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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2026 has been entered.
Response to Amendment
The amendments filed 05/19/2026 have been entered.
Response to Arguments
Applicant’s arguments with respect to the independent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
(Examiner recommends, for compact prosecution, to overcome the current rejection(s) of record, the applicant amend claim 1 to include language similar to: “for each segment on the scan path, commencing a traversal of the segment by actuating the OCT probe with a landing movement that moves the OCT probe downward in a z-axis direction toward the tissue surface until the tissue surface is detected in an OCT image using pixel intensity thresholding; determining a tissue-height measurement µ according to µ = 1 - h/H, where h is a distance between an OCT image frame and the tissue surface and H is a total elevation above a robot-base reference; stopping the landing movement when µ satisfies a predetermined threshold; and controlling z-axis motion of the OCT probe to maintain the tissue-height measurement µ during traversal of the segment” if supported by the specification)
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.
Claims 1, 11 and 20 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.
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In the instant application Claims 1, 11 and 20 recite, “approaching a surface of the tissue specimen on each with a landing movement”. The phrase “on each” renders the claim indefinite because it is unclear whether “each” refers to: each segment, each traversal, each tissue surface, each scan line or some other object.
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In the instant application Claims 1, 11 and 20 recite, “to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface”. The claim fails to clearly define the claimed “proportion, including what quantities form the proportion, whether the proportion is a ratio, percentage, threshold or other mathematical relationship, and what reference frame is used to measure “distance” and “height”.
Claims 2-6 and 8-10 are dependent on claim 1, claims 12-19 are dependent on claim 11 and therefore rejected for at least the same reasons.
The above 112 rejected claims are interpreted, as best understood, in light of the specification, unless otherwise stated.
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.
Claim 1-6, 8-15 and 17-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Yong et al. (“Robotic-arm-assisted flexible large field-of-view optical coherence tomography”, 1July2021, of record), in view of Park et al. (“Minimizing OCT quantification error via a surface-tracking imaging probe”, 1July2021) in view of Walsh et al. (US 2019/0090733).
Regarding claim 1, Yong discloses a method for scanning tissue (Figure 1), comprising: traversing an OCT probe (in at least abstract discloses: a robotic arm and a miniature OCT probe) according to a scan path (Pg. 4597, 4th paragraph discloses: scan path of OTC probe) over a tissue specimen including a region of interest (ROI) (Pg. 4605, 1st paragraph discloses and Figure 10a-e depicts: scanning region, over a finger, a tissue specimen), the scan path including a plurality of parallel segments (Pg. 4605, 1st paragraph discloses: scan path, including at least two parallel segments, see Figure 10a); receiving a signal indicative of a tissue property of the tissue specimen along the scan path (Pg. 4605, 2nd paragraph discloses: profile of sample, see Figure 10e; Examiner notes that the “profile” of the tissue is considered the property of the tissue specimen), the signal based on an attenuation at a tissue location where the signal was received (Pg. 4605, 1st paragraph discloses: each pixel point is projected to the corresponding position in real space to generate point cloud data; Examiner notes that OCT is based on interferometry, or intensity, of light back-scattered from within the tissue, and back-scattered amplitude is a function of optical attenuation; every pixel value used in the point cloud data arises from those same interferometric magnitudes; therefore the point cloud data is considered to be based on the attenuation of the tissue at specific locations); and coalescing a plurality of the received signals over the ROI for generating a 2- dimensional (2D) rendering of 3-dimensional (3D) structures in the tissue specimen indicative of a health of the tissue specimen (Figure 10 depicts: a (2D) rendering of a (3D) structure; Examiner notes that the Figure is considered the 2-dimensional rendering of the fingertip, that was a 3-dimensional structure; Fig. 10a-10e depicts: assembled cloud point data from OCT probe positions of received signal; therefore considered coalescing a plurality of the received signals over the ROI for generating a 2- dimensional (2D) rendering of 3-dimensional (3D) structures; Examiner notes that Yong’s identification of internal subsurface tissue/lumen structures, see Fig. 14e, radial profile of the tube; Fig 10b-10d, stitched fingertip surface and subsurface detail is considered an indication of tissue health), including traversing the tissue specimen further including: for each segment on the scan path (Pg. 4597, second paragraph discloses: actuation system composed of x,y,z, translation stages, therefore considered to include a scan path), commencing a traversal of the segment (Pg. 4597, second paragraph discloses: drive probe on predetermined path; therefore considered transversal of a segment).
