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 .
Status of Claims
2. Claims 1-10, 12-20 and 22 are pending in this application.
Oath/Declaration
The receipt of Oath/Declaration is acknowledged.
Drawings
The receipt of Drawings is acknowledged.
Allowable Subject Matter
5. Claims 6 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
6. The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 6:
None of the prior art(s) searched, cited and/or of record disclose(s) or suggest(s) the teaching(s):
wherein adjusting the location of the tip and/or the insertion point comprises:
extending a line corresponding to a visual portion of the needle in a first direction to a side of the image;
extending the line in a second direction opposite the first direction until a length of the line matches a length of the needle in a previous image in the sequence of images; and
identifying the tip of the needle in a range of pixels surrounding an end of the line.
Regarding Claim 17:
None of the prior art(s) searched, cited and/or of record disclose(s) or suggest(s) the teaching(s):
wherein adjusting the location of the tip and/or the insertion point comprises:
extending a line corresponding to a visual portion of the needle in a first direction to a side of the image;
extending the line in a second direction opposite the first direction until a length of the line matches a length of the needle in a previous image in the sequence of images; and
identifying the tip of the needle in a range of pixels surrounding an end of the line.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 9, 12-16, 20, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patton (US PG. Pub. 2020/0178927 A1).
Referring to Claim 1, Patton teaches a method for tracking a needle (See Patton, Figs. 1-5, Needle tracking device method in ultrasound imaging, Sect. [0011]-[0013], an ultrasound imaging system using a detection of the presence of a needle.), comprising:
determining a visibility of the needle being inserted into a subject in an image of a sequence of images (See Patton, Sect. [0011] lines 3-8 and [0015] lines 10-14, an ultrasound imaging system 10 configured to automatically detect the presence of the interventional instrument 15 such as a needle being inserted into a patient (or subject 20) for determination of direction of entry location by obtaining one or more needle frame images illustrating insertion of the needle 15 into subject 20.);
in response to determining that the visibility satisfies a visibility threshold (See Patton, Sect. [0052] lines 19-43, in order to determine presence of needle 15 entry is satisfied by a score of 0 corresponds to “left-side entry” and 1 corresponds to “right-side entry,” illustrated in an image frame, wherein, a left-side entry may be determined if the score from the classifier algorithm is less than 0.25, and a right-side entry may be determined if the score from the classifier algorithm is greater than 0.75 and the thresholds may be automatically adjusted by the ultrasound imaging system, or may be set by the user for a plurality of frames and/or on a frame by frame basis.), detecting a location of the needle based on at least one first algorithm (See Patton, Sect. [0026] lines 1-10, An instrument detection algorithm is used wherein, the echo data for each of the needle frame created from the transmissions at the different transmit angles may be analyzed for detecting the presence of an interventional instrument needle 15. The images may be analyzed for the presence of a linear segment of pixels that are much brighter (e.g. greater amplitude) than adjacent pixels thereby indicating the presence of a strong linear reflector with the length of the segment data representing interventional instrument presence detection) and a detected curvature of the needle (See Patton, Sect. [0026] lines 9-16, The length of the segment data of the obtained images represents an interventional instrument needle 15 is curved and/or has curvature or is bent when inserted.);
in response to determining that the visibility does not satisfy the visibility threshold (See Patton, Sect. [0052] lines 44-47, In determining presence of needle left- side or right-side entry determines that no threshold score is met), detecting the location of the needle being inserted based on at least one second algorithm (See Patton, Sect. [0052] lines 48-55, since no threshold score was met for presence detection, a classifier algorithm is used for additional image capture and image analysis in order to confirm that there is an interventional instrument needle 15 present, and to determine the direction of entry and further trained to identify which of the shallow, medium, and steep needle frames may be most appropriate for creation of the composite image.); and
tracking the location of the needle in the sequence of images based on locations detected with the at least one first algorithm (See Patton, Fig. 4, Step 450, Sect. [0037] lines 17-20, At step 450, the ultrasound imaging system may detect that the interventional instrument needle 15 exists and its location within the ultrasound images.) and the at least one second algorithm (See Patton, [0027], Sect. [0032], the pixel data used to display the ultrasound images may be analyzed to detect the presence of an interventional instrument needle 15 using the analyzed echo data prior to conversion into pixel data that is ready for display, wherein, echo data that has been amplified, converted to digital and beamformed but not yet scan converted may be analyzed to detect and score segments in the data that represent interventional instruments.).
