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 12/05/2025 has been entered. Claims 17-36 remain pending in the application.
Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 10/02/2025.
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 uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is/are:
“Pulse-echo imaging device” in claims 17 and 25
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification filed 08/29/2024 shows that the following appears to be the corresponding structure for the 35 U.S.C. 112(f), sixth paragraph limitation:
“Pulse-echo imaging device” – The specification discloses pulse-echo systems such as sonar, radar, and ultrasound imaging systems generates a pulse which then generates an echo off a region of interest (¶ [3]) and disclose wherein the pulse-echo imaging device is configured to transmit a pulse and receive an echo off a region of interest (¶ [112]). However, the specification fails to disclose or clearly link corresponding structure to the claimed pulse-echo imaging device.
For the term “pulse-echo imaging device” which lacks corresponding structure, it will be interpreted for the pulse imaging device to be any device configured to transmit a pulse and receive a corresponding echo.
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.
Claims 17 and 25 recites the limitation “H-scan image”. For purposes of examination, it will be interpreted for an “H-scan image” to mean a “Hue-scan image”, an ultrasound image in which hue or color is displayed, or more specifically an image resulting from combining B-mode images with color data, which is consistent with the applicant’s specifications (¶ [0160], “Using transparency overlays to combine the color and B-mode data, the final H-scan image can be displayed”, ¶ [0162], “By combining traditional B-scan and H-scan color map data, transparency of the two data displays H-scan image”). To overcome this interpretation, the examiner suggests clearly defining what an “H-scan image” is within the claim, i.e. including within the claim the definition of an H-scan image. See MPEP § 2173.05(a), “The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention…During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification”.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
Applicant argues “Gauthier generally mentions a method for visualizing blood flow and ‘invasive medical devices’ using a combination of B mode imaging (for the device) and colorflow Doppler imaging (for the blood flow). Gauthier fails to teach or suggest ‘a method of forming an H-scan image of an inhomogeneity in a region of interest’ as recited in the amended claim 17”. Applicant further argues Martin fails to cure the deficiencies of Gauthier.
Examiner respectfully disagrees. 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 claim itself does not clearly define what an “H-scan image” constitutes and nor does the specification. The specification however does disclose that an H-scan image is formed by combining B-mode scan data with color data (¶ [0160], “Using transparency overlays to combine the color and B-mode data, the final H-scan image can be displayed”, ¶ [0162], “By combining traditional B-scan and H-scan color map data, transparency of the two data displays H-scan image”). Accordingly, this is exactly what Gauthier (and Martin) teaches. Gauthier teaches combining B-mode data with color Doppler data to create a color Doppler image, the color Doppler image comprising an “H-scan image” (Abstract, “A B mode image of an anatomical area of interest is created… A color Doppler image is created, and then displayed, by combining some or all of the B mode image”, [0025], “the B mode tissue image overlaid with color Doppler blood flow image further overlaid with the color Doppler invasive device image”). Under broadest reasonable interpretation in light of the specifications, an “H-scan image” is being interpreted as a Hue-scan image, an ultrasound image in which hue or color is displayed, or more specifically an image resulting from combining B-mode images with color data. To overcome the current rejection with Gauthier, the examiner suggests to the applicant to amend the claim to more clearly define what the applicant/inventor believes what an “H-scan image” constitutes.
Regarding forming an image of an inhomogeneity, Martin teaches this in ¶ [0003]. Martin discloses that color flow ultrasound data can be used to assess the degree of angiogenesis in tumors and that the amount of color displayed within a region of interest (ROI) can be trended over subsequent exams of the same patient to assess the progression of a treatment. Tumors are depicted as inhomogeneities in ultrasound imaging of tissue and therefore tumors comprise an inhomogeneity in a region of interest (patient tissue). Martin, similar to Gauthier, also teaches combining B-mode data with color flow Doppler imaging (¶ [0027]). Gauthier modified by the teachings of Gauthier would predictably result in forming color Doppler images of tumors. The motivation would be the ability to assess the degree of angiogenesis in tumors or to track tumor progression. Gauthier in view of Martin therefore teaches a method of forming an H-scan image (Hue-scan image or B-mode image combined with color data) of an inhomogeneity (tumor) in a region of interest (patient tissue) as argued by the Applicant.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17, 24, 25, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218).