Yong fails to disclose a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Young and Park are related because both disclose optical coherence tomography devices.
Park teaches a method of actuating the OCT probe for approaching a surface of the tissue specimen (in at least abstract teaches: a piezo-based linear motor was integrated with the OCT imaging probe and controlled based upon real time feedback of tissue surface position inferred from the OCT images; the surface tracking OCT probe maintains a steady beam focus inside target tissue regardless of surface geometry or physiological motions; therefore considered to teach actuating an OCT probe relative to/for approaching a tissue surface). Young and Walsh are related because both disclose optical coherence tomography devices.
Walsh teaches a method with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold ([0257] teaches: movable or adjustable optical components may be positioned in a plurality of positions, OC data is obtained at each of the positions, component is adjusted to a desired position based comparison of the optical coherence data; [0258] teaches: analyzing A-scans/B-scans and comparing a scan property such as intensity value to determine a preferred position/setting; resultant position/setting may be the position/setting having a value above a threshold or maximum intensity; therefore considered to teach z-axis positioning based on OCT signal/pixel intensity threshold) to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0304] teaches: an A-scan may be used to determine a thickness or depth; [0305] teaches: z-offset adjustment stage adjust the portion of the eye being imaged and that an A-scan boundary may include both an anterior and posterior boundary in the z-direction; [0306] discloses: scans are obtained at different depths, a first scan may adjust an optical component to image a posterior boundary, and distances between anatomical features are determined based on the A-scans and different positions of the z-offset adjustment stage; therefore considered to teach z-height/depth positioning based on top/anterior surface and bottom/posterior surface information) to achieve overlap between consecutive scan lines ([0389] teaches: location of a scan along the longitudinal axis is controlled by the z-offset; translating the z-offset varies the depth being imaged; a plurality of scans are obtained at different depths; controlling the depths at which different scans are obtained affects overlap or spacing between adjacent scans; and the z-offset distance can be configured so that the depth of the next sequential scan is less than the depth previous scan in order to induce overlap of the scan data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yong in view of Park and Walsh and provide a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Doing so would allow for probe to maintain a repeatable imaging position relative to the tissue surface before/during traversal, thereby improving imaging consistency, signal strength, attenuation accuracy, and continuity/stitch-ability between adjacent scan segments.
Regarding claim 2, Yong discloses the method of claim 1 wherein the received signal is based on an attenuation of an optical signal directed towards the tissue specimen (Pg. 4596, Introduction discloses: optical coherence tomography; therefore considered to use an optical signal received based on the attenuation of an optical signal of the fingertip, the tissue specimen).
Regarding claim 3, Yong discloses the method of claim 2 further comprising actuating the OCT probe at a predetermined distance (Pg. 4597, second paragraph discloses: probe to move in a strictly predetermined path; therefore considered to actuating at a predetermined distance) above the tissue specimen for propagation of the optical signal through the tissue specimen (Pg. 4597, second paragraph discloses: movement of probe to determine scanning; Pg. 4599, second paragraph discloses: depth camera fixed horizontally above the optical table).
Regarding claim 4, Yong discloses the method of claim 1 further comprising generating the scan path based on a separation between the parallel segments (pg. 4605, fourth paragraph discloses: 32 single volume stitched; second paragraph discloses: 0.3 mm redundancy between adjacent volumes; Fig. 10a depicts: parallel stitched segment volumes; Examiner notes that the separation between parallel segments is considered to be -0.3 mm), the separation selected for combining information corresponding to a scanned tissue location to information corresponding to a tissue location in an adjacent segment to generate an imaged indication of a 3D structure common to both tissue locations (Figures 11-14 depict: adjacent volumes stitched, considered information corresponding to scanned tissue; pg. 4605, fourth paragraph discloses: 32 single volume stitched; second paragraph discloses: 0.3 mm redundancy between adjacent volumes; therefore considered adjacent segments; Figure 10 depicts: rendering of a (3D) structure).