Referring to Claim 2, the combination of Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking device method in ultrasound imaging.), wherein detecting the location of the needle based on the at least one first algorithm (See Patton, Sect. [0027] lines 10-13,
A Hough transform or other similar techniques may be used to determine the location of pixels representing the inserted needle 15 detected that lie on a linear or parameterized curved segment, from which a score may also be determined.) comprises:
determining a length of a visible portion of the needle being inserted into the subject (See Patton, Sect. [0042], receiving one or more B-mode frames for creation of the composite tissue frame, as well as one or more needle frames depicting the position of the interventional instrument needle 15, the ultrasound imaging system may be able to automatically detect whether the interventional instrument needle 15 has been inserted into the anatomical structure from the left side, or from the right side through user input on the ultrasound imaging system that an interventional instrument needle 15 being used with the anatomical feature of interest.);
in response to determining that the length satisfies a length threshold (See Patton, Sect. [0027] lines 1-5, each segment of bright pixels may be scored to indicate how likely the segment represents an interventional instrument needle 15 by such a score may be adjusted by the length of the bright pixels above a certain threshold), detecting the location of the needle based on a weighted polynomial fitting algorithm and the detected curvature of the needle (See Patton, Sect. [0026] lines 6-16, the images may be analyzed for the presence of a linear segment of pixels that are much brighter (e.g. greater amplitude) than adjacent pixels thereby indicating the presence of a strong linear reflector. The length of the segments that may represent an interventional instrument may be curved if the interventional instrument itself is curved or bends when the instrument is inserted. The segments may seem to be curved in the coordinate system where detection is performed if the images were acquired using a curved transducer geometry (e.g., convex).);
in response to determining that the length does not satisfy the length threshold (See Patton, Sect. [0052] lines 44-51, if a score is determined by the classifier algorithm, but no threshold score is met for either left-side or right-side entry, the classifier algorithm may determine that no interventional instrument is actually present. If no threshold score has been met, the classifier algorithm may determine that additional images must be captured and analyzed in order to confirm that there is an interventional instrument present), detecting the location of the needle based on a straight needle tracking algorithm (See Patton, Sect. [0052] lines 51-55, to determine the direction of entry, the classifier algorithm may be further trained to identify which of the shallow, medium, and steep needle frames may be most appropriate for creation of the composite image.).
Referring to Claim 3, Patton teaches the method of claim 2 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking device method in ultrasound imaging.), wherein detecting the location of the needle based on the weighted polynomial fitting algorithm (See Patton, Instrument detection algorithm with a high score, Sect. [0033] lines 7-11, detecting the presence of the interventional instrument needle 15 where high-quality needle frame(s) is/are chosen adaptively based on the orientations of structures detected by the instrument detection algorithm with a high score (i.e. a high probability for the presence of an interventional instrument) comprises:
segmenting the image by identifying candidate pixels corresponding to the needle based on an intensity threshold (See Patton, Sect. [0027] lines 1-10, each segment of bright pixels may be scored to indicate how likely the segmented image represents an interventional instrument needle 15 with the score being adjusted by the length of the bright pixels above a certain threshold, how straight or linear the segment of pixels is, how much contrast is present between the bright pixels and the adjacent pixels, how strong the edges around the segment of bright pixels are as determined by a gradient or other edge-detection operation);
weighing each pixel of the candidate pixels based on a normalized intensity (See Patton, Sect. [0031] lines 6-8, The processor may copy the pixel data representing the instrument and uses a blending function to combine the copied pixel data with the pixel data in the anatomy image.), a gradient magnitude (See Patton, Sect. [0028] lines 1-10, the brightness data values for an image may be converted into corresponding gradient values by looking at differences between adjacent brightness values along the beam lines. A needle or other bright reflector that is an interventional instrument may be generally characterized by a large positive gradient (e.g. dark to light) in brightness values followed closely by a large negative gradient (e.g. light to dark) of brightness values when viewed in the direction from the transducer and into the tissue.), and a distance to an estimated location of a tip of the needle (See Patton, Automatic Interventional Instrument Needle 15 Entry tip location Detection, Sect. [0048], the automatic detection of an interventional instrument may be combined with an automatic determination of left or right-side entry of the interventional instrument, and automatic identification of shallow, medium, or steep angle as the optimal needle frame to automatically detect the needle entry tip, direction and angle, detect the linear structure by capturing needle frames at the appropriate direction and angle, and generate the blended image for display.); and
fitting a curve to the candidate pixels based on weights of at least a portion of pixels of the candidate pixels (See Patton, Sect. [0027] lines 10-13, A Hough transform or other similar techniques may be used to determine the location of pixels that lie on a linear or parameterized curved segment, from which a score may also be determined.).
