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 .
Response to Arguments
Regarding 35 U.S.C. 112(b)
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment.
Regarding prior art
Applicant's arguments filed 08/07/2026 have been fully considered but they are not persuasive. For example, applicant argues that “as shown above, Friedman mentions that strain values are calculated and stored in a database. The foregoing portion of Friedman is silent regarding determining strain values for only a subset of the image, let alone using a mask image to do so” (REMARKS pg. 10). Examiner respectfully disagrees in that the calculating and storing the strain values in a database does not preclude the nature of the determining of the elastic parameters from being only at positions of the first pixels in the heart wall region based on the mask image. Rather paragraph [0031] explicitly discloses the strain values stored in the data base are associated with a portion of the moving image having the color coded overlay and that they are associated an identified by a pixel position in the first window. Thus it is noted that the strain values calculated and stored are only at positions of the color-coded overlay and thus it is noted that strain values are only determined/stored as pixel values (i.e. the first pixel values) associated with the portion having the color coded overlay (i.e. mask). Additionally/alternatively, examiner notes that the segmented overlay comprises elastic parameters (e.g. average strain value 170) calculated only at positions of the first pixels in the heart wall region (e.g. for each segment) as disclosed in [0032]. Applicant’s arguments that Friedman is silent regarding determining strain values for only a subset of the image are therefore found to be merely conclusory without providing any evidence and it is noted that applicant’s arguments do not replace evidence where evidence is necessary (MPEP 2145).
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 5-6 and 12-13 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.
Claims 5 and 12 recite the limitation “absolute or relative values of elastic parameters”. It is unclear if these are the same values of the same elastic parameters recited previously or if these are different elastic parameters, for examination purposes, it has been interpreted to mean any average or relative values of any elastic parameters, however, clarification is required.
Claims 6 and 13 recite the limitation “said elastic parameters”. It is unclear if said elastic parameters refers to the elastic parameters of claims 1 and 8 or the elastic parameters of claims 5 and 12 respectively. For examination purposes, it has been interpreted to mean any of the previously recited elastic parameters, however, clarification is required.
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.
Claims 1-2, 5, 8-9, 12, 15, 18, and 27-28 are rejected under 35 U.S.C. 103 as being obvious Friedman (US 20070258632 A1), hereinafter Friedman in view of Zhou et al. (US 20190205606 A1), hereinafter Zhou.
Regarding claim 1, 8, and 15,
Friedman teaches a medical imaging system (at least fig. 1 (20) and corresponding disclosure in at least [0015]), comprising:
A scan device (at least fig. 1 (26) which is used to scan a heart region of an examined subject to obtain imaging data ([00;
A processor (at least fig. 1 and 2 (36) and corresponding disclosure in at least [0016]) which is configured for
generating a real-time medical image containing the heart region of the examined subject according to said imaging data ([0016] The ultrasound system 20 also includes a processor module 36 to process the acquired ultrasound information (e.g., RF signal data or IQ data pairs) and prepare frames of ultrasound information for display on a display 38. Acquired ultrasound information may be processed in real-time during a scanning session as the echo signals are received),
inputting said real-time image to a sub-module, receiving, as an output of the sub-module, a mask image containing a heart wall boundary contour of a heart wall region, wherein first pixels that are within the heart wall boundary contour each have a first pixel value, and wherein second pixels that are external to the heart wall boundary contour each have a second pixel value that is different than the first pixel value ([0029] which discloses as shown in FIG. 3, when displaying an image 126 of a heart, six segments may be provided to divide an outline defining an endocardial border and an epicardial border of the myocardium into different regions. Examiner notes that the overlay and division/borders thereof are considered a mask and as can be seen in fig. 3 the pixels that are within the heart wall boundary contour each have a first pixel value and second pixels that are external to the heart wall boundary contour each have a second pixel value (e.g. 0) that is different than the first pixel value));