Regarding claim 5, Yong discloses the method of claim 1 further comprising aggregating the signal received along the segment based on a series of locations along the segment (pg. 4598 fourth paragraph discloses: each volume data consists of 256 B-scans; therefore considered aggregating the signal received along the segment based on a series of locations along the segment) and corresponding received signals at the respective locations (pg. 4597 last paragraph discloses: OCT volume corresponding to spatial location information), the aggregated signal defining a planar region through the tissue specimen parallel to planar regions corresponding to other segments of the plurality of segments (pg. 4603 last paragraph discloses: spatial distribution of the position coordinates).
Regarding claim 6, Yong discloses the method of claim 1 further comprising forming a point cloud representation based on the received signals at each of a plurality of locations at each of the segments on the scan path (pg. 4605 second paragraph discloses: point cloud data of scanning range of the scanning region of adjacent volumes), and coalescing the point cloud data by assembling the received signal and corresponding OCT probe position at which the received signal was gathered (Fig. 10a-10e depicts: assembled cloud point data from OCT probe positions of received signal).
Regarding claim 8, Yong discloses the method of claim 5 further comprising: defining a cartesian volume of the ROI based on the region of interest and an orientation of an actuator directing the traversal of the OCT probe (pg. 4597 last paragraph discloses: at each acquisition point…provides feedback on the relative position of the probe to the target….to optimize the probe position and attitude); forming a tissue point cloud based on the signal received at each location and the position of the OCT probe (pg. 4506 second paragraph discloses: pixel coordinates of each pixel point in the OCT volume can be converted to the robotic arm base coordinate system, and each pixel point is projected to the corresponding position in real space to generate point cloud data), a distance of the OCT probe above a surface of the tissue specimen (pg. 4602 first paragraph discloses: fixed value between probe and tissue plane), and a position along the scan path (pg. 4605 second paragraph teaches: 12 scanning points programmed evenly along the scanning path, see Fig. 10a marked with red line); and rendering a map indicative of the ROI based on a pixel defined by a cartesian position of the ROI within the cartesian volume (Figures 10b-10d depict: 3D reconstruction of the final stitched fingertip and a rendering of 3D map of ROI within cartesian coordinates; Examiner notes that the X, Y, Z coordinates of Yong are considered cartesian coordinates).
Regarding claim 9, Yong discloses the method of claim 8 further comprising generating an attenuation map of the ROI based on thresholding the tissue point cloud for identifying varied attenuation at each cartesian position (Pg. 4605, 2nd paragraph discloses: each pixel point is projected to the corresponding position in real space to generate point cloud data; Examiner notes that OCT is based on interferometry, or intensity, of light back-scattered from within the tissue, and back-scattered amplitude is a function of optical attenuation; every pixel value used in the point cloud data arises from those same interferometric magnitudes; therefore the point cloud data is considered to be based on the attenuation of the tissue at specific locations; Examiner notes that the X, Y, Z coordinates of Yong are considered cartesian coordinates; producing the “virtual cut profile” of Fig. 14 requires selecting voxel values of the point cloud at a given cartesian slice and displaying only those values above/background, which is considered thresholding of the point cloud to identify variation at each cartesian position).
