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 .
Specification
The disclosure is objected to because of the following informalities:
On page 1 of the specification, the status of co-pending applications should be updated.
Appropriate correction is required.
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.
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, 3-10, 13-18, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (US 2009/0177085; hereinafter Maxwell) in view of Bailey et al. (US 2011/0263967; hereinafter Bailey).
Maxwell shows an ultrasound therapy system (abstract), comprising: an /ultrasound therapy transducer array ([0037], [0050]); a generator operatively coupled to the ultrasound therapy transducer array, the generator and ultrasound therapy transducer array being configured to deliver histotripsy pulses into a subject to generate cavitation in the subject ([0033], [0050]); and at least one processor operatively coupled to the generator and configured to control the generator to provide histotripsy therapy to the subject by: place a focus of the ultrasound therapy transducer array within a first treatment location within a target tissue volume ([0037], [0050], [0061]); controlling the generator to deliver histotripsy pulses with the ultrasound therapy transducer array to form a cavitation bubble cloud at the focus within the first treatment location ([0037], [0050], [0061]); controlling the generator to electronically/mechanically beam-steer the cavitation bubble cloud through a plurality of focal locations within the first treatment location (therapy transducer electronically or mechanically scanned; [0037], [0050], [0061]); place the focus of the ultrasound therapy transducer array within a second treatment location within the target tissue volume (therapy transducer electronically or mechanically scanned; [0037], [0050], [0061]); controlling the generator to deliver histotripsy pulses with the ultrasound therapy transducer array to form a cavitation bubble cloud at the focus within the second treatment location (therapy transducer electronically or mechanically scanned; [0037], [0050], [0061]); and controlling the generator to electronically beam-steer the cavitation bubble cloud through a plurality of focal locations within the second treatment location (therapy transducer electronically or mechanically scanned, [0050], [0061]).
Maxwell also shows an imaging system configured to image the cavitation bubble cloud in real-time ([0041], [0054], [0068]); a display configured to display the cavitation bubble cloud in real-time (Fig. 5); wherein the ultrasound therapy system is configured to communicate with an imaging system selected from the group consisting of Magnetic Resonance Imaging (MRI), Computed Tomography (CT), cone beam CT (CBCT), Positron Emission Tomography-Computed Tomography (PET-CT), and/or an ultrasound imaging system ([0041], [0046], [0054], [0068]); wherein the imaging system comprises an ultrasound imaging probe configured within a bore of the ultrasound therapy transducer array ([0068]); wherein the generator is configured to electronically steer the cavitation bubble cloud to form a column-shaped bubble cloud (where electronic scanning is considered to be capable of forming any desired shape of bubble cloud depending on the size and area of the treatment region, in order to generate larger therapy zones; [0042], [0050]); wherein the target tissue volume comprises a superficial target tissue volume ([0050]); wherein controlling the generator to electronically beam-steer the cavitation bubble cloud comprises rapidly electronically steering the bubble cloud in a z-direction through a column of treatment points (where electronic scanning is considered to be capable of forming any desired shape of bubble cloud depending on the size and area of the treatment region, in order to generate larger therapy zones; [0042], [0050]); wherein controlling the generator to electronically beam-steer the cavitation bubble cloud comprises rapidly electronically steering the bubble cloud away from the ultrasound therapy transducer array (where electronic scanning is considered to be capable of forming any desired shape of bubble cloud depending on the size and area of the treatment region, in order to generate larger therapy zones; [0042], [0050]); wherein controlling the generator to electronically beam-steer the cavitation bubble cloud comprises rapidly electronically steering the bubble cloud towards the ultrasound therapy transducer array (where electronic scanning is considered to be capable of forming any desired shape of bubble cloud depending on the size and area of the treatment region, in order to generate larger therapy zones; [0042], [0050]); wherein the focus comprises a natural focus of the ultrasound therapy transducer array ([0050]); wherein controlling the generator to electronically beam-steer the cavitation bubble cloud through the plurality of focal locations includes electronically beam-steering the cavitation bubble cloud through the natural focus ([0050], [0062], [0075], [0088]).
Maxwell fails to teach a handle; an ultrasound therapy transducer array coupled to the handle; a user-input device configured to initiate delivery of the histotripsy pulses; receiving a first input from the user-input device when the handle is mechanically positioned; receiving a second input from the user-input device when the handle is mechanically positioned.
Bailey discloses an ultrasound method for stone detection and clearance. Bailey teaches a handle ([0077]); an ultrasound therapy transducer array coupled to the handle ([0077]); a user-input device configured to initiate delivery of the histotripsy pulses ([0082]-[0084]); receiving a first input from the user-input device when the handle is mechanically positioned ([0082]-[0084]); receiving a second input from the user-input device when the handle is mechanically positioned ([0082]-[0084]). Bailey also shows wherein the imaging system resides at least partially within the handle (Fig. 1); wherein the ultrasound therapy transducer array comprises an annular array ([0113]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Maxwell to utilize a handle and a user interface as taught by Bailey, as a handle allows for the imaging device to be more easily gripped and maneuvered by the operator, and as a user interface provides a mechanism to provide operator control over the characteristics of the therapeutic system, thereby increasing the user’s control and accuracy in specifying the desired treatment region and protocol.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (US 2009/0177085; hereinafter Maxwell) in view of Bailey et al. (US 2011/0263967; hereinafter Bailey) as applied to claim 1 above, and further in view of Ebbini et al. (US 2013/0144165; hereinafter Ebbini).
Maxwell fails to show wherein the generator comprises a field programmable gate array;
Ebbini discloses methods for controlling delivery of ultrasound therapy. Ebbini teaches wherein the generator comprises a field programmable gate array ([0065], [0110], [0114], [0128]-[0133, [0181]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maxwell and Bailey to utilize an FPGA as taught by Ebbini, as an FPGA is a common type of computer processing component which may be selected by one of ordinary skill in the art without undue experimentation as described by Maxwell ([0065]).
Claim(s) 11-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (US 2009/0177085; hereinafter Maxwell) in view of Bailey et al. (US 2011/0263967; hereinafter Bailey) as applied to claim 10 and 18 above, and further in view of Asami et al. (US 2012/0172720; hereinafter Asami).
Maxwell fails to show wherein the target tissue volume comprises a breast nodule of the subject; wherein the target tissue volume comprises a thyroid of the subject.
Asami discloses an ultrasonic treatment device. Asami teaches wherein the target tissue volume comprises a breast nodule of the subject ([0054]); wherein the target tissue volume comprises a thyroid of the subject ([0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maxwell and Bailey to treat the breast or thyroid as taught by Asami, as Asami teaches that target diseases may exist in various areas of the patient’s body including the breasts and thyroid, and that the ultrasound treatment may be customized for the thyroid or other organs depending on the depth of the location ([0054]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Averkiou (US 2018/0169444) discloses methods and apparatus for ultrasound treatment, including robotic control for aiming therapy beams ([0007]) and visualizing bubble clouds ([0032]).
Coussios (US 2012/0259222) discloses ultrasound systems including controlling of a bubble cloud ([0006], [0046]).
Messas (US 2018/0064412) discloses image guided ultrasound treatment techniques, including robotically controlled movement of ultrasound probe ([0171], [0209]).
Roberts (US 2011/0054315) discloses medical imaging and therapy transducers for controlling a bubble cloud ([0045])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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