Referring to Claim 4, Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), further comprising:
filtering the image after identifying the candidate pixels and before weighing each pixel (See Patton, Sect. [0028] lines 10-13, The gradient values may be filtered to ensure that the large changes in the positive and negative gradient values occur within a distance that would be expected for the interventional instrument.); and
identifying additional candidate pixels based on connections to the candidate pixels
Referring to Claim 5, Patton teaches the method of claim 2 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), wherein detecting the location of the needle based on the straight needle tracking algorithm (See Patton, Fig. 4, Steps 430-460, Sect. [0037] lines 17-24, At step 450, the ultrasound imaging system may determine that a linear or straight structure corresponding to an insertion of the interventional instrument needle 15 exists, and its location within the ultrasound images. The ultrasound imaging system may then generate a linear or straight structure image 460 that that depicts the interventional instrument needle with a masked region defined around the linear or straight structure within the same field of view as composite tissue frame 430.) comprises:
adjusting a location of a tip of the needle and/or an insertion point of the needle (See Patton, Sect. [0027] lines 1-5, each segment of bright pixels may be scored to indicate how likely the segment represents an insertion of the interventional instrument needle 15, such a score may be adjusted by the length of the bright pixels above a certain threshold based on how straight or linear the segment of the pixels are shown representing insertion tip of the needle 15).
Referring to Claim 9, Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), wherein detecting the location of the needle based on the at least one first algorithm (See Patton, Sect. [0026] lines 1-10, An instrument detection algorithm is used wherein, the echo data for each of the needle frame created from the transmissions at the different transmit angles may be analyzed for detecting the presence of an interventional instrument needle 15. The images may be analyzed for the presence of a linear segment of pixels that are much brighter (e.g. greater amplitude) than adjacent pixels thereby indicating the presence of a strong linear reflector with the length of the segment data representing interventional instrument presence detection) and the detected curvature of the needle (See Patton, Sect. [0026] lines 9-16, The length of the segment data of the obtained images represents an interventional instrument needle 15 is curved, has curvature or is bent when inserted.) comprises:
estimating a main axis of a region of interest including the needle (See Patton, Sect. [0046] lines 8-19, if an interventional instrument needle 15 is detected, the ultrasound imaging system determines when the steer angle is perpendicular or nearly perpendicular to the primary axis (such as the shaft of a needle) whether the interventional instrument needle 15 is depicted with a left-side entry (e.g. depicted in the negative-angle images) or right-side entry (e.g. depicted in the positive-angle images), since the interventional instrument will be depicted much more strongly in one direction than the other (where the steer angle would instead be closer to parallel with the interventional instrument).).
