DETAILED ACTION
This office action is in response to the communication received on 09/04/2026 concerning application no. 18/990,234 filed on 12/20/2024.
Claims 1-10 are pending (Claims 1 and 4-5 are withdrawn from consideration).
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 .
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: 18/454,469.
It is noted that the instant application is presently being examined under the AIA statutes.
It is noted that all claim limitations are not present in the parent application. Therefore, Applicant is only entitled to the filing of the current application. That filing date is 12/20/2024. If Applicant believes they are entitled to priority, they are required to submit a claim chart that points each limitation of the claims to their corresponding support in the specification of the parent application 18/454,469.
Interference/Derivation
It appears that Applicant is attempting to suggest an interference pursuant to 37 CFR 41.202(a). If this is accurate, Applicant is required to submit a 41.202(a) statement. Due to the AIA -yes status of the application currently, if Applicant wishes to pursue a derivation proceeding, they may file a petition accordingly. See MPEP 2300.
Response to Arguments
Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive.
Regarding the priority, Applicant “Applicant respectfully submits that the present claims are entitled to claim the benefit of Application No. 18/454,469 and each of the other prior applications listed in the priority claim presented in the present application.” Applicant provides a claim chart that is alleged to provide support for all elements of the claims.
Examiner respectfully disagrees. The claim chart fails to address the support for all elements of the claims. In the case of claim 2’s “determining target tissue contour information and fluid ablation tool contour information in each of the plurality of two-dimensional slice images,” Applicant alleges support in paragraphs 0016-17, 0090-98, 0215, 0338, 0383, and 0388. For paragraphs 0016, 0090-98, 0215, 0383, and 0388, contouring of the fluid ablation tool and is instead discussing the contouring of the target tissue. Paragraph 0017 discusses tool identification but does not discuss contouring. Paragraph 0338 discusses the alignment of the image with respect to the probes. However, this is with respect to the axial arrangement of the tool and the identification of the anchor of the treatment probe. The specification does not disclose the determination of the fluid ablation tool in each of the 2D images. Furthermore, the specification does not disclose using this fluid ablation tool contour information as the basis to “determine at least one cutting parameter of each 2D slice images.”
In the case of claim 7’s “determine target tissue boundary information and position and orientation of the nozzle in each of the plurality of two-dimensional slice images,” Applicant alleges support in paragraphs 0017, 0338, and 0390. For paragraph 0390, the specification does not refer to the determination of the position and orientation of the nozzle in each of the 2D images. Paragraph 0017 discusses tool identification but does not discuss determination of the position and orientation of the nozzle in each of the 2D images. Paragraph 0338 discusses the alignment of the image with respect to the probes. However, this is with respect to the axial arrangement of the tool and the identification of the anchor of the treatment probe. The specification does not discuss determination of the position and orientation of the nozzle in each of the 2D images. Furthermore, the specification does not disclose using this position and location of the nozzle as the basis to “determine at least one cutting parameter for each two-dimensional slice image using the determined target tissue boundary information and position and orientation of the nozzle.”
Therefore, Applicant is only entitled to the filing of the current application. That filing date is 12/20/2024.
Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive.
Applicant’s remarks omit reference to the Interference/Derivation issue raised in the non-final rejection, mailed 06/04/2026. As stated before “It appears that Applicant is attempting to suggest an interference pursuant to 37 CFR 41.202(a). If this is accurate, Applicant is required to submit a 41.202(a) statement. Due to the AIA -yes status of the application currently, if Applicant wishes to pursue a derivation proceeding, they may file a petition accordingly. See MPEP 2300.”
Applicant is requested to address this issue.
Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive.
Regarding the 102, Applicant argues “The Office Action rejected the claims as being anticipated by US 12,514,540 ("Shi"). Applicant respectfully traverses. As explained above, the present application claims priority to Application No. 18/454,469, which is part of the chain of continuation applications tracing back to PCT/US2013/028441, filed on February 28, 2013. Shi's earliest filing or publication date is after February 28, 2013. Accordingly, because Shi does not qualify as prior art against the presently pending claims, Applicant respectfully requests withdrawal of these rejections.”
Examiner respectfully disagrees. As discussed above, “It is noted that all claim limitations are not present in the parent application. Therefore, Applicant is only entitled to the filing of the current application. That filing date is 12/20/2024.” Therefore, Shi’s effective filing date precedes the instant application’s filing date.
