DETAILED ACTION
Notice of 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 .
Drawings
The drawings are objected to because Fig. 5D is of insufficient quality and difficult to discern. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim(s) 29 is/are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 29, the recited geometry of the ultrasound transducer is not sufficiently supported in the disclosure to support possession of the claimed features because the description in paragraph [0152] and Fig. 5C do not provide enough detail describing the claimed regions and the transitions therebetween.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 21-25, 30, 31, 36, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cannata (US 2020/0346046) in view of “Assessment of Collaborative Robot (Cobot)-Assisted Histotripsy for Venous Clot Ablation” by K.B. Bader et al. IEEE Trans Biomed Eng. Vol. 68, No. 4, pp.1220-1228, 2021 (Bader).
Regarding claims 21 and 31, Cannata discloses a method of providing ultrasound therapy, comprising: moving an ultrasound transducer array of an ultrasound system along an approach plane to place a focus of the ultrasound transducer array on a target treatment location within a treatment volume of a subject; and delivering ultrasound therapy to the target treatment location with the ultrasound transducer array ([0091]: “histotripsy therapy transducers and an ultrasound imaging system/probe”; [0102]: “Histotripsy comprises short, high amplitude, focused ultrasound pulses”; [0230]: “cavitation focus of the Histrotripsy therapy system”). Cannata does not explicitly disclose determining an aperture width of the ultrasound transducer array in the approach plane at a user-selected depth of an acoustic window; determining a tilt angle that centers an acoustic beam of the ultrasound transducer array on the selected acoustic window while placing the focus of the ultrasound transducer array on the target treatment location; controlling movement of the ultrasound transducer with a robotic positioning system along the approach plane to assume the tilt angle that places the focus on the target treatment location and centers the acoustic beam on the selected acoustic window. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). The robot of Bader would have determined the claimed parameters at least during or prior to the histotripsy procedure, including aperture widths/depths, robotic tilt angles, and focal points. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated maneuverable robot of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Regarding claim 22, Cannata discloses that the ultrasound therapy comprises histotripsy therapy ([0091]: “histotripsy therapy transducers and an ultrasound imaging system/probe”; [0102]: “Histotripsy comprises short, high amplitude, focused ultrasound pulses”).
Regarding claim 23, Cannata discloses delivering ultrasound therapy further comprises generating cavitation at the target treatment location ([0102]: “histotripsy uses acoustic cavitation”).
Regarding claim 24, Cannata does not explicitly disclose determining the aperture width further comprises calculating a beam angle of the ultrasound transducer array in the approach plane. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). The robot of Bader would have determined the claimed parameters at least during or prior to the histotripsy procedure, including aperture widths/depths, robotic tilt angles, and focal points. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated maneuverable robot of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Regarding claim 25, Cannata does not explicitly disclose determining the beam angle is based on the specific ultrasound transducer geometry. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). An artisan in the field of ultrasound imaging probes would have found it obvious that a beam angle is influenced by the geometry of the transducer arrangement. For instance, a linear array and a circular array radiate ultrasound in ways that are specific to their structural configuration. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the ultrasound probe of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Regarding claim 30, Cannata does not explicitly disclose that the approach plane is rotated around a z-axis of the transducer array. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). The robot of Bader would have determined the claimed parameters at least during or prior to the histotripsy procedure, including aperture widths/depths, robotic tilt angles, and focal points. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated maneuverable robot of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Regarding claim 36, Cannata does not explicitly disclose that the tilt angle reduces or eliminates obstruction of at least a portion of a transmit aperture of the ultrasound transducer array. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). The robot of Bader would have determined the claimed parameters at least during or prior to the histotripsy procedure, including aperture widths/depths, robotic tilt angles, and focal points. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated maneuverable robot of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Regarding claim 37, Cannata does not explicitly disclose that the tilt angle is determined with one or more processors of the ultrasound system. However, Bader teaches a robot that may be programmed to navigate an automated trajectory while applying histotripsy treatment procedure (Fig. 1; p.1220: “enable arbitrary angulation of the transducer relative to the target”; p.1221: “six degree-of-freedom cobot was used to translate the histotripsy system…Each axis of the cobot supported 360° rotation”; p.1222: “generate an automated path for the histotripsy source to translate”). The robot of Bader would have determined the claimed parameters at least during or prior to the histotripsy procedure, including aperture widths/depths, robotic tilt angles, and focal points. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated maneuverable robot of Bader to the histotripsy system of Cannata, as to provide robust automated robotic control of a histotripsy device.
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cannata (US 2020/0346046) in view of “Assessment of Collaborative Robot (Cobot)-Assisted Histotripsy for Venous Clot Ablation” by K.B. Bader et al. IEEE Trans Biomed Eng. Vol. 68, No. 4, pp.1220-1228, 2021 (Bader), as applied to claim 21 above, in view of “Acoustic window planning for ultrasound acquisition” by R. Gobl et al. Int J CARS. 12:993-1001, 2017 (Gobl).
Regarding claim 33 and 34, neither Cannata nor Bader explicitly disclose that the depth is a distance from the target treatment location to an obstruction and that the obstruction comprises one or more bones in the subject. However, Gobl teaches accounting for ribs that cause strong reflections (p.996, Figs. 1 and 6). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the consideration of reflectors as taught by Gobl to the ultrasound of Cannata and Bader, as to provide robust accounting of obstructions to ultrasound penetration.
Regarding claim 35, neither Cannata nor Bader explicitly disclose that the one or more bones define the acoustic window. However, Gobl teaches accounting for ribs that cause strong reflections (p.996, Figs. 1 and 6). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the consideration of reflectors as taught by Gobl to the ultrasound of Cannata and Bader, as to provide robust accounting of obstructions to ultrasound penetration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Ip whose telephone number is (571) 270-5387. The examiner can normally be reached Monday - Friday 9a-5p PST.
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/JASON M IP/Primary Examiner, Art Unit 3793