Regarding claim 17, Gauthier teaches a method of forming an H-scan image of a region of interest using a pulse-echo imaging device (Fig. 3, Abstract, “A B mode image of an anatomical area of interest is created… A color Doppler image is created, and then displayed, by combining some or all of the B mode image”, [0012], [0017], [0025], “the B mode tissue image overlaid with color Doppler blood flow image further overlaid with the color Doppler invasive device image”, wherein color Doppler overlaid/combined with B-mode comprises an H-scan image or Hue-scan image), the method comprising:
generating and transmitting a pulse using the pulse-echo imaging device (Fig. 4, [0018], “At step 410, a transducer array transmits ultrasonic pulses into a patient…”);
causing the pulse to be incident on the region of interest to generate a reflected echo (Fig. 4, [0018], “…and receives echo signals from ultrasonic energy reflected by the patient's blood, organs and other tissue”);
receiving the reflected echo in the pulse-echo imaging device (Fig. 4, [0018], “At step 410, a transducer array transmits ultrasonic pulses into a patient, and receives echo signals…”);
comparing a measure of frequency content of the reflected echo to the transmitted pulse and frequency shifted replicas of the transmitted pulse (Fig. 4, [0018], “The I and Q signal samples are further processed by, for example, an FFT processor to produce Doppler frequency shift estimates as shown at step 440”, [0019], “… Doppler ultrasound works by detecting a frequency shift in the returned echo signals compared to the frequency of the signals applied to the body”, wherein doppler frequency shifts are a comparison between the frequency of received frequency shifted replicas of the transmitted pulse [i.e. the reflected echo signal affected by the Doppler effect] and the frequency of the transmitted pulse);
selecting a label based on the comparison (Fig. 4, [0019], “Such a frequency shift can be detected through spectral analysis of the returned echo signals using a fast Fourier transform (FFT) or equivalent signal processing technique. Colorflow image data is created from the results of such analysis since the frequency shift is proportional to velocity and typically, each point in the color image formed from that data will reflect the average velocity, or other measured attribute”, wherein labelling the physical properties of flow such as velocity with a color comprises selecting a label [i.e. color is being used as a label for velocity]; wherein the frequency shift comprises the comparison of frequency between the frequency shifted reflected echo to the transmitted pulse); and
generating an image incorporating the selected label (Fig. 4, [0020], “When imaging and visualizing vasculature, the colorflow image data is created at step 460 using settings that suitable for effective visualization of blood flow”, [0024], “B mode, blood flow optimized, and invasive device optimized image data is combined at step 480 to produce and display the final image… In one mode, step 480 might display the B mode tissue image overlaid with the color Doppler flow image only”, [0025], wherein the color Doppler flow image is an image incorporating the selected label, the selected label being a color).
However, Gauthier fails to teach wherein the H-scan image is of an inhomogeneity in the region of interest and wherein each frequency shifted replica is associated with a unique label.
