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 .
DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Dalal et al. (US 8,267,927 (provided in the IDS)) and in view of Shevlev et al. (US 2020/0246079).
Addressing claim 20, Dalal discloses a system for performing at least one ablation comprising:
at least one communication interface for communicating with an imaging device and an ablation tool (see Fig. 1; elements 12 ablation tool; 16 imaging device; 18 communication interface);
a processor (see Fig. 1, element 21);
a memory storing instructions for execution by the processor that, when executed, cause the processor to: receive image data corresponding to a mass to be ablated (see Figs. 1-2; element 20 memory; step 30 receive image and identify plan target volume/tumor (ptv) to be ablated);
segment a volume of the mass to yield a plurality of sub-volumes, each one of the plurality of sub-volumes corresponding to one of a plurality of ablation steps (see abstract, Figs. 6-7, col. 1, lines 51 – col. 2, line 21 and col. 9, lines 40-41; plurality of ablation volumes to be ablated in plurality of steps (composite ablation));
identify an ablation center of each sub-volume of the plurality of sub- volumes (see col. 11, lines 5-8, Figs. 2 and 7, elements 34 and 36; center 114 of each sub-volume 108);
calculate, for one ablation step of the plurality of ablation steps, an ablation tool position, wherein the imaging device position is determined without reference to or dependency on the ablation tool position, cause the ablation tool to be positioned based on the calculated ablation tool position, and wherein the imaging device position is defined in a coordinate system different from that used for the ablation tool position and cause the ablation tool to activate based on the one ablation step (see col. 5, lines 35-67; col. 11, lines 15-43; col. 24, lines 32-36; physician proceed with ablation after select, placement of ablation tool and visual feedback tracking ablation tool; ablation tool works with register images; the imaging system is a separate CT system with a different coordinate system connect with RF ablation system that has a different coordinate system; the imaging system is in a different coordinate system that why the system has to register the image; registration is to put the imaging system and treatment system in the same coordinate system for display; as see in applicant’s specification [0008] and [0070]; register image data to ablation coordinates; registered image or registration is used when there are multiple device in different coordinate system so registration to put them in the same coordinate system; for example imaging camera in one coordinate system and treatment catheter in a different coordinate system then register the image to the treatment coordinate system or register both images and treatment device to a common third coordinate system).
Dalal does not explicitly disclose calculate a position for imaging tool and placing the imaging tool in the calculate position. In the same field of endeavor, which is treatment by ablation, Shevlev discloses calculate a position for imaging tool and placing the imaging tool in the calculate position (see [0045], [0061] and Fig. 9; undertake an image analysis of the fluoroscopic 3D reconstruction to determine an angle for placement of the fluoroscopic imaging device 124 to optimally engage in the target overlay tab; place imaging device at a certain angle position). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dalal to calculate a position for imaging tool and placing the imaging tool in the calculate position as taught by Shevlev because this allows operator to view treatment tool and target on the image (see [0061] and Fig. 9).
4. Addressing claims 21-27, Dalal discloses:
addressing claim 21, wherein the instructions, when executed, further cause the processor to: identify, based on the corresponding ablation center and mass volume, at least one of an ablation size and shape for at least one of the plurality of ablation steps (see col. 4, lines 8-25, col. 15, line 34 – col. 17, line 14, Figs. 5 and 10; choose shape and size of ablation probe that cover the size and mass of the tumor sub-volume).
addressing claim 22, wherein the instructions, when executed, further cause the processor to: identify an updated ablation center for a subsequent ablation step of the plurality of ablation steps after the one ablation step is completed; and calculate, for the subsequent ablation step and after the one ablation step of the plurality of ablation steps is completed, an updated ablation tool position and an updated imaging device position (see col. 8, lines 36-40 and col. 9, lines 4-7; ablation tool tip move to different ablation locations to cover the PTV is updated ablation tool position and ablation center after a subsequent ablation step; each PTV has a different ablation ellipses centers; Shevlev discloses update imaging device position (see [0061] and Fig. 9); steps 901, 902 and in between; following the local registration (e.g., step 901) the computing device 122 may undertake an image analysis of the fluoroscopic 3D reconstruction to determine an angle for placement of the fluoroscopic imaging device 124 to optimally engage in the target overlay tab; Fig. 9 shows after 901 there is loop when 902 is answer No; update to get the position of the image tool until the image show treatment tool tip and the target) then the answer would be yes and move on).
addressing claim 23, wherein the instructions, when executed, further cause the processor to: cause, for the subsequent ablation step, the ablation tool to be positioned based on the updated ablation tool position and the imaging device to be positioned based on the updated imaging device position (see Fig. 1, col. 5, lines 50-52, col. 6, lines 10-25, col. 8, lines 36-40, col. 9, lines 4-7 and col. 11, lines 35-43; ablation tool tip move to different ablation locations to cover the PTV is updated ablation tool position and ablation center after a subsequent ablation step; each PTV has a different ablation ellipses centers; Shevlev discloses update imaging device position (see [0061] and Fig. 9); steps 901, 902 and in between; following the local registration (e.g., step 901) the computing device 122 may undertake an image analysis of the fluoroscopic 3D reconstruction to determine an angle for placement of the fluoroscopic imaging device 124 to optimally engage in the target overlay tab; Fig. 9 shows after 901 there is loop when 902 is answer No; update to get the position of the image tool until the image show treatment tool tip and the target) then the answer would be yes and move on; composite ablation/repeat treatment with real-time tracking of tool tip and optimizing using real-time images involve updating position of tool tip to improve accuracy).
