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 .
Response to Amendment
The amendments filed 01/30/2026 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.
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 Rempel et al. (US 2019/015495).
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 to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Yong and Rempel are related because both disclose optical systems.
Rempel teaches a method of actuating the OCT probe ([0120] teaches: moving OCT probe relative to the sample surface) for approaching a surface of the tissue specimen ([0120] teaches: determine a target position, i.e., a z position for a desired height) on each with a landing movement ([0120] teaches: determine a target position) that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0025] teaches: initial position of probe; Examiner notes that the target position and initial position is determined based on the height of the specimen, see [0120]).
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 the invention of Yong to incorporate the teachings of Rempel 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 to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Doing so would allow for better positioning of the OCT probe prior to scanning, thereby improving imaging consistency, signal quality and repeatability across 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 device actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Yong and Rempel are related because both disclose optical systems.
Rempel teaches a device actuating the OCT probe ([0120] teaches: moving OCT probe relative to the sample surface) for approaching a surface of the tissue specimen ([0120] teaches: determine a target position, i.e., a z position for a desired height) on each with a landing movement ([0120] teaches: determine a target position) that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0025] teaches: initial position of probe; Examiner notes that the target position and initial position is determined based on the height of the specimen, see [0120]).
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 the invention of Yong to incorporate the teachings of Rempel and provide a device actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Doing so would allow for better positioning of the OCT probe prior to scanning, thereby improving imaging consistency, signal quality and repeatability across 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 program 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 to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Yong and Rempel are related because both disclose optical systems.
Rempel teaches a program of actuating the OCT probe ([0120] teaches: moving OCT probe relative to the sample surface) for approaching a surface of the tissue specimen ([0120] teaches: determine a target position, i.e., a z position for a desired height) on each with a landing movement ([0120] teaches: determine a target position) that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface ([0025] teaches: initial position of probe; Examiner notes that the target position and initial position is determined based on the height of the specimen, see [0120]).
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 the invention of Yong to incorporate the teachings of Rempel and provide a program by actuating the OCT probe for approaching a surface of the tissue specimen on each with a landing movement that disposes the OCT probe downward to a height based on a proportion of a distance above the tissue surface and a height above a bottom tissue surface. Doing so would allow for better positioning of the OCT probe prior to scanning, thereby improving imaging consistency, signal quality and repeatability across scan segments.
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 John Sipes whose telephone number is (703)756-1372. The examiner can normally be reached Monday - Thursday 6:00 - 11:00 and 1:00 - 6:00.
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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.
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/J.C.S./Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872