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 Amendment
The amendment filed 08/27/2026 has been entered. Claims 1-14 remain pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder (i.e., a module) that is coupled with functional language (i.e.,, “to receive” and “to determine”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a communicator configured to transmit” in claim 1, line 8. Interpreted as a communication part that includes an NIC, a LAN adapter, and a communication module including a receiver and a transmitter ([0053], [0062]).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3, 5 - 8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Barnard et al (US 20090112089), hereinafter Barnard, in view of McMorrow et al (US 20050288584), hereinafter McMorrow.
Regarding claim 1, Regarding claim 1, Barnard teaches an ultrasonic diagnostic apparatus (10A) (Figs. 1A and 3-6) comprising:
a hardware processor (“a microprocessor” [0138]) (“The transceiver is controlled by a microprocessor and software associated with the microprocessor" [0138]);
an ultrasonic probe (part of 10) (part of 10A-C) configured to transmit an ultrasonic wave to the subject and receive an ultrasonic image signal reflected in the subject (“echo information" [0301]) (“FIG. 9A is a B-mode ultrasound image of a bladder in a transverse section using the either of the transceivers 10A-C” [0115]. “The portable embodiment of the ultrasound transceiver of the present invention is shown in FIG. 1. The transceiver 10 includes … a transceiver housing 18 attached to the handle 12, a transceiver dome 20 and a display 24 for user interaction, attached to the transceiver housing 18 at an end opposite the transceiver dome 20. The transceiver 10 is held in position against the body of a patient by a user…The transceiver is controlled by a microprocessor and software associated with the microprocessor and a digital signal processor of a computer system." [0138]);
a communicator (“a wireless link” [0198]) configured to transmit image data (25C-1) based on the ultrasonic image signal of the subject received by the ultrasonic probe to an information processing apparatus (52) (“the transceiver 10 may be coupled to the computer device 52 by the connecting cable 53, or by means of a wireless link, such as an ETHERNET link, or an infrared wireless link. The transceiver 10 and/or the computer device 52 are configured to process the digital signals using algorithms”. [0198] "Wireless signals 25C-1 include echo information that is conveyed to and processed by the image processing algorithm in the personal computer device 52." [0301]; Figs. 5-7);
the hardware processor (“a microprocessor” [0138]) (“The transceiver is controlled by a microprocessor and software associated with the microprocessor" [0138]) being further configured to acquire diagnostic information (“the volume of urine” [0278]) from the information processing apparatus (“the computer device 52 … configured to process the digital signals using algorithms”. [0198]; Figs. 5-7. "After the scan, the transceiver displays the volume of urine retained within the bladder" [0278]), which is configured to generate the diagnostic information by constructing, using the image data, three-dimensional image data (56B) (“Information from the inertial reference unit, as described in greater detail below, permits updated real-time scan cone image acquisition, so that a scan cone 40B having a complete image of the organ 56B can be obtained." [0303] Fig. 6) and performing a predetermined process on the three-dimensional image data ("FIG. 13 is an expansion of the process data to delineate bladder sub-algorithm 178-8 of FIGS. 12A and 12B." [0314]; “Thereafter, at block 186-10C, the iso-surface layer is defined as a plurality of voxel cubes having eight pixel vertices." [0319]. “The algorithm 186-20 begins with block 186-20A by creating a triangular mesh of voxels or pixel volume elements defined as an iso-surface or a provisional working representation of the sub-serosal layer 148." [0320]; Figs. 10-20) (“FIG. 9 depicts a substantially bas-relief 2D presentation volume rendering of the left (first) and right (second) half bladder hemisphere views of a bladder. The first and second hemispheric views are virtual images that provides to the physician the similar look of a bladder as seen with an optical cystoscope and provides a non-invasive means to diagnose bladder-related programs using the volume renderings from image processing of digitized ultrasound echoes presented in the image cones. The image cones are either the 3D arrays of 2D scanplanes, or the 3D scan cone of 3D distributed scanlines.” [0181]); and
a display (16) that displays the acquired diagnostic information (“After the scan, the transceiver displays the volume of urine retained within the bladder” [0278]; "The display 16 on the device may also display the calculated bladder volume." [0299]; Fig. 1A).
Barnard does not teach a hardware processor configured to execute a plurality of different measurement modes for measuring different parts of a subject and to obtain user selection of a selected measurement mode of the plurality of different measurement modes; the ultrasonic probe configured to transmit the ultrasonic wave to the subject and receive the ultrasonic image signal reflected in the subject based on the selected measurement mode.
