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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to parent Application No. JP2025-022392, filed on 14 February 2025. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: ULTRASOUND CONTRAST AGENT INTENSITY DISTRIBUTION AVOIDING CONTRAST BUBBLE BREAKAGE ENSURING MINIMUM CONTRAST
Claim Rejections - 35 USC § 112(b)
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 1-7 is 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.
In particular, Claim 2 recites “calculate an evaluation value representing a size of a portion satisfying an appropriate intensity condition for contrast agent imaging in the intensity distribution”; however, the limitation “appropriate” is undefined because the limitation relies on relative terminology. Since the instant specification fails to provide some standard establishing an “appropriate” intensity condition, the meaning of the terms of degree cannot be ascertained by one of ordinary skill in the art when reading the disclosure.
For the purposes of compact prosecution, the limitation will be interpreted as “calculate an evaluation value representing a size of a portion satisfying a predetermined intensity condition for contrast agent imaging in the intensity distribution” which is commensurate with ¶ [0002] of the instant specification. It should be noted that such an interpretation has not been evaluated for compliance with the written description requirement under 35 U.S.C. 112(a).
Claims 2 & 5 recite similar limitations and are rejected under the same rationale as claim 1. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 2, the claim recites “wherein the appropriate intensity condition includes an intensity lower limit threshold value for ensuring a minimum contrast of the ultrasound image and an intensity upper limit threshold value for avoiding contrast agent breakage”; however, the limitation of “ensuring a minimum contrast” is undefined because the limitations relies on relative terminology. Since the instant specification fails to provide some standard for measuring that the minimum contrast is ensured, the meaning of the terms of degree cannot be ascertained by one of ordinary skill in the art when reading the disclosure.
For the purposes of compact prosecution, the limitation will be interpreted as “wherein the appropriate intensity condition includes a predetermined intensity lower limit threshold value for a minimum contrast of the ultrasound image and an intensity upper limit threshold value for avoiding contrast agent breakage” which is commensurate with ¶ [0002] of the instant specification. It should be noted that such an interpretation has not been evaluated for compliance with the written description requirement under 35 U.S.C. 112(a).
Claim 5 recites similar limitations and are rejected under the same rationale as claim 2. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 6, the claim appears to be a run-on sentence . Even in light of corresponding ¶ [0077], one of ordinary skill in the art would not be able to interpret the claim such that an examination on the merits could be performed. Therefore Claim 6 is undefined under 35 U.S.C. 112(b).
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 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) 1-5 &7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chomas (US PGPUB 20060064018).
With regards to Claim 1, an ultrasound diagnostic apparatus (ultrasound system 10 for determining optimal transmit power by comparing both contrast agent destruction and contrast agent specificity; see Chomas FIG. 1 & ¶ [0048]) comprising:
a processor (processor 18; see Chomas FIG. 1),
wherein the processor is configured to:
select a provisional measurement condition from a plurality of measurement conditions that cause different transmission beams to be generated (selecting and applying a detection technique such as B-mode, intensity, amplitude, power detection, harmonic, nonlinear imaging, phase or pulse inversion techniques {i.e. provisional measurement condition}; see Chomas ¶ [0030]);
generate an intensity distribution by performing a simulation or preliminary transmission and reception (the process of FIG. 3 is a preliminary transmission because after the transmit power is set, the algorithm is exited and a diagnostic scan with said transmit power is acquired; see Chomas ¶ [0066]) based on the provisional measurement condition (two sequential sets of data {i.e. contrast agent specificity} are compared then thresholded; see Chomas ¶ [0055-0056]), the intensity distribution being a sound pressure distribution along a depth direction in a specific subject (a plurality of different powers, such as three or more {i.e. intensity distribution} are used to acquire a frame of data along different scan lines {i.e. different depths}; see ¶ [0057]) (claimed in the alternative);
calculate an evaluation value representing a size of a portion satisfying an appropriate intensity condition for contrast agent imaging in the intensity distribution (evaluating specificity based on contrast agent to tissue contrast ratio; see Chomas ¶ [0043 & 0048]);
select a main measurement condition from the plurality of measurement conditions based on a plurality of evaluation values each corresponding to the plurality of measurement conditions (a maximum contrast agent specificity is identified, such as identifying the transmit power associated with the greatest ratio of contrast agent signal to tissue signal, wherein the most optimal transmit power may be identified by comparing both contrast agent destruction {i.e. upper limit threshold} and contrast agent specificity {i.e. lower limit threshold}; see Chomas ¶ [0049]); and
generate an ultrasound image representing a contrast agent distribution in the specific subject based on reception information obtained from the specific subject by performing transmission and reception for contrast-enhanced ultrasonography based on the main measurement condition (once the optimal transmit power is set, the system continues imaging contrast agents for medical diagnosis; see Chomas ¶ [0058]).