Examiner respectfully maintains the rejection.
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 2-3 and 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 2 is indefinite for the following reasons:
Recites “the fluid ablation tool module”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “the fluid ablation tool module” is the same as the “the fluid ablation tool” established in the preceding claim element or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the fluid ablation tool module”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “the fluid ablation tool module” is the same as the “the ablation tool module” established in the preceding claim element or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the fluid ablation tool module”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is indefinite for the following reasons:
Recites “is configured to guide energy to the target tissue through the fluid 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 2, 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.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 2-3 and 6-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shi et al. (US Patent No. 12,514,540).
Regarding claim 2, Shi teaches a tissue resection system for resecting prostate 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;an ablation tool module, wherein the ablation tool module comprises a fluid ablation tool, and the fluid 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;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; and determine at least one 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 at least one cutting parameter comprising a cutting position parameter, a cutting depth parameter, and a cutting angle parameter, wherein the fluid ablation tool module performs cutting based on the at least one cutting parameter calculated by the processor (Col. 3, lines 34-37 teaches the target tissue is a benign prostatic hyperplasia tissue, the ablation tool is a fluid ablation tool, and the three-dimensional ultrasonic image is obtained by a rectal ultrasound probe. Col. 3, lines 40-Col. 4, lines 4, teaches a tissue resection system for resecting a target tissue, which comprises: 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 an 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; 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 ablation tool contour information in each of the plurality of two-dimensional slice images; and determine a cutting parameter on the basis of the determined target tissue contour information and ablation tool contour information, the cutting parameter comprising at least one of 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).
Regarding claim 3, Shi teaches the tissue resection system for resecting prostate tissue in claim 2, as discussed above.
Shi further teaches a tissue resection system for resecting prostate tissue, wherein, the fluid ablation tool is in the shape of a shaft, with an end provided with a fluid exit port, and is configured to guide energy to the target tissue through the fluid exit port, so as to ablate and resect the target (Col. 4, lines 5-9 teaches the ablation tool is in the shape of a slender shaft, with an end provided with an energy 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. Col. 3, line 34-37, teaches the target tissue is a benign prostatic hyperplasia tissue, the ablation tool is a fluid ablation tool, and the three-dimensional ultrasonic image is obtained by a rectal ultrasound probe. See Fig. 1).
Regarding claim 6, Shi teaches the tissue resection system for resecting prostate tissue in claim 2, as discussed above.
Shi further teaches a tissue resection system for resecting prostate tissue, wherein: the processor is configured to determine a plurality of cutting parameters of each two- dimensional slice image on the basis of the determined target tissue contour information and fluid ablation tool contour information; and the cutting position parameter corresponds to an axial position along the ultrasonic probe, the cutting depth parameter corresponds to a radial distance from the fluid ablation tool, and the cutting angle parameter corresponds to an angular span of a resection sector (Claim 1 teaches determining a set of cutting parameters of each two-dimensional slice image on the basis of the determined target tissue contour information and ablation tool contour information, the set of cutting parameters comprising a cutting position parameter, a cutting depth parameter, and a cutting angle parameter, wherein the cutting position parameter corresponds to an axial position along the ultrasonic probe, the cutting depth parameter corresponds to a radial distance from the fluid ablation tool, and the cutting angle parameter corresponds to an angular span of a resection sector, performing the cutting according to the set of cutting parameters).
