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 .
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-10, 15, 22-23, 26, 33-34, 36-37 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D1.1
With regard to claim 1, D1 teach method of imaging a cytologic sample (see ¶ 45), the method comprising:(a) dispersing a cytologic sample in a preparation solution to prepare a sample solution (see ¶¶ 39-40: reagent for fixing cells); (b) filtering the sample solution by directing the sample solution through a flow channel intersected by a filter, thereby generating a layer of analytes adhered to the filter (see ¶¶ 16, 34: polycarbonate filter to isolate cancer cells); (c) mounting the layer of analytes adhered to the filter using a carrier (see ¶¶ 80, 89, 91, 105: mounting with ProLong mounting medium and covered with coverslip or carrier); and (d) generating a digital microscopic image of the layer of analytes adhered to the filter, thereby imaging the cytologic sample (see ¶¶ 45, 80: imaging using electron microscope).
With regard to claim 6, D1 teach wherein generating the digital microscopic image is accomplished by at least one of: stimulated Raman scattering (SRS) microscopy, coherent anti-Stokes Raman scattering (CARS) microscopy, fluorescent microscopy (FM), deconvolution microscopy (DM), confocal fluorescence (CF) microscopy, confocal reflection (CR) microscopy, multiphoton fluorescence microscopy (MPM), light-sheet microscopy (LSM), microscopy with ultraviolet surface excitation (MUSE), or structured light illumination microscopy (SLIM) (see ¶ 80: Leica DMIRE2 inverted microscope uses fluorescence imaging).
With regard to claim 7, D1 teach wherein the layer of analytes comprises a layer of cells (see abstract, ¶ 16: cells).
With regard to claim 8, D1 teach wherein the filter and the carrier are adjacent after said mounting (see ¶¶ 80, 89, 91, 105: filter covered with coverslip or carrier, inherently adjacent).
With regard to claim 9, D1 teach wherein the layer of analytes and the carrier are adjacent after said mounting (see ¶¶ 80, 89, 91, 105: filter with layer of analytes covered with coverslip or carrier, inherently adjacent).
With regard to claim 10, D1 teach wherein the preparation solution comprises water, saline, a phosphate buffer, an agent for lysing cells, an agent for preventing clotting of cells and extracellular contents, an agent for fixing the cells, a fluorescent contrast agent, or a combination thereof (see ¶¶ 39-40: reagent for fixing cells).
With regard to claim 15, D1 teach the agent for lysing cells comprises ammonium chloride, acetic acid, glacial acetic acid, potassium carbonate, CytoLyt solution, CytoRich solution, or any combination thereof; (ii) the agent for preventing clotting of cells and extracellular contents comprises heparin, ammonium oxalate, potassium Ethylenediaminetetraacetic acid (EDTA), Citrate, or potassium oxalate, or any combination thereof; (iii) the agent for fixing the cells further comprises methanol, ethanol, formaldehyde, formalin, acetone, Glutaraldehyde, Osmium tetroxide, Potassium Dichromate, Mercuric Chloride, Zenker's fixative, Helly's fixative, Bouin's Fixative, Carnoy's fixative, or Saccomanno Fluid, or any combination thereof; and (iv) the fluorescent contrast agent further comprises at least one of: 4' ,6-diamidino-2-phenylindole, DAPI, acridine orange, DRAQ5, eosin Y, fluorescein, Thiazine dye, methylene blue, azure A, Hoechst 33342, rhodamine, CellLight nucleus-cfp, NucBlue, CellLight Histone 2B-GFP, CellLight Nucelue-GIP, Syto 9 Green, CellLight Histon 2B-RFP, CellLight Nucelus-RFP, Propidium Iodide, Syto 82 Orange, SytoX Orange, NucReld Live 647, Syto 59 Red, or oil red, or any combination thereof (see ¶¶ 39-40: formaldehyde).
With regard to claim 22, D1 teach comprising diluting the sample solution prior to filtration (see ¶¶ 80, 97: dilution).