In an analogous method including incorporating of color into an image field of endeavor, Martin teaches such a feature. Martin teaches a process (30) for generating and displaying ultrasound image data that includes color ([0020]). Martin teaches producing a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image, i.e. color flow maps ([0027]); Martin teaches obtaining frequency shifts and displaying the frequency shift as a color pixel ([0027]). Martin teaches frequency or Doppler shifts towards the ultrasound beam are labeled red and shifts away from the ultrasound beam are labeled blue ([0028]). Martin further teaches wherein the magnitude of the frequency or Doppler shifts may be shown using different color hues or lighter saturation, thereby creating unique labels for each frequency shift ([0028]). Martin therefore teaches wherein each frequency shifted replica [i.e. frequency shift] is associated with a unique label, the unique label being a color and its hue or saturation. Martin further teaches wherein color flow ultrasound data may be used to assess the degree of angiogenesis in tumors ([0003]). Because tumors are depicted as tissue inhomogeneities in a region of interest (patient tissue) in ultrasound imaging, tumors therefore comprise an inhomogeneity and Martin therefore also teaches forming an H-scan (i.e. color flow ultrasound data) of an inhomogeneity.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to assign a color to each frequency shift and show magnitude by using different color hues or saturation as taught by Martin ([0027-0028]) and to form the H-scan image or color flow ultrasound image of tumors as taught by Martin ([0003]). By assigning color to frequency shifts and using different color hues or saturation to show magnitude thereby producing a unique label, a viewer may more easily tell the direction and magnitude of the Doppler shift or blood flow as recognized by Martin ([0028]). Moreover, by forming colored ultrasound data or images of inhomogeneities such as tumors, a degree of angiogenesis may be assessed as recognized by Martin ([0003]).
Regarding claim 24, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
Gauthier further teaches selecting a color for display based on the comparison (Fig. 4, [0019], “Such a frequency shift can be detected through spectral analysis of the returned echo signals using a fast Fourier transform (FFT) or equivalent signal processing technique. Colorflow image data is created from the results of such analysis since the frequency shift is proportional to velocity and typically, each point in the color image formed from that data will reflect the average velocity, or other measured attribute”; wherein the frequency shift comprises the comparison of frequency between the frequency shifted reflected echo to the transmitted pulse); and
generating an image incorporating the selected color (Fig. 4, [0020], “When imaging and visualizing vasculature, the colorflow image data is created at step 460 using settings that suitable for effective visualization of blood flow”, [0024], “B mode, blood flow optimized, and invasive device optimized image data is combined at step 480 to produce and display the final image… In one mode, step 480 might display the B mode tissue image overlaid with the color Doppler flow image only”, [0025]).
However, Gauthier fails to explicitly teach wherein each frequency shifted replica is associated with a color.
In an analogous method including incorporating of color into an image field of endeavor, Martin teaches such a feature. Martin teaches a process (30) for generating and displaying ultrasound image data that includes color ([0020]). Martin teaches producing a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image, i.e. color flow maps ([0027]); Martin teaches obtaining frequency shifts and displaying the frequency shift as a color pixel ([0027]). Martin teaches assigning a color to frequency shifts based on direction and with magnitude shown using different color hues or saturation ([0028]). Martin therefore teaches wherein each frequency shifted replica [i.e. frequency shift] is associated with a color.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to assign a color to each frequency shift as taught by Martin ([0027-0028]). By assigning color to frequency shifts, a viewer may more easily tell the direction and magnitude of the Doppler shift or blood flow as recognized by Martin ([0028]).
