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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 5/7/26 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/7/26.
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.
Claim(s) 1-9 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piron et al. (US 2005/0080333; hereinafter Piron).
Piron shows a biopsy system and method that performs a biopsy of a breast while capturing an ultrasound image with an ultrasonography apparatus ([0136], [0171]), the biopsy system comprising: a compression member that has an opening portion into which a biopsy needle and an ultrasound probe used for capturing the ultrasound image are inserted and that compresses the breast ([0142]-[0143], [0168], [0174]-[0175], [0183]); at least one processor configured to perform guide processing for guiding a target insertion position and a target insertion angle of the biopsy needle inserted into the breast and a target scanning position of the ultrasound probe ([0136], [0142], [0144], [0148], [0152], [0177], [0179]); and an acoustic matching body that is provided between the ultrasound probe and the breast in a non-contact state with the biopsy needle ([0142]-[0143], [0166], [0174], [0183]).
Piron also shows wherein the acoustic matching body is mounted on the ultrasound probe ([0144], [0174]); wherein the processor is configured to: acquire a current insertion position and a current insertion angle of the biopsy needle inserted into the breast; acquire a current scanning position of the ultrasound probe; and perform the guide processing based on the current insertion position and the current insertion angle of the biopsy needle, the current scanning position of the ultrasound probe, a current position of a distal end of the biopsy needle, the target insertion position and the target insertion angle of the biopsy needle, and the target scanning position of the ultrasound probe ([0136], [0142], [0144], [0148], [0152], [0177], [0179]); wherein the processor is configured to, as the guide processing: acquire at least one of a radiation image of the breast or the ultrasound image captured by the ultrasonography apparatus ([0123], [0136], [0142], [0144], [0148], [0152], [0177], [0179]); derive the target insertion position and the target insertion angle of the biopsy needle based on a region of interest in the radiation image of the breast or a region of interest in the ultrasound image of the breast, and present the derived target insertion position and target insertion angle of the biopsy needle ([0136], [0142], [0144], [0148], [0152], [0177], [0179]); and derive the target scanning position of the ultrasound probe that is in a non-contact position with the biopsy needle based on the derived target insertion position and target insertion angle of the biopsy needle, and present the derived target scanning position of the ultrasound probe ([0136], [0142], [0144], [0148], [0152], [0177], [0179]); wherein the processor is configured to: in a case in which a target is calcification, derive the target insertion position and the target insertion angle of the biopsy needle based on the region of interest in the radiation image ([0173], [0181]); and in a case in which the target is a tumor, derive the target insertion position and the target insertion angle of the biopsy needle based on the region of interest in the ultrasound image ([0173], [0181]); a moving mechanism that moves the ultrasound probe, wherein the processor is configured to present the target scanning position of the ultrasound probe to the moving mechanism, and the moving mechanism moves the ultrasound probe to the target scanning position ([0142], [0144]); wherein the moving mechanism enables capturing of ultrasound images in a major axis direction and a minor axis direction of the biopsy needle by rotating the ultrasound probe with respect to the biopsy needle ([0142]. [0144]); wherein the processor is configured to perform guide processing for guiding a scanning position of the ultrasound probe to a position where a final destination of the biopsy needle based on the derived target insertion position and target insertion angle of the biopsy needle is able to be imaged ([0142], [0144], [0151]-[0152]); a disposition mechanism for disposing the biopsy needle, wherein the processor is configured to: present the target insertion position and the target insertion angle of the biopsy needle to the disposition mechanism ([0136], [0168]); and the disposition mechanism disposes the biopsy needle according to the target scanning position and the target insertion angle ([0136], [0168], [0175], [0217]); an image processing apparatus configured to: acquire a plurality of ultrasound images captured by the ultrasonography apparatus; and generate a three-dimensional ultrasound image from the plurality of ultrasound images ([0139], [0144], [0163]); wherein the acoustic matching body is in a form of a gel, and the processor is configured to: acquire at least one of a radiation image of the breast or the ultrasound image captured by the ultrasonography apparatus; derive the target insertion position and the target insertion angle of the biopsy needle based on a region of interest in the radiation image of the breast or a region of interest in the ultrasound image of the breast; and further perform guide processing for guiding a disposition position of the acoustic matching body to a disposition position where the acoustic matching body does not come into contact with the biopsy needle based on the derived target insertion position and target insertion angle of the biopsy needle ([0143], [0168], [0174]).
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US 2005/0080333; hereinafter Piron) in view of Bharat et al. (US 2021/0259660; hereinafter Bharat).
Piron shows the invention substantially as described in the 102 rejection above.
Piron fails to show wherein the processor is configured to: determine whether or not there is a likelihood that the acoustic matching body and the biopsy needle come into contact with each other; and give a warning in a case in which there is a likelihood of contact.
Bharat discloses biopsy prediction and guidance with ultrasound imaging. Bharat teaches wherein the processor is configured to: determine whether or not there is a likelihood that an undesired object and the biopsy needle come into contact with each other; and give a warning in a case in which there is a likelihood of contact ([0100]).
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 Piron to provide warnings when the biopsy needle may come into contact with an undesired object as taught by Bharat, in order to ensure that the biopsy needle is accurately guided to the target while avoiding critical structures by alerting the user in regards to the biopsy needle path. Furthermore, it would have been an obvious modification to provide warnings regarding the intersection of the biopsy needle with various objects present in the scene, including unwanted intersection of the needle with the acoustic matching body of Piron, in order to effectively perform the procedure while avoiding contact of the biopsy needle with undesired objects that would otherwise impede the biopsy procedure and cause potential damage to the needle and object.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Anderson (US 2006/0241423) discloses an ultrasound scanning apparatus for breast imaging and associated compression plates (abstract), including an acoustic coupling medium to facilitate acoustic coupling between the breast and an acoustic matching layer on the ultrasound probe ([0062]);
Carson (US 2013/0116570) discloses an ultrasound scanning apparatus for breast imaging including a compression system and a device for acoustic coupling gel (abstract);
O’Connor (US 2013/0101083) discloses an ultrasound scanning apparatus for breast imaging and biopsy including an acoustic coupling plate ([0038, [0050]);
Shmulewitz (US 5474072) discloses an ultrasound scanning apparatus for breast imaging and biopsy including a compression system and acoustic coupling medium (Fig. 1).
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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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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