determining values of elastic parameters only at positions of the first pixels in the heart wall region based on the mask image ([0031] which discloses the strain value may be calculated in any known manner using, for example, the strain sub-module 64, the strain values may be stored in a database that associates the strain value with a portion of the moving image having the color coded overlay and associated and identified, for example, by a pixel position in the first window 150),
generating a real-time local elastic image (at least fig. 4 (152 and/or 122) and corresponding disclosure in at least [0031]-[0032]) of said heart wall region based the values of the elastic parameters ([0031] which discloses calculated strain values may be stored in an addressable table wherein each address corresponds to a different displayed pixel or region of the color coded overlay 162 and [0032] which discloses each of the segments 124 may be defined by a different colored solid line generally defining an area (e.g., a rectangular area). The color coded legend 164 also may be provided similar to the first window 150. In this embodiment, an average strain value 170 is provided within each of the segments 124. In particular, an average strain value 170 as a function of time for the region defined by the segment 124 is displayed in the corresponding segment 124. See also [0024]-[0025] disclosing aspects of the processor including mapping the of the type of data to a color map for video display.);
and a display (at least fig. 1 (38) and corresponding disclosure in at least [0017]) which displays said real-time local elastic image at a position of said heart wall region in said real-time medical image in an overlapping manner [0025] Referring again to FIG. 2, a 2D video processor sub-module 94 combines one or more of the frames generated from the different types of ultrasound information. For example, the 2D video processor sub-module 94 may combine a different image frames by mapping one type of data to a grey map and mapping the other type of data to a color map for video display. In the final displayed image, the color pixel data is superimposed on the grey scale pixel data to form a single multi-mode image frame 98 that is again re-stored in the memory 90 or communicated over the bus 96. See also at least figs. 3 and 4 and corresponding disclosure in at least [0027] and [0030] in which it is disclosed that the overlaid images of figs. 3 and 4 are displayed on display 38),
wherein the real-time local elastic image of the heart wall region is displayed only at the position of said heart wall region determined by the mask image (see at least figs. 3-4 in which the color data (i.e. local elastic image of the heart wall region) is displayed only at the position of said heart wall region determined the mask image (i.e. the segments defined by the mask image of fig. 3)).
Friedman fails to explicitly teach inputting said real-time medical image into an artificial intelligence (AI) model and receiving, as an output of the AI model, the mask image.
Zhou, in a similar field of endeavor involving medical image processing, teaches inputting medical image (at least fig. 12 (1202) and corresponding disclosure in at least [0103]. See also [0062] which discloses medical image is received which can be acquired using ultrasound and [0156] which discloses the image acquisition device(s) may be an ultrasound device to input image data to the computer 2502) into an artificial (AI) model (1200) and corresponding disclosure in at least [0103]) and receiving, as an output of the AI model, a mask image (at least fig. 12 (1208) and corresponding disclosure in at least [0103]) containing a heart wall boundary contour of a heart wall region, wherein first pixels that are within the heart wall boundary contour each have a first pixel value, and wherein second pixels that are external to the heart wall boundary contour each have a second pixel value that is different than the first pixel value (see at least fig. 12 depicting first pixels that are within the heart wall boundary contour in white and second pixels external to the heart wall boundary contour in black).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Friedman to include inputting the real-time medical image into an AI model and receiving as an output of the AI model, the mask image as taught by Zhou in order to perform robust segmentation of the myocardium (Zhou [0099]). Furthermore, such a modification would allow for segmentation results with excellent myocardium and prevent the extraction of diagnostically unacceptable myocardium contours (Zhou [0101]).
Examiner notes that in the modified system the real-time elastic image is necessarily determined based on the mask of Zhou and displayed only at the position of said heart wall region determined by the mask of Zhou (i.e. the myocardium).
Examiner further notes that the modified system would perform the medical imaging method of claim 1 and could comprise the medical imaging apparatus of claim 8 each having corresponding method steps/structure functionality.
