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
Applicant's arguments filed 03/19/2026 have been fully considered but they are not persuasive. For example, applicant argues that “the ‘553 application fails to disclose that the first region and the second region are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set” and “the ‘553 application discloses that, as shown in Fig. 4, the first ROI (401) and the second ROI (402) are merely display regions that are independent selected by the user and there is no functional or structural linkage between them” and “the two regions have a linked relationship based on the physical quantities observed in each region. Further, in this example, the apparatus of claim 1 utilizes the linkage to configured the first region and the second region so that they operate in conjunction with each other, as such that one region is automatically set based on the setting of the other” (REMARK pg. 10-11). Examiner respectfully disagrees in that the claim broadly recites that that the first and second region are associated with each other and that one is set in accordance with the other, but does not explicitly nor implicitly require any functional or structural linkage between the first and second region nor is there any automatic setting recited by the claims. Examiner thus notes that in view of the broadly recited limitation the setting of the first and second ROIs of Nam although set by a user are considered to be associated with each other (e.g. via the image from which they are selected) and it is noted that the user selects both, thus it is interpreted that the setting of one of the ROIs is in accordance with the remaining ROI in that a user sets the first one and then sets the second in accordance with the first in its broadest reasonable interpretation and the claim does not specify the nature of the association nor the setting. Examiner further notes that although the claims are broadly recited an alternative 103 rejection is set forth which relies upon teachings from Sonoyama to teach associating the first and second ROI such that they are “linked” or associated as required by the claims and such that the setting of one is in accordance with another.
Claim Rejections - 35 USC § 102/103
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 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.
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, 3, 5, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nam et al. (US 20150262553 A1), hereinafter Nam or in the alternative under 35 U.S.C. 103 as obvious over Nam in view of Sonoyama (US 20190183461 A1), hereinafter Sonoyama.
Regarding claim 1
Nam teaches an ultrasound diagnostic apparatus comprising processing circuitry (at least figs 5/6 (500)) configured to:
define a first region (at least fig. 4 (401) and corresponding disclosure in at least [0085]) for acquiring a first index value based on a shear wave that propagates through a living body and a second region (at least fig. 4 (402) and corresponding disclosure in at least [0085]) for acquiring a second index value based on an attenuation of an ultrasound wave inside the living body;
Conduct a first scan and a second scan by way of an ultrasonic probe in a predetermined order, the first scan being for acquiring the first index value at each position in the first region and the second scan being for acquiring the second index value at each position in the second region ([0051] which discloses all functional images and parametric images may be generated and then displayed, which may be obtained through one scanning of a region of interest of an object without changing the location of a probe and [0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object. [0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal. Examiner notes that a person having ordinary skill in the art would have recognized a first and second scan for the different images (i.e. a first scan for the shear modulus image and a second scan for the attenuation image));
Generate a first image (at least fig. 4 (410/430) and corresponding disclosure in at least [0085]-[0086]) corresponding to the first region based on the first index value acquired from the first scan ([0085] which discloses a PDI, a shear wave velocity image and an attenuation image may be included in the second image set 410); generate a second image (at least fig. 4 (420/440) and corresponding disclosure in at least [0085]-[0086]) corresponding to the second region based on the second index value acquired from the second scan ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the first image and the second image to be displayed on a display at display positions that are different from each other and aligned with each other (see at least fig. 4 depicting the first and second image displayed on a display at display positions different from each other ([0086] which discloses a second image 425 selected in the second image set 420 produced in correspondence to the second ROI 402 may be disposed next to the first image 210 in parallel for a display 440), wherein the first region (401) and the second region (402) are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set (See at least fig. 4 depicting regions which are associated with each other in its broadest reasonable interpretation. Where the first ROI and second ROI are selected, thus in accordance with a setting of the first ROI 401 the second ROI 402 is necessarily set).
Alternatively, if the selection of the first region or second region of Nam is not considered to be in accordance with the remaining region, Sonoyama, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor configured to define a first region for acquiring an index value and a second region for acquiring a second index value, wherein the first region and the second region are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set ([0077] which discloses it is desirable that the region of interest setting unit 50 has a function of interlocking setting of changing the set position of one of the first region of interest and the second region of interest in accordance with change of the set position of the other one. In the interlocking setting, while maintaining e.g., the relative positional relationship between the first region of interest and the second region of interest, the one set position is changed in accordance with change of the other set position)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include associating the first region and the second region as taught by Sonoyama in order to maintain the relative positional relationship between the first region of interest and the second region of interest (Sonoyama [0077]). Such a modification would allow for setting of a desired positional relationship between the first region and second region such that if one is moved/set the other is moved/set to have the same positional relationship accordingly which may be a desired function by the user.
