells analyzed.
Allowable Subject Matter
Claim 23 would be allowable if rewritten to overcome the rejection(s) under non-statutory double patenting set forth in this Office action and to include 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: Limitations pertaining to “the optical imager comprises a spatial filter, the spatial filter comprising a plurality of slits, and wherein a resolution of the two-dimensional image of the cell is diffraction limited in the flow direction with respect to a length of one or more slits of the plurality of slits in the flow direction”, in conjunction with other limitations present in claim 23 and intervening and independent claim(s), distinguish over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Atiba Fitzpatrick whose telephone number is (571) 270-5255. The examiner can normally be reached on M-F 10:00am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached on (571) 270-5183. The fax phone number for Atiba Fitzpatrick is (571) 270-6255.
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Atiba Fitzpatrick
/ATIBA O FITZPATRICK/
Primary Examiner, Art Unit 2677