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 .
Election/Restrictions
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/4/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is 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.
Regarding claim 8, the claim recites the limitation "the transmission unit". There is insufficient antecedent basis for this limitation in the claim. For examination purposes this limitation will be interpreted as referring to the previously set forth transmitter.
Regarding claim 8, the claim recites the limitation "the range". There is insufficient antecedent basis for this limitation in the claim. For examination purposes this limitation will be interpreted as referring to a range.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9-10, and 13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lu et al. (US20180000446, hereafter Lu).
Regarding claim 1, Lu discloses a puncture guiding apparatus (Lu, Para 1; “The present invention generally relates to ultrasound-guided target biopsies (e.g., liver biopsy, renal biopsy, etc.). The present invention specifically relates to a prediction of a needle trajectory during a target biopsy procedure.”) (Lu, Para 15; “To facilitate an understanding of the present invention, exemplary embodiments of the present invention will be provided herein directed to an ultrasound guided target biopsy procedure for a liver 11 of a patient 10 as shown in FIG. 1. From the description of the exemplary embodiments of the present invention, those having ordinary skill in the art will appreciate how to make and use the present invention for any type of ultrasound-guided target biopsy procedure (e.g., prostate, kidney, breast etc.) involving various types of ultrasound probes and target biopsy needles.”) comprising:
a detector (ultrasound receivers 31) configured to detect passage of a puncture needle, the detector arranged in a vicinity of a living body contacting surface (Lu, Para 20; “The present invention attaches two or more ultrasound receivers 31 (i.e., a receiver or a transceiver) for sensing the ultrasound plane as target biopsy needle 30 is being inserted within abdominal region 12 of patient 10. As known in the art, a degree of sensing the ultrasound plane is a function of a distance between an ultrasound receiver 31 and the ultrasound plane.”) (Lu, Para 26; “Receiver tracking module 46 is structurally configured to sense data SD from ultrasound receivers 31 representative of a sensing of the ultrasound plane as the target biopsy needle 30 is inserted into abdominal region 12 of patient 11, and to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”) of an ultrasonic probe (ultrasound probe 20) that is brought into contact with a living body (Lu, Para 18; “Ultrasound probe 20 employs one or more ultrasound transducers, transmitters receivers and/or transceivers for projecting an ultrasound plane intersecting an abdominal region 12 (e.g., ultrasound plane 21 as shown in FIG. 2). Examples of ultrasound probe 20 include, but are not limited to, two-dimensional and three-dimensional ultrasound probes with sector, curvilinear or linear geometries.”); and
processing circuitry configured to output identification information for identifying a positional relationship between the puncture needle and a scanning plane of the ultrasonic probe based on a detection result obtained by the detector (Lu, Para 20; “The present invention attaches two or more ultrasound receivers 31 (i.e., a receiver or a transceiver) for sensing the ultrasound plane as target biopsy needle 30 is being inserted within abdominal region 12 of patient 10. As known in the art, a degree of sensing the ultrasound plane is a function of a distance between an ultrasound receiver 31 and the ultrasound plane.”) (Lu, Para 26; “Receiver tracking module 46 is structurally configured to sense data SD from ultrasound receivers 31 representative of a sensing of the ultrasound plane as the target biopsy needle 30 is inserted into abdominal region 12 of patient 11, and to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”).
Regarding claim 2, Lu discloses all of the limitations of claim 1 as discussed above.
Lu further discloses wherein the processing circuitry is configured to output identifying information for identifying whether or not the puncture needle is located in a plane including the scanning plane (Lu, Para 21; “In one embodiment, as shown in FIG. 1, distal ultrasound receiver 31 d is attached to/embedded within target biopsy needle 30 adjacent a tip of target biopsy needle 30 and a proximal ultrasound receiver 31 p is attached to/embedded within target biopsy needle 30 is a middle of shaft of target biopsy needle 30. In an alternative embodiment, target biopsy needle 30 includes a coaxial introducer through which target biopsy needle 30 into abdominal region 12 with receivers 31 being attached to/embedded within the coaxial introducer.”) (Lu, Para 26; “to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”).
Regarding claim 3, Lu discloses all of the limitations of claim 2 as discussed above.
Lu further discloses wherein the detector detects passage of the puncture needle in the plane including the scanning plane (Lu, Para 21; “In one embodiment, as shown in FIG. 1, distal ultrasound receiver 31 d is attached to/embedded within target biopsy needle 30 adjacent a tip of target biopsy needle 30 and a proximal ultrasound receiver 31 p is attached to/embedded within target biopsy needle 30 is a middle of shaft of target biopsy needle 30. In an alternative embodiment, target biopsy needle 30 includes a coaxial introducer through which target biopsy needle 30 into abdominal region 12 with receivers 31 being attached to/embedded within the coaxial introducer.”) (Lu, Para 26; “to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”), the detector arranged on the plane including the scanning plane (Lu, Para 26; “For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”).
Regarding claim 4, Lu discloses all of the limitations of claim 1 as discussed above.