Regarding claims 2 and 9,
Friedman further discloses wherein the said medical image is a grayscale image and said real-time local elastic image is a color image ([0025] which discloses for example, the 2D video processor sub-module 94 may combine a different image frames by mapping one type of data to a grey map and mapping the other type of data to a color map for video display. In the final displayed image, the color pixel data is superimposed on the grey scale pixel data to form a single multi-mode image frame 98 that is again re-stored in the memory 90 or communicated over the bus 96. See also at least figs. 3 and 4 and corresponding disclosure in at least [0027] and [0030] in which it is disclosed that the overlaid images of figs. 3 and 4 are displayed on display 38 and [0031] which discloses overlaid on the moving image 160, for example, a color coded overlay showing a color coded scale representing different strain value or levels and [0032] which discloses Thus, when the marker 166 is placed at any point in the color coded overlay 162 in the first window 150, the peak systolic value 172 corresponding to that point is displayed in the second window 152. Alternatively, the peak systolic value 172 may be displayed in other regions of the display 38, for example, in the first window 150. It should be noted that the peak systolic value 172 in one embodiment is the peak systolic strain, and more particularly, the peak negative strain if the peak occurs during systole or end systolic strain if the peak occurs later. This value generally may be the strain value as a function of any time during the heart cycle.
Regarding claims 5, 12, and 18,
Friedman further teaches wherein the one or more processors are further configured to determine absolute or relative values of elastic parameters at various positions in said heart wall region ([0031] which discloses the strain value may be calculated in any known manner using, for example, the strain sub-module 64 (shown in FIG. 2); determine color codes corresponding to the absolute or relative values of said elastic parameters ([0031] which discloses the calculated strain values may be stored in a database that associates the strain value with a portion of the moving image 160 having the color coded overlay 162 and associated and identified, for example, by a pixel position in the first window 150. For example, calculated strain values may be stored in an addressable table wherein each address corresponds to a different displayed pixel or region of the color coded overlay 162 [0031] The first window 150 may also include information overlaid on the moving image 160, for example, a color coded overlay 162 displayed as a function of time and defined by a color coded legend 164 showing a color coded scale representing different strain value or levels, such as, percentage levels where such color coding requires determining color codes corresponding to the absolute or relative values of strain (i.e. elastic parameters)); and generate said real-time local elastic image according to the corresponding color codes at various positions in said heart wall region ([0031] which discloses the first window 150 may also include information overlaid on the moving image 160, for example, a color coded overlay 162 displayed as a function of time and defined by a color coded legend 164 showing a color coded scale representing different strain value or levels, such as, percentage levels, where such generation of a color coded overlay requires a generation module to generate said real-time local elastic image (i.e. color overlay for any or all of the segments thereof)).
Regarding claim 27,
Friedman, as modified, teaches the elements of claim 1 as previously stated. Zhou, as applied to claim 1 above, further teaches wherein the mask image is a same size as the real-time medical image (see at least fig. 12).
Regarding claim 28,
Friedman, as modified, teaches the elements of claim 1 as previously stated. Zhou, as applied to claim 1 above, further teaches wherein the first pixel value is 1 and wherein the second pixel value is 0 (see at least fig. 12 depicting first pixels that are within the heart wall boundary contour in white (1) and second pixels external to the heart wall boundary contour in black (0)).
Claims 6, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman and Zhou, as applied to claims 5, 12, and 18 above, and further in view of WIPO Kanai et al. (WO 2007072720 A1), hereinafter Kanai.
Regarding claims 6, 13, and 19,
Friedman teaches the elements of claims 5, 12, and 18 as previously stated. Friedman fails to explicitly teach wherein the elastic parameters reflect the stiffness of a tissue organ, including one of Young’s modulus, elastic modulus, shear modulus, and shear wave propagation velocity.