Regarding claim 25, Gauthier teaches a method of forming an H-scan image of a region of interest using a pulse-echo imaging device (Fig. 3, Abstract, “A B mode image of an anatomical area of interest is created… A color Doppler image is created, and then displayed, by combining some or all of the B mode image”, [0012], [0017], [0025], “the B mode tissue image overlaid with color Doppler blood flow image further overlaid with the color Doppler invasive device image”, wherein color Doppler overlaid/combined with B-mode comprises an H-scan image or Hue-scan image), the method comprising:
generating and transmitting a pulse using the pulse-echo imaging device (Fig. 4, [0018], “At step 410, a transducer array transmits ultrasonic pulses into a patient…”);
causing the pulse to be incident on the region of interest to generate a reflected echo (Fig. 4, [0018], “…and receives echo signals from ultrasonic energy reflected by the patient's blood, organs and other tissue”);
receiving the reflected echo in the pulse-echo imaging device (Fig. 4, [0018], “At step 410, a transducer array transmits ultrasonic pulses into a patient, and receives echo signals…”);
comparing a measure of frequency content of the reflected echo to the transmitted pulse and frequency shifted replicas of the transmitted pulse (Fig. 4, [0018], “The I and Q signal samples are further processed by, for example, an FFT processor to produce Doppler frequency shift estimates as shown at step 440”, [0019], “… Doppler ultrasound works by detecting a frequency shift in the returned echo signals compared to the frequency of the signals applied to the body”, wherein doppler frequency shifts are a comparison between the frequency of received frequency shifted replicas of the transmitted pulse [i.e. the reflected echo signal affected by the Doppler effect] and the frequency of the transmitted pulse);
selecting a color for display based on the comparison (Fig. 4, [0019], “Such a frequency shift can be detected through spectral analysis of the returned echo signals using a fast Fourier transform (FFT) or equivalent signal processing technique. Colorflow image data is created from the results of such analysis since the frequency shift is proportional to velocity and typically, each point in the color image formed from that data will reflect the average velocity, or other measured attribute”; wherein the frequency shift comprises the comparison of frequency between the frequency shifted reflected echo to the transmitted pulse); and
generating an image incorporating the selected color (Fig. 4, [0020], “When imaging and visualizing vasculature, the colorflow image data is created at step 460 using settings that suitable for effective visualization of blood flow”, [0024], “B mode, blood flow optimized, and invasive device optimized image data is combined at step 480 to produce and display the final image… In one mode, step 480 might display the B mode tissue image overlaid with the color Doppler flow image only”, [0025]).
However, Gauthier fails to teach wherein the H-scan image is of an inhomogeneity in the area of interest.
In an analogous method including incorporating of color into an image field of endeavor, Martin teaches such a feature. Martin teaches a process (30) for generating and displaying ultrasound image data that includes color ([0020]). Martin teaches producing a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image, i.e. color flow maps ([0027]); Martin teaches obtaining frequency shifts and displaying the frequency shift as a color pixel ([0027]). Martin teaches frequency or Doppler shifts towards the ultrasound beam are labeled red and shifts away from the ultrasound beam are labeled blue ([0028]). Martin further teaches wherein the magnitude of the frequency or Doppler shifts may be shown using different color hues or lighter saturation, thereby creating unique labels for each frequency shift ([0028]). Martin therefore teaches wherein each frequency shifted replica [i.e. frequency shift] is associated with a unique label, the unique label being a color and its hue or saturation. Martin further teaches wherein color flow ultrasound data may be used to assess the degree of angiogenesis in tumors ([0003]). Because tumors are depicted as tissue inhomogeneities in a region of interest (patient tissue) in ultrasound imaging, tumors therefore comprise an inhomogeneity and Martin therefore also teaches forming an H-scan (i.e. color flow ultrasound data) of an inhomogeneity.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to form the H-scan image or color flow ultrasound image of tumors as taught by Martin ([0003]). By forming colored ultrasound data or images of inhomogeneities such as tumors, a degree of angiogenesis may be assessed as recognized by Martin ([0003]).
Regarding claim 36, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
Gauthier further teaches selecting a color for display based on the comparison (Fig. 4, [0019], “Such a frequency shift can be detected through spectral analysis of the returned echo signals using a fast Fourier transform (FFT) or equivalent signal processing technique. Colorflow image data is created from the results of such analysis since the frequency shift is proportional to velocity and typically, each point in the color image formed from that data will reflect the average velocity, or other measured attribute”); and
generating an image incorporating the selected color (Fig. 4, [0020], “When imaging and visualizing vasculature, the colorflow image data is created at step 460 using settings that suitable for effective visualization of blood flow”, [0024], “B mode, blood flow optimized, and invasive device optimized image data is combined at step 480 to produce and display the final image… In one mode, step 480 might display the B mode tissue image overlaid with the color Doppler flow image only”, [0025]).
However, Gauthier fails to explicitly teach wherein each frequency shifted replica is associated with a color.
