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 Objections
Claims 5 and 11 are objected to because of the following informalities:
In claim 5, line 21, it appears ‘a’ should be ‘the’.
In claim 11, line 12, it appears ‘is adjusted’ should be deleted. In line 15, the third ‘a’ should be ‘the’. In line 17, the first ‘the’ should be ‘a’. In line 19, the second ‘a’ should be ‘the’.
Appropriate correction is required.
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 5-8 and 11 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.
These claims are set forth as method claims but the body of the claims only provide limitations to the structure. While structure may be set forth in a method claim, there must be steps as is typically done. Currently, the steps are provided for as functional limitations are the controller.
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 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Son et al (US Pub 2016/0007960 -cited by applicant as EP 2962729).
Re claims 9, 11: Son discloses a HIFU sonication apparatus and method for adjusting a focus point (see Abstract) comprising:
a transducer control unit configured to control a plurality of ultrasound transducers placed along a concave surface [0027, 0053, Fig 5B; see the concave surface with therapy transducers 110; and see the control unit 240];
a data acquisition unit that acquires B mode image data by the ultrasound probe placed on a central axis of the concave surface [0030, 0054; see the image processing unit 130 for acquiring B-mode images from the imager 120]; and
a controller configured to control the transducer control unit and the data acquisition unit [0046; see the control unit 150], wherein the controller is configured to execute:
a process in which, during a period in which the plurality of ultrasound transducers are caused to transmit ultrasounds, while a delay time of the ultrasound emitted from each transducer is adjusted, a focal point, of the ultrasounds emitted from the plurality of ultrasound transducers and which appears as a magnitude of brightness in a B mode image indicated by the B mode image data, is searched for based on the B mode image data [0071, 0110-0115, fig 9; see the transmission of HIFU and imaging ultrasounds wherein the imaging signal is received to search for a focal position that appears as a brightness wherein the focus is compensated until it is in the correct position; also see the adjustment to the delay such that the imager and therapy is synchronized].
Son further discloses the controller is configured to, in a state in which the ultrasound probe rests at the rotational angle position at which the focal point is detected, further adjust a delay time of the ultrasound emitted from each of the plurality of ultrasound transducers, so that the focal point moves closer to the central axis or the focal point is positioned on the central axis [0071, Fig 5A; see the determination of the delay amount for synchronizing the imager 120 and the therapy transducers 110 wherein the delay is adjusted such that the focus is placed closer to the central axis].
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 1-8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Son et al (US Pub 2016/0007960 -cited by applicant as EP 2962729) in view of Xu et al (US Pub 2023/0329559).
Re claims 1, 3, 5, 7, 13: Son discloses a HIFU sonication apparatus and method for adjusting a focus point (see Abstract) comprising:
a transducer control unit configured to control a plurality of ultrasound transducers placed along a concave surface [0027, 0053, Fig 5B; see the concave surface with therapy transducers 110; and see the control unit 240];
a data acquisition unit that acquires B mode image data by the ultrasound probe placed on a central axis of the concave surface [0030, 0054; see the image processing unit 130 for acquiring B-mode images from the imager 120]; and
a controller configured to control the transducer control unit and the data acquisition unit [0046; see the control unit 150], wherein the controller is configured to execute:
a step of transmitting ultrasound, during a period in which the plurality of ultrasound transducers are caused to transmit ultrasounds, and a step of searching for a focal point of the ultrasounds emitted from the plurality of ultrasound transducers and which appears as a magnitude of brightness in a B mode image indicated by the B mode image data [0110-0115, fig 9; see the transmission of HIFU and imaging ultrasounds wherein the imaging signal is received to search for a focal position that appears as a brightness wherein the focus is compensated until it is in the correct position]; and
a step in which the ultrasound probe rests at the rotational angle position at which the focal point is detected (fig 9, see step S960).
Son discloses all features including an imager 220 placed on a central axis of the concave surface (fig 5B), but does not disclose a probe driver or a transducer driver that changes a rotation angle of the probe or rotates the transducers such that a rotational angle position of the probe or angles of the transducer about the central axis is changed. However, Xu teaches of a combined therapy ultrasound device 102 on a concave surface with an imaging probe 104 (fig 1A) including a probe driver and transducer driver that rotates the probe and the transducers such that a rotational angle positions of the probe and the transducers about the central axis is changed [0078-0082; see the probe that is independently rotatable and the therapy applicator that is coupled to a robot arm that is rotatable about a central axis]. It would have been obvious to the skilled artisan to modify Son, to rotate the applicator and probe as taught by Xu, in order to facilitate more accurate imaging and therapy of a target.
Re claims 2, 4, 6, 8: Son disclose the controller is configured to, in a state in which the ultrasound probe rests at the rotational angle position at which the focal point is detected, adjust a delay time of the ultrasound emitted from each of the plurality of ultrasound transducers, so that the focal point moves closer to the central axis or the focal point is positioned on the central axis [0071, Fig 5A; see the determination of the delay amount for synchronizing the imager 120 and the therapy transducers 110 wherein the delay is adjusted such that the focus is placed closer to the central axis].
Response to Arguments
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive. Regarding the 112 rejection, Applicant submitted that the rejection is overcome. Respectfully, the Examiner disagrees and maintains the rejection for the reasons set forth.
Regarding the art rejection, Applicant argues that the motivation to combine Son and Xu is missing. However, the Examiner finds that the motivation to in order to facilitate more accurate imaging and therapy of a target is sufficient. This is not merely a general statement of desired improvement as Applicant asserts, but rather uses a known rotation capability of Xu’s device to improve Son’s device in the same way. Xu and Son further relate to similar devices in their combined therapy/imaging transducer. This rationale to combine is well established. Regarding claim 2, Applicant argues that Son is silent about adjusting a delay to move or position the focal point. However, the Examiner finds that Figure 9 refers to the focal point 510 that can be compensated, which corresponds to a moving/positioning of the focal point to coincide with the target. While Son’s figure 5A shows the focal point already placed on the central axis, the disclosure describes the claimed limitation, i.e. 0047 further refers to beam steering which moves the focal point. Regarding claim 3, Applicant argues that a transducer driver is not disclosed in Xu. However, the limitation is met. Applicant acknowledges Xu teaches the encoding mechanism to rotate the imaging probe independent of the therapy transducer. However, Xu teaches the imaging probe 104 with its encoding mechanism (the claimed ‘probe driver’) enabling its rotation. Independently, the therapy transducer 102 with its structure coupled to the robot arm (the claimed ‘transducer driver’) is said to rotate with 6 degrees of freedom, which rotates the plurality of transducers.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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