DETAILED ACTION
This office action is in response to the communication received on 08/04/2025 concerning application no. 19/289,216 filed on 08/04/2025.
Claims 1-6 are pending.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “claim1”. This claim element should be amended to “claim 1”. This amendment will ensure proper grammar.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
Recites “a preset step size”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what parameter of the ultrasonic image information is according to a “preset step size”. That is, it is unclear if the operation is discretized with respect to the frame rate, the frequency, amplitude, or some other imaging parameter.
Applicant is encouraged to provide consistent and clear language.
Recites “the cutting parameter comprising a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β)”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim requires a single cutting parameter as the term “the cutting parameter” indicates as it is in the singular or requires a plurality of cutting parameters.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting position parameter (L)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting depth parameter (R)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting angle parameter (β)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Claim 2 is indefinite for the following reasons:
Recites “a benign prostatic hyperplasia tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “benign prostatic hyperplasia tissue” is the same as the “benign prostatic hyperplasia tissue” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “characterized in that”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a further limitation of the tissue resection system or is providing intended use limitations for the system.
Applicant is encouraged to provide consistent and clear language.
The term “slender” is a relative term which renders the claim indefinite. The term “slender” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term does not have a frame of reference or an established consideration such that it can establish what is considered to be slender and what is not considered to be slender.
Recites “is configured to guide energy to a to-be-resected target tissue through the energy exit port, so as to ablate and resect the target tissue”. This claim element is indefinite. The instant claim via the term “fluid exit port” and the preceding claim 1 establish the ablative tool to be a fluid ablative tool. It would be unclear to one with ordinary skill in the art if the ablation is fluid or energy based.
Applicant is encouraged to provide consistent and clear language.
Recites “the energy exit port”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the energy exit port”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “energy exit port” is the same as the “fluid exit port” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 3 is indefinite for the following reasons:
Recites “a benign prostatic hyperplasia tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “benign prostatic hyperplasia tissue” is the same as the “benign prostatic hyperplasia tissue” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “characterized in that”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a further limitation of the tissue resection system or is providing intended use limitations for the system.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting depth parameter (R)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting angle parameter (β)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Claim 4 is indefinite for the following reasons:
Recites “a benign prostatic hyperplasia tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “benign prostatic hyperplasia tissue” is the same as the “benign prostatic hyperplasia tissue” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “characterized in that”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a further limitation of the tissue resection system or is providing intended use limitations for the system.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting depth parameter (R)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting angle parameter (β)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Claim 5 is indefinite for the following reasons:
Recites “a benign prostatic hyperplasia tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “benign prostatic hyperplasia tissue” is the same as the “benign prostatic hyperplasia tissue” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “characterized in that”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a further limitation of the tissue resection system or is providing intended use limitations for the system.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting depth parameter (R)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting angle parameter (β)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Claim 6 is indefinite for the following reasons:
Recites “a benign prostatic hyperplasia tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “benign prostatic hyperplasia tissue” is the same as the “benign prostatic hyperplasia tissue” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “characterized in that”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a further limitation of the tissue resection system or is providing intended use limitations for the system.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting depth parameter (R)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “a cutting angle parameter (β)”. This claim element is indefinite. It is unclear what the parenthetical is attempting to convey. If it is attempting to defined the parameter, there is no mathematical equation in which a variable is required in the claim.
Applicant is encouraged to provide consistent and clear language.
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)(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 1-2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aljuri et al. (PGPUB No. US 2025/0120737; hereinafter referred to as “Aljuri ‘737”).