In an analogous method including incorporating of color into an image field of endeavor, Martin teaches such a feature. Martin teaches a process (30) for generating and displaying ultrasound image data that includes color ([0020]). Martin teaches producing a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image, i.e. color flow maps ([0027]); Martin teaches obtaining frequency shifts and displaying the frequency shift as a color pixel ([0027]). Martin teaches assigning a color to frequency shifts based on direction and with magnitude shown using different color hues or saturation ([0028]). Martin therefore teaches wherein each frequency shifted replica [i.e. frequency shift] is associated with a color.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to assign a color to each frequency shift as taught by Martin ([0027-0028]). By assigning color to frequency shifts, a viewer may more easily tell the direction and magnitude of the Doppler shift or blood flow as recognized by Martin ([0028]).
Claims 18 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claims 17 and 25 above, and further in view of Hope (US20120059264).
Regarding claim 18, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of instantaneous frequency.
In an analogous method including incorporating of color into an image field of endeavor, Hope teaches such a feature. Hope teaches transmitting an ultrasonic pulse/wave and receiving ultrasonic echoes in response ([0014]). Hope teaches using a wall filter (37) to remove undesired Doppler shift components ([0015]). Moreover, Hope teaches wherein instantaneous frequencies at different points in an image may be color-coded in correspondence with the measured frequencies ([0015]). Hope therefore teaches wherein a measure of frequency content includes a measure of instantaneous frequency.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to also measure instantaneous frequency as taught by Hope ([0015]). The instantaneous frequencies may be displayed to a clinician, giving them a view of instantaneous flow or motion dynamically shown in real time as recognized by Hope ([0015]).
Regarding claim 30, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of instantaneous frequency.
In an analogous method including incorporating of color into an image field of endeavor, Hope teaches such a feature. Hope teaches transmitting an ultrasonic pulse/wave and receiving ultrasonic echoes in response ([0014]). Hope teaches using a wall filter (37) to remove undesired Doppler shift components ([0015]). Moreover, Hope teaches wherein instantaneous frequencies at different points in an image may be color-coded in correspondence with the measured frequencies ([0015]). Hope therefore teaches wherein a measure of frequency content includes a measure of instantaneous frequency.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to also measure instantaneous frequency as taught by Hope ([0015]). The instantaneous frequencies may be displayed to a clinician, giving them a view of instantaneous flow or motion dynamically shown in real time as recognized by Hope ([0015]).
Claims 19 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claims 17 and 25 above, and further in view of Tamura (US20080242994).
Regarding claim 19, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of first moment of an analytic spectrum.
In an analogous method including incorporating of color into an image field of endeavor, Tamura teaches such a feature. Tamura teaches a color flow processor (921) and a Doppler spectrum processor and analyzer (915, 919) which outputs a Doppler spectrum (925) (Fig. 9, [0035]). Tamura teaches a mean frequency may be calculated as the first moment from the Doppler spectrum (925) ([0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to calculate the first moment of the Doppler spectrum as taught by Tamura ([0060]). Calculating he first moment gives the mean frequency as recognized by Tamura ([0060]), thus allowing for mean blood flow velocity to be calculated and displayed as blood flow velocity is proportional to the measured frequency.
Regarding claim 31, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of first moment of an analytic spectrum.
In an analogous method including incorporating of color into an image field of endeavor, Tamura teaches such a feature. Tamura teaches a color flow processor (921) and a Doppler spectrum processor and analyzer (915, 919) which outputs a Doppler spectrum (925) (Fig. 9, [0035]). Tamura teaches a mean frequency may be calculated as the first moment from the Doppler spectrum (925) ([0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to calculate the first moment of the Doppler spectrum as taught by Tamura ([0060]). Calculating he first moment gives the mean frequency as recognized by Tamura ([0060]), thus allowing for mean blood flow velocity to be calculated and displayed as blood flow velocity is proportional to the measured frequency.
Claims 20 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claims 17 and 25 above, and further in view of He (US20030088182).