Regarding claim 7, Shi teaches a tissue resection system for resecting prostate tissue, comprising: a first linkage comprising a first portion that provides a fixed reference frame and a second portion connected to the first portion; a second linkage connected to the first portion; a treatment probe comprising a nozzle, the treatment probe configured to be connected to the second portion of the first linkage, the second portion of the first linkage configured to move the treatment probe (Col. 6, lines 60-Col. 7, lines 20, teaches a tissue resection system for resecting a target tissue according to the present invention is a medical water jet robot system for treating benign prostatic hyperplasia. The system comprises a motion control module, an ablation tool module, a three-dimensional ultrasonic imaging module, and a processor. The motion control module comprises a fixed base 100 as a fixed reference component, and a first motion control component and a second motion control component that are connected to the fixed base 100. The first motion control component may be a first mechanical arm 110, and the second motion control component may be a second mechanical arm 120. The first mechanical arm 110 and the second mechanical arm 120 are in rotation-fit connection with the fixed base 100. Ends of the first mechanical arm 110 and the second mechanical arm 120 are each provided with an encoder, or other similar position feedback apparatuses or positioning apparatuses that can be used to transmit position information of the first mechanical arm and the second mechanical arm. The first mechanical arm 110 and/or second mechanical arm 120 may be the same or different, and those skilled in the art can select as required. For example, 6-axis or 7-axis mechanical arms may be selected, both may be active mechanical arms or passive mechanical arms, or one is an active mechanical arm and the other is a passive mechanical arm. In addition, in some embodiments, the first mechanical arm 110 and/or the second mechanical arm 120 may be replaced by a rotatable support);
an elongate ultrasound probe configured to acquire ultrasound images of a target tissue, the ultrasound probe configured to be connected to the second linkage configured to move the ultrasound probe (Col. 7, lines 57 to Col. 8, lines 9 teaches the three-dimensional ultrasonic imaging module comprises an ultrasonic probe 122, and the ultrasonic probe 122 is in the shape of a slender tube. A rear end of the ultrasonic probe is inserted and fitted with a second adapter 121 fixedly provided at a front end of a second mechanical arm 120, and the second mechanical arm 120 and the second adapter 121 can drive the ultrasonic probe 122 to move forward or backward in an axial direction of the slender tube and rotate around an axis of the slender tube as a rotation axis. The second mechanical arm 120 drives the image position-calibrated ultrasonic probe 122 to move forward at a predetermined speed. The slender tubular ultrasonic probe 122 is inserted into the human body along a rectal passage of a patient. During the insertion, the ultrasonic probe 122 sequentially collects ultrasound sagittal plane images and ultrasonic transverse plane images. A three-dimensional ultrasonic image can be reconstructed according to an acquired ultrasound transverse plane image sequence. The three-dimensional ultrasonic image may also be obtained by other methods); and
a processor configured to: obtain a plurality of two-dimensional slice images from the ultrasound images, each of the plurality of two- dimensional slice images being a cross-sectional image perpendicular to an axial direction of the ultrasound probe (Col. 3, lines 40-Col. 4, lines 4, teaches a tissue resection system for resecting a target tissue, which comprises: 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 ablation tool contour information in each of the plurality of two-dimensional slice images; and determine a cutting parameter on the basis of the determined target tissue contour information and ablation tool contour information, the cutting parameter comprising at least one of 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);
determine target tissue boundary information and position and orientation of the nozzle in each of the plurality of two-dimensional slice images (Col. 13, lines 37-44 teaches changing the cutting radius (cutting depth) and the cutting angle (including an orientation, a working angle, etc. of a cutting tool, etc.), a plurality of groups of candidate resection areas are obtained, which can improve the possibility of obtaining the best cutting area. Abstract teaches determining contour information the two-dimensional slice images; and calculating a cutting parameter on the basis of the determined contour information comprising contour information of an ablation tool and contour information of the target tissue, the cutting parameter comprising at least one of: a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β). Col. 6, lines 40-49 teaches the term “cutting position” refers to a position where the energy exit port of a tissue ablation apparatus is located when moving in an axial direction during the surgery. The term “cutting contour” refers to an outer contour line of an overall shape of cutting path planning formed at a cutting position according to a determined cutting depth parameter and cutting angle parameter. The part within the contour line becomes a “cutting range” while the area within the cutting range is referred to as a “cutting area”); and
determine at least one cutting parameter for each two-dimensional slice image using the determined target tissue boundary information and position and orientation of the nozzle, the at least one cutting parameter comprising an axial position of the nozzle, a cutting depth, and a cutting angle , wherein the treatment probe is configured to perform cutting of the target tissue based on the at least one cutting parameter (Col. 3, lines 40-Col. 4, lines 4, teaches a tissue resection system for resecting a target tissue, which comprises: determine a cutting parameter on the basis of the determined target tissue contour information and ablation tool contour information, the cutting parameter comprising at least one of 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).
Regarding claim 8, Shi teaches the tissue resection system for resecting prostate tissue in claim 7, as discussed above.