Regarding claim 1, Aljuri ‘737 teaches a tissue resection system for resecting a benign prostatic hyperplasia tissue (Claim 2 teaches a tissue resection system for resecting a benign prostatic hyperplasia tissue), comprising:
a motion control module, wherein the motion control module comprises a fixed reference component, and a first motion control component and a second motion control component that are connected to the fixed reference component (Claim 2 teaches a motion control module, wherein the motion control module comprises a fixed reference component, and a first motion control component and a second motion control component that are connected to the fixed reference component);
an ablation tool module, wherein the ablation tool module comprises a fluid ablation tool, and the ablation tool is connected to the first motion control component (Claim 2 teaches an ablation tool module, wherein the ablation tool module comprises a fluid ablation tool, and the ablation tool is connected to the first motion control component);
an ultrasonic imaging module, wherein the ultrasonic imaging module comprises a longitudinal ultrasonic probe for acquiring ultrasonic image information of a target tissue, and the ultrasonic probe is connected to the second motion control component (Claim 2 teaches an ultrasonic imaging module, wherein the ultrasonic imaging module comprises a longitudinal ultrasonic probe for acquiring ultrasonic image information of a target tissue, and the ultrasonic probe is connected to the second motion control component); and
a processor, wherein the processor is configured to obtain a plurality of two-dimensional slice images from the ultrasonic image information according to a preset step size, each of the plurality of two-dimensional slice images being a cross-sectional image perpendicular to an axial direction of the ultrasonic probe, and determine target tissue contour information and fluid ablation tool contour information in each of the plurality of two-dimensional slice images; and determine a cutting parameter of each two-dimensional slice image on the basis of the determined target tissue contour information and fluid ablation tool contour information, the cutting parameter comprising a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β) (Claim 2 teaches a processor, wherein the processor is configured to obtain a plurality of two-dimensional slice images from the ultrasonic image information according to a preset step size, each of the plurality of two-dimensional slice images being a cross-sectional image perpendicular to an axial direction of the ultrasonic probe, and determine target tissue contour information and fluid ablation tool contour information in each of the plurality of two-dimensional slice images; and determine a cutting parameter of each two-dimensional slice image on the basis of the determined target tissue contour information and fluid ablation tool contour information, the cutting parameter comprising a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β));
the ablation tool module performs cutting based on the cutting parameter calculated by the processor (Claim 2 teaches the ablation tool module performs cutting based on the cutting parameter calculated by the processor).
Regarding claim 2, Aljuri ‘737 teaches the tissue resection system in claim 1, as discussed above.
Aljuri ‘737 further teaches a tissue resection system, characterized in that, the ablation tool is in the shape of a slender shaft, with an end provided with an fluid exit port, and is configured to guide energy to a to-be-resected target tissue through the energy exit port, so as to ablate and resect the target tissue (Claim 3 teaches the tissue resection system for resecting a benign prostatic hyperplasia tissue according to claim 2, characterized in that, the ablation tool is in the shape of a slender shaft, with an end provided with an fluid exit port, and is configured to guide energy to a to-be-resected target tissue through the energy exit port, so as to ablate and resect the target tissue).
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 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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (PGPUB No. US 2025/0120737; hereinafter referred to as “Aljuri ‘737”) in view of Lampotang et al. (PGPUB No. US 2022/0133284).
Regarding claim 3, Aljuri ‘737 teaches the tissue resection system in claim 1, as discussed above.
However, Aljuri ‘737 is silent regarding a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour as a detected circle center; and determine, with the detected circle center as a circle center, the cutting depth parameter (R) and the cutting angle parameter (j3) by means of a sector fitting method or a rotation radius method, so as to obtain an optimal resection area within a safety range.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour as a detected circle center; and determine, with the detected circle center as a circle center, the cutting depth parameter (R) and the cutting angle parameter (j3) by means of a sector fitting method or a rotation radius method, so as to obtain an optimal resection area within a safety range (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aljuri ‘737 with Aljuri ‘251’s teaching of the use of a fitted circle center for parameter selection. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Regarding claim 4, modified Aljuri ‘737 teaches the tissue resection system in claim 1, as discussed above.
However, Aljuri ‘737 is silent regarding a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour, determine the cutting depth parameter (R) based on a minimum value of a distance between the circle center and each intersection point on a target tissue contour within a preset angle range, and determine the cutting angle parameter (β) based on an intersection point of an arc with the fitted circle center of the fluid ablation tool contour as a circle center and the cutting depth parameter (R) as a radius.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour, determine the cutting depth parameter (R) based on a minimum value of a distance between the circle center and each intersection point on a target tissue contour within a preset angle range, and determine the cutting angle parameter (β) based on an intersection point of an arc with the fitted circle center of the fluid ablation tool contour as a circle center and the cutting depth parameter (R) as a radius (Paragraphs 0165-66 teach the angle selection for treatment. Fig. 10 shows the angular treatment range on the ultrasound image according to the position of the treatment tool. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image. Paragraph 0176 teaches the calibration and the assessment of the marks to determine the location. The scale is allowed to be controlled and reset).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aljuri ‘737 with Aljuri ‘251’s teaching of the assessment of the depth parameter based on the tool center. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Regarding claim 5, Aljuri ‘737 teaches the tissue resection system in claim 1, as discussed above.
