DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the previous combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Declaration under 37 CFR 1.132 filed 9/16/2025 has been reviewed and in combination with the claim amendments, overcome the rejection of previously submitted claims based upon 103 Rejection under Lee. Therefore, in view of the current amendments made to the claims modifying the scope, the previous 103 Rejection with Lee is withdrawn. An updated search with respect to the amendments made to the claims was conducted resulting in new prior art and the modified 103 Rejection set forth below.
Applicant argues about claim 12 and the art of record not defining the hexapod assembly as claimed. The following figure 2 from the current application defines the hexapod assembly (as shown below) with linear actuators 181-186 [0051]. The disclosure does not provide any further clarification on the claimed configuration beyond this figure.
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Figure 34 (below) of the Frankel reference shows the hexapod assembly comprising ball and socket joints, a parallel mechanism comprising two rigid plates, connected with six links [0111] with very similar configuration as the above figure in present application. It is suggested claim language provide further clarity with respect to the hexapod drive how the claimed hexapod drive is distinct from the prior art. For these reasons the rejection with respect to claim 12 is maintained and repeated below, in combination with the other remaining Frankel rejections (claims 13-15).
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In view of the amendments, the 112(b) rejection is withdrawn.
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.
Claim(s) 1, 3, 4, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. (2023/0346400) in view of Chiang et al. (2021/0015456) and further in view of Linguraru et al. (2024/0374189).
With respect to claim 1, Bloem et al. teach of a therapy system with an ultrasound treatment source such as an ultrasonic lithotripter probe [0020, 0023] and an ultrasound based imaging system that is coupled to a neural network for the identification of kidney stone [0021]. Bloem et al. teach of a concernment detector or a kidney stone identification system where the neural network can be implemented by the kidney stone identification system and ablation of the stone fragment [0021].
Bloem et al. do not explicitly teach of a video processor that is used to detect a kidney with the neural network. In a similar field of endeavor Chiang et al. teach of an ultrasound based system with an ultrasound imaging equipment 10, 100 [0143] configured to provide a video signal 4908 and the video processor including a neural network configured to detect at least one kidney in the video signal [0332]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Chiang et al. to modify Bloem et al. to perform machine learning operations using the acquired images to perform automated image processing and guidance for real time imaging procedures and used for diagnosis [Chiang, 0021].
Chiang et al. teach of the neural network configured to detect at least one kidney in the video signal that is coupled to a video processor including a neural network but do not explicitly teach of forwarding a position information of the kidney. With respect to claims 1 and 3, in a related field of endeavor Linguraru et al. teach of a system and method for ultrasound based scoring of renal obstructions via a deep learning model [0020]. Linguraru et al. teach of a deep learning-based approach to analyze ultrasound images of the kidney and segmenting or boundary localization to identify the kidney boundary via an oriented bounding box and localized using a convolution neural network [0026, 0027]. Linguraru et al. teach of the boundary representation on display with user input of the coordinates or pixel coordinates with respect to the classification of the kidney area to identify the position, orientation, or size of the kidney in the ultrasound image [0031, 0034]. The combination of above the references would use the video processor including the neural network to detect a kidney in the video signal and use the position information of the kidney with the concernment detector or the kidney stone identification system to detect the kidney stone in the video signal at a position relative to the kidney on the video signal. Bloem et al. teach of controlling the position of the probe for ablation of the target [0020, 0023, 0056] and would be obvious to combine with the Chiang and Linguraru references to obtain the position information of the kidney stone to effectively treat the stone. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Linguraru et al. to modify the previous references to effectively segment out the kidney in the ultrasound image and determine the position, orientation, or size of the kidney for segmentation [Linguraru et al., 0031].
With respect to claim 4, the combination of the references teaches of the neural network being configured to detect the kidney (as set forth by Chiang and Linguraru references) and using an image processor to detect a concernment or kidney stone [Bloem, 0021] based on the information about the kidney from the initial segmentation of the kidney (as set forth by Linguraru, [0031, 0034]). The combination of above the references would use the video processor including the neural network to detect a kidney in the video signal and use the position information of the kidney with the concernment detector or the kidney stone identification system to detect the kidney stone in the video signal at a position relative to the kidney on the video signal. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Linguraru et al. to modify the previous references to effectively segment out the kidney in the ultrasound image and determine the position, orientation, or size of the kidney for segmentation [Linguraru et al., 0031].