Regarding claim 20, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of variance of an analytic spectrum.
In an analogous method including incorporating of color into an image field of endeavor, He teaches such a feature. He teaches an ultrasound imaging system including a pulse-Doppler processor for color flow imaging or mapping ([0017]). He teaches performing Fast-Fourier Transforms (FFTs) to yield a velocity distribution of a region of interest and that mean blood flow velocity is estimated from the frequency spectra of the echoes ([0018-0019]). He teaches wherein a variance of the velocity profile can be calculated ([0018]) and that the variance of the spectrum may indicate turbulence in blood flow ([0022]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to also measure the variance of the frequency spectrum as taught by He ([0018-0019], [0022]). The measure of variance may provide insight to the condition of blood flow; high variance may indicate turbulence and low variance may indicate laminar or stable flow as recognized by He ([0022]).
Regarding claim 32, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of variance of an analytic spectrum.
In an analogous method including incorporating of color into an image field of endeavor, He teaches such a feature. He teaches an ultrasound imaging system including a pulse-Doppler processor for color flow imaging or mapping ([0017]). He teaches performing Fast-Fourier Transforms (FFTs) to yield a velocity distribution of a region of interest and that mean blood flow velocity is estimated from the frequency spectra of the echoes ([0018-0019]). He teaches wherein a variance of the velocity profile can be calculated ([0018]) and that the variance of the spectrum may indicate turbulence in blood flow ([0022]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to also measure the variance of the frequency spectrum as taught by He ([0018-0019], [0022]). The measure of variance may provide insight to the condition of blood flow; high variance may indicate turbulence and low variance may indicate laminar or stable flow as recognized by He ([0022]).
Claims 21 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) and He (US20030088182) as applied to claims 20 and 32 above, and further in view of Monaghan (US5255683). Monaghan is cited in the IDS filed 08/30/2024.
Regarding claim 21, Gauthier in view of Martin and He teaches the invention as claimed above in claim 20.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of higher order moments of the spectrum.
In an analogous method including incorporating of color into an image field of endeavor, Monaghan teaches such a feature. Monaghan teaches detecting Doppler frequency shift and assigning colors to an image based upon the detected shift (Column 1 lines 14-41). Monaghan teaches a frequency analyzer (28) that detects frequency characteristics of a reflected signal (echo) (Column 6 lines 3-38). Monaghan teaches results of a comparison of frequency content is provided to a color coder (34) to help display an image with color superimposed thereon (Column 6 lines 3-48). Monaghan teaches the frequency analyzer (28) may detect a characteristic of the overall frequency spectra of the reflected signals and so it may detect skewness or kurtosis of the spectrum (Column 7 lines 17-24). Monaghan teaches the frequency parameters [i.e. skewness or kurtosis] may be compared by a comparator (32) and the results of the comparison may be passed to the color coder (34) for development of color display data (Column 7 lines 20-28). Skewness is the third order moment and kurtosis is the fourth order moment. Monaghan therefore teaches wherein a measure of frequency content includes a measure of higher order moments of a spectrum.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to further measure skewness and/or kurtosis of the frequency spectrum as taught by Monaghan (Column 7 lines 17-24). Skewness may provide information of whether the blood flow is accelerating or decelerating, and kurtosis may suggest laminar or turbulent flow.
Regarding claim 33, Gauthier in view of Martin and He teaches the invention as claimed above in claim 32.
However, Gauthier fails to teach wherein the measure of frequency content includes a measure of higher order moments of the spectrum.