However, in the ultrasound imaging systems field of endeavor, McMorrow discloses remote evaluation system for ultrasound information obtained by programmed application specific data acquisition device, which is analogous art. McMorrow teaches the hardware processor (22) configured to execute a plurality of different measurement modes for measuring different parts of a subject (“the bladder … other organs” [0020]; “a kidney…the abdominal aorta” [0039]) (“The significant disadvantage of application-specific ultrasound machines is that they are, in fact, just that--useful for just a single application. It would be too expensive and too cumbersome for a physician, particularly a general practitioner, to maintain a large number of application-specific ultrasound machines” [0008]; “if the bladder is to be imaged, DCD 12 is placed on the skin area adjacent the bladder. The same procedure would be followed for other organs or areas of the body.” [0020]; Fig. 1; “FIG. 3 shows microprocessor 22 controlling a DCD with a total of four identical modules, each with its own transducer.” [0034]; “in the ultrasound examination of a kidney, a three-dimensional picture of an imaged kidney can be produced, along with any interior stones, which could be shown as interior solid objects. In another example, the abdominal aorta could be shown in three dimensions, along with an indication of the maximum diameter of the aorta.” [0039]; Fig. 3) and to obtain user selection of a selected measurement mode of the plurality of different measurement modes (“PDA 17 will then display a list of application-specific programs for possible use by the data collection device 12. The selected program will then control the operation of the DCD for a specific ultrasound application.” [0022] “The operator will select one from the list of programs available, which will then be downloaded into the data collection device 12.” [0023] Fig. 1);
the ultrasonic probe (12) configured to transmit the ultrasonic wave to the subject and receive the ultrasonic image signal reflected in the subject based on the selected measurement mode (“A data collection device (DCD) is shown generally at 12. DCD 12 includes a conventional ultrasound transducer (transmitter/receiver) 14 (FIG. 3). DCD 12 is programmed, as described below, to perform a specific ultrasound examination… As an example, if the bladder is to be imaged, DCD 12 is placed on the skin area adjacent the bladder. The same procedure would be followed for other organs or areas of the body. The ultrasound information obtained by the DCD is then transmitted to a remote location where it is processed to produce a recognizable result of some kind, such as a three-dimensional model of the body part being imaged or specific numerical result.” [0020]; Fig. 1).
Therefore, based on McMorrow’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard to employ the hardware processor configured to execute a plurality of different measurement modes for measuring different parts of a subject and to obtain user selection of a selected measurement mode of the plurality of different measurement modes; the ultrasonic probe configured to transmit the ultrasonic wave to the subject and receive the ultrasonic image signal reflected in the subject based on the selected measurement mode, as taught by McMorrow, in order to facilitate ultrasound imaging of various organs using the same system and reduce costs.
Regarding claim 2, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1, wherein Barnard teaches that the predetermined process is a process of numerically converting the three-dimensional image data or a process of simplifying the three-dimensional image data (“FIG. 9 depicts a substantially bas-relief 2D presentation volume rendering of the left (first) and right (second) half bladder hemisphere views of a bladder. The first and second hemispheric views are virtual images that provides to the physician the similar look of a bladder as seen with an optical cystoscope and provides a non-invasive means to diagnose bladder-related programs using the volume renderings from image processing of digitized ultrasound echoes presented in the image cones. The image cones are either the 3D arrays of 2D scanplanes, or the 3D scan cone of 3D distributed scanlines.” [0181]).
Regarding claim 3, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1, wherein the ultrasonic probe, the communicator (“the data being wirelessly uploaded” [0298]) and the hardware processor are provided in a same housing (18) (“the transceiver 10 may be a self-contained device that includes a microprocessor positioned within the housing 18 and software associated with the microprocessor to operably control the transceiver 10, and to process the reflected ultrasound energy to generate the ultrasound image.” [0186]; “FIG. 5 depicts images showing the abdominal area of a patient 68 being scanned by a transceiver 10C and the data being wirelessly uploaded to a personal computer during initial targeting of a region of interest (ROI) that is left of the umbilicus 68 and umbilicus midline 68C." [0298]).
Regarding claim 5, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1, wherein the information processing apparatus is a smartphone, a tablet, a general-purpose personal computer (52) or a workstation (“FIG. 6 depicts images showing the patient being scanned by the transceiver and the data being wirelessly uploaded to a personal computer of a properly targeted ROI in the abdominal area;” [0112]; “the transceiver 10 may be coupled to the computer device 52 ... The transceiver 10 and/or the computer device 52 are configured to process the digital signals using algorithms”. [0198]; Figs. 5-8).
