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 . Information Disclosure Statement
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 19, 2023 is in compliance with 37 CFR 1.97 and 1.98 and therefore has been considered by the examiner and placed in the file.
Response To Restriction Requirement
In the response to the Restriction Requirement, Applicant elected claims 1-4 of Group I for prosecution on the merits without traverse.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation (BRI) 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 BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification.
In the following, some of the terms in the claims have been given BRIs in light of the specification. These BRIs are used for purposes of searching for prior art and examining the claims, but cannot be incorporated into the claims. Should Applicant believe that different interpretations are appropriate, Applicant should point to the portions of the specification that clearly support a different interpretation.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
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Claim 1 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of commonly assigned, U.S. Pat. No. 12,482,098 B2 (“the ‘098 Patent”). Although the conflicting claims are not identical, they are not patentably distinct from each other because all the claimed limitations are transparently found in the ‘098 Patent with obvious wording variations as shown in the following table.
Instant Application
The ‘098 Patent
Notes
A plaque detection method, comprising the steps of:
A plaque detection method, comprising the steps of:
Verbatim language
using above focus images to detect a presence of live cells without detecting lysed cell materials
using above focus images to detect the presence of live cells without detecting the lysed cell materials
Nearly verbatim language with same meaning (“a presence” in claim 1 vs. “the presence” in claim 11)
applying a localized adaptive threshold process to the images to produce a map of spots where intensity has concentrated
applying a localized adaptive threshold process to the images to produce a map of spots where intensity has concentrated
Verbatim language
using below focus images where virtual dark regions exist which are similar to cell shadows
using below focus images wherein virtual dark regions exist which are similar to cell shadows
Nearly verbatim language with same meaning (“where” in claim 1 vs. “wherein” in claim 11)
using bright spots in the below focus images as seeds in a segmentation process to produce segmented regions
using bright spots in the below focus images as seeds in a segmentation process
Nearly verbatim language with same meaning (“to produce segmented regions” recited in claim 1 is missing from claim 11)
defining contours around each of the regions and using parameters of shape and size to filter the contours to a subset that are more likely to be part of the cell population to define a cell map
defining contours around each resulting shape; using parameters of shape and size to filter these contours to a subset that are more likely to be part of the cell population
Nearly verbatim language with same meaning (“to define a cell map” recited in claim 1 is missing from claim 11)
rendering the contours that remain onto an image and detect regions that are empty
rendering the contours that remain onto an image and detect regions that are empty
Verbatim language
creating a distance map in which each pixel value is the distance of that pixel from the nearest pixel of the cell map
creating a distance map in which each pixel value is the distance of that pixel from the nearest pixel of the cell map
Verbatim language
thresholding the distance map to create a first image of the places which are far from the cells
thresholding the distance map to create a first image of the places which are relatively far from the cells
Verbatim language
creating a second image with a small distance threshold to get an image that mimics the edges of the cells
creating a second image with a smaller distance threshold to get an image that mimics the edges of the cells
Verbatim language
using the first image as a set of seeds for an additional application of a watershed algorithm
using the first image as a set of seeds for an additional application of a watershed algorithm
Verbatim language
and using the second image for topography
and using the second image as the topography
Verbatim language
With respect to “a presence” in claim 1 vs. “the presence” in claim 11, this is an obvious wording difference that results in no difference in the corresponding limitations. Likewise, with respect to “where” in claim 1 vs. “wherein” in claim 11, this is an obvious wording difference that results in no difference in the meaning of the corresponding limitations. With respect to the language “to produce segmented regions” recited in claim 1 but missing from claim 11, the language of the corresponding limitation of claim 11 necessarily results in producing segmented regions because the purpose of performing a segmentation process is to produce segmented regions. Therefore, this limitation of claim 1 is an obvious variation of the corresponding limitation of claim 11. Likewise, with respect to the language “to define a cell map” recited in claim 1 but missing from claim 11, the language of the corresponding limitation of claim 11 necessarily results in defining a cell map because the phrase “the cell map” is recited later in claim 11 and there are no other steps recited in claim 1 that could have resulted in defining a cell map. Therefore, this limitation of claim 1 is an obvious variation of the corresponding limitation of claim 11.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the ‘098 Patent and the instant application no longer contain claims directed to the same invention.
Claim Objections
Claim 3 is objected to because of the following informalities: the term “filed” in line 1 of claim 3 should be changed to –field--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, line 11, the term “the cell population” lacks antecedent basis.
In claim 1, lines 16 and 17, the language “the places which are far from the cells” is indefinite because “the places” lacks antecedent basis. Furthermore, the limitation is indefinite because it is unclear what places would and would not be a distance from the cells that is considered “far”.
Claims 2-4 are indefinite due to their direct or indirect dependencies from claim 1.
