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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a method for analysis without significantly more. The claim(s) recite(s) analyzing a shear wave, setting a condition for scan data, performing a scan, and obtaining scan data. This judicial exception is not integrated into a practical application because the method step of analysis is generically recited, the act of setting a scan “condition” is generically recited and ubiquitous in the art area of medical imaging and diagnostics, as is the performance of a scan and the obtaining of scan data.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no tie to a device, specific conditions requiring more than human hand/processing to perform (analysis, setting, performing a scan, and obtaining the scan are all data gathering or mental processes), nor is there significant details to the method which would require throughput, processing, or other aspects of calculation which exclude human processing (analysis of a propagated shear wave can include manual analysis, analysis of previously calculated, processed, computed datasets, or even simply analysis of a visual output from a previous dataset, all of which are capable of being performed by human processing/hand).
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 1-18 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.
Regarding claims 1, 17, and 18, the recitation of “an obtaining condition” is indefinite, as it is unclear what aspects of an obtaining condition are included or excluded from the step/setting. Reciting that it is on the basis of an “analysis result” provides no definite scope for what temporal, intensity, location, acquisition, timing, frequency, etc. aspects are included or excluded from the scope of the claim. At most, the claim scope can include those aspects of an “obtaining condition” recited in the specification, but as instantly recited, the claims do not provide a definitive scope for said limitation. For the purpose of examination, anything data or data related, including timing, frequency, intensity, whether a pulse has been transmitted or dataset exists at all, etc., which can be derived from shear wave dataset is being considered to meet the instant limitation.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honjo et al (US 2016/0367223).
Regarding claims 1, 17, and 18, Honjo et al (‘223) discloses and teaches nn ultrasound diagnosis apparatus including processing circuitry configured to analyze a shear wave that has propagated in a subject (Abs, Fig 1, 0018, 003), set an obtaining condition for scan data on a basis of an analysis result of the shear wave (0058-0065, Fig 4), and perform a scan on the subject on a basis of the obtaining condition and to obtain the scan data of the subject (0063-0066, Fig 4, 70-71 for time phase and timing of pulses).
Regarding claims 2-7, Honjo et al (‘223) discloses and teaches the processing analysis of a first sheave wave which has reflected after propagating through a measurement region, and setting based on the result, a transmission condition of a push pulse for a 2nd shear wave in a second measurement region and a t/r condition for a tracking pulse to track the 2nd shear wave (0059-0062, fig 4), the ability to change the scan size, timing, and position of the ROI for each interrogation (0060, 0063-0067 for calculation, 0074, 0076, including setting based on analysis from the calculations), and finally the processing of the shear wave the obtain tissue properties as an index value, and the setting of the following pulse condition based on the index value at various positions in the measured data (0052-0054, 0069-0074, modulus (0037-0038)
Regarding claims 8-13, Honjo et al (‘223) discloses and teaches a measurement to indicate the accuracy of the propagation data, and the setting of a subsequent value based on the reliability (accuracy) dataset (0087, Fig 6, Fig 1, 0122-0124), as well as the indication based on ranges (sending message if values at a particular range 0088) along with the ultrasound image, the updating of the scan values via modeling (0016, claim 8, 15, 0035-0038, 0055-0056, 0061-0067) to provide the analysis result of the shear wave to set a subsequent obtaining condition based on the range of values (0088), and the display of ultrasound image data with particular coordinate, filtering, values, and character information for parameters of the image (0043-0047,0074, 0052, 0060-0063 (pulse setting display)).
Regarding claims 14-16, 17, and 18, Honjo et al (‘223) discloses and teaches the setting of the obtaining values/parameters based on B-mode and Doppler data (0031-0032) received, and the analysis of the propagation of pulses in different regions of the subject (Fig 2a-b), and the setting of the obtaining condition/parameters based on the results of values in multiple different regions (0040, 0050-0054, 0069-0080), including iterative division and processing to set timing/scan values for the region(s).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes cited US 10,806,429 and 10,856,849 which both disclose and teach ultrasound diagnostic feedback control based on reflected shear wave values during elastography procedures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL LAMPRECHT/ Primary Examiner, Art Unit 3798
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