addressing claim 24, wherein at least one of the imaging device and the ablation tool is positioned automatically (see Fig. 1 and col. 5, lines 19-25; optimization component and processor automatically position ablation component to optimize a number of ablations performed to ablate the entire tumor mass.).
addressing claim 25, wherein the imaging device generates real-time image data during activation of the ablation tool (see col. 11, lines 35-43; real-time visual images during activation of the ablation tool to track tool tip).
addressing claim 26, wherein the imaging device is an ultrasound probe (see col. 5, lines 55-60; also see Shevlev’s paragraph [0002]).
addressing claim 27, wherein the memory stores additional instructions for execution by the processor that, when executed, further cause the processor to identify an ablation technique for the one ablation step, and further wherein the ablation tool position is based at least in part on the identified ablation technique (see Figs. 20-21, col. 11, lines 5-35 and col. 24, line 24-50; base on ellipsoidal center ablation technique user choose tool dimension and the system determine ablation tool position base on tool dimension and ellipsoidal centers technique).
Response to Arguments
Applicant's arguments filed 11/04/24 have been fully considered but they are not persuasive. Applicant argues Dalal fails to teach or suggest that the imaging device position is determined without reference to or dependency on the ablation tool position. Applicant’s argument is not persuasive because the images are used to track the target so that ablation tool can be position that would allow the ablation beam to accurately hit the target or the images are used to track the target so that the ablation beam can accurately treat the target. The imaging device position is not related to ablation tool. The system only uses images identify target and guide treatment. Applicant argues Dalal’s descriptions at column 11, lines 15-43 and column 24, lines 32-36 teach that a “physician proceed[s] with [the] ablation after [selection and], placement of [the] ablation tool and visual feedback tracking [of the] ablation tool” and Dalal illustrates in FIG. 1 and describes at column 5, lines 53-55 that “system 10 includes an ablation component 12 that is operatively connected to each of an optimization component 14 and an imaging component 16,” thereby implying interdependent positioning and a coordinated operation. Applicant’s argument is not persuasive because Fig. 1, column 5, lines 53-55, column 11, lines 15-43 and column 24, lines 32-36 only teach track target and tool to guide treatment. Imaging component connect with ablation component and optimization component just mean the optimization component receive images to guide ablation. Applicant’s Fig. 1 discloses imaging device 112 with arrow into 102 and ablation tool 118 with arrow into 102 therefore this must mean they are connected and interdependent on each other. Applicant incorrectly implying Dalal discloses interdependent positioning and a coordinated operation of the ablation tool and imaging component. As see in Dalal’s col. 5, line 53-col. 6, line 55 and col. 7, lines 22-40, imaging component is CT scanner, etc. that generate 3-D images of object such as lesion, organ etc. and these 3-D images are imported to the optimization component at a later time for ablation procedure. There nothing in Dalal disclose or implied the imaging component 16 is position based on the tool position.
Applicant argues, Shevlev at paragraph [0029] describes “systems and methods [that] combine the benefits of CT machines and fluoroscopic imaging devices to help clinicians navigate medical devices to targets, including small soft-tissue objects,” where the navigated medical devices, such as an ablation tool, is dependent upon the imaging device’s guidance. Thus, this feature is a distinction over the cited references. Applicant’s argument is not persuasive because this discloses use images to guide treatment. Yes, the ablation tool is dependent upon the imaging device’s guidance. This is different from the claim limitation “the imaging device position is determined without reference to or dependency on the ablation tool position”. Shevlev does not suggest determine imaging device position base on ablation tool position. Shevlev suggests use images to guide treatment. The images allow the physician to see the target therefore move the treatment device to the target. The imaging device position does not depend on treatment tool.
Applicant argues the cited references also fail to disclose, teach or suggest “wherein the imaging device position is defined in a coordinate system different from that used for the ablation tool position” and as best understood, both Dalal and Shevlev employ shared or co-registered coordinate. Applicant is correct that both Dalal and Shevlev employ shared or co-registered coordinate. The image and the ablation tool are in different coordinate system so there has to be a registration process to put them in a common coordinate system. As see in applicant’s specification paragraphs [0008] and [0070]; applicant register the image with the ablation tool coordinate system. Dalal and Shevlev are doing the same thing register the images and the ablation tool to the same coordinate system because imaging device position is defined in a coordinate system different from that used for the ablation tool position (see Dalal’s col. 5, lines 35-67; col. 11, lines 15-43). Registration is required when images is in a different coordinate system than the treatment device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2003/0093067 (see [0007], [0010-0011] and [0035]; the image data and the ablation catheter/element in separate coordinate systems therefore they are register into three-dimensional coordinate system so the display could display ablation element with image data).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793
Prosecution Insights