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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/22/25 has been entered.
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) 1, 11, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ertel et al. (US 2013/0261445; hereinafter Ertel) in view of Tolkowsky et al. (US 2014/0121513; hereinafter Tolkowsky), Flohr et al. (US 2019/0038239; hereinafter Flohr), and Barnes et al. (US 2020/0234442; hereinafter Barnes).
Ertel shows a medical image processing device and method (abstract) comprising processing circuitry configured to: detect individual microbubbles in a contrast medium from a medical image (time density curves represented for individual pixels; [0022]), set a first region of interest and a second region of interest in the medical image (time density curve for each pixel in the entire image encompasses multiple regions, to determine perfusion parameters such as inflow of contrast medium; [0022], [0031]), calculate based on the detected microbubbles a density of microbubbles in a first region of interest in the medical image, and a density of microbubbles in a second region of interest (time density curves; [0022], [0031]).
Ertel also shows calculate a motion vector of the contrast medium by tracking a position of the contrast medium in each of a plurality of medical images arranged in time series (inflow of contrast agent and associated perfusion parameters represented as dynamic image or parameter map, [0031]); an ultrasonic diagnostic device ([0015]).
Ertel fails to show output information that allows comparison of temporal changes between the calculated density of microbubbles in the first region of interest and the calculated density of microbubbles in the second region of interest.
Ertel fails to show wherein the second region of interest is a region inside the first region of interest and surrounded by the first region of interest. Also, the first region of interest is an annular region.
Ertel fails to show calculate a density by dividing a number of microbubbles in the region of interest by an area of the region of interest.
Tolkowsky discloses apparatus and methods for measuring velocity of a contrast agent. Tolkowsky teaches output information that allows comparison of temporal changes between the calculated density of microbubbles in the first region of interest and the calculated density of microbubbles in the second region of interest (compare density of contrast agent in a healthy section of the lumen to the density of contrast agent in other parts of the lumen, [0395]; [0324], [0327], [0351], [0354]-[0356], [0415], [0460]).
Flohr discloses medical image analysis techniques. Flohr teaches wherein the second region of interest is a region inside the first region of interest and surrounded by the first region of interest. Also, the first region of interest is an annular region ([0083], [0119]-[0121]; Figs. 4-5).
Barnes discloses methods and systems for image analysis of tumor samples. Barnes teaches calculate a density by dividing a number of objects in the region of interest by an area of the region of interest ([0076], [0210]).
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 Ertel to output comparison of temporal changes between the density of microbubbles in a first and second region of interest as taught by Tolkowsky, as Tolkowsky teaches that a comparison type densitometry measurement of different regions of the patient’s blood vessel allows for determining diagnostic parameters such as the cross-sectional area and blood velocity, thereby improving the quality of the diagnostic measurement ([0351], [0354]-[0355], [0392], [0415]).
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 combined invention of Ertel and Tolkowsky to utilize measurement regions such as annular regions where one region surrounds and excludes the other region as taught by Flohr, as Flohr teaches that this type of measurement arrangement is particularly suitable for the examination of tissue functions where the tissue structure has structural and functional differences between the center and edge regions, as the measurement arrangement allows for the differences to be advantageously determined.
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 combined invention of Ertel and Tolkowsky, and Flohr to calculate density in each of the first and second regions by dividing a number of detected objects by the area of the region of interest as taught by Barnes, as a mathematical calculation for density is known and may be applied to image analysis techniques to more accurately quantify the number of objects in the imaged region of interest.
Claim(s) 3-4 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ertel et al. (US 2013/0261445; hereinafter Ertel) in view of Tolkowsky et al. (US 2014/0121513; hereinafter Tolkowsky), Flohr et al. (US 2019/0038239; hereinafter Flohr), and Barnes et al. (US 2020/0234442; hereinafter Barnes as applied to claim 1 above, and further in view of Schormans et al. (US 2015/0262358; hereinafter Schormans).
Ertel fails to show calculate a density ratio between a density of the contrast medium included in the first region of interest and a density of the contrast medium included in the second region of interest.
Ertel fails to show calculate an inflow/outflow ratio of the contrast medium in at least one of the first region of interest and the second region of interest.
Ertel fails to show the processing circuitry calculates, as the density ratio, a value in a predetermined time phase, or a cumulative value or an average value in a predetermined section; the processing circuitry calculates the cumulative value or the average value in the predetermined section while eliminating double-counting of an identical bubble; calculates, as the inflow/outflow ratio, a value in a predetermined time phase, or a cumulative value or an average value in a predetermined section; the processing circuitry calculates, as the inflow/outflow ratio, at least one of a value obtained by dividing the number of inflow bubbles by the number of inflow/outflow bubbles, a value obtained by dividing the number of outflow bubbles by the number of inflow/outflow bubbles, a value obtained by dividing the number of inflow bubbles by the number of outflow bubbles, and a value obtained by dividing the number of outflow bubbles by the number of inflow bubbles.
Schormans discloses a method and apparatus for quantitative measurement on sequences of images. Schormans teaches calculate a density ratio between a density of the contrast medium included in the first region of interest and a density of the contrast medium included in the second region of interest (calculate regurgitant fraction by processing time intensity curves according to formula of areas and volumes of left ventricular and aortic regions of interest, [0010]; time-density curves created for ventricular area and reference area, [0072]; region of left ventricle sub-divided into several different regions, [0075]-[0076], Figure 3A; time-density curves created for aortic area, [0081]; compare densitometry values in different defined areas, [0092]-[0093]; quantify regurgitation regarding inflow/outflow and display as color map, [0096], [0099]-[0100]). Also, calculate an inflow/outflow ratio of the contrast medium in at least one of the first region of interest and the second region of interest ([0010], [0100]); wherein the first region of interest is a region surrounding the second region of interest (different regions of the heart such as left ventricular and aortic regions, [0010], [0071], [0075]); the processing circuitry calculates, as the density ratio, a value in a predetermined time phase, or a cumulative value or an average value in a predetermined section (computing within each pixel, integral of time density curve, [0100]); the processing circuitry calculates the cumulative value or the average value in the predetermined section while eliminating double-counting of an identical bubble (as each pixel is computed individually, the technique is considered to eliminate double counting of any same region of contrast; [0100]); the processing circuitry calculates, as the inflow/outflow ratio, at least one of a value obtained by dividing the number of inflow bubbles by the number of inflow/outflow bubbles, a value obtained by dividing the number of outflow bubbles by the number of inflow/outflow bubbles, a value obtained by dividing the number of inflow bubbles by the number of outflow bubbles, and a value obtained by dividing the number of outflow bubbles by the number of inflow bubbles (time density curves are representative of the contrast agent/bubble; [0010], [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 combined invention of Ertel, Tolkowsky, Flohr, and Barnes to calculate a density ratio as taught by Schormans, as a variety of different flow related parameters are known in the art, and a ratio will be particularly beneficial in characterizing flow parameters related to regurgitation as taught by Ertel ([0010]).
Allowable Subject Matter
Claims 12-17 and 19 are allowed over the prior art of record.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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
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