However, Aljuri ‘737 is silent regarding a tissue resection system, characterized in that, for each of the plurality of two-dimensional slice images, a plurality of groups of candidate resection areas are calculated by changing a cutting depth and/or a cutting angle, a maximum area in the plurality of groups of candidate resection areas is selected as an optimal resection area, and a cutting depth and a cutting angle corresponding to the optimal resection area are taken as the cutting depth parameter (R) and the cutting angle parameter (β).
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, for each of the plurality of two-dimensional slice images, a plurality of groups of candidate resection areas are calculated by changing a cutting depth and/or a cutting angle, a maximum area in the plurality of groups of candidate resection areas is selected as an optimal resection area, and a cutting depth and a cutting angle corresponding to the optimal resection area are taken as the cutting depth parameter (R) and the cutting angle parameter (β) (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. The selection is between the narrower and broader angular ranges. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aljuri ‘737 with Aljuri ‘251’s teaching of the selection amongst a plurality of candidate resection areas. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (PGPUB No. US 2025/0120737; hereinafter referred to as “Aljuri ‘737”) in view of Aljuri et al. (PGPUB No. US 2021/0121251; hereinafter referred to as “Aljuri ‘251”) further in view of Ebata et al. (PGPUB No. US 2021/0353261).
Regarding claim 6, modified Aljuri ‘737 teaches the tissue resection system in claim 1, as discussed above.
However, Aljuri ‘737 is silent regarding a tissue resection system, characterized in that, for adjacent two-dimensional slice images in the plurality of two-dimensional slice images, the cutting depth parameter (R) and the cutting angle parameter (β) of each of the adjacent two- dimensional slice images are determined in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, for adjacent two-dimensional slice images in the plurality of two-dimensional slice images, the cutting depth parameter (R) and the cutting angle parameter (β) of each of the adjacent two- dimensional slice images are determined (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aljuri ‘737 with Aljuri ‘251’s teaching of the determination of the angular and depth parameters. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
However, the combination of Aljuri ‘737 and Aljuri ‘251 is silent regarding an apparatus, in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above.
In an analogous imaging field of endeavor, regarding ablation treatments, Ebata teaches a tissue resection system, in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above (Paragraph 0023 teaches the thresholding according to the ratio of the area in the two images being overlapped. Paragraph 0023 teaches this is used in the determination of the ultrasound scan).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘737 and Aljuri ‘251 with Ebata’s teaching of thresholding according to ratio overlap of areas in the ultrasound image. This basis can provide the basis of the assessment of the parameters as Aljuri teaches that the parameters are based on the image. Ebata establishes that the thresholding is to assess the success of the ultrasound scanning. Such a thresholding can ensure that the scanning is satisfactory for the assessment of a parameter. This modified apparatus would allow the user to measure patient areas with excellent accuracy (Paragraph 0007 of Ebata). Furthermore, the modification assesses the success of ultrasound scanning of patient anatomy (Paragraph 0023 of Ebata).
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (PGPUB No. US 2015/0057646; hereinafter referred to as “Aljuri ‘646”) in view of Lampotang et al. (PGPUB No. US 2022/0133284).