Referring to Claim 12, Patton teaches a system for tracking a needle (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), comprising at least one computing device programmed or configured to (See Patton, Fig. 2, Processor 40, Sect. [0024] lines 1-4, the processor 40 may be programmed to create a composite image of the tissue being examined and an interventional instrument being introduced into the tissue.):
determine a visibility of the needle being inserted into a subject in an image of a sequence of images (See Patton, Sect. [0011] lines 3-8 and [0015] lines 10-14, an ultrasound imaging system 10 configured to automatically detect the presence of the interventional instrument 15 such as a needle being inserted into a patient (or subject 20) for determination of direction of entry location by obtaining one or more needle frame images illustrating insertion of the needle 15 into subject 20.);
in response to determining that the visibility satisfies a visibility threshold (See Patton, Sect. [0052] lines 19-43, in order to determine presence of needle 15 entry is satisfied by a score of 0 corresponds to “left-side entry” and 1 corresponds to “right-side entry,” illustrated in an image frame, wherein, a left-side entry may be determined if the score from the classifier algorithm is less than 0.25, and a right-side entry may be determined if the score from the classifier algorithm is greater than 0.75 and the thresholds may be automatically adjusted by the ultrasound imaging system, or may be set by the user for a plurality of frames and/or on a frame by frame basis.), detect a location of the needle based on at least one first algorithm (See Patton, Sect. [0026] lines 1-10, An instrument detection algorithm is used wherein, the echo data for each of the needle frame created from the transmissions at the different transmit angles may be analyzed for detecting the presence of an interventional instrument needle 15. The images may be analyzed for the presence of a linear segment of pixels that are much brighter (e.g. greater amplitude) than adjacent pixels thereby indicating the presence of a strong linear reflector with the length of the segment data representing interventional instrument presence detection) and a detected curvature of the needle (See Patton, Sect. [0026] lines 9-16, The length of the segment data of the obtained images represents an interventional instrument needle 15 is curved and/or has curvature or is bent when inserted.);
in response to determining that the visibility does not satisfy the visibility threshold (See Patton, Sect. [0052] lines 44-47, In determining presence of needle left- side or right-side entry determines that no threshold score is met), detect the location of the needle being inserted based on at least one second algorithm (See Patton, Sect. [0052] lines 48-55, since no threshold score was met for presence detection, a classifier algorithm is used for additional image capture and image analysis in order to confirm that there is an interventional instrument needle 15 present, and to determine the direction of entry and further trained to identify which of the shallow, medium, and steep needle frames may be most appropriate for creation of the composite image.); and
track the location of the needle in the sequence of images based on locations detected with the at least one first algorithm (See Patton, Fig. 1, Sect. [0031], the processor may be programmed to identify segments of pixel data from one or more of the needle frames created from the transmissions taken at the various transmit angles that have a score that indicates the pixels likely represent an interventional instrument. The processor may copy the pixel data representing the instrument and uses a blending function to combine the copied pixel data with the pixel data in the anatomy image.) and/or the at least one second algorithm (See Patton, Sect. [0032], the pixel data used to display the ultrasound images may be analyzed to detect the presence of an interventional instrument needle 15 using the analyzed echo data prior to conversion into pixel data that is ready for display, wherein, echo data that has been amplified, converted to digital and beamformed but not yet scan converted may be analyzed to detect and score segments in the data that represent interventional instruments.) as continuously or continually determined based on comparing the visibility of the needle to the visibility threshold (See Patton, Sect. [0043], the ultrasound imaging system may detect the presence of an interventional instrument from the B-mode frames alone with analysis of the tissue warping in the B-mode frames that is consistent with a right-side entry of a needle into the frame and may compare B-mode frames over time, and detect movement corresponding to a left-side entry of an interventional instrument. With detections of left or right entry of the interventional instrument, the ultrasound imaging system may automatically capture one or more needle frames from angles corresponding to the detected side. If the ultrasound imaging system determines from the B-mode frames that there is a left-side entry of a needle, the ultrasound imaging system may capture three needle frame images corresponding to a left-side entry at shallow, medium, and steep angle images suitable for left side entry and then determines the linear structure corresponding to the needle using all three images.).
Referring to Claim 13, arguments analogous to claim 2 are applicable herein. The functions of “The method” in claim 2 perform all of the operations of “The system” in claim 13. Thus, “The System” in claim 13 is rejected for the same reasons as discussed in the rejection of claim 2.
Referring to Claim 14, arguments analogous to claim 3 are applicable herein. The functions of “The method” in claim 3 perform all of the operations of “The system” in claim 14. Thus, “The System” in claim 14 is rejected for the same reasons as discussed in the rejection of claim 3.
Referring to Claim 15, arguments analogous to claim 4 are applicable herein. The functions of “The method” in claim 4 perform all of the operations of “The system” in claim 15. Thus, “The System” in claim 15 is rejected for the same reasons as discussed in the rejection of claim 4.
Referring to Claim 16, arguments analogous to claim 5 are applicable herein. The functions of “The method” in claim 5 perform all of the operations of “The system” in claim 16. Thus, “The System” in claim 16 is rejected for the same reasons as discussed in the rejection of claim 5.
