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 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) 1-3, 5-9 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]); 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]); 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: 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.
Response to Arguments
Applicant's arguments filed 8/24/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding Piron, examiner respectfully disagrees. Piron teaches the limitations as described in the rejection above:
“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])”. The examiner notes that the broadest reasonable interpretation of the claim language has been provided. Applicant argues that Piron fails to teach “both” a radiographic image and an ultrasound image. However, the claim language refers to “at least one of a radiation image of the breast or the ultrasound image”. The claim language does not require “both”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., both a radiographic image and an ultrasound image) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s arguments regarding claim 2, examiner respectfully disagrees. The examiner notes that the broadest reasonable interpretation of the claim language has been provided. The claim language does not describe structural details regarding the connection between the ultrasound probe and the acoustic matching body. The examiner maintains that the ultrasound probe mounts/attaches to the acoustic matching body in Piron, in order to accurately transmit and receive ultrasound waves, where the benefit of acoustic matching is known. It is suggested to more clearly define the structural features associated with the limitation “mounted”.
In response to applicant’s arguments regarding claim 10, examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN CWERN/Primary Examiner, Art Unit 3797
Prosecution Insights