Regarding claim 6, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1, wherein the display includes a liquid crystal display or an organic EL display that is a flat panel or a bendable panel ("The display 24 may be a liquid crystal display (LCD)," [0139]).
Regarding claim 7, Barnard teaches an ultrasonic diagnostic system (100) (Fig. 7) comprising:
an ultrasonic diagnostic apparatus (10) (10A-C) (Figs. 1A and 3-6) configured to transmit an ultrasonic wave to a subject and acquire image data corresponding to an ultrasonic image signal reflected in the subject (“echo information” [0301]) (“FIG. 9A is a B-mode ultrasound image of a bladder in a transverse section using the either of the transceivers 10A-C” [0115]. “The portable embodiment of the ultrasound transceiver of the present invention is shown in FIG. 1. The transceiver 10 includes … a transceiver housing 18 attached to the handle 12, a transceiver dome 20 and a display 24 for user interaction, attached to the transceiver housing 18 at an end opposite the transceiver dome 20. The transceiver 10 is held in position against the body of a patient by a user…The transceiver is controlled by a microprocessor and software associated with the microprocessor and a digital signal processor of a computer system." [0138]), and transmit the image data (“FIG. 6 depicts images showing the patient being scanned by the transceiver and the data being wirelessly uploaded to a personal computer of a properly targeted ROI in the abdominal area;” [0112]; “the transceiver 10 may be coupled to the computer device 52 ... The transceiver 10 and/or the computer device 52 are configured to process the digital signals using algorithms”. [0198]; Figs. 5-8); and
an information processing apparatus (52) configured to construct, using the image data transmitted from the ultrasonic diagnostic apparatus, three-dimensional image data (56B) (“the 3D arrays of 2D scanplanes, or the 3D scan cone of 3D distributed scanlines.” [0181]; “the computer device 52 …configured to process the digital signals using algorithms”. [0198] "Wireless signals 25C-1 include echo information that is conveyed to and processed by the image processing algorithm in the personal computer device 52." [0301]; Fig. 7) (“Information from the inertial reference unit, as described in greater detail below, permits updated real-time scan cone image acquisition, so that a scan cone 40B having a complete image of the organ 56B can be obtained." [0303] Fig. 6), acquire diagnostic information (“volume rendering… of a bladder” [0181]) (“the volume of urine” [0278]) by performing a predetermined process on the three-dimensional image data (“FIG. 9 depicts a substantially bas-relief 2D presentation volume rendering of the left (first) and right (second) half bladder hemisphere views of a bladder…The image cones are either the 3D arrays of 2D scanplanes, or the 3D scan cone of 3D distributed scanlines.” [0181]) ("FIG. 13 is an expansion of the process data to delineate bladder sub-algorithm 178-8 of FIGS. 12A and 12B." [0314]; “Thereafter, at block 186-10C, the iso-surface layer is defined as a plurality of voxel cubes having eight pixel vertices." [0319]. “The algorithm 186-20 begins with block 186-20A by creating a triangular mesh of voxels or pixel volume elements defined as an iso-surface or a provisional working representation of the sub-serosal layer 148." [0320]; Figs. 10-20), and transmit the diagnostic information, wherein the ultrasonic diagnostic apparatus is configured to receive the diagnostic information transmitted from the information processing apparatus (“the transceiver 10 may be coupled to the computer device 52 by the connecting cable 53, or by means of a wireless link, such as an ETHERNET link, or an infrared wireless link. The transceiver 10 and/or the computer device 52 are configured to process the digital signals using algorithms”. [0198] Figs. 5-7), and
display the diagnostic information on a display (16) thereof (“After the scan, the transceiver displays the volume of urine retained within the bladder” [0278]; "The display 16 on the device may also display the calculated bladder volume." [0299]; Fig. 1A).