Referring to Claim 20, arguments analogous to claim 9 are applicable herein. The functions of “The method” in claim 9 perform all of the operations of “The system” in claim 20. Thus, “The System” in claim 20 is rejected for the same reasons as discussed in the rejection of claim 9.
Referring to Claim 22, arguments analogous to claim 12 are applicable herein. Thus, “A computer program product for tracking a needle, comprising at least one non-transitory computer-readable medium” of claim 22 is explicitly/inherently taught as evidenced by (See Patton, Sect. [0065], A computer storage medium may be, or may be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium may be a source or destination of computer program instructions encoded in an artificially-generated propagated signal. The computer storage medium also may be, or may be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices) and various memories stored therein.
Claim Rejections - 35 USC § 103
10. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
11. 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.
12. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
13. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7, 8, 10, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patton (US PG. Pub. 2020/0178927 A1) in view of Whitcomb (US PG. Pub. 2010/0056900 A1).
Referring to Claim 7, Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), wherein detecting the location of the needle being inserted based on the at least one second algorithm comprises (See Patton, Sect. [0032], the pixel data used to display the ultrasound images may be analyzed to detect the presence of an interventional instrument needle 15 using the analyzed echo data prior to conversion into pixel data that is ready for display, wherein, echo data that has been amplified, converted to digital and beamformed but not yet scan converted may be analyzed to detect and score segments in the data that represent interventional instruments.).
Patton fails to explicitly teach
comprises:
calculating a histogram gradient for each cell in the image (); and
detecting a deformation of tissue based on the histogram gradient of each cell for the image and a static background image.
However, Whitcomb teaches
comprises:
calculating a histogram gradient for each cell in the image (See Whitcomb, Sect. [0237], the accuracy performance of the hybrid tracking method according to the present invention was compared to the active tracking method, by obtaining error histograms of 36 active tracking orientations and of 16 passive tracking orientations. Since the hybrid tracking method is comprised of initial passive tracking and subsequent encoder tracking, an error model for the encoders was added to the passive tracking results. The optical encoders, contemplated for use for the tracking have a resolution of 0.25 degrees. Therefore a random, zero mean error with uniform distribution and an amplitude of 0.25 degrees was added to the passive tracking results to simulate the combined error of the hybrid tracking method. For the passive tracking error, the marker combination 1 and 3 with one circle per marker for segmentation was selected for comparison to the active tracking. Markers 1 and 3 are located at a distance of 45 mm from each other. This distance between markers can be implemented in our device design, making this combination a logical choice.); and
detecting a deformation of tissue based on the histogram gradient of each cell for the image and a static background image (See Whitcomb, Fig. 22, Sect. [0229], In FIG. 22, correlation between the tissue enhancement (seen in the second column, after the injection, but not in the first column, before the injection) in the histogram diagrams and the tissue stained with the Trypan Blue dye (FIG. 22, third column) showing deformation in the images.).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to incorporate comprises: calculating a histogram gradient for each cell in the image; and detecting a deformation of tissue based on the histogram gradient of each cell for the image and a static background image. The motivation for doing so would have been to provide improved devices, apparatuses and methods for inserting a medical device such as a needle into a mammalian body while the body is within the imaging field of a medical imager, particularly devices, apparatuses and methods for inserting and guiding a needle to a target site within a body while the body is within the imaging field of a medical imager, and more particularly to devices, apparatuses and methods for inserting and guiding a needle to a target site within a body selected by the user while the body is within the imaging field of a medical imager (See Sect. [0003] of the Whitcomb reference). Therefore, it would have been obvious to combine Patton and Whitcomb to obtain the invention as specified in claim 7.
Referring to Claim 8, Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging), wherein detecting the location of the needle being inserted based on the at least one second algorithm (See Patton, Sect. [0032], the pixel data used to display the ultrasound images may be analyzed to detect the presence of an interventional instrument needle 15 using the analyzed echo data prior to conversion into pixel data that is ready for display, wherein, echo data that has been amplified, converted to digital and beamformed but not yet scan converted may be analyzed to detect and score segments in the data that represent interventional instruments.)
Patton fails to explicitly teach
comprises:
estimating, with a kinematics tracking algorithm, a location of a tip of the needle based on kinematics data and a compensation factor based on a confidence score.