Regarding claim 3,
Nam further teaches, wherein the first index value is an elasticity index value indicating elasticity of a tissue in the living body ([0085] which discloses a PDI, a shear wave velocity image (where a shear wave velocity is considered an elasticity index value) and an attenuation image may be included in the second image set 410),
the second index value is an attenuation index value indicating attenuation of the ultrasound wave inside the living body ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402), and
The processing circuitry is configured to generate as the first image an elasticity image corresponding to the first region based on the elasticity index value ([0085] which discloses a PDI, a shear wave velocity image (considered an elasticity image in its broadest reasonable interpretation) and an attenuation image may be included in the second image set 410);
Generate as the second image an attenuation image corresponding to the second region based on the attenuation index value ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the elasticity image and the attenuation image to be displayed at display positions that are different from each other and aligned with each other (see at least fig. 4).
Regarding claim 5,
Nam further teaches wherein the first index value is a propagation index value of a shear wave that propagates through the living body ([0085] which discloses a PDI, a shear wave velocity image (where a shear wave velocity is considered a propagation index value) and an attenuation image may be included in the second image set 410),
the second index value is an attenuation index value indicating attenuation of the ultrasound wave inside the living body ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402), and
The processing circuitry is configured to:
generate as the first image a propagation image corresponding to the first region based on the propagation index value ([0085] which discloses a PDI, a shear wave velocity image (considered a propagation image) and an attenuation image may be included in the second image set 410);
Generate as the second image an attenuation image corresponding to the second region based on the attenuation index value ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the propagation image and the attenuation image to be displayed at display positions that are different from each other and aligned with each other (see at least fig. 4).
Regarding claim 13,
Nam further teaches wherein the processing circuitry is further configured to generate an elasticity image as the first image [0085] which discloses a PDI, a shear wave velocity image (i.e. elasticity image) and an attenuation image may be included in the second image set 410); generate an attenuation image as the second image ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 40), and associate a first measurement region that overlaps the first image and the second measurement region that overlaps the second image with each other (Examiner notes that the entire image and data therein is considered a first measurement region that is associated with and overlaps the first image and the entire second image is considered a second measurement region that is associated with and overlaps the second image)
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 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Sonoyama (US 20190183461 A1), hereinafter Sonoyama.
Regarding claim 2,
Nam teaches the elements of claim 1 as previously stated. Nam further teaches wherein the processing circuitry is further configured to cause the first image to be displayed at a first display position and the second image to be displayed at a second position determined to be aligned with the first display position and having a display area different from a display area of the first display position (see at least fig. 4).
Nam fails to explicitly teach the display area of the second display position is different from the first display position in shape and size.
Sonoyama, in a similar field of endeavor involving ultrasound imaging, teaches wherein ROIs have display areas different in shape and size (See at least fig. 5 (R2 and R1)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include display areas having different shape and size as taught by Sonoyama in order to allow for image data to be produced for regions having different shapes and sizes as desired by a user. Such a modification allows for different data to be shown/displayed to a user. Furthermore, such a modification amounts to merely an obvious design change lacking criticality to the claimed invention, thus rendering the claim obvious (MPEP 2144.04)
Regarding claim 12,
Nam, or Nam as modified by Sonoyama, teaches the elements of claim 1 as previously stated. Nam further teaches wherein the first region is for acquiring an index value indicating elasticity or viscosity ([0085] which discloses a PDI, a shear wave velocity image (where a shear wave velocity is considered a propagation index value) and an attenuation image may be included in the second image set 410) and the second region is for acquiring an index value indicating an attenuation as the second index value ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402).
Nam fails to explicitly teach wherein the processing circuitry is further configured to change, in accordance with change of a position of one of the first region and the second region, a position of the remaining one of the first region and the second region
Nonetheless, Sonoyama further teaches wherein the processing circuitry is further configured to change, in accordance with change of a position of one of the first region and the second region, a position of the remaining one of the first region and the second region (Sonoyama [0077] which discloses it is desirable that the region of interest setting unit 50 has a function of interlocking setting of changing the set position of one of the first region of interest and the second region of interest in accordance with change of the set position of the other one. In the interlocking setting, while maintaining e.g., the relative positional relationship between the first region of interest and the second region of interest, the one set position is changed in accordance with change of the other set position),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include associating the first region and the second region as taught by Sonoyama in order to maintain the relative positional relationship between the first region of interest and the second region of interest (Sonoyama [0077]). Such a modification would allow for setting of a desired positional relationship between the first region and second region such that if one is moved/set the other is moved/set to have the same positional relationship accordingly which may be a desired function by the user.