Regarding claim 8, Barnard modified by McMorrow teaches the ultrasonic diagnostic system according to claim 7, wherein the image data includes a bladder (“the bladder” [0322]), an intestine or a blood vessel, and wherein the information processing apparatus is configured to perform, as the predetermined process, quantification of an amount of urine accumulated in the bladder (“the volume of urine” [0278]), quantification of a hardness of feces accumulated in the intestine or quantification of a diameter of the blood vessel (“FIG. 21 shows sample delineations of the bladder in scan planes 242-2, 4, and 6 respectively. Here the perimeter of the bladder lumen 250-2, 4, and 6 is outlined by sub-mucosal layers 246-2, 4, and 6 using the Find Initial Walls sub-algorithm 180A as previously described. The outlining approximates the general location of the sub-mucosal layers 246-2, 4, and 6 for the purposes of delineating the perimeter of the hypo-echoic bladder lumen 250-2, 4, and 6 to provide a basis to estimate urine volume. The urine volume is estimated to assess whether or not the bladder contains between 200 and 400 ml so that more exacting positioning of the sub-mucosal and sub-serosal layers may be determined by sub-algorithms 178-12, 186, 186-10, and 182-20.” [0322]).
Regarding claim 10, Barnard teaches a non-transitory computer-readable storage medium storing a program (“software associated with the microprocessor to operably control the transceiver 10, and to process the reflected ultrasound energy to generate the ultrasound image" [0186]; “algorithms” [0198]; "If the image processing occurs in the computer device 52, each computer device 52 includes imaging software having instructions to prepare and analyze a plurality of one dimensional images from the stored signals and to transform the plurality of images into a plurality of two-dimensional scanplanes ... " [0200]) causing a computer (10) (“the transceiver 10 may be a self-contained device that includes a microprocessor positioned within the housing 18 and software associated with the microprocessor to operably control the transceiver 10, and to process the reflected ultrasound energy to generate the ultrasound image.” [0186]; Figs. 5-8) to perform:
transmitting, to an information processing apparatus (52), image data (25C-1) based on an ultrasonic image signal obtained by transmission and reception of an ultrasonic wave to and from the subject ("Wireless signals 25C-1 include echo information that is conveyed to and processed by the image processing algorithm in the personal computer device 52." [0301]; Fig. 7) (“FIG. 6 depicts images showing the patient being scanned by the transceiver and the data being wirelessly uploaded to a personal computer of a properly targeted ROI in the abdominal area;” [0112]; “FIG. 9A is a B-mode ultrasound image of a bladder in a transverse section using the either of the transceivers 10A-C” [0115]; “the computer device 52 … configured to process the digital signals using algorithms”. [0198]; Figs. 5-8);
acquiring diagnostic information (“the volume of urine” [0278]) obtained by the information processing apparatus (“the computer device 52 … configured to process the digital signals using algorithms”. [0198]; Figs. 5-7);
constructing, using the image data, three-dimensional image data (56B) (“Information from the inertial reference unit, as described in greater detail below, permits updated real-time scan cone image acquisition, so that a scan cone 40B having a complete image of the organ 56B can be obtained." [0303] Fig. 6) and performing a predetermined process on the three-dimensional image data (“The image cones are either the 3D arrays of 2D scanplanes, or the 3D scan cone of 3D distributed scanlines.” [0181]) ("FIG. 13 is an expansion of the process data to delineate bladder sub-algorithm 178-8 of FIGS. 12A and 12B." [0314]; “Thereafter, at block 186-10C, the iso-surface layer is defined as a plurality of voxel cubes having eight pixel vertices." [0319]. “The algorithm 186-20 begins with block 186-20A by creating a triangular mesh of voxels or pixel volume elements defined as an iso-surface or a provisional working representation of the sub-serosal layer 148." [0320]; Figs. 10-20) (“FIG. 21 shows sample delineations of the bladder in scan planes 242-2, 4, and 6 respectively... The urine volume is estimated to assess whether or not the bladder contains between 200 and 400 ml so that more exacting positioning of the sub-mucosal and sub-serosal layers may be determined by sub-algorithms 178-12, 186, 186-10, and 182-20.” [0322]), and
outputting the acquired diagnostic information (“After the scan, the transceiver displays the volume of urine retained within the bladder” [0278]; "The display 16 on the device may also display the calculated bladder volume." [0299]; Fig. 1A).
Barnard does not teach obtaining user selection of a selected measurement mode of a plurality of different measurement modes for measuring different parts of a subject; the image data based on the ultrasonic image signal obtained by transmission and reception of the ultrasonic wave to and from the subject based on the selected measurement mode.