With regards to Claim 21, Chomas discloses wherein the appropriate intensity condition includes an intensity lower limit threshold value for ensuring a minimum contrast of the ultrasound image and an intensity upper limit threshold value for avoiding contrast agent breakage (a maximum contrast agent specificity is identified, such as identifying the transmit power associated with the greatest ratio of contrast agent signal to tissue signal, wherein the most optimal transmit power may be identified by comparing both contrast agent destruction {i.e. upper limit threshold} and contrast agent specificity {i.e. lower limit threshold}; see Chomas ¶ [0049]), and
the portion satisfying the appropriate intensity condition is a portion of the sound pressure distribution that falls between the intensity lower limit threshold value and the intensity upper limit threshold value (contingent limitation, Chomas clearly discloses structure for performing the said function, e.g. Chomas discloses determining an optimal transmit power as detailed above).
With regards to Claim 31, wherein the measurement condition is a transmission parameter set that is a transmission condition for generating a transmission beam (identifying the most optimal transmit power {i.e. transmission condition} based on a comparison between both contrast agent destruction {i.e. upper limit} and contrast agent specificity {i.e. lower limit}).
With regards to Claim 43, wherein the processor is configured to:
perform preliminary transmission and reception for obtaining a biological parameter set representing an ultrasound propagation state in the specific subject based on the reception information obtained from the specific subject (of Act 56, the threshold is a predetermined threshold based on experimental expectations of a particular contrast agent, imaging application, imaging settings, transducer, patient characteristic, other variable or combination thereof; see Chomas ¶ [0056]; wherein the transmit power {i.e. transmission parameter} is optimized based on ratio of contrast agent signal to tissue signal, the contrast agent specificity which is patient dependent); and
execute the simulation by using the transmission parameter set and the biological parameter set as input parameters to estimate the sound pressure distribution along the depth direction in the specific subject (the different data responsive to the different transmit powers {i.e. transmission parameter input parameter} are acquired from different locations for determining the contrast agent imaging power level {i.e. sound pressure distribution along a depth direction}; see Chomas ¶ [0040]; contrast agent specificity data, such as contrast agent to tissue contrast ratio {i.e. biological parameter} compared to a predetermined threshold {i.e. biological parameter input parameter} is responsive to the different transmit powers is detected; see Chomas ¶ [0043]).
With regards to Claim 51, wherein the appropriate intensity condition has an intensity lower limit threshold value for ensuring a desired contrast of the ultrasound image (wherein the most optimal transmit power may be identified by comparing both contrast agent destruction {i.e. upper limit threshold} and contrast agent specificity {i.e. lower limit threshold}; see Chomas ¶ [0049]),
the portion satisfying the appropriate intensity condition is a portion of the distribution related to the harmonic wave that is equal to or higher than the intensity lower limit threshold value (using harmonic imaging to determine a ratio of contrast agent signals to tissue {i.e. the contrast ratio specificity}; see Chomas ¶ [0043]; the most optimal transmit power may be identified by comparing both contrast agent destruction {i.e. upper limit} and contrast agent specificity {i.e. lower limit}; see Chomas ¶ [0049]).
With regards to Claim 71, wherein the processor is configured to calculate the evaluation value based on (claimed in the alternative) a range of interest in the depth direction in the specific subject (the contrast agent specificity, e.g. contrast agent to tissue contrast ratio, is determined for a plurality of different powers, such as three or more {i.e. intensity distribution} which are used to acquire a frame of data along different scan lines {i.e. different depths}; see ¶ [0057]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chomas et al. (US PGPUB 20060030779);
Chomas et al. (US PGPUB 20050187476);
Philips et al. (US PAT 6899681B1); and
Li et al. (US PGPUB 20030158479).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (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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/ASHISH S. JASANI/Examiner, Art Unit 3798
/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798
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