Regarding claim 1, Aljuri ‘646 teaches tissue resection system for resecting a benign prostatic hyperplasia tissue, comprising:
a motion control module, wherein the motion control module comprises a fixed reference component, and a first motion control component and a second motion control component that are connected to the fixed reference component (Paragraphs 0100-05 teaches many embodiments further comprise a first linkage connected to the inner carrier and a second linkage connected to the imaging probe, wherein one or more controllers is configured to move the first linkage together with the second linkage to move the inner carrier along a treatment axis and move the imaging probe along an imaging probe axis in order to view interaction of the carrier with tissue as the carrier moves along the axis. In many embodiments, the coupling comprises: a base; a first arm extending from the base and connected to a proximal end of the elongate treatment probe; and a second arm extending from the base and connected to a proximal end of the elongate imaging probe; wherein the base supports the elongate treatment probe and the elongate imaging probe when the first arm comprises a stiff configuration and the second arm comprises a stiff configuration. Paragraph 0279 teaches the patient treatment probe and the imaging probe can be coupled to a common base);
an ablation tool module, wherein the ablation tool module comprises a fluid ablation tool, and the ablation tool is connected to the first motion control component (Paragraph 0122 teaches embodiments provide an apparatus to treat tissue of a patient. An arm is coupled to a base. The arm comprises a first movable configuration and a second stiff configuration. A treatment probe to treat a patient comprises an outer elongate structure having a working channel and an inner carrier rotatable and translatable within the working channel to position and orient a nozzle to release a pressurized stream of fluid toward the tissue. A processor comprises instructions to rotate and translate the carrier to treat the patient. A linkage is coupled to the processor and the probe to rotate and translate the probe in response to the instructions. Paragraph 0019 teaches a first arm can extend from the base to the elongate treatment probe, and a second arm can extend from the base to the elongate imaging probe. The first arm and the second arm may each comprise a first movable configuration in which the arm can be moved to insert the probe into the patient and a second locked configuration in which movement of the arm is inhibited.);
an ultrasonic imaging module, wherein the ultrasonic imaging module comprises a longitudinal ultrasonic probe for acquiring ultrasonic image information of a target tissue, and the ultrasonic probe is connected to the second motion control component (Paragraph 0021 teaches the imaging probe may comprise a trans-rectal ultrasound probe inserted from a posterior side of the patient and the treatment probe is inserted into the urethra of the patient from an anterior side of the patient. Paragraph 0019 teaches a second arm can extend from the base to the elongate imaging probe. The first arm and the second arm may each comprise a first movable configuration in which the arm can be moved to insert the probe into the patient and a second locked configuration in which movement of the arm is inhibited. The second arm may comprise actuators to allow fine movement and positioning of the imaging probe in order to align the imaging probe with the treatment probe and target tissue. Paragraph 0306 teaches the imaging probe 460 can be mounted on a second linkage and configured to move with the nozzle of carrier 382, so as to image interaction of the energy stream from carrier 382 when tissue is treated. The images of the treatment may comprise axial images and sagittal images from the imaging probe 460); and
a processor, wherein the processor is configured to obtain a plurality of two-dimensional slice images from the ultrasonic image information, each of the plurality of two-dimensional slice images being a cross-sectional image perpendicular to an axial direction of the ultrasonic probe, and determine target tissue contour information and fluid ablation tool contour information in each of the plurality of two-dimensional slice images (Paragraphs 0090-93 teach many embodiments further comprise a processor comprising instructions configured: to provide a plurality of images of a tissue on a display visible to a user, each image of the plurality comprising a plane of a three dimensional representation of the tissue; to receive input from the user to define a treatment profile along said each image of the plurality of images; and to determine a three-dimensional treatment profile based on the treatment profile along said each of the plurality of images. Paragraph 0016 teaches in many embodiments, a three dimensional data of the target tissue of the patient is obtained, and may be displayed to the user as a three dimensional representation. The three dimensional data may be shown in sagittal and axial cross sections, and the cross-sections may comprise segmentation of the targeted tissue. The three dimensional data can be obtained in one or more of many ways, and may comprise ultrasound data, magnetic resonance imaging data, positron emission tomography data, or computerized axial tomography data. In many embodiments, three dimensional data of the prostate are obtained, and segmented images along sagittal and transverse planes are displayed to the user. Paragraph 0017 teaches the images of the patient shown on the display can be aligned mapped to the treatment coordinate reference system, and the mapped treatment profile shown on the patient images. The images of the patient may comprise one or more structures of the probe inserted into the patient, and the structures of the probe in the image can be identified in order to align the image with the markers of the treatment plan shown on the display. Paragraph 0215 teaches as used herein, the transverse plane of an image may be referred to as the horizontal plane of the image, the axial plane of the image, or transaxial plane of the image. An image along an