Claims 4 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Honjo et al. (US 2017156700 A1), hereinafter Honjo.
Regarding claim 4,
Nam further teaches, wherein the first index value is a viscosity index value indicating viscosity of a tissue of the living body (Examiner notes that the first index value in claim 1 is recited in an intended use limitation above (i.e. “for acquiring a first index value” and “for acquiring the first index value”), examiner notes thus notes that the scan for shear wave imaging for the first region would be capable of being used for acquiring a first index value that is a viscosity index value indicating viscosity of a tissue in the living body), the second index value is an attenuation index value indicating attenuation of the ultrasound wave inside the living body, and
The processing circuitry is configured to generate the first image corresponding to the first region based on the first index value ([0085] which discloses a PDI, a shear wave velocity image and an attenuation image may be included in the second image set 410);
Generate as the second image an attenuation image corresponding to the second region based on the attenuation index value ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the first image and the attenuation image to be displayed at display positions that are different from each other and aligned with each other (see at least fig. 4).
Nam fails to explicitly teach wherein the processing circuitry is configured to generate as the first image a viscosity image corresponding to the first region based on the viscosity index value.
Honjo, in a similar field of endeavor involving ultrasound imaging, teaches processing circuitry (at least fig. 1 (100/130) and corresponding disclosure in at least [0026] and [0032]) configured to:
conduct a first scan for acquiring a viscosity index value (at least fig. 7 (S102) and corresponding disclosure in at least [0086]) at each position in a first region (at least figs. 12-14 (21) and corresponding disclosure in at least [0079] or at least figs. 12-13 (40) and corresponding disclosure in at least [0138]);
generate a viscosity image (at least figs. 6 and 12-14 (21) and corresponding disclosure in at least [0168] and [0079] which discloses [0079] For example, the image processing function 132 generates an index image 21 in which hues corresponding to the index values are assigned and [0075] which discloses In other words, by analyzing the detected shear wave, the signal processing function 131 calculates the index value that indicates the viscosity within the object and that is not dependent on any physical model related to viscoelasticity and [0101] which discloses is configured to calculate the index values of viscosity by expressing the changes in the shapes of the curves in the time-displacement curves corresponding to the viscosity levels as differences in the phase velocity values of the time-displacement curves and [0168] which discloses [0168] As explained above, the signal processing function 131 calculates the index values of the viscosity at the sampling points in the depth direction and the direction of orientation. Further, for example, the image processing function 132 generates an index image illustrated in FIG. 6, by assigning colors corresponding to the index values of the viscosity at the sampling points in the depth direction and the direction of orientation) corresponding to the first region based on the viscosity index value acquired from the first scan.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include generating a viscosity image as taught by Honjo in order to provide additional functional diagnostic data of the patient accordingly. Such a modification would allow for further diagnostic advantages of viscoelastic properties of the tissue (Honjo [0003]) thus enhancing the overall diagnosis of the patient.
Examiner notes that in the modified system, the viscosity image is an additional image which would be included in either of 410/420 of Nam and/or would be selected as image 430, thus would be aligned with the attenuation image found in either 410/420 or selected as image 440.
