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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/10/26 has been entered.
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 1-4, 6, 7, 9-12, 17-19, and 187 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al (US Pub 2011/0054315 -previously cited) in view of Ueyama et al (US Pub 2020/0397519).
Re claim 1: Roberts discloses a minimally invasive system for treating a targeted tissue structure of a patient (see abstract; therapy device), comprising:
an electromechanical support assembly having a proximal portion and a distal portion [0031, fig 1; micro-manipulator system 102 with robotic arm with proximal end at stand 116 and distal end at 106];
a computing system operatively coupled to the electromechanical support assembly [0031, 0032, fig 1; control system 104 having computer coupled to system 102]; and
a HIFU treatment transducer array coupled to the distal portion of the electromechanical support assembly and operatively coupled to the computing system [0030, 0033, fig 1; HIFU system 106 including transducers to generate cavitational microbubbles in tissue, and which is located at the distal end and coupled to computer];
wherein the computing system is configured to:
operate the HIFU treatment transducer array to generate a pulsatile wavefront including pressure waves directed at the treatment focus, the pulsatile wavefront produces one or more vapor bubbles within the targeted tissue structure followed by cavitation of the one of more vapor bubbles to produce a lysed portion of the targeted tissue structure [0017, 0018, 0021, 0029-0033, 0041, 0044, fig 1; see the controller hardware and software to control movement of the manipulator system thereby controlling the focus of the transducer to be aligned to treat the tissue and to create a pulsatile wavefront directed at the focus, wherein the transducer can be a histotripsy transducer to generate cavitational bubbles such that a lysed portion of the tissue is created; also see the computing system includes a mechanism to control yaw, pitch, and roll].
Roberts discloses all features except that the support is operated to control the position of the HIFU array to maintain interfacial loading between the array and the tissue above a predetermined minimum and below a predetermined maximum such that the array is aligned to treat a portion of the target tissue. However, Ueyama teaches of a robotic arm with a diagnostic ultrasound probe 32 with HIFU irradiator 31 that is controlled such that interfacial loading is maintained between the array and the tissue above a predetermined minimum and below a predetermined maximum such that the array is aligned to treat a portion of the target tissue [0072, 0073; see the preset threshold value that corresponds to a maximum limit and see the “predetermined amount” that the probe moves which corresponds to a minimum limit between which the pressing force is maintained]. It would have been obvious to the skilled artisan to modify Roberts, to maintain the loading as taught by Ueyama, in order to prevent patient pain due to too high a pressing force while still keeping a force sufficient enough to achieve the therapy and imaging [0075].
Re claim 2: Roberts discloses the electromechanical support assembly comprises a plurality of elongate portions coupled by one or more movable joints [0031, fig 1; see the elongated portions of system 102 coupled by movable joints].
Re claim 3: Roberts discloses the one or more movable joints are coupled to one or more encoders operatively coupled to the computing system and configured to provide inputs to the computing system for determining positions of the one or more movable joints [0031, 0032, fig 1; the joints are controlled by computer which determines positions by encoders coupled thereto].
Re claim 4: Roberts discloses the electromechanical support assembly comprises one or more sensors configured to sense one or more loads within the electromechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient [0031-0033, fig 1; the manipulator system 106 holds the weight of the imaging system 108 and therapy system 106 steady which includes a sensor to sense the weight to maintain steadiness, the weight associated with a physical interface between the transducers and patient].
Re claim 6: Roberts discloses the system includes one or more motors operatively coupled to the electromechanical support assembly and configured to apply loads thereto to maintain or change position or orientation of the electromechanical support assembly [0031-0032, fig 1; see the joints controlled by computer wherein motors are coupled to the joints to apply loads thereto to maintain or change position].
Re claim 7: Roberts discloses the electromechanical support assembly comprises a robotic arm [0031, fig 1; the system 102 includes a robot arm].
Re claim 9: Roberts discloses the electromechanical support assembly is controlled by the computer in response to inputs provided by an operator [0032; the computer is responsive to input by a physician].
Re claims 10-12: Roberts discloses the inputs provided by the operator are manual electromechanical support assembly movement commands and are commands to automatically follow a prescribed set of movements [0038; the inputs by the physician are manually performed to correspond to programmed commands according to a surgical plan to automatically position and move the manipulator system].
Re claim 17: Roberts discloses the system includes an imaging ultrasound transducer having a ultrasound imaging field of view aligned to capture at least a portion of the treatment focus of the HIFU treatment transducer array [0033-0035, fig 1; imaging system 108 has a FOV to capture a portion of the treatment focus].