axial plane may be referred to as an axial image. Paragraph 0337 teaches FIG. 20A shows mapping and alignment of an image of the patient with the treatment coordinate reference frame. The image 510 of the organ can be obtained in one or more of many ways as described herein. The image may comprise an image reference frame, for example comprising X, Y and Z coordinate references. The treatment probe 450 comprises a treatment reference frame, for example cylindrical coordinate references R, Z, theta. The orientation of the axes of the probes can be determined as described herein. A marker reference 536, such as the anchor of the treatment probe can be identified from the image, in order to align the two images with a common known reference point. Paragraph 0382 teaches FIGS. 21C to 21F show a plurality of axial images 525 of a target tissue to define a three dimensional treatment plan and a user defined treatment profile in each of the plurality of images. The user interface comprises a first tab 527 to select a Z-slice view and a second tab 529 to select a Y-view, of a three dimensional representation of a target tissue such as an organ that may comprise the prostate. The Z-slice view may correspond to a sagittal image of the target tissue and the Y-slice view may correspond to an axial view of the target tissue. Paragraph 0387 teaches FIG. 21G shows a sagittal view of the target tissue and planes of the axial images of FIGS. 21C to 21F. The z-slice view can be selected with tab 527, so as to show a sagittal view of the target tissue. The plurality of images 525 are shown as lines extending through the sagittal view); and determine a cutting parameter of each two-dimensional slice image on the basis of the determined target tissue contour information and fluid ablation tool contour information, the cutting parameter comprising a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β) (Paragraph 0383 teaches each image 510 comprises a user input treatment profile 520. The user input treatment profile may comprise a plurality of points that are user adjustable on the image to define the treatment profile. The first plurality of images 525A shows the treatment profile partially positioned by the user, and a plurality of treatment profile marker points 521 have yet to be placed on the target tissue location by the user. The user can adjust the location of the points with the user interface, for example with a pointing device or touch screen display. The processor as described herein comprises instructions to receive the plurality of points input by the user. Paragraph 0389 teaches FIG. 21I shows a user input treatment profile of an image among a plurality of images as described herein. The user can adjust the plurality of points 521 in one or more of many ways, and the user can determine the treatment profile based on patient need. The treatment profile can be selected so as not to extend to an outer boundary of a tissue structure, for example an outer structure of an organ such as a prostate as shown in FIG. 21I. Paragraph 0336 teaches the processor system comprises instructions to map and transform the reference treatment profile on the image of the patient to the machine coordinate references of the treatment probe 450 and linkage 430 and anchor 24 as described herein. Paragraph 0339 teaches in many embodiments, the user can identify a plurality of points of a treatment profile on the image of the tissue of the patient, and the plurality of points are mapped to the treatment coordinate reference, and shown on the display so that the user can verify that the treatment coordinates of the treatment profile shown on the display treat the targeted tissue as intended by the user. Paragraph 0036 teaches in many embodiments, the plurality of input parameters comprises one or more of a longitudinal distance of the removal profile, a radial distance of the removal profile, an angular distance of the removal profile around a longitudinal axis of the removal profile, an axis of the removal profile, a central location of the removal profile, or a user defined input removal profile in response to the user moving a pointer over the image of the prostate. Paragraph 0045 teaches in many embodiments, a nozzle is identified among a plurality of nozzles to treat the patient with a pressurized fluid stream based on a radial distance of the tissue removal profile input into the processor);
the ablation tool module performs cutting based on the cutting parameter calculated by the processor (Paragraphs 0287-88 teaches the processor, controller and control electronics and circuitry can include one or more of many suitable components, such as one or more processor, one or more field-programmable gate array (FPGA), and one or more memory storage devices. In many embodiments, the control electronics controls the control panel of the graphic user interface (hereinafter "GUI") to provide for pre-procedure planning according to user specified treatment parameters as well as to provide user control over the surgery procedure. The linkage 430 comprises components to move energy delivery region 20 to a desired target location of the patient, for example, based on images of the patient. The linkage 430 comprises a first portion 432 and a second portion 434 and a third portion 436. The first portion 432 comprises a substantially fixed anchoring portion. The substantially fixed anchoring portion 432 is fixed to support 438. Support 438 may comprise a reference frame of linkage 430. Support 438 may comprise a rigid chassis or frame or housing to rigidly and stiffly couple arm 442 to treatment probe 450. The first portion 432 remains substantially fixed, while the second portion 434 and third portion 436 move to direct energy from the probe 450 to the patient. The first portion 432 is fixed to the substantially constant distance 438 to the anchor 434. The substantially fixed distance 438 between the anchor 24 and the fixed first portion 432 of the linkage allows the treatment to be accurately placed. The first portion 434 may comprise the linear actuator to accurately position the high pressure nozzle in treatment region 20 at a desired axial position along an elongate axis of probe 450).