Kanai, in a similar field of endeavor involving ultrasound imaging, teaches determining absolute or relative values of elastic parameters at various positions of a heart ([0057] which discloses it is possible to determine the elastic modulus at a plurality of measurement positions and [0064] which discloses the elastic modulus distribution of the blood vessel wall in the living body may be obtained non-invasively using the ultrasonic diagnostic apparatus and [0088] which discloses the case of the two dimensional distribution of the elastic modulus of the blood vessel wall is exemplified. The ultrasonic tissue identification device of the present invention is a cardiovascular tissue other than the blood vessel wall such as the heart or the liver), determining color codes corresponding to the absolute or relative values of said elastic parameters ([0060] which discloses the elastic modulus distribution may be a two-dimensional color image using a color scheme corresponding to the elastic modulus value in the image. Such display of an image using a color scheme would require determining color codes corresponding to the absolute or relative values of said elastic parameters); and generating an elastic image according to the corresponding color codes at various positions of a heart ([0060] which discloses the elastic modulus distribution may be a two-dimensional color image using a color scheme corresponding to the elastic modulus value in the image), wherein the elastic parameter is a parameter reflecting stiffness of a tissue organ including elastic modulus ([0088] which discloses the case of the two dimensional distribution of the elastic modulus of the blood vessel wall is exemplified. The ultrasonic tissue identification device of the present invention is a cardiovascular tissue other than the blood vessel wall such as the heart or the liver).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Friedman to include an elastic parameter reflecting stiffness including elastic modulus as taught by Kanai in order to evaluate additional/alternative elasticity values for the heart. Such a modification would therefore enhance diagnostics of the heart by providing an elastic modulus distribution for evaluating the stiffness of the heart tissue. . Furthermore, it is noted that determination of an elastic parameter reflecting stiffness including elastic modulus amounts to merely a simple substitution of one known physical characteristic/elastic parameter for another yielding predictable results with respect to cardiac evaluation (see Kanai [0021] which discloses the physical characteristic value is at least one of a maximum tissue thickness variation, strain, elastic modulus viscosity, etc)
Claims 7, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman and Zhou, as applied to claims 1, 8, and 15 above, and further in view of Torres et al. (US 20200100768 A1), hereinafter Torres and Beqiri et al. (US 20230104425 A1), hereinafter Beqiri.
Regarding claims 7, 14, and 20,
Friedman teaches the elements of claims 1, 8, and 15 as previously stated. Friedman fails to explicitly teach wherein said processor is further configured for: determining an end of diastole of the heart of said examined subject; and, acquiring said medical image from the scan at said end of diastole, as well as generating said real-time local elastic image at said end of diastole.
Torres, in a similar field of endeavor involving ultrasound imaging, teaches a processor/determination unit configured for acquiring a medical image from a scan at said end diastole (see at least fig. 5D and corresponding disclosure in at least [0017], and [0089]), as well as calculating elastic data at said end of diastole ([0090])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Friedman to include acquiring a medical image from a scan at end diastole in order to acquire image data from a specific phase of the heart cycle for corresponding evaluation thereof.
While acquiring a medial image from a scan at said end diastole would appear to require that the processor/determination unit determines an end of diastole of the heart of said examined subject, this feature is not explicitly disclosed by Torres. Thus Friedman, as modified, fails to explicitly teach wherein said processor/determination unit is configured for determining an end of diastole of the heart of said examined subject.
Nonetheless, Beqiri, in a similar field of endeavor involving ultrasound imaging, teaches a processor ([0044] which discloses a first responder) configured for determining an end of diastole of the heart of said examined subject ([0044] which discloses the first responder is arranged to determine the end-systole and end-diastole), acquiring a medical image from the scan at said end of diastole ([0044] which discloses determining end-diastole frames), and calculating elastic data at said end of diastole ([0045]-[0048])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Friedman, as currently modified, to include determining an end diastole of the heart as taught by Beqiri in order to provide for automatically identifying the medical image at said end of diastole (i.e. determining the end-diastolic frame). Such a modification would provide for an automated system which can more easily and efficiently diagnose the patient (Beqiri [0012]).
Examiner notes that in the modified system, the processor generates the real-time local elastic image based on the calculations of elastic data, therefore, generates the real-time local elastic image at said end of diastole accordingly (i.e. the time at which the elastic values are calculated in the modified system/method).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou et al. (WO 2022141257 A1) teaches only performing color mapping and strain imaging on the target tissue and calculating the mean strain value of the target tissue only (see pg. 11)
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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