Shi further teaches a tissue resection system for resecting prostate tissue, wherein, the treatment probe comprises an elongate shaft with an end supporting the nozzle, and wherein the treatment probe is configured to guide energy to the target tissue through the nozzle so as to ablate and resect the target tissue (Col. 7, lines 32-57 teaches ablation tool module comprises an ablation tool, an endoscope, and a sheath. The ablation tool and the endoscopic apparatus are integrated in the sheath 112. The ablation tool is in the shape of a slender shaft, with a tail end provided with an energy exit port (not shown in the figure). Through the energy exit port, energy for resecting the target tissue may be transferred to the target tissue working area, and the target tissue is cut by means of the energy. An energy source for resecting a tissue may be water jet, laser or electric energy. In the medical water jet robot system for treating benign prostatic hyperplasia, the energy used by ablation tool is water jet, and the water jet with a certain pressure is output to the target tissue, so that the target tissue can be broken or removed. Rear ends of the ablation tool and the endoscopic apparatus extend out from the sheath 112 to be inserted and fitted with a first adapter 111 fixedly arranged at a front end of the first mechanical arm 110, so that the first mechanical arm 110 can drive the calibrated ablation tool to move forward or backward in an axial direction of the slender shaft, and can drive the ablation tool to rotate around a central axis of the slender shaft as a rotation axis, so that the energy exit port rotates and swings in an exit direction. The sheath 112 is in the shape of a slender tube, and the sheath 112 is inserted into a prostate 200 along a urethra during resection of the benign prostatic hyperplasia tissue).
Regarding claim 9, Shi teaches the tissue resection system for resecting prostate tissue in claim 7, as discussed above.
Shi further teaches a tissue resection system for resecting prostate tissue, wherein: the processor is configured to determine a set of cutting parameters for each two- dimensional slice image using the determined target tissue boundary information and position and orientation of the nozzle (Col. 13, lines 37-44 teaches changing the cutting radius (cutting depth) and the cutting angle (including an orientation, a working angle, etc. of a cutting tool, etc.), a plurality of groups of candidate resection areas are obtained, which can improve the possibility of obtaining the best cutting area. Abstract teaches determining contour information the two-dimensional slice images; and calculating a cutting parameter on the basis of the determined contour information comprising contour information of an ablation tool and contour information of the target tissue, the cutting parameter comprising at least one of: a cutting position parameter (L), a cutting depth parameter (R), and a cutting angle parameter (β). Col. 6, lines 40-49 teaches the term “cutting position” refers to a position where the energy exit port of a tissue ablation apparatus is located when moving in an axial direction during the surgery. The term “cutting contour” refers to an outer contour line of an overall shape of cutting path planning formed at a cutting position according to a determined cutting depth parameter and cutting angle parameter. The part within the contour line becomes a “cutting range” while the area within the cutting range is referred to as a “cutting area”); and the axial position of the nozzle corresponds to an axial position along the treatment probe aligned with the ultrasound probe, the cutting depth corresponds to a radial distance from a treatment axis along which the treatment probe is positioned, and the cutting angle corresponds to an angular extent of treatment around the treatment axis (Col. 9, lines 36-38 teaches axial position where the one or more two-dimensional slices are located is a cutting position, and a cutting position parameter L may be expressed as L1, L2, L3… Claim 1 teaches wherein the cutting position parameter corresponds to an axial position along the ultrasonic probe, the cutting depth parameter corresponds to a radial distance from the fluid ablation tool, and the cutting angle parameter corresponds to an angular span of a resection sector, performing the cutting according to the set of cutting parameters).
Regarding claim 10, Shi teaches the tissue resection system for resecting prostate tissue in claim 7, as discussed above.
Shi further teaches a tissue resection system for resecting prostate tissue, wherein the processor is configured to determine the at least one cutting parameter such that treatment does not extend to an outer boundary of the target tissue (Col. 12, lines 1-4 teaches that the cutting radius is defined in a manner that it is within the target contour. See Fig. 5. Col. 2, lines 61 to col. 3, lines 6 teaches the step of determining a cutting parameter further comprises: acquiring a fitted circle center of an ablation tool contour, determining 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 determining the cutting angle parameter (β) based on an intersection point of an arc with the fitted circle center of the ablation tool contour as a circle center and the cutting depth parameter (R) as a radius. According to the present invention, the resection range can be simply determined based on the fitted circle center of the ablation tool contour and the target tissue contour information).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shroff et al. (PGPUB No. US 2010/0137857): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
Keidar (PGPUB No. US 20040147920): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
Jenkins et al. (PGPUB No. US 20100312095): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
Sharma (PGPUB No. US 20140200568): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
McGovern et al. (PGPUB No. US 20010018585): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
Sharonov (PGPUB No. US 9,662,165): Teaches determination and implementation of at least one cutting parameter for ablative treatments.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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