However, Aljuri ‘646 is silent regarding a system, according to a preset step size.
In an analogous imaging field of endeavor, regarding ablation treatments, Lampotang teaches a system, a processor, wherein the processor is configured to obtain a plurality of two-dimensional slice images from the ultrasonic image information according to a preset step size (Paragraph 0052 teaches that the acquisition of the 2D image slices of the organ via TRUS. Paragraph 0054 teaches that the view imaging can be sagittal, coronal and transverse. Fig. 3 shows the image perpendicular to the axial cross-section of the TRUS. The reconstruction of the 3D can be based on the multiple 2D slices. Paragraph 0055 teaches the control of the side-fire guide. Paragraph 0103 teaches a sweep of the dorsal (rectal) side of the prostate by the TRUS probe may be made horizontally while the transrectal ultrasound probe location and orientation is recorded. The transverse plane is manually adjusted until it passes through the sensor midpoint. Paragraph 0107-09 teaches the spacing of the planes).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aljuri ‘646 with Lampotang’s teaching of preset step size. This modified apparatus would allow the user to have a substantial improvement in collection of tissue samples (Paragraph 0095 of Lampotang). Furthermore, the modification provides the accuracy for biopsy and treatment and assist in guided interventional procedures (Paragraph 0003 of Lampotang).
Regarding claim 2, modified Aljuri ‘646 teaches the tissue resection system in claim 1, as discussed above.
Aljuri ‘646 further teaches a tissue resection system, characterized in that, the ablation tool is in the shape of a slender shaft, with an end provided with an fluid exit port, and is configured to guide energy to a to-be-resected target tissue through the energy exit port, so as to ablate and resect the target tissue (Paragraph 0262 teaches referring now to FIG. 11, the device comprises an elongate element 310, such as a shaft, configured to be inserted into a body region. The elongate element 310 comprises a window exposing a carrier tube 380 and other components described below. The window reveals a carrier tube 380 and a high pressure fluid delivery element 320 disposed on the carrier tube 380. The fluid delivery element 320 is connected to a fluid source (not shown) via a fluid lumen 390 which delivers fluid from the source to the fluid delivery element 320. Paragraph 0266 teaches the fluid delivery element 320 may be a single nozzle, a plurality of nozzles, or an array of nozzles of various configurations. The fluid delivery element 320 is configured to emit a fluid radially outwardly as a fluid stream 331, with sufficient force so that upon contact with the tissue the fluid stream 331 resects the tissue).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (PGPUB No. US 2015/0057646; hereinafter referred to as “Aljuri ‘646”) in view of Lampotang et al. (PGPUB No. US 2022/0133284) further in view of Aljuri et al. (PGPUB No. US 2021/0121251; hereinafter referred to as “Aljuri ‘251”).
Regarding claim 3, modified Aljuri ‘646 teaches the tissue resection system in claim 1, as discussed above.
However, the combination of Aljuri ‘646 and Lampotang is silent regarding a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour as a detected circle center; and determine, with the detected circle center as a circle center, the cutting depth parameter (R) and the cutting angle parameter (j3) by means of a sector fitting method or a rotation radius method, so as to obtain an optimal resection area within a safety range.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour as a detected circle center; and determine, with the detected circle center as a circle center, the cutting depth parameter (R) and the cutting angle parameter (j3) by means of a sector fitting method or a rotation radius method, so as to obtain an optimal resection area within a safety range (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘646 and Lampotang with Aljuri ‘251’s teaching of the use of a fitted circle center for parameter selection. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Regarding claim 4, modified Aljuri ‘646 teaches the tissue resection system in claim 1, as discussed above.