In an analogous method including incorporating of color into an image field of endeavor, Monaghan teaches such a feature. Monaghan teaches detecting Doppler frequency shift and assigning colors to an image based upon the detected shift (Column 1 lines 14-41). Monaghan teaches a frequency analyzer (28) that detects frequency characteristics of a reflected signal (echo) (Column 6 lines 3-38). Monaghan teaches results of a comparison of frequency content is provided to a color coder (34) to help display an image with color superimposed thereon (Column 6 lines 3-48). Monaghan teaches the frequency analyzer (28) may detect a characteristic of the overall frequency spectra of the reflected signals and so it may detect skewness or kurtosis of the spectrum (Column 7 lines 17-24). Monaghan teaches the frequency parameters [i.e. skewness or kurtosis] may be compared by a comparator (32) and the results of the comparison may be passed to the color coder (34) for development of color display data (Column 7 lines 20-28). Skewness is the third order moment and kurtosis is the fourth order moment. Monaghan therefore teaches wherein a measure of frequency content includes a measure of higher order moments of a spectrum.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to further measure skewness and/or kurtosis of the frequency spectrum as taught by Monaghan (Column 7 lines 17-24). Skewness may provide information of whether the blood flow is accelerating or decelerating, and kurtosis may suggest laminar or turbulent flow.
Claims 22, 26-27 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claims 17 and 25 above, and further in view of Sorinaka (JP2001276070; translation provided).
Regarding claim 22, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
However, Gauthier fails to teach wherein the measure of frequency includes a plurality of band pass filters.
In an analogous method including incorporating of color into an image field of endeavor, Sorinaka teaches such a feature. Sorinaka teaches detecting the doppler shift frequency generated in an ultrasonic echo from blood flow ([0001], [0008-0009], [0023]). Sorinaka teaches performing frequency discrimination [i.e. comparison] on the received echoes ([0009]) and teaches frequency phase detection units (54a, 54b) for doing so ([0023]). Sorinaka teaches prior to being received by the frequency phase detection units (54a, 54b) for measuring and comparing frequency, using a plurality (two) of band pass filters (BPFs) (52a, 52b) to filter the received echoes (Fig. 1, [0009], [0021]). Sorinaka therefore teaches wherein the measure of frequency includes a plurality of band pass filters.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to use a plurality of band pass filters for comparing the frequency of the echoes as taught by Sorinaka (Fig. 1, [0009], [0021], [0023]). By using a plurality of band pass filters, the received signal/echo may be split into parallel frequency bands, allowing for simultaneous measure of multiple blood flow velocities at difference frequencies as recognized by Sorinaka ([0028]).
Regarding claim 26, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the step of comparing a measure of frequency comprises comparing the output of a plurality of band pass filters applied to the reflected echoes.
In an analogous method including incorporating of color into an image field of endeavor, Sorinaka teaches such a feature. Sorinaka teaches detecting the doppler shift frequency generated in an ultrasonic echo from blood flow ([0001], [0008-0009], [0023]). Sorinaka teaches performing frequency discrimination [i.e. comparison] on the received echoes ([0009]) and teaches frequency phase detection units (54a, 54b) for doing so ([0023]). Sorinaka teaches the detection units (54a, 54b) detect a Doppler shift signal corresponding to blood flow velocity ([0023], wherein detecting a Doppler shift comprises comparing the phase and/or frequency of the output to the transmitted phase/frequency). Sorinaka teaches prior to being received by the frequency phase detection units (54a, 54b), using a plurality (two) of band pass filters (BPFs) (52a, 52b) to filter the received echoes (Fig. 1, [0009], [0021]). Sorinaka therefore teaches wherein a step of comparing a measure of frequency comprises comparing the output of a plurality of band pass filters applied to the reflected echoes.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to use a plurality of band pass filters for comparing the frequency of the echoes as taught by Sorinaka (Fig. 1, [0009], [0021], [0023]). By using a plurality of band pass filters, the received signal/echo may be split into parallel frequency bands, allowing for simultaneous measure of multiple blood flow velocities at difference frequencies as recognized by Sorinaka ([0028]).
Regarding claim 27, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the step of selecting a color for display comprises comparing the output of a plurality of band pass filters applied to the reflected echoes.
