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 .
Claim Objections
Claims 1-6 and 9-20 are objected to because of the following informalities: “laparascopic robot” should state “laparoscopic robot”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al (2017/0079519) in view of Xu et al (2021/0252313).
Regarding claim 1, Sung et al disclose a therapy system, comprising:
a fluid source in communication with a distal portion of a catheter, the fluid source being configured to deliver a fluid to a natural lumen (delivering acoustic coupling fluid into the region of the body lumen beyond the expandable member via the tubular member – [0030]);
a sealing member operably associated with the catheter and configured to seal the natural lumen, wherein activation of the sealing member seals the natural lumen such that fluid delivered to the natural lumen via the catheter is retained within the natural lumen to create an acoustic window within the natural lumen (expanding an expandable member on the distal portion within the body lumen to isolate a region of the body lumen beyond the distal portion…the fluid enhancing acoustic coupling between the imaging device and tissue surrounding the body lumen – [0030]).
Sung et al fail to explicitly disclose a robotic therapy system comprising an endoscopic robot configured to navigate a catheter within a natural lumen of a patient; a laparoscopic robot configured to navigate a surgical tool to a target tissue to resect at least a portion of the target tissue; and a robotically driven histotripsy ultrasound transducer controllable to position the histotripsy ultrasound transducer outside the patient and deliver ultrasonic energy into the patient, through the acoustic window within the natural lumen, and into the target tissue within the patient via the acoustic window to form a cavitation bubble cloud within a remaining portion of the target tissue.
However, Xu et al teach in the same medical field of endeavor, a laparoscopic robot configured to navigate a surgical tool to a target tissue to resect at least a portion of the target tissue (laparoscopic surgical robot – [0139]); a robotic therapy system comprising an endoscopic robot configured to navigate a catheter within a natural lumen of a patient (endoscope systems - [0139]; surgically resected – [0238]); and a robotically driven histotripsy ultrasound transducer controllable to position the histotripsy ultrasound transducer outside the patient and deliver ultrasonic energy into the patient, through the acoustic window with the natural lumen, and into the target tissue within the patient (the robotic positioning system comprises a robotic arm that directs a histotripsy therapy transducer through a pre-programmed three-dimensional treatment program – [0051]) via an acoustic window (man-made acoustic window – [0139]) to form a cavitation bubble cloud within a remaining portion of the target tissue (histotripsy “bubble cloud” – [0101]; acoustic cavitation/histotripsy via non-invasive transthoracic treatment (e.g., transducer externally placed on/around patient – [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the catheter of Sung et al with a robot therapy system including an endoscopic robot, a laparoscopic robot and a robotically driven histotripsy ultrasound transducer as it would provide automated positioning and therapy.
Regarding claim 2, Sung et al disclose wherein the catheter is a balloon catheter, and wherein the sealing member is a balloon (catheters may include a balloon or other expandable member on the distal portion – [0016]; an elongate tubular member having an expandable member – [0030]).
Regarding claim 3, Sung et al disclose wherein the balloon is in communication with the fluid source (expandable member 246’ or 230’ and fluid may be injected through one of the first and second lumens 217’ – fig.5B).
Regarding claim 4, Sung et al disclose further comprising a localization component on the catheter configured to identify a location of a distal portion of the catheter within the natural lumen (the guide instrument may include one or more locatable guides – [0007]).
Regarding claim 5, Sung et al as modified by Xu et al disclose the invention as claimed and discussed above. Sung et al fail to explicitly disclose wherein the localization component is a shape sensor.
However, Xu et al teach in the same medical field of endeavor, a localization component is a shape sensor (shape-sensing – [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the localization component of Sung et al with a shape sensor of Xu et al as it would provide a well-known and conventional type of navigation system.
Regarding claim 6, Sung et al disclose wherein the localization component is an electromagnetic field sensor (components of electromagnetic navigation systems – [0007]. Examiner notes electromagnetic field sensors are structures of an electromagnetic navigation system).
Regarding claim 9, Sung et al as modified by Xu et al disclose the invention as claimed and discussed above. Sung et al fail to explicitly disclose further comprising an ultrasound imaging transducer operably associated with the robotically driven histotripsy ultrasound transducer and configured to visualize the target in or near the lumen.
However, Xu et al teach in the same medical field of endeavor, an ultrasound imaging transducer operably associated with a robotically driven histotripsy ultrasound transducer and configured to visualize a target in or near a lumen (a therapy transducer 102 an imaging system 104 – [0094]; fig.1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Sung et al with an ultrasound imaging transducer operably associated with a robotically driven histotripsy ultrasound transducer as it would provide imaged guided therapy.