Allowable Subject Matter
Claim 1 would be allowable if rewritten to overcome the double patenting rejection and the rejection under 35 U.S.C. 112(b). Claims 2-4 recite allowable subject matter due to their direct or indirect dependencies from claim 1.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 recites a particular combination of steps for detecting plaque that is not taught or suggested by the prior art. As discussed below in the Citation of Pertinent Art, some, but not all, of the individual steps are taught by the prior art. For example, using above focus and below focus images to obtain bright spots that are used as seeds in a segmentation process to segment regions to perform cell detection is disclosed in the prior art. Using various region-growing algorithms to define contours about the regions containing cells, such as Otsu’s method or watershed methods, for example, and filtering the contours to perform cell classification and/or various types of cell statistical analyses are also taught by the prior art. Generating distance maps of pixel values for use in cell detection is also taught by the prior art, but the prior art does not teach or suggest, in combination with the other recited steps, thresholding the distance maps multiple times using multiple thresholds to obtain a first image that is used as a set of seeds in a watershed algorithm and a second image that is used for topography. For these reasons, the combination of steps recited in claim 1 is not taught or suggested by the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Publ. Appl. No. 2021/0117729 A1 discloses systems uses distance maps to determine contours of cell regions. A FogBank algorithm (Chalfoun et al., FogBank: a single cell segmentation across multiple cell lines and image modalities, BMC Bioinformatics 15, 431 (2014)) was chosen to segment each fluorescently labeled image. The FogBank algorithm uses thresholding derived from intensity distributions in combination with geodesic distance maps of edges to establish RPE cell regions.
U.S. Publ. Appl. No. 2020/0250822 A1 discloses using above focus and below focus brightfield images to perform cell detection. A processor 202 generates a cell image based on the above focus and the below focus first and second images 415 and 420, respectively, and enhances the first brightfield image 415 and the second brightfield image 420 based on a third brightfield image 405 that is centered around the focal plane utilizing at least one of a plurality of pixel-wise mathematical operations or feature detection. Then, the processor 202 calculates transform parameters to align the first brightfield image 415 and the second brightfield image 420 with the at least one phase contrast image 400. Next, the processor 202 combines brightness levels for each pixel of the aligned second brightfield image 420 by a brightness level of corresponding pixels in the aligned first brightfield image 415 to thereby form the cell image 425. The combination of brightness levels for each pixel can be achieved via any of the mathematical operations described above. The technical effect of generating the cell image 425 is to remove brightfield artefacts (e.g., shadows) and enhance image contrast to increase cell detection for the seed mask 430. Bright spots in the cell image 425 are used for seeding in a region-growing algorithm that is used to determine contours of cell regions.
U.S. Publ. Appl. No. 2017/0103521 A1 discloses using a watershed algorithm to perform cell membrane segmentation in combination with Otsu’s thresholding algorithm, which is used to maximize between-class variance as a statistical discriminant analysis measure.
U.S. Publ. Appl. No. 2017/0098310 A1 discloses systems and methods for performing cell nucleus segmentation by generating a locally adaptive threshold image for foreground detection performing operations including creating a saliency edge strength image or layer indicating edge or border pixels of the nuclei by performing tensor voting on pixels neighboring the initial edge pixels within an image region to refine true edges are featured. Further, for each of a plurality of regions or blocks of the image, an adaptive threshold image is determined by sampling a foreground pixel and a background pixel for each initial edge pixel or refined edge pixel, generating histograms for both background and foreground saliency (or gradient magnitude) modulated histograms, determining a threshold range for each block of the image, and interpolating the threshold at each pixel based on the threshold range at each block. Comparing the input image with the resulting locally adaptive threshold image enables extraction of significantly improved foreground.
U.S. Pat. No. 10,282,841 B1 discloses systems and methods for bioinformatic analysis of vascular patterning that use distance maps and thresholding to determine diameters of blood vessels.
U.S. Publ. Appl. No. 2011/0254943 A1 discloses a system and method for automatically observing and counting cells without using a stain or a fluorescent material. The system includes an optical microscope having a sensor that provides an electrical signal representative of a field of view. The microscope is motorized so as to allow automatic change of focus. A sample containing cells to be analyzed is provided. No stain or fluorescent substance is used. When the microscope is operated in a deliberately out-of-focus condition, cells appear to have either a bright or a dark spot that can be used to report the number of cells in the sample. The intensity variation detected in images acquired in different focal planes is used to identify cell shapes using image analysis software such as CellProfiler. A result is reported in any convenient format, such as a false color image.
An article entitled “A New Unsupervised Approach for Segmenting and Counting Cells in High-Throughput Microscopy Image Sets”, by Riccio et al., published in January 2019 in IEEEJOURNALOFBIOMEDICALANDHEALTHINFORMATICS, VOL.23, NO.1, discloses systems and methods for cell segmentation and statistical analysis that uses adaptive thresholding in combination with distance maps and cell curvature analysis.
An article entitled “PHASE-BASED SEGMENTATION OF CELLS FROM BRIGHTFIELD MICROSCOPY”, by Ali et al., published in April 2007 in 2007 4th IEEE International Symposium on Biomedical Imaging: From Nano to Macro (2007, Page(s): 57-60), discloses systems for segmentation of transparent cells in brightfield microscopy images for facilitating the quantitative analysis of corresponding fluorescence images. However, this presents a challenge due to irregular morphology and weak intensity variation, particularly in ultra-thin regions. A boundary detection technique is applied to a series of variable focus images whereby a level set contour is initialised on a defocused image with improved intensity contrast, and subsequently evolved towards the correct boundary using images of improving focus. Local phase coherence is used to identify features within the images, driving contour evolution particularly in near-focus images which lack intensity contrast.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL J SANTOS whose telephone number is (571)272-2867. The examiner can normally be reached M-F 9-5.
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/DANIEL J. SANTOS/
Examiner, Art Unit 2667
/MATTHEW C BELLA/ Supervisory Patent Examiner, Art Unit 2667
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