However, the combination of Aljuri ‘646 and Lampotang is silent regarding a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour, determine the cutting depth parameter (R) based on a minimum value of a distance between the circle center and each intersection point on a target tissue contour within a preset angle range, and determine the cutting angle parameter (β) based on an intersection point of an arc with the fitted circle center of the fluid ablation tool contour as a circle center and the cutting depth parameter (R) as a radius.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, the processor is further configured to acquire a fitted circle center of the fluid ablation tool contour, determine the cutting depth parameter (R) based on a minimum value of a distance between the circle center and each intersection point on a target tissue contour within a preset angle range, and determine the cutting angle parameter (β) based on an intersection point of an arc with the fitted circle center of the fluid ablation tool contour as a circle center and the cutting depth parameter (R) as a radius (Paragraphs 0165-66 teach the angle selection for treatment. Fig. 10 shows the angular treatment range on the ultrasound image according to the position of the treatment tool. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image. Paragraph 0176 teaches the calibration and the assessment of the marks to determine the location. The scale is allowed to be controlled and reset).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘646 and Lampotang with Aljuri ‘251’s teaching of the assessment of the depth parameter based on the tool center. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Regarding claim 5, modified Aljuri ‘646 teaches the tissue resection system in claim 1, as discussed above.
However, the combination of Aljuri ‘646 and Lampotang is silent regarding a tissue resection system, characterized in that, for each of the plurality of two-dimensional slice images, a plurality of groups of candidate resection areas are calculated by changing a cutting depth and/or a cutting angle, a maximum area in the plurality of groups of candidate resection areas is selected as an optimal resection area, and a cutting depth and a cutting angle corresponding to the optimal resection area are taken as the cutting depth parameter (R) and the cutting angle parameter (β).
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, for each of the plurality of two-dimensional slice images, a plurality of groups of candidate resection areas are calculated by changing a cutting depth and/or a cutting angle, a maximum area in the plurality of groups of candidate resection areas is selected as an optimal resection area, and a cutting depth and a cutting angle corresponding to the optimal resection area are taken as the cutting depth parameter (R) and the cutting angle parameter (β) (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. The selection is between the narrower and broader angular ranges. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘646 and Lampotang with Aljuri ‘251’s teaching of the selection amongst a plurality of candidate resection areas. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (PGPUB No. US 2015/0057646; hereinafter referred to as “Aljuri ‘646”) in view of Lampotang et al. (PGPUB No. US 2022/0133284) further in view of Aljuri et al. (PGPUB No. US 2021/0121251; hereinafter referred to as “Aljuri ‘251”) further in view of Ebata et al. (PGPUB No. US 2021/0353261).
Regarding claim 6, modified Aljuri ‘646 teaches the tissue resection system in claim 1, as discussed above.
However, the combination of Aljuri ‘646 and Lampotang is silent regarding a tissue resection system, characterized in that, for adjacent two-dimensional slice images in the plurality of two-dimensional slice images, the cutting depth parameter (R) and the cutting angle parameter (β) of each of the adjacent two- dimensional slice images are determined in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above.
In an analogous imaging field of endeavor, regarding ablation treatments, Aljuri ‘251 teaches a tissue resection system, characterized in that, for adjacent two-dimensional slice images in the plurality of two-dimensional slice images, the cutting depth parameter (R) and the cutting angle parameter (β) of each of the adjacent two- dimensional slice images are determined (Paragraph 0165 teaches the selection of the treatment angle according to the apex of the tool as seen in Fig. 10. The rotation is shown to be about the apex to encompass a selected angular range. Paragraphs 0168 teach that the probe tip is identified and used according to the target. Paragraphs 0180-81 teach the selection of the angle, scale and depth for the cutting according to the probe position and image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘646 and Lampotang with Aljuri ‘251’s teaching of the determination of the angular and depth parameters. This modified apparatus would allow the user to provide improved treatment to the patient (Paragraph 0064 of Aljuri ‘251). Furthermore, the modification can be helpful in determining appropriate adjustments to a planned surgical treatment (Paragraph 0062 of Aljuri ‘251).