Regarding claim 10, Yong discloses the method of claim 8 further comprising generating a lumen map of the ROI indicative of lumen structures discernible in the tissue specimen based on a threshold of the signal corresponding to a plurality of adjacent locations forming a continuous structure in the tissue specimen below a surface of the tissue specimen in the ROI (Figure 14 depicts: plastic tube outlined by the yellow box to demonstrate the flexible large FOV imaging capability of the system; Figure 14b-14d depicts: front view, top view, back view and virtual cut profile; demonstrating a continuous hollow, lumen, structure below the surface of the sample that is rendered from adjacent volume data; Examiner notes that identifying the continuous hollow interior of the plastic tube in Fig. 14 requires selecting voxel values that correspond to the lumen interior versus surrounding material, which is considered thresholding of the signal to render a lumen map).
Regarding claim 11, A Yong discloses a medical scanning device (Figure 1), comprising: an OCT probe (in at least abstract discloses: a robotic arm and a miniature OCT probe) for traversing a scan path (Pg. 4597, 4th paragraph discloses: scan path of OTC probe) over a tissue specimen including a region of interest (ROI) (Pg. 4605, 1st paragraph discloses and Figure 10a-e depicts: scanning region, over a finger, a tissue specimen), the scan path including a plurality of parallel segments (Pg. 4605, 1st paragraph discloses: scan path, including at least two parallel segments, see Figure 10a); a robotic arm for actuating the OCT probe (Figure 2 depicts: OCT probe robotic arm) at a predetermined distance (Pg. 4597, second paragraph discloses: probe to move in a strictly predetermined path; therefore considered to actuating at a predetermined distance) above the tissue specimen for propagation of the optical signal through the tissue specimen (Pg. 4597, second paragraph discloses: movement of probe to determine scanning; Pg. 4599, second paragraph discloses: depth camera fixed horizontally above the optical table); an image processor connected to the OCT probe for receiving a signal indicative of a tissue property of the tissue specimen along the scan path (pg. 4598, 3rd paragraph discloses: a SDOCT imaging engine), the signal based on an attenuation at a tissue location where the signal was received (Pg. 4605, 1st paragraph discloses: each pixel point is projected to the corresponding position in real space to generate point cloud data; Examiner notes that OCT is based on interferometry, or intensity, of light back-scattered from within the tissue, and back-scattered amplitude is a function of optical attenuation; every pixel value used in the point cloud data arises from those same interferometric magnitudes; therefore the point cloud data is considered to be based on the attenuation of the tissue at specific locations; Examiner notes that the X, Y, Z coordinates of Yong are considered cartesian coordinates); and coalescing a plurality of the received signals over the ROI for generating a 2- dimensional (2D) rendering of 3-dimensional (3D) structures in the tissue specimen indicative of a health of the tissue specimen (Figure 10 depicts: a (2D) rendering of a (3D) structure; Examiner notes that the Figure is considered the 2-dimensional rendering of the fingertip, that was a 3-dimensional structure; ; Fig. 10a-10e depicts: assembled cloud point data from OCT probe positions of received signal; therefore considered coalescing a plurality of the received signals over the ROI for generating a 2- dimensional (2D) rendering of 3-dimensional (3D) structures), wherein the robotic arm is configured to drive an actuator for traversing the tissue specimen by, for each parallel segment on the scan path (Pg. 4597, second paragraph discloses: actuation system composed of x,y,z, translation stages, therefore considered to include a scan path), commencing a traversal of the segment (Pg. 4597, second paragraph discloses: drive probe on predetermined path; therefore considered transversal of a segment).
Yong fails to disclose a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Young and Park are related because both disclose optical coherence tomography devices.
Park teaches a method of actuating the OCT probe for approaching a surface of the tissue specimen (in at least abstract teaches: a piezo-based linear motor was integrated with the OCT imaging probe and controlled based upon real time feedback of tissue surface position inferred from the OCT images; the surface tracking OCT probe maintains a steady beam focus inside target tissue regardless of surface geometry or physiological motions; therefore considered to teach actuating an OCT probe relative to/for approaching a tissue surface). Young and Walsh are related because both disclose optical coherence tomography devices.