Regarding claim 8,
Nam teaches an ultrasound diagnostic apparatus comprising processing circuitry (at least figs 5/6 (500)) configured to:
define a first region (at least fig. 4 (401) and corresponding disclosure in at least [0085]) for acquiring an elasticity index value indicating elasticity of a tissue of a living body ([0085] which discloses that the second set of images produced in correspondence to the first ROI may include a shear wave velocity image) and a viscosity index value indicating viscosity of the tissue (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first region. Examiner notes that the first region of Nam is capable of being used for acquiring a viscosity index value indicating viscosity of the tissue, thus meets the claim), and a second region (at least fig. 4 (402) and corresponding disclosure in at least [0085]) for acquiring an attenuation index value indicating attenuation of an ultrasound wave inside the living body ([0085] disclosing that the second image sets 420 produced in correspondence with the second ROI may include an attenuation image);
Conduct a first scan and a second scan by way of an ultrasonic probe in a predetermined order ([0051] which discloses all functional images and parametric images may be generated and then displayed, which may be obtained through one scanning of a region of interest of an object without changing the location of a probe and [0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object. [0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal. Examiner notes that a person having ordinary skill in the art would have recognized a first and second scan (i.e. a first scan for the shear wave velocity/shear modulus image and a second scan for the attenuation image) performed in a predetermined order for the different images to be generated accordingly), the first scan being for acquiring the elasticity index value ([0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object) and the viscosity index value at each position in the first region (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first scan. Examiner notes that the first scan of Nam is a shear wave imaging scan and thus is capable of being used for acquiring a viscosity index value indicating viscosity of the tissue. Therefore, the teachings of Nam meets the claim) and the second scan being for acquiring the attenuation index value at each position in the second region ([0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal);
Generate an elasticity image (at least fig. 4 (410/430) and corresponding disclosure in at least [0085]-[0086]) corresponding to the first region based on the first index value acquired from the first scan ([0085] which discloses a PDI, a shear wave velocity image (i.e. elasticity image) and an attenuation image may be included in the second image set 410); generate an attenuation image (at least fig. 4 (420/440) and corresponding disclosure in at least [0085]-[0086]) corresponding to the second region based on the second index value acquired from the second scan ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the first image and the second image to be displayed on a display at display positions that are different from each other and aligned with each other (see at least fig. 4 depicting the first and second image displayed on a display at display positions different from each other ([0086] which discloses a second image 425 selected in the second image set 420 produced in correspondence to the second ROI 402 may be disposed next to the first image 210 in parallel for a display 440), wherein the first region (401) and the second region (402) are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set (See at least fig. 4 depicting regions which are associated with each other in its broadest reasonable interpretation. Where the first ROI and second ROI are selected, thus in accordance with a setting of the first ROI 401 the second ROI 402 is necessarily set).
Alternatively, if the selection of the first region or second region of Nam is not considered to be in accordance with the remaining region, Sonoyama, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor configured to define a first region for acquiring an index value and a second region for acquiring a second index value, wherein the first region and the second region are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set ([0077] which discloses it is desirable that the region of interest setting unit 50 has a function of interlocking setting of changing the set position of one of the first region of interest and the second region of interest in accordance with change of the set position of the other one. In the interlocking setting, while maintaining e.g., the relative positional relationship between the first region of interest and the second region of interest, the one set position is changed in accordance with change of the other set position)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include associating the first region and the second region as taught by Sonoyama in order to maintain the relative positional relationship between the first region of interest and the second region of interest (Sonoyama [0077]). Such a modification would allow for setting of a desired positional relationship between the first region and second region such that if one is moved/set the other is moved/set to have the same positional relationship accordingly which may be a desired function by the user.
Nam fails to explicitly teach wherein the processing circuitry is configured to generate a viscosity image corresponding to the first region based on the viscosity index value acquired from the first scan.
Honjo, in a similar field of endeavor involving ultrasound imaging, teaches processing circuitry (at least fig. 1 (100/130) and corresponding disclosure in at least [0026] and [0032]) configured to:
conduct a first scan for acquiring an elasticity index value and a viscosity index value (at least fig. 7 (S102) and corresponding disclosure in at least [0086]) at each position in a first region (at least figs. 12-14 (21) and corresponding disclosure in at least [0079] or at least figs. 12-13 (40) and corresponding disclosure in at least [0138]);
generate an elasticity image (at least figs. 13-14 (50) and corresponding disclosure in at least [0144]) corresponding to the first region based on the elasticity index value acquired from the first scan and a viscosity image (at least figs. 6 and 12-14 (21/50) and corresponding disclosure in at least [0168] and [0079] which discloses [0079] For example, the image processing function 132 generates an index image 21 in which hues corresponding to the index values are assigned and [0075] which discloses In other words, by analyzing the detected shear wave, the signal processing function 131 calculates the index value that indicates the viscosity within the object and that is not dependent on any physical model related to viscoelasticity and [0101] which discloses is configured to calculate the index values of viscosity by expressing the changes in the shapes of the curves in the time-displacement curves corresponding to the viscosity levels as differences in the phase velocity values of the time-displacement curves and [0168] which discloses As explained above, the signal processing function 131 calculates the index values of the viscosity at the sampling points in the depth direction and the direction of orientation. Further, for example, the image processing function 132 generates an index image illustrated in FIG. 6, by assigning colors corresponding to the index values of the viscosity at the sampling points in the depth direction and the direction of orientation) corresponding to the first region based on the viscosity index value acquired from the first scan
cause the elasticity image (21) and the viscosity image (50) to be displayed on a display at display positions that are different from each other and aligned with each other (See at least figs. 13-14)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include generating a viscosity image as taught by Honjo in order to provide additional functional diagnostic data of the patient accordingly. Such a modification would allow for further diagnostic advantages of viscoelastic properties of the tissue (Honjo [0003]) thus enhancing the overall diagnosis of the patient.
