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 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 185 and 186 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.
In claim 185, lines 19-20, it is unclear how a transducer array can be operated to control movement of the instrument, as the array itself is used to generate the therapeutic ultrasound.
In claim 186, it is unclear how an imaging probe is an instrument that physically addresses the target tissue. It appears only a needle/catheter would perform this function.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 183-186 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Roberts et al (US Pub 2011/0054315 -previously cited).
Re claims 183-186: 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 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];
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 a treatment focus of the HIFU treatment transducer array is aligned to treat at least a portion of the targeted tissue structure of the patient,
operate the HIFU treatment transducer array to controllably create a pulsatile wavefront of ultrasound radiation directed at the 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].
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, 14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al (US Pub 2011/0054315 -previously cited) in view of Maschke (US Pub 2009/0088639).
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 electromechanical support assembly to control a position or orientation of the transducer array relative to the patient such that a treatment focus of the HIFU treatment transducer array is aligned to treat at least a portion of the targeted tissue structure of the patient, and
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 further adjust the position or orientation of the array to maintain interfacial loading between the array and the target tissue within a predetermined loading range. However, Maschke teaches of an ultrasound device that is operated to further adjust the position or orientation of the array to maintain interfacial loading between the array and the target tissue within a predetermined loading range [0014; see the control based on sensor information such that application of the force is maintained within a preset range]. It would have been obvious to the skilled artisan to modify Roberts, to use the loading control as taught by Maschke, in order to prevent inadmissible pressure on a patient [0014].
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 claims 14, 16: Roberts discloses the HIFU treatment transducer array and support assembly are operatively coupled to the computing system using a wired connectivity configuration [0031, fig 1; the system is connected via a wire].
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].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts/Maschke, as applied to claim 4, in view of Jackson et al (US Pub 2018/0194003).
Re claim 5: Roberts/Maschke 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/Maschke, to include the sensors as taught by Jackson, in order to facilitate precise control of robotic movement and to provide force feedback.
Claim 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts/Maschke, as applied to claim 1, in view of Keenan et al (US Pub 2010/0228122).
Re claims 13, 15: Roberts/Maschke 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/Maschke, 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/Maschke, as applied to claim 19, in view of Vaezy et al (US Pub 2003/0233045).
Re claim 20: Roberts/Maschke 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/Maschke, to include the hyrdrogel as taught by Vaezy, in order to improve imaging and visualization via the hydrogel.
Response to Arguments
Applicant’s arguments with respect to claim 1 has 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
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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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797