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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4, 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari et al. (US 2003/0004411, hereinafter Govari ‘411).
In re claim 1, Govari ‘411 teaches a method for localizing an implantable target in an individual, comprising:
transmitting an ultrasonic signal from a transducer array (fig. 10, 0076, three transducers are an array);
generating radiofrequency (RF) signal data based on a reflected signal received at the transducer array, the reflected signal resulting from the transmitted ultrasonic signal, wherein at least a portion of the reflected signal includes a signal reflected from the implantable target (0076, 0077);
determining a location of the implantable target relative to the transducer array based on the RF signal data (0079, 0081); and
providing a location indicator to an operator, the location indicator being based on the determined location of the implantable target, wherein the location indicator comprises a direction of the implantable target relative to the transducer array (0054, 0078).
In re claim 2, Govari ‘411 teaches wherein the implantable target is a fiducial marker (tag 120, 0076).
In re claim 3, Govari ‘411 teaches wherein the location indicator further comprises a distance from the implantable target to the transducer array (0076-0078).
In re claim 4, Govari ‘411 teaches wherein determining a location of the implantable target comprises distinguishing the implantable target from other artifacts in the RF signal data (0074, triangulation to yield the location reads on it; 0076, also at frequency f2).
In re claim 12, Govari ‘411 teaches wherein the location indicator is an audible tone and/or a visual display (0054, 0055, 0070).
In re claim 13, Govari ‘411 teaches wherein a pitch and/or volume of the audible tone varies according to the location of the implantable target (0054).
In re claim 14, Govari ‘411 teaches wherein the visual display provides a visual representation of a distance from the implantable target to the transducer array and/or the direction of the implantable target relative to the transducer array (0070, fig. 7).
In re claim 15, Govari ‘411 teaches wherein the steps of transmitting an ultrasound signal and generating RF signal data are repeated (0055, 0073, 0083).
In re claim 16, Govari ‘411 teaches further comprising updating the location of the implantable target (0055, 0073, 0083).
In re claim 17, Govari ‘411 teaches further comprising: transmitting an additional ultrasonic signal from a transducer array; generating RF signal data based on a reflected signal received at the transducer array, the reflected signal resulting from the transmitted additional ultrasonic signal, wherein no portion of the reflected signal includes a signal reflected from the implantable target; and identifying that no implantable target is present in the reflected signal (0055, 0083, it is inherent that when no reflected signal from the target/tag 120, the target is not there).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 4, 5, 8, 9, 11, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari ‘411 in view of Mahfouz et al. (US 2013/0144135, From IDS filed on November 15, 2024, hereinafter Mahfouz ‘135).
In re claim 5, Govari ‘411 fails to teach wherein the location of the implantable target is determined by feature extraction using a machine learning classifier on the RF signal data.
Mahfouz ‘135 teaches wherein the location of the target is determined by feature extraction using a machine learning classifier on the RF signal data (0084-0088, 0121, note neural network, svm with training are machine learning).
Furthermore, in re claim 4, Mahfouz ‘135 also teaches wherein determining a location of the target includes distinguishing the target from other artifacts in the RF signal data (fig.10, 162 vs 162a; 0081-0083, bone and soft-tissue-bone, 0089).
In re claim 8, Mahfouz ‘135 teaches wherein the location of the target is determined using image processing of a B-mode image reconstructed from the RF signal data (0071, 0072, 0098).
In re claim 9, Mahfouz ‘135 teaches wherein the image processing comprises: analyzing the B-mode image to identify the target; and determining a distance from the target to the transducer array based on the identified target (0071, 0072, 0097, 0098, 0100).
In re claim 11, Mahfouz ‘135 teaches wherein analyzing the B-mode image comprises image segmentation and/or classification (0093-0095; 0107).
In re claim 17, Mahfouz ‘135 teaches further comprising: transmitting an additional ultrasonic signal from a transducer array; generating RF signal data based on a reflected signal received at the transducer array, the reflected signal resulting from the transmitted additional ultrasonic signal, wherein no portion of the reflected signal includes a signal reflected from the target; and identifying that no target is present in the reflected signal (0072).
Note that Govari ‘411 already teach using imaging processing of an ultrasound image (0065).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Govari ‘411 to include the features of Mahfouz ‘135 in order to provide real target visualization for better viewing experiences during diagnostics or therapy.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari ‘411 in view of Patil et al. (US 2017/0333006, hereinafter Patil ‘006).
In re claims 6-7, Govari ‘411 fails to teach claim 6: further comprising preprocessing the RF signal data to increase a signal-to-noise ratio of the RF signal data; claim 7: wherein the preprocessing comprises: transforming the RF signal data into frequency domain signal data; and applying one or more filters to the frequency domain signal data.
Patil ‘006 teaches claim 6: further comprising preprocessing the RF signal data to increase a signal-to-noise ratio of the RF signal data; claim 7: wherein the preprocessing comprises: transforming the RF signal data into frequency domain signal data; and applying one or more filters to the frequency domain signal data.
(0029-0030).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Govari ‘411 to include the features of Patil ‘006 in order to reduce noise and increase SNR.
Claim(s) 10, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari ‘411 and Mahfouz ‘135 in view of Tsushima (US 2018/0199918, hereinafter Tsushima ‘918).
In re claim 10, Govari ‘411 and Mahfouz ‘135 fail to teach wherein the image processing further comprises determining a direction of the implantable target relative to the transducer array based on the identified implantable target.
Tsushima ‘918 teaches wherein the image processing further comprises determining a direction of the target inside the patient relative to the transducer array based on the identified target (figs. 6, 7, 9, 10, 11, 20; 0089-0093, 0142-0143, 0155-0161, 0170, 0186, 0196, 0199, 0217).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Govari ‘411 and Mahfouz ‘135 to include the features of Tsushima ‘503 in order to ensure delay in transmission is correctly obtain so that high quality images with high resolution and low noise can be obtained.
In re claim 13, Tsushima ‘918 teaches wherein a pitch and/or volume of the audible tone varies according to the location of the target (0055, 0067, 0155, 0177, 0207).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797