Lu further discloses wherein the processing circuitry is configured to output identifying information for identifying whether or not at least a part of the puncture needle is located out of the plane including the scanning plane (Lu, Para 21; “In one embodiment, as shown in FIG. 1, distal ultrasound receiver 31 d is attached to/embedded within target biopsy needle 30 adjacent a tip of target biopsy needle 30 and a proximal ultrasound receiver 31 p is attached to/embedded within target biopsy needle 30 is a middle of shaft of target biopsy needle 30. In an alternative embodiment, target biopsy needle 30 includes a coaxial introducer through which target biopsy needle 30 into abdominal region 12 with receivers 31 being attached to/embedded within the coaxial introducer.”) (Lu, Para 26; “to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”).
Regarding claim 5, Lu discloses all of the limitations of claim 4 as discussed above.
Lu further discloses wherein the detector is arranged outside the plane including the scanning plane (Lu, Para 21; “In one embodiment, as shown in FIG. 1, distal ultrasound receiver 31 d is attached to/embedded within target biopsy needle 30 adjacent a tip of target biopsy needle 30 and a proximal ultrasound receiver 31 p is attached to/embedded within target biopsy needle 30 is a middle of shaft of target biopsy needle 30. In an alternative embodiment, target biopsy needle 30 includes a coaxial introducer through which target biopsy needle 30 into abdominal region 12 with receivers 31 being attached to/embedded within the coaxial introducer.”) (Lu, Para 26; “to execute a known process for tracking a position of each ultrasound receiver 31 relative to the ultrasound plane intersecting abdominal region 12. For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”), and detects passage of the puncture needle outside the plane including the scanning plane (Lu, Para 26; “For each ultrasound receiver 31, the tracked position indicates whether the particular ultrasound receiver 31 is within the ultrasound plane (i.e., in-plane) or outside of the ultrasound plane (i.e., out-of-plane). More particularly, the sensing of the ultrasound plane of the particular ultrasound receiver 31 will indicate a three-dimensional (“3D”) position of each ultrasound receiver 31 in terms of height, width and depth whereby in-plane has zero (0) depth and out-of-plane has a non-zero depth.”).
Regarding claim 9, Lu discloses all of the limitations of claim 1 as discussed above.
Lu further discloses wherein the detector and the processing circuitry are integrated with the ultrasonic probe (Lu, Para 4; “One form of the present invention is a target biopsy system employing an ultrasound probe, a target biopsy needle, two or more ultrasound receivers and an ultrasound guide controller. In operation, the ultrasound probe projects an ultrasound plane intersecting an anatomical region (e.g. an abdominal region, a cranial region, a mammary region, an abdominal region, etc.). The ultrasound receiver(s) sense the ultrasound plane as the target biopsy needle is inserted into the anatomical region. In response to the ultrasound receiver(s) sensing the ultrasound plane, the ultrasound guide controller predicts a biopsy trajectory of the target biopsy needle within the anatomical region relative to ultrasound plane. The prediction indicates the biopsy trajectory is either within the ultrasound plane (i.e., an in-plane biopsy trajectory) or outside of the ultrasound plane (i.e., an out-of-plane biopsy trajectory)”). The detector and processing circuitry are interpreted as being integrated with the ultrasonic probe because they are communication with and are therefore linked/coordinated with the ultrasonic probe.
Regarding claim 10, Lu discloses all of the limitations of claim 1 as discussed above.
Lu further discloses wherein the detector and the processing circuitry are detachably attached to the ultrasonic probe (Lu, Para 22; “While not shown, in practice, ultrasound probe 20 and ultrasound receivers 31 are connected/coupled to workstation 43 in any manner as known in the art.”). A person having ordinary skill in the art would understand this to include detachable cables and wires.
Regarding claim 13, Lu discloses all of the limitations of claim 1 as discussed above.
Lu further discloses an ultrasonic diagnostic system comprising: the ultrasonic probe (ultrasound probe 20); and the puncture guiding apparatus of claim 1 (Lu, Para 13; “FIG. 1 illustrates an exemplary embodiment of a target biopsy system in accordance with the present invention.”) (Lu, Figures 1-4 showing this).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 6 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lu and Stolka et al. (US20190374290, hereafter Stolka).
Regarding claim 6, Lu discloses all of the limitations of claim 1 as discussed above.
Lu does not clearly and explicitly disclose wherein the detector has a camera for capturing an image of a range in which passage of the puncture needle is detected.
In an analogous surgical visualization field of endeavor Stolka discloses a camera for capturing an image of a range in which passage of a surgical instrument is detected (Stolka, Para 9; “FIG. 1 depicts an example of an ultrasound system (e.g., Clear Guide SCENERGY system) having an ultrasound probe having mounted thereon a tracking device (e.g., one or more cameras) for tracking a position of an interventional or surgical tool when operating on a patient's body, according to an embodiment of the present disclosure;”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lu wherein the detector has a camera for capturing an image of a range in which passage of the puncture needle is detected in order to improve real-time navigation accuracy in a convenient manner as taught by Stolka (Stolka, Para 3-6).
Regarding claim 11, Lu as modified by Stolka above discloses all of the limitations of claim 6 as discussed above.