However, in the ultrasound imaging systems field of endeavor, McMorrow discloses remote evaluation system for ultrasound information obtained by programmed application specific data acquisition device, which is analogous art. McMorrow teaches obtaining user selection of a selected measurement mode of a plurality of different measurement modes for measuring different parts of a subject (“PDA 17 will then display a list of application-specific programs for possible use by the data collection device 12. The selected program will then control the operation of the DCD for a specific ultrasound application.” [0022] “The operator will select one from the list of programs available, which will then be downloaded into the data collection device 12.” [0023] Fig. 1) (“the bladder … other organs” [0020]; “a kidney…the abdominal aorta” [0039]);
the image data based on the ultrasonic image signal obtained by transmission and reception of the ultrasonic wave to and from the subject based on the selected measurement mode (“A data collection device (DCD) is shown generally at 12. DCD 12 includes a conventional ultrasound transducer (transmitter/receiver) 14 (FIG. 3). DCD 12 is programmed, as described below, to perform a specific ultrasound examination… As an example, if the bladder is to be imaged, DCD 12 is placed on the skin area adjacent the bladder. The same procedure would be followed for other organs or areas of the body. The ultrasound information obtained by the DCD is then transmitted to a remote location where it is processed to produce a recognizable result of some kind, such as a three-dimensional model of the body part being imaged or specific numerical result.” [0020]; Fig. 1).
Therefore, based on McMorrow’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard to employ the step of obtaining user selection of a selected measurement mode of a plurality of different measurement modes for measuring different parts of a subject; and the image data based on the ultrasonic image signal obtained by transmission and reception of the ultrasonic wave to and from the subject based on the selected measurement mode, as taught by McMorrow, in order to facilitate ultrasound imaging of various organs using the same system and reduce costs.
Regarding claim 11, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1, wherein Barnard teaches that the diagnostic information is a measured value obtained by numerical conversion on the three-dimensional image data ("The maximum and minimum and mean values of these thicknesses are used in the mass calculation and historical tracking of data. In the embodiment shown, this final thickness determination marks the end of the process identified in the seventh block 58 of FIG. 6." [0177]; “the bladder is assumed to have a uniform wall thickness, so that a mean wall thickness value is derived from the scanned data and used for the bladder mass determination. Only three scanlines are shown in a plane, each separated by 1.5 degrees from each other. Both the number of scanlines in the plane and the angles separating each scanline within a plane may be varied." [0178] "Bladder mass determination. Once the thickness and the surface area have been measured, the mass of the bladder may be calculated." [0179]; “the volume of urine retained within the bladder” [0278]) or a simple image (56B) obtained by simplification on the three-dimensional image data (“a complete image of the organ 56B" [0303] Fig. 6).
Regarding claim 12, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1.
Barnard does not teach that the plurality of measurement modes include at least two of urine volume measurement, inferior aorta diameter measurement, stool hardness estimation, and blood collection guide.
However, in the ultrasound imaging systems field of endeavor, McMorrow discloses remote evaluation system for ultrasound information obtained by programmed application specific data acquisition device, which is analogous art. McMorrow teaches that the plurality of measurement modes include at least two of urine volume measurement, inferior aorta diameter measurement, stool hardness estimation, and blood collection guide (“There are many examples of application-specific or single purpose ultrasound machines…a device for measuring the amount of urine in the bladder.” [0004] “As an example, if the bladder is to be imaged, DCD 12 is placed on the skin area adjacent the bladder.” [0020] “PDA 17 will then display a list of application-specific programs for possible use by the data collection device 12. The selected program will then control the operation of the DCD for a specific ultrasound application.” [0022] “In another example, the abdominal aorta could be shown in three dimensions, along with an indication of the maximum diameter of the aorta.” [0039]; Fig. 1).
Therefore, based on McMorrow’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard to employ the plurality of measurement modes that include at least two of urine volume measurement, inferior aorta diameter measurement, stool hardness estimation, and blood collection guide, as taught by McMorrow, in order to facilitate ultrasound imaging of various organs using the same system and reduce costs.
Regarding claim 13, Barnard teaches the ultrasonic diagnostic apparatus according to claim 1.
Barnard does not teach that each measurement mode of the plurality of different measurement modes is associated with respective transmission/reception conditions.
However, in the ultrasound imaging systems field of endeavor, McMorrow discloses remote evaluation system for ultrasound information obtained by programmed application specific data acquisition device, which is analogous art. McMorrow teaches that each measurement mode of the plurality of different measurement modes is associated with respective transmission/reception conditions (“successive scan lines are separated by 1.5.degree., although this can be readily varied. The resulting three-dimensional ultrasound "cone" coverage is shown in FIG. 2. It should be understood, however, that other coverage patterns can be successfully used, depending upon the ultrasound procedure to be accomplished.” [0027]. “In generating the ultrasound signals, the microprocessor 24 pulses a digital signal processor (DSP) 30 to produce the ultrasound signals, at a typical frequency of 3.7 mHz, although this could be within the range of 1-12 mHz.” [0028]).