Re claim 18: Roberts discloses the treatment transducer array and the imaging ultrasound transducer are both coupled to the distal portion of the electromechanical support assembly [0031-0034, fig 1; the therapy system 106 and imaging system 108 are couple to the distal portion of manipulator system 102].
Re claim 19: Roberts discloses the system includes a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient [0033; see the acoustic coupling medium to conduct sound energy to the patient].
Re claim 187: Roberts discloses the system is configured to operate the support assembly to maintain a relative orientation between the array and a most immediately adjacent portion of the patient body [0031; see that the manipulator is a 6 degree of freedom manipulator which allows operation to maintain orientation of the array relative to the immediately adjacent patient body].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts/Ueyama, as applied to claim 4, in view of Jackson et al (US Pub 2018/0194003 -previously cited).
Re claim 5: Roberts/Ueyama disclose all features except that the one or more sensors are chosen from the group consisting of: a joint load sensor, a joint torque sensor, a strain gauge, and a deflection gauge. However, Jackson teaches one or more sensors are chosen from the group consisting of: a joint load sensor, a joint torque sensor, a strain gauge, and a deflection gauge [0035; robot arm with joint mechanisms having torque sensors]. It would have been obvious to the skilled artisan to modify Roberts/Ueyama, to include the sensors as taught by Jackson, in order to facilitate precise control of robotic movement and to provide force feedback.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts/Ueyama, as applied to claim 1, in view of Keenan et al (US Pub 2010/0228122 -previously cited).
Re claim 13: Roberts/Ueyama discloses all features except that the support or transducer array is coupled to the computing system using a wireless configuration. However, Keenan teaches of an ultrasound device and a support coupled wirelessly to a computing system [0127, 0143]. It would have been obvious to the skilled artisan to modify Roberts/Ueyama, to include the wireless configuration as taught by Keenan, in order to improve the flexibility and mobility of the system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts/Ueyama, as applied to claim 19, in view of Vaezy et al (US Pub 2003/0233045 -previously cited).
Re claim 20: Roberts/Ueyama discloses all features except for the layer of acoustic gel. However, Vaezy teaches of a layer of acoustic gel between the delivery interface and the patient [0089, 0092, 0093; see the hydrogel]. It would have been obvious to the skilled artisan to modify Roberts/Ueyama, to include the hyrdrogel as taught by Vaezy, in order to improve imaging and visualization via the hydrogel.
Claims 183 and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al (US Pub 2011/0054315 -previously cited) in view of Peyman (US Pub 2021/0220480).
Re claims 183, 184: Roberts discloses a minimally invasive system for treating a targeted tissue structure of a patient (see abstract; therapy device), comprising:
an electromechanical support assembly having a proximal portion and a distal portion [0031, fig 1; micro-manipulator system 102 with robotic arm with proximal end at stand 116 and distal end at 106];
a computing system operatively coupled to the electromechanical support assembly [0031, 0032, fig 1; control system 104 having computer coupled to system 102]; and
a treatment transducer array coupled to the distal portion of the electromechanical support assembly and operatively coupled to the computing system [0030, 0033, fig 1; HIFU system 106 including transducers to generate cavitational microbubbles in tissue, and which is located at the distal end and coupled to computer];
an elongate waveguide instrument having a distal end that is configured to be positioned within the patient and configured to physically address the tissue structure [0036, Fig 3B; see the instrument (imaging probe/waveguide) 308 within the patient, wherein the instrument guides ultrasound energy along a specific path which is a waveguide; see that the instrument is positioned adjacent the prostate target and the target is considered as the region of the prostate];
wherein the computing system is configured to:
operate the electromechanical support assembly to control a position of the transducer assembly relative to the patient such that the array is aligned to treat at least a portion of the targeted tissue structure of the patient [0017, 0018, 0021, 0029-0033, 0041, 0044, fig 1; see the controller hardware and software to control movement of the manipulator system],
operate the treatment transducer array to controllably create a pulsatile high intensity wavefront of ultrasound radiation directed at a treatment focus, the pulsatile wavefront including pressure waves and configured to produce one or more vapor bubbles within the targeted tissue structure and to controllably produce cavitation of the one of more vapor bubbles such that a controllably lysed portion of the targeted tissue structure is created [0017, 0018, 0021, 0029-0033, 0041, 0044, fig 1; see the controller hardware and software to control movement of the manipulator system thereby controlling the focus of the transducer to be aligned to treat the tissue and to create a pulsatile wavefront directed at the focus, wherein the transducer can be a histotripsy transducer to generate cavitational bubbles such that a lysed portion of the tissue is created],
operate the array to further control movement of the instrument to position the distal end of the instrument at or near the targeted tissue [0043; see that the control system uses feedback to automatically position the imaging and therapy systems], and
operate the instrument to physically address at least a portion of the targeted tissue [0043, Fig 3B; see the instrument that is positioned adjacent the targeted tissue];
wherein the elongate instrument assists in transmitting and focusing the pressure waves such that the wavefront reaches the targeted tissue [0036, Fig 3B; see that the ultrasound imaging is used to image the focal point 322 within its FOV].