Examiner notes that in the modified system, the viscosity image is an additional image which would be included in either of 410/420 of Nam and therefore would be aligned with the elasticity image and attenuation image accordingly.
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have arranged the attenuation image, the elasticity image, and the viscosity image to be aligned with each other in the same manner as the four images of Honjo shown in fig. 14 in order to provide simultaneous display of each of the functional images (Honjo [0151]) acquired and superimposed over the B-mode image. Such a modification would enhance a user’s ability to visualize all of the generated images relative to the corresponding surrounding structures.
Regarding claim 9,
Nam teaches an ultrasound diagnostic apparatus comprising processing circuitry (at least figs 5/6 (500)) configured to:
define a first region (at least fig. 4 (401) and corresponding disclosure in at least [0085]) for acquiring an elasticity index value indicating elasticity of a tissue of a living body ([0085] which discloses that the second set of images produced in correspondence to the first ROI may include a shear wave velocity image) and a propagation index value of a shear wave that propagates through the living body (Examiner notes that the limitation for acquiring a propagation index value is directed towards intended use of the first region. Examiner notes that the first region of Nam is capable of being used for acquiring a propagation index value of a shear wave that propagates through the living body, thus meets the claim), and a second region (at least fig. 4 (402) and corresponding disclosure in at least [0085]) for acquiring an attenuation index value indicating attenuation of an ultrasound wave inside the living body ([0085] disclosing that the second image sets 420 produced in correspondence with the second ROI may include an attenuation image);
Conduct a first scan and a second scan by way of an ultrasonic probe in a predetermined order([0051] which discloses all functional images and parametric images may be generated and then displayed, which may be obtained through one scanning of a region of interest of an object without changing the location of a probe and [0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object. [0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal. Examiner notes that a person having ordinary skill in the art would have recognized a first and second scan (i.e. a first scan for the shear wave velocity/shear modulus image and a second scan for the attenuation image) performed in a predetermined order for the different images to be generated accordingly), the first scan being for acquiring the elasticity index value ([0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object) and the propagation index value at each position in the first region (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first scan. Examiner notes that the first scan of Nam is a shear wave imaging scan and thus is capable of being used for acquiring a propagation index value at each position in the first region. Therefore, the teachings of Nam meets the claim) and the second scan being for acquiring the attenuation index value at each position in the second region ([0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal);
Generate an elasticity image (at least fig. 4 (410/430) and corresponding disclosure in at least [0085]-[0086]) corresponding to the first region based on the first index value acquired from the first scan ([0085] which discloses a PDI, a shear wave velocity image (i.e. elasticity image) and an attenuation image may be included in the second image set 410); generate an attenuation image (at least fig. 4 (420/440) and corresponding disclosure in at least [0085]-[0086]) corresponding to the second region based on the second index value acquired from the second scan ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the first image and the second image to be displayed on a display at display positions that are different from each other and aligned with each other (see at least fig. 4 depicting the first and second image displayed on a display at display positions different from each other ([0086] which discloses a second image 425 selected in the second image set 420 produced in correspondence to the second ROI 402 may be disposed next to the first image 210 in parallel for a display 440), wherein the first region (401) and the second region (402) are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set (See at least fig. 4 depicting regions which are associated with each other in its broadest reasonable interpretation. Where the first ROI and second ROI are selected, thus in accordance with a setting of the first ROI 401 the second ROI 402 is necessarily set).
Alternatively, if the selection of the first region or second region of Nam is not considered to be in accordance with the remaining region, Sonoyama, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor configured to define a first region for acquiring an index value and a second region for acquiring a second index value, wherein the first region and the second region are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set ([0077] which discloses it is desirable that the region of interest setting unit 50 has a function of interlocking setting of changing the set position of one of the first region of interest and the second region of interest in accordance with change of the set position of the other one. In the interlocking setting, while maintaining e.g., the relative positional relationship between the first region of interest and the second region of interest, the one set position is changed in accordance with change of the other set position)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include associating the first region and the second region as taught by Sonoyama in order to maintain the relative positional relationship between the first region of interest and the second region of interest (Sonoyama [0077]). Such a modification would allow for setting of a desired positional relationship between the first region and second region such that if one is moved/set the other is moved/set to have the same positional relationship accordingly which may be a desired function by the user.