Therefore, based on McMorrow’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard to employ each measurement mode of the plurality of different measurement modes that is associated with respective transmission/reception conditions, as taught by McMorrow, in order to facilitate ultrasound imaging of various organs using the same system and reduce costs.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Barnard and McMorrow as applied to claim 1, and further in view of Phelps et al (US 20040002652), hereinafter, Phelps.
Regarding claim 4, Barnard modified by McMorrow teaches the ultrasonic diagnostic apparatus according to claim 1.
Barnard modified by McMorrow does not teach that the ultrasonic probe includes a plurality of elements having a micro electro mechanical systems (MEMS) structure and arranged two-dimensionally.
However, in the ultrasound imaging field of endeavor, Phelps discloses receive circuit for ultrasound imaging, which is analogous art. Phelps teaches that the ultrasonic probe (20) includes a plurality of elements having a micro electro mechanical systems (MEMS) structure (“One transducer probe 20 comprises an array of piezoelectric or microelectromechanical elements 24 for transducing between acoustic and electrical energies. [0027]) and arranged two-dimensionally (“The probe 20 includes … a multi-dimensional array of elements.” [0027]. “FIG. 8 shows thirty-two elements 24. In alternative embodiments, different numbers of elements are provided, such as 1,536 elements in 64 azimuthally spaced rows 202 and 24 elevational spaced columns 204, or 2,048 elements in 64 azimuthally spaced rows 202 and 32 elevation spaced columns 204." [0082]).
Therefore, based on Phelps’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard and McMorrow to have the ultrasonic probe that includes a plurality of elements having a micro electro mechanical systems (MEMS) structure and arranged two-dimensionally, as taught by Phelps, in order to facilitate ultrasound imaging.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Barnard and McMorrow as applied to claim 7, and further in view of Inoue et al (WO 2022168521), hereinafter, Inoue.
Regarding claim 9, Barnard modified by McMorrow teaches the ultrasonic diagnostic system according to claim 7.
Barnard modified by McMorrow does not teach that the image data includes at least a blood vessel and a nerve, and that the information processing apparatus is configured to perform, as the predetermined process, generation of a simple image indicating arrangement of one or both of the blood vessel and the nerve.
However, in the ultrasound imaging field of endeavor, Inoue discloses ultrasonic diagnostic device and method for controlling ultrasonic diagnostic device, which is analogous art. Inoue teaches that the image data includes at least a blood vessel and a nerve, and that the information processing apparatus performs, as the predetermined process, generation of a simple image indicating arrangement of one or both of the blood vessel and the nerve (“A blood vessel can be identified based on tissue information about tissues surrounding the blood vessel included in the ultrasound image, such as nerve, muscle, and bone tissue”; p. 6, 1st para.; “by linking the highlighting of the short-axis image of the blood vessel and the notification of the notification information, the user can intuitively grasp the state of the highlighting function of the short-axis image of the blood vessel”; p. 10, 2nd para. from the bottom; “It should be noted that the present invention is not limited to highlighting short-axis images of blood vessels, and can also highlight other tissues such as nerves, muscles, and bones.”; p. 12, 3rd complete para.).
Therefore, based on Inoue’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Barnard and McMorrow to employ the image data that includes at least a blood vessel and a nerve, and the information processing apparatus that is configured to perform, as the predetermined process, generation of a simple image indicating arrangement of one or both of the blood vessel and the nerve, as taught by Inoue, in order to facilitate ultrasound imaging or regions of interest.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 08/27/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Barnard in view of McMorrow.
Response to the 35 U.S.C. §102 and 103 rejection arguments on pages 7-9 of the REMARKS.
Claims 1-14
The Applicant argues that “Barnard fails to teach or suggest the above limitations because Barnard discloses a transceiver configured specifically for bladder measurements to assess bladder dysfunction (see, e.g., paragraph [0019] of Barnard) and fails to teach or suggest different measurement modes for measuring different parts of a subject.” (Page 7). The Examiner agrees and therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Barnard in view of McMorrow. The dependent claims are not allowable because the independent claims are not allowable and because additional secondary references meet additional limitations of the dependent claims, with the exception of claim 14.
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 extension fee 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.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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