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 Arguments
Applicant's arguments filed 11/5/2025 have been fully considered but they are not persuasive.
Applicant asserts on page 9 that Berezhna fails to teach “wherein the processor is configured to detect red blood cells and to dynamically adjust the scan area in response to a number of detected red blood cells.” Applicant also asserts that dynamically adjusting the scan area in response to a number of detected red blood cells is not a simple substitution of one known element for another.
However, the examiner does not find these arguments persuasive. Specifically, Berezhna explicitly teaches the counting of blood cells in order to dynamically adjust, via magnification, the scan area of the slide, see [0061], [0064], and [0067]. The examiner considers the simple substitution of counting red blood cells as opposed to the total cell count as within the skill of one of ordinary skill in the art. A predictable result would be obtained regardless of the cell count used, i.e. the morphological assessment of the scanned area in order to determine the optimal area (the monolayer) of the blood smear to scan and analyze.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-7, 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0156713 to Berezhna et al, hereinafter referred to as “Berezhna.”
As per claim 1 and claim 10, Berezhna discloses a system for scanning a hematology sample (Fig 6, [0056]) of a patient, the system comprising: a scanning apparatus to scan the hematology sample [0007]; a processor coupled to the scanning apparatus and a memory [0007] and configured to execute instructions which cause the system to: receive a first image of the sample at a first resolution [0061] and [0064]; determine a scan area of the sample to scan in response to the first image of the sample (a morphology assessment area is determined, i.e. the area of the blood smear with optimal cell distribution); scan the scan area to generate an image of the scan area at a second resolution greater than the first resolution (see [0067] where lower resolution is the original non-magnified image, in contrast with the morphology assessment area being scanned at a higher magnification (10x, 20x, etc) with the magnified image being able to resolve finer features than the original scanned image, and thus has a greater optical resolution); classify a plurality of cells from the image of the scan area into cell data comprising a plurality of cell parameters for the plurality of cells (see 0064] and [0065], classification of cell parameters, white blood cells, red blood cells, etc); and output the cell data (output to a display [0164].
Berezhna teaches a blood smear scanning device that uses total blood cell counts to determine optimal areas to adjust the scanner to in order to further scan the optimal are at a higher resolution (magnification). However, Berezhna fails to disclose “wherein the processor is configured to detect red blood cells and to dynamically adjust the scan area in response to a number of detected red blood cells” (claim 1) or only white blood cells (claim 10).
However, it would have been obvious before the effective filing date of the claimed invention to have modified the cell counting feature of Berezhna to include the ability to count only red blood cells or only white blood cells because such a modification is the result of simple substitution of one known element for another producing a predictable result. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). More specifically, whether Berezhna performs the cellular count relying on a total blood cell count, or a red blood cell count, or a white blood cell count would have resulted in a predictable function, the predictable function being the ability to alter the scan in light of a cellular count. Since each individual element (blood cells in general, red blood cells, and white blood cells) are known in the prior art, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the substitution of a total blood cell count with either a blood cell count of only red blood cells or of only white blood cells. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
As per claim 4, Berezhna teaches the system of claim 1, wherein the hematology sample comprises a body, a monolayer of cells and a feathered edge (see Fig 6) and wherein, the processor is configured to select the scan area in response to one or more of a location of the body, a location of the monolayer of cells, or a location of the feathered edge (see [0061] where the optimal area is selected as the “morphology assessment area”).
As per claim 5, Berezhna teaches the system of claim 1, wherein the first image comprises one or more of a preview image, a webcam image, or an image from the scanning apparatus (an image from a scanner [0066]).
As per claim 6, Berezhna teaches the system of claim 5, wherein the first image comprises a plurality of first images [0079] (“acquiring a plurality of images”) captured over different fields of view, the plurality of first images comprising no more than two images.
As per claim 7, Berezhna teaches the system of claim 5, wherein the processor is configured to determine the scan area in response to one or more of identified locations of cells in the first image (see [0063] and [0184] and [0185]), a density of cells in an area of the first image, or relative densities of cells at different areas of the first image.