Nam fails to explicitly teach wherein the processing circuitry is configured to generate a propagation image (interpreted to be different from the elasticity image) corresponding to the first region based on propagation index value acquired from the first scan.
Honjo, in a similar field of endeavor involving ultrasound imaging, teaches processing circuitry (at least fig. 1 (100/130) and corresponding disclosure in at least [0026] and [0032]) configured to:
conduct a first scan for acquiring an elasticity index value and a propagation index value (at least fig. 7 (S102) and corresponding disclosure in at least [0086]) at each position in a first region (at least figs. 12-14 (21) and corresponding disclosure in at least [0079] or at least figs. 12-13 (40) and corresponding disclosure in at least [0138]);
generate an elasticity image (at least figs. 13-14 (50) and corresponding disclosure in at least [0144]) corresponding to the first region based on the elasticity index value acquired from the first scan and a propagation image (at least figs 14 (60) and corresponding disclosure in at least and corresponding disclosure in at least [0151]) corresponding to the first region based on the propagation index value acquired from the first scan,
cause the elasticity image (21) and the propagation image (60) to be displayed on a display at display positions that are different from each other and aligned with each other (See at least figs. 14)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include generating a propagation image as taught by Honjo in order to provide additional functional diagnostic data of the patient accordingly. Such a modification would allow for further diagnostic advantages of viscoelastic properties of the tissue (Honjo [0003]) thus enhancing the overall diagnosis of the patient.
Examiner notes that in the modified system, the propagation image is an additional image which would be included in 410 of Nam and therefore would be aligned with the elasticity image and attenuation image accordingly.
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have arranged the attenuation image, the elasticity image, and the propagation image to be aligned with each other in the same manner as the four images of Honjo shown in fig. 14 in order to provide simultaneous display of each of the functional images (Honjo [0151]) acquired and superimposed over the B-mode image. Such a modification would enhance a user’s ability to visualize all of the generated images relative to the corresponding surrounding structures.
Regarding claim 10,
Nam teaches an ultrasound diagnostic apparatus comprising processing circuitry (at least figs 5/6 (500)) configured to:
define a first region (at least fig. 4 (401) and corresponding disclosure in at least [0085]) for acquiring an elasticity index value indicating elasticity of a tissue of a living body ([0085] which discloses that the second set of images produced in correspondence to the first ROI may include a shear wave velocity image), a viscosity index value indicating viscosity of the tissue (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first region. Examiner notes that the first region of Nam is capable of being used for acquiring a viscosity index value indicating viscosity of the tissue, thus meets the claim) and a propagation index value of a shear wave that propagates through the living body (Examiner notes that the limitation for acquiring a propagation index value is directed towards intended use of the first region. Examiner notes that the first region of Nam is capable of being used for acquiring a propagation index value of a shear wave that propagates through the living body, thus meets the claim), and a second region (at least fig. 4 (402) and corresponding disclosure in at least [0085]) for acquiring an attenuation index value indicating attenuation of an ultrasound wave inside the living body ([0085] disclosing that the second image sets 420 produced in correspondence with the second ROI may include an attenuation image);
Conduct a first scan and a second scan by way of an ultrasonic probe in a predetermined order([0051] which discloses all functional images and parametric images may be generated and then displayed, which may be obtained through one scanning of a region of interest of an object without changing the location of a probe and [0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object. [0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal. Examiner notes that a person having ordinary skill in the art would have recognized a first and second scan (i.e. a first scan for the shear wave velocity/shear modulus image and a second scan for the attenuation image) performed in a predetermined order for the different images to be generated accordingly), the first scan being for acquiring the elasticity index value ([0057] Also, the shear modulus image may include an image expressed by using acoustic force that is relatively and strongly focused to generate a shear wave in tissue of the object and calculating a velocity of movements of the shear wave generated therefrom in the object to calculate a shear modulus of the object), the viscosity index (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first scan. Examiner notes that the first scan of Nam is a shear wave imaging scan and thus is capable of being used for acquiring a viscosity index value indicating viscosity of the tissue. Therefore, the teachings of Nam meets the claim) and the propagation index value at each position in the first region (Examiner notes that the limitation for acquiring a viscosity index value is directed towards intended use of the first scan. Examiner notes that the first scan of Nam is a shear wave imaging scan and thus is capable of being used for acquiring a propagation index value at each position in the first region. Therefore, the teachings of Nam meets the claim) and the second scan being for acquiring the attenuation index value at each position in the second region ([0058] Also, the attenuation image may include an image generated based on the attenuation coefficients calculated using variations of RF echoes over a depth, knowing backscattering properties in the ROI of the object beforehand or assuming that the same does not change in the ROI. The variations in the RF echo signal may be determined by analyzing changes in a frequency or a magnitude of the RF echo signal);