With respect to claim 18, Bloem et al. in view of Chiang et al. in view of Linguraru et al. teach of the ultrasound imaging system [0021] that would include an ultrasonic transducer for ultrasonic imaging and Chiang et al. also teach of the ultrasound transducer for ultrasound imaging (Chiang, 0146].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. in view of Chiang et al. in view of Linguraru et al. and further in view of Ayvali et al. Linguraru et al. teach of marking the boundary of the segmented kidney or localizing the boundary of the kidney (claim 1) but do not explicitly teach of video display and marking the video display. Ayvali et al. teach of the video processor configured to mark in the video signal or make annotations made by video marker and marked with colored segments [0089-0091] or annotations [0070, 0078, 0089, 0090] the at least one kidney stone and/or at least one kidney itself (fig. 2A, stone 165, [0076]). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Ayvali et al. to modify the previous references to effectively annotate, mark or delineate different segments corresponding to the different phases on the captured video and enable more accurate diagnostic and removal of kidney stones [Ayvali, 0089, 0090].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. in view of Chiang et al. in view of Linguraru et al. and further in view of Pelissier et al. The previous references do not explicitly teach of showing different kidneys with and without stones. In a similar field of endeavor Pelissier et al. teach of inputting medical image into a trained machine learning model to identify one or more target image features and may be trained to segment the presence of kidney stones or detect the absence of such an image feature [0105]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Pelissier to modify the previous teachings to identify more correctly the relevant features in image tied to a kidney stone and prevent inaccuracies in mistreating image regions without the presence of kidney stones [Pelissier, 0077].
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. in view of Chiang et al. in view of Linguraru et al. and further in view of Tower et al. The previous references do not explicitly teach of evaluating the intensity distributions of the video signal with respect to the kidney stone. In a similar field of endeavor Tower et al. teach of nephroscope for kidney stone removal where the video signal can be evaluated in terms of the intensity distributions of the video signal where ethe sensor provides intensity values for red light, green light, and blue light for each pixel in the video image and the circuit board can produce a digital video signal representing the captured video image of the illuminated kidney stone [0039]. With respect to claim 16, Ayvali et al. teach of detecting the stone information in the video signal with the use of statistical evaluation of the video signal [0032]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Tower et al. to modify the previous references to provide more effective image guided kidney stone removal based on detected intensity distributions of the video signals [Tower, 0039].
Claim(s) 9-11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. in view of Chiang et al. in view of Linguraru et al. and further in view of Owen et al. (2008/0091125). Bloem et al. teach of the ultrasound lithotripter probe [0023] and tracking the ablation based on imaging [0079] but the previous references do not explicitly teach of the focal volume of the ultrasound source and generating an image containing information of the focal volume of the therapy system. In a related field of endeavor Owen et al. teach of a system and method to detect fragmentation of kidney stones by measuring acoustic scatter [0069]. Owen et al. teach of localizing the stone within the focus of a lithotripter where for targeting, the sensitive volume of the overlapping foci was smaller than the focal volume of the lithotripter and a stone detected within the VA-focus, which overlaps the focal volume of the lithotripter will most likely be hit by a shock wave [0141]. Owen et al. further teach of the path of the stone overlapping with the lithotripter focus and therefore aligned parallel [0142] where the focal regions of the acoustical sources are compared to determine the trigger for application of the shockwave [0137] and therefore providing indication of when to trigger treatment. Owen et al. teach of the acoustic sources to have overlapping foci and used to produce an image or where two focused sources with overlapping foci are used to generate a dynamic radiation force within the focal region of the lithotripter with detection of a moving kidney stone within the overlapping foci of the focus sources and therefore within the focus of the lithotripter and a shock wave will be triggered [0133]. Therefore, the imaging transducer is located at the center of the ultrasound or shockwave source and coaxially to the ultrasound or shockwave source. Under broadest reasonable interpretation, Owen et al. with the combination of the references therefore teach of generating an image of a part or all of a focal volume of the ultrasound or shockwave source where the image includes indicia of a focal volume of the therapy system. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Owen et al. to modify the previous references to provide sufficient indications of the location of the kidney stone relative to the therapy system and effective ablation of the kidney stone [Owen, 0008, 0100].
Claim(s) 7, 8, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bloem et al. in view of Chiang et al. in view of Linguraru et al. and further in view of Frankel et al. The previous references do not teach of the shockwave/ultrasound sources to be suspended on a hexapod drive. In a related field of endeavor Frankel et al. teach of hexapod assembly to facilitate effective movement of an ultrasound transducer relative to a subject (fig. 34, 0111). Frankel et al. teach of rigidly coupling the ultrasound transducer to the ultrasound source and/or hexapod drive such that movements of the hexapod drive are directly coupled to the transducer [0111]. With respect to claims 12, 13 and 15, Frankel et al. teach of the use linear actuators [0079, 0102, 0126], a hexapod drive to include a ball joint [0111] and provide at least five degrees of freedom including displacement along orthogonal axes and degrees of tilt [0078, 0097, 0112]. With respect to claim 14. Frankel et al. teach of the linear actuator to include a hydraulic actuator [0079, 0115]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Frankel et al. to modify the previous references to provide three axis of motion in a simple, compact mechanism and provide precise position and alignment of parts and components [Frankel, 0111].
Conclusion
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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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797