Walsh teaches a method with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold ([0257] teaches: movable or adjustable optical components may be positioned in a plurality of positions, OC data is obtained at each of the positions, component is adjusted to a desired position based comparison of the optical coherence data; [0258] teaches: analyzing A-scans/B-scans and comparing a scan property such as intensity value to determine a preferred position/setting; resultant position/setting may be the position/setting having a value above a threshold or maximum intensity; therefore considered to teach z-axis positioning based on OCT signal/pixel intensity threshold) to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0304] teaches: an A-scan may be used to determine a thickness or depth; [0305] teaches: z-offset adjustment stage adjust the portion of the eye being imaged and that an A-scan boundary may include both an anterior and posterior boundary in the z-direction; [0306] discloses: scans are obtained at different depths, a first scan may adjust an optical component to image a posterior boundary, and distances between anatomical features are determined based on the A-scans and different positions of the z-offset adjustment stage; therefore considered to teach z-height/depth positioning based on top/anterior surface and bottom/posterior surface information) to achieve overlap between consecutive scan lines ([0389] teaches: location of a scan along the longitudinal axis is controlled by the z-offset; translating the z-offset varies the depth being imaged; a plurality of scans are obtained at different depths; controlling the depths at which different scans are obtained affects overlap or spacing between adjacent scans; and the z-offset distance can be configured so that the depth of the next sequential scan is less than the depth previous scan in order to induce overlap of the scan data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yong in view of Park and Walsh and provide a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Doing so would allow for probe to maintain a repeatable imaging position relative to the tissue surface before/during traversal, thereby improving imaging consistency, signal strength, attenuation accuracy, and continuity/stitch-ability between adjacent scan segments.
Regarding claim 12, Yong discloses the method of claim 11 wherein the received signal is based on an attenuation of an optical signal directed toward the tissue specimen (pg. 4605, second paragraph discloses: each pixel point is projected to the corresponding position in real space to generate point cloud data; Examiner notes that OCT is based on interferometry, or intensity, of light back-scattered from within the tissue, and back-scattered amplitude is a function of optical attenuation; every pixel value used in the point cloud data arises from those same interferometric magnitudes; therefore the point cloud data is considered to be based on the attenuation of the tissue at specific locations).
Regarding claim 13, Yong discloses the method of claim 11 wherein the scan path is based on a separation between the parallel segments, the separation selected for combining information corresponding to a scanned tissue location to information corresponding to a tissue location in an adjacent segment to generate an imaged indication of a 3D structure common to both tissue locations (pg. 4605, second paragraph discloses: 12 scanning points were programmed evenly along the scanning path marked with the green line; fourth paragraph discloses: a redundancy of 0.3 mm between two adjacent scanning points during the scanning process to ensure that there is an overlap between two adjacent scanning areas; Figures 10 and 11 depict: parallel stitched segments with predetermined separation for combining adjacent volume information into a continuous 3-D structure).
Regarding claim 14, Yong discloses the method of claim 11 wherein the image processor is configured to aggregate the signal received along the segment based on a series of locations along the segment and corresponding received signals at the respective locations, the aggregated signal defining a planar region through the tissue specimen parallel to planar regions corresponding to other segments of the plurality of segments (pg. 4599 discloses: each volume data consists of 256 B-scans with image size of 1024 c 1024 pixels, the system was running at imaging speed of 20 fps; Figure 8a depicts: OCT images of same chessboard intersection area; pg. 4605 discloses: planar B-scans are stacked in parallel to form a continuous 3-D volume; Figure 10b-10d depicts: 3-D reconstruction of the final stitched fingertip from isotropic view, front view and top view; Examiner notes that this is considered to be aggregation of signals along each segment to define planar regions parallel to other segments within the ROI).
Regarding claim 15, Yong discloses the method of claim 11 wherein the image processor includes a memory configured for forming a point cloud representation based on the received signals at each of a plurality of locations at each of the segments on the scan path, the image processor configured for coalescing the point cloud data by assembling the received signal and corresponding OCT probe position at which the received signal was gathered (pg. 4605, second paragraph discloses: each pixel point is projected to the corresponding position in real space to generate point cloud data; pixel coordinates of each pixel point in the OCT volume can be converted to the robotic arm base coordinate system and each pixel point is projected to the corresponding position in real space to generate point cloud data; Figures 10a-10e depict: the assembled cloud point data from OCT probe position of received signal; therefore, Yong is considered to form and coalesce point cloud data based on received OCT signals and probe position; Examiner notes that the workstation and GPU-accelerated OCT signal processing necessarily store the pixel coordinates and OCT volume data in memory for processing; this is considered memory configured for forming the point cloud).