Generate an elasticity image (at least fig. 4 (410/430) and corresponding disclosure in at least [0085]-[0086]) corresponding to the first region based on the first index value acquired from the first scan ([0085] which discloses a PDI, a shear wave velocity image (i.e. elasticity image) and an attenuation image may be included in the second image set 410); generate an attenuation image (at least fig. 4 (420/440) and corresponding disclosure in at least [0085]-[0086]) corresponding to the second region based on the second index value acquired from the second scan ([0085] which discloses only a PDI, an attenuation image, and a sound velocity image may be included in the second image set 420 produced in correspondence to the second ROI 402); and
Cause the first image and the second image to be displayed on a display at display positions that are different from each other and aligned with each other (see at least fig. 4 depicting the first and second image displayed on a display at display positions different from each other ([0086] which discloses a second image 425 selected in the second image set 420 produced in correspondence to the second ROI 402 may be disposed next to the first image 210 in parallel for a display 440), wherein the first region (401) and the second region (402) are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set (See at least fig. 4 depicting regions which are associated with each other in its broadest reasonable interpretation. Where the first ROI and second ROI are selected, thus in accordance with a setting of the first ROI 401 the second ROI 402 is necessarily set).
Alternatively, if the selection of the first region or second region of Nam is not considered to be in accordance with the remaining region, Sonoyama, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor configured to define a first region for acquiring an index value and a second region for acquiring a second index value, wherein the first region and the second region are associated with each other so that, in accordance with a setting of one of the first region and the second region, a remaining one of the first region and the second region is set ([0077] which discloses it is desirable that the region of interest setting unit 50 has a function of interlocking setting of changing the set position of one of the first region of interest and the second region of interest in accordance with change of the set position of the other one. In the interlocking setting, while maintaining e.g., the relative positional relationship between the first region of interest and the second region of interest, the one set position is changed in accordance with change of the other set position)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include associating the first region and the second region as taught by Sonoyama in order to maintain the relative positional relationship between the first region of interest and the second region of interest (Sonoyama [0077]). Such a modification would allow for setting of a desired positional relationship between the first region and second region such that if one is moved/set the other is moved/set to have the same positional relationship accordingly which may be a desired function by the user.
Nam fails to explicitly teach wherein the processing circuitry is configured to generate a viscosity image corresponding to the first region based on the viscosity index value acquired from the first scan and a propagation image (interpreted to be different from the elasticity image) corresponding to the first region based on the propagation index value acquired from the first scan.
Honjo, in a similar field of endeavor involving ultrasound imaging, teaches processing circuitry (at least fig. 1 (100/130) and corresponding disclosure in at least [0026] and [0032]) configured to:
conduct a first scan for acquiring an elasticity index value, a viscosity index value, and a propagation index value (at least fig. 7 (S102) and corresponding disclosure in at least [0086]) at each position in a first region (at least figs. 12-14 (21) and corresponding disclosure in at least [0079] or at least figs. 12-13 (40) and corresponding disclosure in at least [0138]);
generate an elasticity image (at least figs. 13-14 (50) and corresponding disclosure in at least [0144]) corresponding to the first region based on the elasticity index value acquired from the first scan,
a viscosity image corresponding to the first region based on the viscosity index value acquired from the first scan ((at least figs. 6 and 12-14 (21/50) and corresponding disclosure in at least [0168] and [0079] which discloses [0079] For example, the image processing function 132 generates an index image 21 in which hues corresponding to the index values are assigned and [0075] which discloses In other words, by analyzing the detected shear wave, the signal processing function 131 calculates the index value that indicates the viscosity within the object and that is not dependent on any physical model related to viscoelasticity and [0101] which discloses is configured to calculate the index values of viscosity by expressing the changes in the shapes of the curves in the time-displacement curves corresponding to the viscosity levels as differences in the phase velocity values of the time-displacement curves and [0168] which discloses As explained above, the signal processing function 131 calculates the index values of the viscosity at the sampling points in the depth direction and the direction of orientation. Further, for example, the image processing function 132 generates an index image illustrated in FIG. 6, by assigning colors corresponding to the index values of the viscosity at the sampling points in the depth direction and the direction of orientation), and a propagation image (at least figs 14 (60) and corresponding disclosure in at least and corresponding disclosure in at least [0151]) corresponding to the first region based on the propagation index value acquired from the first scan,
cause the elasticity image (21) and the propagation image (60) to be displayed on a display at display positions that are different from each other and aligned with each other (See at least figs. 14)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include generating a viscosity image and a propagation image as taught by Honjo in order to provide additional functional diagnostic data of the patient accordingly. Such a modification would allow for further diagnostic advantages of viscoelastic properties of the tissue (Honjo [0003]) thus enhancing the overall diagnosis of the patient.