As per claim 9, Berezhna teaches the system of claim 1 wherein the number comprises a number per unit area and wherein the scan area is adjusted in response to a number of non-overlapping red blood cells ([0099] wherein Berezhna teaches adjusting via a count of overlapping cells). Similar to the rationale of claim 1, counting of cells, and in particular, counting of red blood cells would have been within the level of one of ordinary skill in the art. Furthermore, counting of cells that are either overlapping (taught by Berezhna) or non-overlapping (as claimed) would also have been obvious to one of ordinary skill in the art as a simple substitution with the predictable result being an accurate morphological assessment of the scanned area.
As per claim 11, Berezhna teaches the system of claim 1, wherein the processor is configured to classify the plurality of cell parameters during the scan of the scan area and to dynamically adjust the scan area to scan in response to the plurality of cell parameters and wherein the plurality of cell parameters comprises a plurality of cell types, see [0064] and [0187] .
As per claims 12 and 13, Berezhna teaches the system of claim 11, wherein the processor is configured to classify the plurality of cell parameters with an artificial intelligence (Al) algorithm during the scan of the scan area (“neural network”, see [0003]).
As per claim 14, Berezhna teaches the system of claim 12, wherein the processor is configured to run at least 10 classifiers in parallel with each other and with the scanning of the scan area (see [0065] and [0066], with “classifiers” being counted as the different cell types and subcellular components, of which over 10 are listed).
As per claim 15, Berezhna teaches the system of claim 1, wherein the processor is configured to dynamically adjust the scan area in response to a gradient of cells in the scan area [0061].
As per claims 16 and 17, Berezhna teaches the system of claim 1, wherein the processor is configured to dynamically adjust the scan area from a first area scanned with the scanning apparatus to a second area not yet scanned with the scanning apparatus in response to the cell data (see [0061] and [0184]-[0191] with non-overlapping areas [0192]).
As per claim 18, Berezhna teaches the system of claim 1, wherein the cell data comprises one or more of a cell type, a rare cell type, a density of cells of a cell type, a number of cells of a cell type, or a target number of cells of a cell type (see [0187] and [0065]).
Claims 2, 3, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Berezhna in view of WO2018/078448, hereinafter referred to as “WO’448”.
As per claims 2 and 3, Berezhna teaches the blood smear scanning device as noted above for claim 1. In addition, Berezhna also teaches a scan are of at least 0.4 cm2, see [0150]. However, Berezhna fails to explicitly disclose an optical resolution of 200nm to 500nm and a pixel resolution of 100nm to 250nm.
In the same field of endeavor, WO’448 teaches a pixel resolution of 150nm [0010] and an optical resolution capable of resolving sub-cellular features of 100nm, 200nm to 300nm and up [0060].
It would have been obvious before the effective filing date of the claimed invention to have provided the scanning equipment of Berezhna with the resolutions taught by WO’448 as doing so would ensure accurate analysis of the images, and in particular be able to discern sub-cellular features more readily.
As per claims 19 and 20, while Berezhna recognizes the importance of ascertaining different cellular features in the morphologic analysis of the blood smear and is able to dynamically alter the scanning ability of the scanner via recognition of cell counts as noted above. Berezhna fails to disclose the recognition of rare cell types of one or more of a blast cell, a plasma cell, a myelocyte or a promyelocyte, a circulating lymphoma cell, an immature cell, a hairy cell, a binucleated cell ("buttocks cell"), a Sezary cell, or a cup-like blast. And in response to the rare cell type increase the scan area.
However, WO’448 teaches in [0006]-[0007] the importance of having the scanning device be capable of recognizing rare cell types in the high-resolution image. Thus, it would have been obvious before the effective filing date of the claimed invention to have provided the scanning device of Berezhna with the ability to recognize rare cell types in the blood smears as doing so would expand the capabilities and usefulness of the Berezhna scanning device by permitting medical practitioners the ability to diagnose rare blood diseases with more certainty and accuracy.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OMETZ whose telephone number is (571)272-7593. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached at 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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DAVID OMETZ
Primary Examiner
Art Unit 2672
/DAVID OMETZ/Primary Examiner, Art Unit 2672