Regarding claim 17, Yong discloses the method of claim 14 wherein the image processor is further configured to: define a cartesian volume of the ROI based on the region of interest and an orientation of an actuator directing the traversal of the OCT probe; form a tissue point cloud based on the signal received at each location and the position of the OCT probe, a distance of the OCT probe above a surface of the tissue specimen, and a position along the scan path; and render a map indicative of the ROI based on a pixel defined by a cartesian position of the ROI within the cartesian volume (pg. 4597, last paragraph discloses: based on the depth camera information, target sample is located and the starting path of the scan point is set, in addition with the help of the RGB camera image, OCT probe is finely aligned with the imaging target; pg. 4605, second paragraph discloses: pixel coordinates of each pixel point in the OCT volume can be converted to the robotic arm base coordinate system, and each pixel point is projected to the corresponding position in real space to generate point cloud data; pg. 4602, first paragraph discloses: distance between probe and the tissue plane is a fixed value; pg. 4605, third paragraph discloses: 3D reconstruction of the final stitched fingertip from isotropic view, see Figures 10b-10d; Examiner notes that these passages describe defining a cartesian coordinate system from the ROI, forming point cloud data from each pixel based on probe position and distance, and rendering a 3D map of the ROI corresponding to the cartesian volume).
Regarding claim 18, Yong discloses the method of claim 17 further comprising a visual display having a rendered attenuation map of the ROI based on thresholding the tissue point cloud for identifying varied attenuation at each cartesian position (pg. 4607 Figure 14a-14d depicts: imaging area with the plastic tube outlined by the yellow box, 3D reconstruction of the tube, front view, top view, back view and virtual cut profile; Examiner notes that Fig. 14e depicts a visual rendering of a cross-sectional attenuation profile through the imaged region; pg. 4605, second paragraph discloses: OCT volume data and corresponding spatial coordinated for 3D reconstruction, visualization and analysis were saved; Examiner notes that these passages demonstrate a visual display rendering of the reconstructed ROI, with voxel-based variations corresponding to optical attenuation at each cartesian coordinate; producing the “virtual cut profile” of Fig. 14 requires selecting voxel values of the point cloud at a given cartesian slice and displaying only those values above/background, which is considered thresholding of the point cloud to identify variation at each cartesian position).
Regarding claim 19, Yong discloses the method of claim 17 further comprising a visual display having a rendered lumen map of the ROI indicative of lumen structures discernible in the tissue specimen based on a threshold of the signal corresponding to a plurality of adjacent locations forming a continuous structure in the tissue specimen below a surface of the tissue specimen in the ROI (pgs. 4606-4607, section 3.2 discloses: to demonstrate the flexible large FOV imaging capability of the system with pose optimization, a curve plastic tube sample filled with red dye was placed in an arc-shaped skin phantom; Figure 14 depicts: imaging area with plastic tube outlined by the yellow box, 3D reconstruction of the tube, front view, top view, back view and virtual cut profile; demonstrating a continuous hollow, lumen, structure below the surface of the sample that is rendered from adjacent volume data based on threshold signal corresponding to adjacent locations forming a continuous structure; Examiner notes that selecting and visualizing the internal hollow region of the tube in Fig. 14b-14e is considered generating a lumen map by applying a threshold to differentiate lumen interior from surrounding material).