Examiner notes that in the modified system, the viscosity image and the propagation image are additional images which would be included in 410 of Nam and therefore would be aligned with the elasticity image and attenuation image accordingly.
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have arranged the attenuation image, the elasticity image, the viscosity image and the propagation image to be aligned with each other in the same manner as the four images of Honjo shown in fig. 14 in order to provide simultaneous display of each of the functional images (Honjo [0151]) acquired and superimposed over the B-mode image. Such a modification would enhance a user’s ability to visualize all of the generated images relative to the corresponding surrounding structures.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Ralston et al. (US 20160331353 A1), hereinafter Ralston.
Regarding claim 6,
Nam teaches the elements of claim 1 as previously stated. Nam fails to explicitly teach wherein the processing circuitry is configured to: between one scan of the first scan and the second scan and a cooling time, provide the other scan of the first scan and the second scan; conduct the one scan and the other scan (as noted above the processing circuitry conducts the first scan and the second scan and any time thereafter is considered to be cooling time);
Nam fails to explicitly teach wherein the processing circuitry is configured to lower the heat generated at the ultrasonic probe by the one scan and the other scan.
Ralston, in a similar field of endeavor involving ultrasound imaging, teaches wherein processing circuitry is configured to lower the heat generated at the ultrasonic probe (onboard sensors 322 may obtain data indicating that the temperature of at least one component of the probe (e.g., the probe's circuitry) has exceeded a desired threshold and the probe may adjust the way in which it performs imaging to reduce the probe's temperature (e.g., by reducing the power of the transmitted pulses, by reducing the frequency at which the probe emits pulses, by performing less processing of the acquired data, etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include lowering heat generated at the ultrasonic probe as taught by Ralston in order to ensure that the probe’s temperature stays below a desired threshold (Ralson [0071]). Such a modification would enhance the safety of operating the ultrasound probe when performing scans.
Examiner notes that in the modified system the heat generated would be by the different scans.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Crocco et al. (US 20210022710 A1), hereinafter Crocco.
Regarding claim 7,
Nam teaches the elements of claim 1 as previously stated. Nam fails to explicitly teach wherein the processing circuitry is configured to: define a cooling time between the first scan and the second scan to lower heat generated at the ultrasonic probe; conduct the first scan; between the first scan and the second scan, lower heat generated at the ultrasonic probe by the first scan; and conduct the second scan.
Crocco, in a similar field of endeavor involving ultrasound imaging, teaches wherein processing circuitry is configured to:
Define a cooling time between a first scan and a second scan to lower heat generated at the ultrasonic probe; Conduct the first scan; Between the first scan and the second scan, lower heat generated at the ultrasonic probe by the first scan; and conduct the second scan ([0118] which discloses each series of excitation pulses is interrupted for a certain period by a cooling period before being carried out again. Examiner notes that such a cooling period would lower the heat generated at the ultrasonic probe by the first scan. Examiner notes that such a certain period is necessarily defined by processing circuitry)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Nam to include defining a cooling period as taught by Crocco in order to allow for hardware to be prepared to perform new transmissions and at the same time of allowing the probe and the tissues to cool (Crocco [0119]), thereby enhancing the safety of the system. Furthermore, such a modification would further allow for a B-mode image to be refreshed by a new image acquisition during the cooling period (Crocco [0118]) prior to performing the second scan of Nam.
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 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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