However, Whitcomb teaches
comprises:
estimating, with a kinematics tracking algorithm, a location of a tip of the needle based on kinematics data and a compensation factor based on a confidence score (See Whitcomb. Sect. [0188], The computer 1010 calculates three parameters for controlled motion: translation length for the end-effector 150, 525, 850,950 rotation angle for the end-effector, and insertion length for the needle 350. The program displays this information to the user, who can actuate the interventional device 100, 500, 800, 900 accordingly. The three stages of motion are kinematically decoupled in the interventional device and thus can be executed sequentially. This enables the user to acquire new image upon completing a phase of the motion and determine whether the sequence of motions was calculated and executed correctly. The image guidance mechanism is equally applicable with MRI, CT, X-ray, and ultrasound imaging.).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to incorporate comprises: estimating, with a kinematics tracking algorithm, a location of a tip of the needle based on kinematics data and a compensation factor based on a confidence score. The motivation for doing so would have been to provide improved devices, apparatuses and methods for inserting a medical device such as a needle into a mammalian body while the body is within the imaging field of a medical imager, particularly devices, apparatuses and methods for inserting and guiding a needle to a target site within a body while the body is within the imaging field of a medical imager, and more particularly to devices, apparatuses and methods for inserting and guiding a needle to a target site within a body selected by the user while the body is within the imaging field of a medical imager (See Sect. [0003] of the Whitcomb reference). Therefore, it would have been obvious to combine Patton and Whitcomb to obtain the invention as specified in claim 8.
Referring to Claim 10, Patton teaches the method of claim 1 (See Patton, Figs. 1-5, Sect. [0011]-[0013], Needle tracking system method in ultrasound imaging).
Patton fails to explicitly teach
further comprising:
in response to determining that the visibility satisfies a visibility threshold, updating kinematics information associated with the at least one second algorithm.
However, Whitcomb teaches
further comprising:
in response to determining that the visibility satisfies a visibility threshold, updating kinematics information associated with the at least one second algorithm (See Whitcomb, Sect. [0190] lines 9-16, the computer 1010 can compute the kinematic sequence for the individual motion stages: the length of translation of the end-effector inside the rectum, the degree of rotation of the end-effector inside the rectum, and the depth of insertion for the needle 350. The order of translation and rotation are interchangeable, but both are completed before the needle 350 is inserted into the tissues.).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to incorporate further comprising: in response to determining that the visibility satisfies a visibility threshold, updating kinematics information associated with the at least one second algorithm. The motivation for doing so would have been to allow user to send and receive faxes. Therefore, it would have been obvious to combine Matoba and Takesada to obtain the invention as specified in claim 10.
Referring to Claim 18, arguments analogous to claim 7 are applicable herein. The functions of “The method” in claim 7 perform all of the operations of “The system” in claim 18. Thus, “The System” in claim 18 is rejected for the same reasons as discussed in the rejection of claim 7.
Referring to Claim 19, arguments analogous to claim 8 are applicable herein. The functions of “The method” in claim 8 perform all of the operations of “The system” in claim 19. Thus, “The System” in claim 19 is rejected for the same reasons as discussed in the rejection of claim 8.
Cited Art
15. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Duffy et al. (US PG. PUB. No. 2020/0205774 A1) discloses a needle assembly for use with an autonomous ultrasound imaging system includes a needle having a proximal end and a distal end adapted to be inserted into a patient. The needle assembly also includes a needle transducer mounted to an exterior surface of the needle and is electrically coupled to a power source. The needle transducer is configured to receive data signals from the autonomous ultrasound imaging system which contain information relating to a plurality of ultrasound waves generated by an ultrasound probe of the autonomous ultrasound imaging system. The needle assembly further includes at least one processor configured to perform one or more operations, including but not limited to, generating a location signal for at least one portion of the needle based on the data signals from the autonomous ultrasound imaging system and modifying at least one characteristic of the location signal so as to improve visibility of the location signal on the display screen, wherein the modified location signal is displayed on a display screen during use of the needle assembly so as to locate the at least one portion of the needle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARRYL V DOTTIN whose telephone number is (571)270-5471. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abderrahim Merouan can be reached on 571-270-5254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DARRYL V DOTTIN/Primary Examiner, Art Unit 2683
/DARRYL V DOTTIN/Primary Examiner, Art Unit 2683