Regarding claim 10, Sung et al disclose further comprising an imaging system selected from the group consisting of a computed tomography (CT) imaging system, a magnetic resonance (MR) imaging system, and an ultrasound imaging system ([0096]).
Regarding claim 11, Sung et al disclose wherein the imaging system is configured to collect pre therapy images of a patient and present one or more of the images in a user interface on a display (the expansion and/or other manipulation of the capture structure may be monitored – [0096]).
Regarding claim 12, Sung et al as modified by Xu et al disclose the invention as claimed and discussed above. Sung et al fail to explicitly disclose wherein the imaging system is registered to the robotically driven histotripsy ultrasound transducer.
However, Xu et al teach in the same medical field of endeavor, wherein an imaging system is registered to a robotically driven histotripsy ultrasound transducer (said system registers the image data to a coordinate system defined by the system, that further allows the system’s Therapy and Robotics sub-systems to deliver synchronized acoustic cavitation/histotripsy to said marked tumor ([0138]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Sung et al with registering an imaging system to an ultrasound transducer of Xu et al as it would provide synchronized acoustic cavitation/histotripsy to a tumor.
Regarding claims 13 and 14, Sung et al as modified by Xu et al disclose the invention as claimed and discussed above. Sung et al fail to explicitly disclose wherein data from the imaging system provides pose and position data for aligning a geometric focus of the robotically driven histotripsy ultraosund transducer on the target; and wherein the imaging system is rotatable away from the robotically driven histotripsy ultrasound transducer to enable positioning of the robotically driven histotripsy ultrasound transducer relative to the target.
However, Xu et al teach in the same medical field of endeavor, wherein data from the imaging system provides pose and position data for aligning a geometric focus of the robotically driven histotripsy ultraosund transducer on the target (moving/adjusting dynamically - [0126]; 6 degree of freedom positioning – [0151]); and wherein the imaging system is rotatable away from the robotically driven histotripsy ultrasound transducer to enable positioning of the robotically driven histotripsy ultrasound transducer relative to the target (rotation – [0126]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Sung et al with providing pose and position data as well as rotating the imaging system for alignment as it would provide for micro positioning to enhance image guided therapy.
Regarding claim 15, Sung et al disclose wherein the catheter further comprises optical or ultrasound visualization elements, configured to collect images from within the natural lumen (fiber optic cameras – [0012]; ultrasound imaging device - abstract).
Regarding claim 16, Sung et al as modified by Xu et al disclose the features of the robotically driven histotripsy ultrasound transducer as set forth and discussed above. Sung et al further discloses wherein the visualization elements enable real-time visualization of the target during an application of ultrasonic energy (therapy - [0017]; real-time imaging capabilities – [0018]).
Regarding claim 17, Sung et al disclose wherein the catheter includes a working channel for passage of one or more instrument therethrough (a working channel – [0006]).
Regarding claim 18, Sung et al disclose wherein the fluid delivered to the natural lumen is water or saline (ultrasound-conducting fluid, such as water or saline solution – [0016]).
Regarding claim 19, Sung et al disclose wherein the catheter is configured to navigate to one or more of airways (airway of a lung - abstract); small intestine; a large intestine; a colon, central or peripheral vasculature; blood vessels; veins or arteries ([0036]).
Regarding claim 20, Sung et al as modified by Xu et al disclose the invention as claimed and discussed above. Sung et al fail to explicitly disclose wherein the ultrasonic energy comprises histotripsy pulses configured to generate cavitation at the target.
However, Xu et al teach in the same medical field of endeavor, wherein ultrasonic energy comprises histotripsy pulses configured to generate cavitation at the target (histotripsy is a non-invasive ablation method that delivers focused, microsecond-length, high-pressure, ultrasound pulses that create cavitation microbubbles in the target tissue – [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Sung et al with the ultrasonic energy comprising histotripsy pulses configured to generate cavitation at the target as it would provide a well-known and conventional treatment protocol to a target.
Response to Arguments
Applicant's arguments filed 4 March 2026 have been fully considered but they are not persuasive.
Applicant states claim 1 has being amended to further define that the histotripsy transducer is positionable outside the patient to direct ultrasonic energy through the acoustic window formed by the catheter, and additionally amended to add a laparoscopic robot configured to navigate a surgical tool to a target tissue to resect at least a portion of the target tissue. The claimed invention provided a multi-approach surgical robot system that the cited art does not teach and or suggest.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Examiner’s position is the prior art of Sung et al and Xu et al disclose the invention as claimed. Specifically, Xu et al disclose the amended limitations as set forth and discussed above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ROCHELLE D TURCHEN/ Primary Examiner, Art Unit 3797
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