With regard to claim 23, D1 teach wherein the filtering the dispersed sample comprising applying a pressure or gravity, wherein the pressure comprises a positive pressure or a negative pressure (see ¶¶ 12, 16: passing through filter, polycarbonate filter are pressure driven or vacuum driven).
With regard to claim 26, D1 teach method of claim 22 wherein the filtering the dispersed sample comprises using a syringe, using a pump, or using centrifugation (see ¶¶ 5-6, 13: centrifugation).
With regard to claim 33, D1 teach wherein the filter comprises a cellulose acetate filter, a mixed cellulose esters (MCE) filter, a polycarbonate filter, a PVP-free polycarbonate filter, a MilliPore filter, or a NuclePore filter (see ¶¶ 16, 23: polycarbonate filter).
With regard to claim 34, D1 teach wherein the method further comprises analyzing the microscopic image to determine at least one of: adequacy of the sample, presence of tumor in the sample, or diagnosis, or any combination thereof (see abstract: diagnosis)
With regard to claim 36, D1 the method of claim 34, wherein the analyzing the microscopic image is by a human reader or by means of a computer-assisted image interpretation, wherein the computer-assisted image interpretation is based on a convolutional neuronal network (see ¶ 80: cells counted by visual inspection).
With regard to claim 37, D1 teach method of claim 36, wherein the analyzing comprises determining: adequacy of the sample, presence of tumor in the sample, a diagnosis, or a combination thereof (see abstract: diagnosis).
With regard to claim 40, D1 teach method of claim 39, wherein the immunochemistry or molecular or cytogenic techniques comprise DNA sequencing, RNA sequencing, PCR assay, or any combination thereof (see ¶¶ 68-69: hybridization between target and probe, DNA sequencing).
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over D1 and further in view of D2.2
With regard to claim 2, D1 teach method of claim 1, but fails to explicitly teach wherein dispersing the cytologic sample comprises applying mechanical agitation, however D2 teach the missing feature (see D2 ¶ 212: mechanical agitation). One skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, it would have been obvious to incorporate known teachings of mechanical agitation of a sample as taught by D2 into the configuration of D1 yielding predictable and enhanced results of disaggregation of cells by mechanical agitation.
With regard to claim 3, D2 teach wherein the mechanical agitation comprises vortexing, ultrasonic actuation, aspiration, or any combination thereof (see ¶¶ 204, 206: vortex mixer).
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over D1.
With regard to claim 38, D1 teach method of claim 36, but fails to explicitly teach wherein the computer-assisted image interpretation comprises creating image patches of individual cells or clusters of cells for further analysis. However, Examiner takes Official Notice to the fact that computer assisted image interpretation is extremely well known in the art before the effective filing date and that one skilled in the art would have been motivated to incorporate computer vision into D1 to process, analyze or classify images of cells yielding predictable and enhanced results.
With regard to claim 39, D1 fails to explicitly teach wherein the method further comprises re-processing the sample for immunochemistry or molecular or cytogenic techniques. However, Examiner takes Official Notice to the fact that re-processing of sample is extremely well known in the art before the effective filing date and that one skilled in the art would have been motivated to use known teachings of re-processing the sample to further analyze the cells.
With regard to claim 41, D1 teach method of claim 40, but fails to explicitly teach wherein the re-processing comprises re- suspending the filter with the sample in a re-processing solution, wherein the re-processing further comprises applying mechanical agitation. However, Examiner takes Official Notice to the fact that re-processing of sample is extremely well known in the art before the effective filing date and that one skilled in the art would have been motivated to use known teachings of re-processing the sample to further analyze the cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVINASH YENTRAPATI whose telephone number is (571)270-7982. The examiner can normally be reached on 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached on (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVINASH YENTRAPATI/Primary Examiner, Art Unit 2672
1 US Publication No. 2014/0193833.
2 US Publication No. 2008/0262384.