Lu does not clearly and explicitly disclose wherein the detector is configured to focus the camera on the puncture needle, and the processing circuitry is configured to calculate an angle of the puncture needle with respect to an acoustic radiation direction of the ultrasonic probe based on a focus position.
In an analogous surgical visualization field of endeavor Stolka discloses focusing a camera on a surgical instrument (Stolka, Para 9; “FIG. 1 depicts an example of an ultrasound system (e.g., Clear Guide SCENERGY system) having an ultrasound probe having mounted thereon a tracking device (e.g., one or more cameras) for tracking a position of an interventional or surgical tool when operating on a patient's body, according to an embodiment of the present disclosure;”), and calculating an angle of the surgical instrument based on a focus position (Stolka, Para 32; “2. Determine 5-DoF (five-degree of freedom) instrument shaft and tip pose M_2 (directly using Method C), or using Method B with possible manual corrective input (as illustrated in FIG. 4, lower right quadrant). Set arbitrary long-axis orientation.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lu wherein the detector is configured to focus the camera on the puncture needle, and the processing circuitry is configured to calculate an angle of the puncture needle with respect to an acoustic radiation direction of the ultrasonic probe based on a focus position in order to improve real-time navigation accuracy in a convenient manner as taught by Stolka (Stolka, Para 3-6).
Regarding claim 12, Lu as modified by Stolka above discloses all of the limitations of claim 11 as discussed above.
Lu further discloses wherein the processing circuitry predicts a path through which the puncture needle passes if the puncture needle advances to the scanning plane and outputs the predicted path and the angle (Lu, Para 3; “The present invention enhances such ultrasound-based tracking technology by providing a precise prediction of a three-dimensional (“3D”) in-plane biopsy trajectory or a 3D out-of-plane biopsy trajectory on the ultrasound image.”) (Lu, Para 4; “In response to the ultrasound receiver(s) sensing the ultrasound plane, the ultrasound guide controller predicts a biopsy trajectory of the target biopsy needle within the anatomical region relative to ultrasound plane. The prediction indicates the biopsy trajectory is either within the ultrasound plane (i.e., an in-plane biopsy trajectory) or outside of the ultrasound plane (i.e., an out-of-plane biopsy trajectory).”) (Lu, Para 27; “Trajectory prediction module 47 is structurally configured to receive needle data ND, pre-operatively or intra-operatively, representative of a dimension/configuration profile of target biopsy needle 30 whereby parameters of needle 30 are known for determining an orientation of needle 30 relative to the ultrasound plane intersecting abdominal region 12 including, but not limited to, (1) a length of needle 30 prior to and subsequent to a firing of needle 30 and (2) an attachment point of each ultrasound receiver 31.”).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lu and Cagnan et al. (US20120099770, hereafter Cagnan).
Regarding claim 7, Lu discloses all of the limitations of claim 1 as discussed above.
Lu does not clearly and explicitly disclose wherein the detector has an optical sensor for detecting passage of the puncture needle.
In an analogous surgical visualization field of endeavor Cagnan discloses an optical sensor for detecting passage of a puncture needle (Cagnan, Para 14; “A surgical probe with integrated fiber for optical reflectance measurement is used for local anatomic mapping at probe's tip (‘photonic needle’). The 3D image information and associated anatomic labeling is updated by perioperative 3D x-ray using a flat panel rotational x-ray system. Optical spectra are acquired at different probe positions. Optical spectra are visualized together with a map that visualizes proximity and directionality of certain anatomic labeling with respect to the surgical probe's tip based on the navigated trajectory of the surgical probe's tip in the 3D (anatomically labeled) image.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lu wherein the detector has an optical sensor for detecting passage of the puncture needle in order to enhance accuracy and precision for surgical planning and operation as taught by Cagnan (Cagnan, Para 3-5).
Regarding claim 8, Lu as modified by Cagnan above discloses all of the limitations of claim 7 as discussed above.
Lu does not clearly and explicitly disclose wherein the optical sensor includes a transmitter configured to transmit light and a receptor configured to receive the transmitted light, the transmitter and the receptor arranged in the range in which passage is detected.
Cagnan further discloses a transmitter configured to transmit light and a receptor configured to receive the transmitted light, the transmitter and the receptor arranged in the range in which needle passage is detected (Cagnan, Para 14; “A surgical probe with integrated fiber for optical reflectance measurement is used for local anatomic mapping at probe's tip (‘photonic needle’). The 3D image information and associated anatomic labeling is updated by perioperative 3D x-ray using a flat panel rotational x-ray system. Optical spectra are acquired at different probe positions. Optical spectra are visualized together with a map that visualizes proximity and directionality of certain anatomic labeling with respect to the surgical probe's tip based on the navigated trajectory of the surgical probe's tip in the 3D (anatomically labeled) image.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lu wherein the optical sensor includes a transmitter configured to transmit light and a receptor configured to receive the transmitted light, the transmitter and the receptor arranged in the range in which passage is detected in order to enhance accuracy and precision for surgical planning and operation as taught by Cagnan (Cagnan, Para 3-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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/JOHN D LI/Primary Examiner, Art Unit 3798