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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and 20 in the reply filed on 12/08/25 is acknowledged.
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 1-7, 9-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wijlemans et al. (Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation of liver tumours (provided in the IDS)) and in view of Cannata et al. (US 2020/0346046).
Addressing claim 1, Wijlemans discloses a method of planning therapy, comprising:
obtaining at least one diagnostic image of a subject including a target tissue location (see page 391, left column, 2nd paragraph, page 392 and Figs. 4-5; MRI tracking of target and 3D anatomical imaging);
generating a three-dimensional (3D) digital model of the subject and the target tissue location from the at least one diagnostic image (see Fig. 5, 3d anatomical image is basically a digital model of the subject or subject organ);
positioning a virtual therapy transducer array near the 3D model with a geometric focus of the virtual therapy transducer positioned on or near the target tissue location in the 3D digital model (see page 392 and Fig. 5; 5d shows virtual transducer array in 3d with a geometric focus of the virtual therapy transducer positioned on or near the target tissue location in the 3D digital model (the white bar are transducer elements at the target tissue location in the 3d model));
sampling the virtual therapy transducer array to provide starting points for a plurality of rays that correspond to simulated ultrasound energy delivered by transducer elements of the virtual therapy transducer (see page 392 and Fig. 5; 5b-d white dash line and red line show rays (ray tracing) and beam path);
tracing the plurality of rays through the 3D digital model and identifying one or more obstructed or partially obstructed transducer elements of the virtual therapy transducer array corresponding to rays that pass through an obstruction in the 3D digital model (see page 392 and Fig. 5, 5b-d show beam path and ray tracing and deactivate transducer element that is obstructed.
Wijlemans does not disclose using the method for histotripsy. Cannata discloses planning histotripsy treatment (see abstract and [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wijlemans to use for planning histotripsy treatment as taught by Cannata because this allow for treatment of other medical issue and histotripsy provide several important advantages in soft tissue therapy treatment (see [0003] and [0007]).
Addressing claims 2-4, 7 and 11, Wijlemans discloses:
addressing claim 2, comprising displaying the rays that pass through an obstruction to a user (see page 392 and Fig. 5; display beam path and rays tracing so user can see rays and beam path hitting bones; the transducer elements that are obstructed by the bones/ribs are deactivated so that user can see what is passing and what is not, different colors or dashes or solid lines).
addressing claim 3, providing a first graphical representation of the rays that pass through an obstruction and providing a second graphical representation of the rays that do not pass through an obstruction (see Fig. 5 and page 391-392; circle shows bone obstruction; projection of bones on to transducer surface so viewer can see bone obstruction and no obstruction in ultrasound rays tracing so viewer could deactivate certain transducer elements).
addressing claim 4, wherein rays that pass through an obstruction are displayed in a first color and rays that do not pass through an obstruction are displayed in a second color (see Fig. 5 and pages 391-392; yellow circle are bones in the beam path; white dash line are rays from transducer elements that have bone obstruction and solid white lines in 5e are transducer elements that do not have rays obstruction).
addressing claim 7, wherein displaying the rays that pass through an obstruction further comprises providing a 2D view of the plurality of rays (see Fig. 5, red beam, white line and white dash line are 2D).
addressing claim 11, segmenting one or more target tissues or organs in proximity to the target tissue location (see Fig. 5, segment bones near the target).
Addressing claims 5-6 and 9-10, Cannata discloses:
wherein the 3D digital model further comprises a skin surface model of the subject (see [0154]; map/model of electrical properties of the skin surface).
addressing claim 6, presenting a map of rays that pass through an obstruction on the skin surface model (see Wijlemans’s pages 391-392; Wijleman disclose rays map pass through an obstruction of the tissue 3d images/mode; Cannata discloses taking images and measurement of skin surface conductivity and permittivity, skin surface impedance map; Wijlemans in view of Cannata could map rays into the skin surface images/models).
addressing claim 9, further comprising generating a digital treatment plan that includes the target tissue location and a pose or position of the virtual histotripsy therapy transducer array (see [0093], [0196], [0244] and [0249]; planning, comprising imaging the patient (and target location/anatomy) with the freehand imaging probe, and robot assisted imaging with the transducer head for final gross and fine targeting, including contouring the target with a target and margin contour, of which are typically spherical and ellipsoidal in nature, and running a test protocol (e.g., test pulses) including a bubble cloud calibration step, and a series of predetermined locations in the volume to assess cavitation initiation threshold and other patient/target specific parameters (e.g., treatment depth), that together inform a treatment plan accounting for said target's location and acoustic pathway, and any related blockage (e.g., tissue interfaces, bone, etc.) that may require varied levels of drive amplitude to initiate and maintain histotripsy; guiding pathway for probe; Wijlemans discloses target tissue location and pose/position of the virtual therapy transducer and guide treatment; he just does not explicitly disclose digital planning treatment; Cannata explicitly disclose digital planning treatment).
addressing claim 10, wherein the digital treatment plan further includes a depth and size of the target tissue location (see [0093] and [0196]).
Addressing claim 20, the system of claim 20 perform the method of claim 1 therefore claim 20 is being rejected for the same reason as claim 1.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wijlemans et al. (Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation of liver tumours (provided in the IDS)), in view of Cannata et al. (US 2020/0346046), further in view of Bueler et al. (US 10,729,585) and Wood et al. (US 2003/0215186).
Addressing claim 8, Wijlemans does not disclose adjust device position/pose and repeat ray tracing to identify obstructed transducer element. Repeating the process to find the best device position for treatment is just optimization within prior art conditions or through routine experimentation. Bueler discloses repeat the ray tracing process to find the best, the reference lens shape (see claims 3, 7 and Fig. 7; adjust lens shape/position and then ray tracing until one get the best lens shape base on ray tracing). Wood discloses adjust the position of light source and perform rays/beams tracing until the beam is on target (see [0063]). Examiner only relies on Bueler and Wood to provide evidences that repeat ray tracing process is obvious step for optimization.
Conclusion
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793