Roberts discloses all features except the system operates the array to generate pulsatile low-intensity ultrasound configured to reshape a portion of the tissue. However, Peyman teaches of a treatment and diagnostic system wherein the ultrasound transducer applies HIFU and LIFU, wherein the LIFU is configured to reshape a portion of the tissue [0076, 0436; see the HIFU and LIFU, wherein LIFU is pulsed low intensity ultrasound that reshapes tissue (i.e. cosmetic rejuvenation)]. It would have been obvious to the skilled artisan to modify Roberts, to configure the array to generate LIFU as taught by Peyman, in order to facilitate additional or supplemental treatment procedures for the patient.
Claims 185 and 186 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al (US Pub 2011/0054315 -previously cited) in view of Dogra et al (US Pub 2012/0095336).
Re claims 185, 186: Roberts discloses a minimally invasive system for treating a targeted tissue structure of a patient (see abstract; therapy device), comprising:
an electromechanical support assembly having a proximal portion and a distal portion [0031, fig 1; micro-manipulator system 102 with robotic arm with proximal end at stand 116 and distal end at 106];
a computing system operatively coupled to the electromechanical support assembly [0031, 0032, fig 1; control system 104 having computer coupled to system 102]; and
a treatment transducer array coupled to the distal portion of the electromechanical support assembly and operatively coupled to the computing system [0030, 0033, fig 1; HIFU system 106 including transducers to generate cavitational microbubbles in tissue, and which is located at the distal end and coupled to computer];
an elongate waveguide instrument having a distal end that is configured to be positioned within the patient and configured to physically address the tissue structure [0036, Fig 3B; see the instrument (imaging probe/waveguide) 308 within the patient, wherein the instrument guides ultrasound energy along a specific path which is a waveguide; see that the instrument is positioned adjacent the prostate target and the target is considered as the region of the prostate];
wherein the computing system is configured to:
operate the electromechanical support assembly to control a position of the transducer assembly relative to the patient such that the array is aligned to treat at least a portion of the targeted tissue structure of the patient [0017, 0018, 0021, 0029-0033, 0041, 0044, fig 1; see the controller hardware and software to control movement of the manipulator system],
operate the treatment transducer array to controllably create a pulsatile high intensity wavefront of ultrasound radiation directed at a treatment focus, the pulsatile wavefront including pressure waves and configured to produce one or more vapor bubbles within the targeted tissue structure and to controllably produce cavitation of the one of more vapor bubbles such that a controllably lysed portion of the targeted tissue structure is created [0017, 0018, 0021, 0029-0033, 0041, 0044, fig 1; see the controller hardware and software to control movement of the manipulator system thereby controlling the focus of the transducer to be aligned to treat the tissue and to create a pulsatile wavefront directed at the focus, wherein the transducer can be a histotripsy transducer to generate cavitational bubbles such that a lysed portion of the tissue is created],
operate the support assembly to further control movement of the instrument to position the distal end of the instrument at or near the targeted tissue [0043; see that the control system uses feedback to automatically position the imaging and therapy systems], and
operate the instrument to physically address at least a portion of the targeted tissue [0043, Fig 3B; see the instrument that is positioned adjacent the targeted tissue];
wherein the elongate instrument assists in transmitting and focusing the pressure waves such that the wavefront reaches the targeted tissue [0036, Fig 3B; see that the ultrasound imaging is used to image the focal point 322 within its FOV].
Roberts discloses all features except that the instrument is a needle or catheter coupled to the array. However, Dogra teaches of a robotic control system with a HIFU transducer coupled to a needle [0021, figure 1; see the biopsy needle coupled the array] It would have been obvious to the skilled artisan to modify Roberts, to incorporate the needle as taught by Dogra, in order to facilitate aspiration during the procedure.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The prior 112 rejections are withdrawn due to amendments.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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