Regarding claim 20, Yong discloses a computer program embodying program code on a non-transitory computer readable storage medium that, when executed by a processor, performs steps for implementing a method for scanning tissue, the method comprising: traversing an OCT probe according to a scan path over a tissue specimen including a region of interest (ROI), the scan path including a plurality of parallel segments; receiving a signal indicative of a tissue property of the tissue specimen along the scan path, the signal based on an attenuation at a tissue location where the signal was received; and coalescing a plurality of the received signals over the ROI for generating a 2- dimensional (2D) rendering of 3-dimensional (3D) structures in the tissue specimen indicative of a health of the tissue specimen (pg. 4598, third paragraph discloses: customized system software was developed for OCT and depth-camera data acquisition, processing, display, storage and system control; GPU accelerated OCT signal processing was implemented based on CUDA; Examiner notes that these passages are considered to disclose computer program code stored and executed by a processor for performing OCT scanning, image acquisition, and 3D rendering steps, corresponding to the computer readable medium executing the method; the customized system software and GPU accelerated OCT signal processing acquire OCT data during robotic scanning, process that data, and generate 3D reconstruction/visualization and analysis, which is considered to perform the recited steps of traversing the OCT probe along the scan path, receiving the signal, and coalescing the received signal to generate the 2D rendering of the 3D structures) including traversing the tissue specimen further including: for each segment on the scan path (Pg. 4597, second paragraph discloses: actuation system composed of x,y,z, translation stages, therefore considered to include a scan path), commencing a traversal of the segment (Pg. 4597, second paragraph discloses: drive probe on predetermined path; therefore considered transversal of a segment).
Yong fails to disclose a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Young and Park are related because both disclose optical coherence tomography devices.
Park teaches a method of actuating the OCT probe for approaching a surface of the tissue specimen (in at least abstract teaches: a piezo-based linear motor was integrated with the OCT imaging probe and controlled based upon real time feedback of tissue surface position inferred from the OCT images; the surface tracking OCT probe maintains a steady beam focus inside target tissue regardless of surface geometry or physiological motions; therefore considered to teach actuating an OCT probe relative to/for approaching a tissue surface). Young and Walsh are related because both disclose optical coherence tomography devices.
Walsh teaches a method with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold ([0257] teaches: movable or adjustable optical components may be positioned in a plurality of positions, OC data is obtained at each of the positions, component is adjusted to a desired position based comparison of the optical coherence data; [0258] teaches: analyzing A-scans/B-scans and comparing a scan property such as intensity value to determine a preferred position/setting; resultant position/setting may be the position/setting having a value above a threshold or maximum intensity; therefore considered to teach z-axis positioning based on OCT signal/pixel intensity threshold) to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0304] teaches: an A-scan may be used to determine a thickness or depth; [0305] teaches: z-offset adjustment stage adjust the portion of the eye being imaged and that an A-scan boundary may include both an anterior and posterior boundary in the z-direction; [0306] discloses: scans are obtained at different depths, a first scan may adjust an optical component to image a posterior boundary, and distances between anatomical features are determined based on the A-scans and different positions of the z-offset adjustment stage; therefore considered to teach z-height/depth positioning based on top/anterior surface and bottom/posterior surface information) to achieve overlap between consecutive scan lines ([0389] teaches: location of a scan along the longitudinal axis is controlled by the z-offset; translating the z-offset varies the depth being imaged; a plurality of scans are obtained at different depths; controlling the depths at which different scans are obtained affects overlap or spacing between adjacent scans; and the z-offset distance can be configured so that the depth of the next sequential scan is less than the depth previous scan in order to induce overlap of the scan data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yong in view of Park and Walsh and provide a method of actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward via z-axis travel based on a pixel intensity threshold to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface to achieve overlap between consecutive scan lines. Doing so would allow for probe to maintain a repeatable imaging position relative to the tissue surface before/during traversal, thereby improving imaging consistency, signal strength, attenuation accuracy, and continuity/stitch-ability between adjacent scan segments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Sipes whose telephone number is (703)756-1372. The examiner can normally be reached Monday - Friday 4:30 -10/12-6:30 (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at (571) 272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
John Sipes
Examiner
Art Unit 2872
/J.C.S./Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872
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