However, the combination of Aljuri ‘646, Lampotang, and Aljuri ‘251is silent regarding an apparatus, in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above.
In an analogous imaging field of endeavor, regarding ablation treatments, Ebata teaches a tissue resection system, in such a manner that a ratio of an overlapping area of projections of respective resection areas of the adjacent two-dimensional slice images in an axial direction of the ultrasonic probe to each of the respective resection areas is a specified threshold or above (Paragraph 0023 teaches the thresholding according to the ratio of the area in the two images being overlapped. Paragraph 0023 teaches this is used in the determination of the ultrasound scan).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Aljuri ‘646, Lampotang, and Aljuri ‘251 with Ebata’s teaching of thresholding according to ratio overlap of areas in the ultrasound image. This basis can provide the basis of the assessment of the parameters as Aljuri teaches that the parameters are based on the image. Ebata establishes that the thresholding is to assess the success of the ultrasound scanning. Such a thresholding can ensure that the scanning is satisfactory for the assessment of a parameter. This modified apparatus would allow the user to measure patient areas with excellent accuracy (Paragraph 0007 of Ebata). Furthermore, the modification assesses the success of ultrasound scanning of patient anatomy (Paragraph 0023 of Ebata).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ingle et al. (PGPUB No. US 2003/0178032): Teaches shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues.
Carol (PGPUB No. US 2020/0023207): Teaches HIFU treatment of prostatic tissue via ablation and rectal insertion of a medical treatment device.
Christopherson et al. (PGPUB No. US 2006/0089636): Teaches treatment of BPH.
Burdette et al. (PGPUB No. US 2003/0229282): Teaches treatment planning according to contouring data from imaging.
Xu et al. (PGPUB No. US 2017/0020558): Teaches segmenting for treatment.
Glossop et al. (PGPUB No. US 2016/0008074): Teaches assisting or performing guided interventional procedures using custom templates.
Kumar et al. (PGPUB No. US 2010/0172559): Teaches tools to improve a 3-D image aided biopsy or treatment procedure for prostate gland by providing additional functionality and additional visual cues on an output image of the prostate, which may be generated substantially in real-time.
Elevelt et al. (PGPUB No. US 2018/0280089): Teaches treatment planning according to axial information of the tool.
Desai (PGPUB No. US 2003/0073908): Teaches treatment of prostatic cancer.
Zvuloni et al. (PGPUB No. US 2009/0118724): Teaches delivering a surgical instrument to a treatment site within the body of a subject, enabling accurate placement of surgical tools in areas not directly visible to a surgeon during a surgical procedure, while reducing or eliminating need for real-time imaging modalities to guide placement of those surgical tools.
Chaney et al. (PGPUB No. US 2012/0027278): Teaches mapping a model of an object comprising an anatomical structure in a planning image and an intervention target region within it to intervention-guiding image data.
Salcudean et al. (PGPUB No. US 2015/0087975): Teaches monitoring the cryoablation of a target volume of tissue with ultrasound elastography.
Stapert et al. (PGPUB No. US 2019/0261944): Teaches indicating a position of an interventional device feature.
Badiei et al. (PGPUB No. US 2009/0136108): Teaches delineating the contour of an object in captured medical images by first transforming the shape of the object into a simple geometric shape that is more computationally tractable than the shape of the object.
Tehrani et al. (PGPUB No. US 2016/0338679): Teaches tissue analysis and therapy.
Trachtenberg (PGPUB No. US 2002/0010502): Teaches a hydrodissection apparatus for treatment of the prostate of a patient.
Amthor et al. (PGPUB No. US 2017/0043180): Teaches treatment planning system configured for determining a set of catheter or needle insertion positions to be used during treatment.
Kee et al. (PGPUB No. US 2024/0335235): Teaches determining a trajectory of an elongated tool includes receiving positional information of a region of interest and receiving positional information of one or more structures at least partially occluding or obstructing access to the region of interest.
Shi et al. (PGPUB No. US 2024/0299003): Teaches a tissue resection system.
DiMaio et al. (US Patent No. 11,259,870): Teaches the use of a teleoperational imaging and tissue resection system.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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