In an analogous method including incorporating of color into an image field of endeavor, Sorinaka teaches such a feature. Sorinaka teaches detecting the doppler shift frequency generated in an ultrasonic echo from blood flow ([0001], [0008-0009], [0023]). Sorinaka teaches performing frequency discrimination [i.e. comparison] on the received echoes ([0009]) and teaches frequency phase detection units (54a, 54b) for doing so ([0023]). Sorinaka teaches the detection units (54a, 54b) detect a Doppler shift signal corresponding to blood flow velocity ([0023], wherein detecting a Doppler shift comprises comparing the phase and/or frequency of the output to the transmitted phase/frequency). Sorinaka teaches prior to being received by the frequency phase detection units (54a, 54b), using a plurality (two) of band pass filters (BPFs) (52a, 52b) to filter the received echoes (Fig. 1, [0009], [0021]). Sorinaka therefore teaches wherein a step of comparing a measure of frequency comprises a comparison of the output of a plurality of band pass filters. Sorinaka further teaches a blood flow velocity calculation unit (71) that uses the output of the BPFs and frequency detection units (54a, 54b) for calculating blood flow velocity (Fig. 1, [0026-0027]), allowing for simultaneous measure of multipole blood flow velocities at different reference frequencies ([0028]). Sorinaka further teaches color processing means (82) for displaying the plurality of blood flow velocities at the plurality of locations in different colors and generating a corresponding color-coded image (Fig. 1, [0011], [0030], [0032]). As shown in figure 1, the color processing unit 82 depends on the output of the plurality of band pass filters (52a, 52b). Sorinaka therefore further teaches wherein a step of selecting a color for display comprises comparing the output of a plurality of band pass filters applied to the reflected echoes.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to use a plurality of bandpass filters to select a color for display as taught by Sorinaka (Fig. 1, [0009], [0011], [0021], [0030], [0032]). The plurality of band pass filters allow for a plurality of blood flow velocities to be measured simultaneously, which further allows for a separate color to be assigned to each blood flow velocity as recognized by Sorinaka ([0030-0032]).
Regarding claim 34, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the measure of frequency includes a plurality of band pass filters.
In an analogous method including incorporating of color into an image field of endeavor, Sorinaka teaches such a feature. Sorinaka teaches detecting the doppler shift frequency generated in an ultrasonic echo from blood flow ([0001], [0008-0009], [0023]). Sorinaka teaches performing frequency discrimination [i.e. comparison] on the received echoes ([0009]) and teaches frequency phase detection units (54a, 54b) for doing so ([0023]). Sorinaka teaches prior to being received by the frequency phase detection units (54a, 54b) for measuring and comparing frequency, using a plurality (two) of band pass filters (BPFs) (52a, 52b) to filter the received echoes (Fig. 1, [0009], [0021]). Sorinaka therefore teaches wherein the measure of frequency includes a plurality of band pass filters.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to use a plurality of band pass filters for comparing the frequency of the echoes as taught by Sorinaka (Fig. 1, [0009], [0021], [0023]). By using a plurality of band pass filters, the received signal/echo may be split into parallel frequency bands, allowing for simultaneous measure of multiple blood flow velocities at difference frequencies as recognized by Sorinaka ([0028]).
Claims 23 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claims 17 and 25 above, and further in view of Sato (US20080221449).
Regarding claim 23, Gauthier in view of Martin teaches the invention as claimed above in claim 17.
However, Gauthier fails to teach wherein the measure of frequency content is taken after correction for frequency dependent attenuation.
In an analogous method including incorporating of color into an image field of endeavor, Sato teaches such a feature. Sato teaches an ultrasonic apparatus (1) including a reception circuit (4), a frequency dependent attenuation (FDA) measuring unit (5), and a color Doppler processing system (7) Fig. 1, [0034]). Sato teaches the reception circuit (4) obtains corrected information from the FDA measuring unit (5) and supplies a corrected IQ signal to a B-mode processing system (6) and the color Doppler processing system (7) (Fig. 1, [0039]). Sato teaches the FDA measuring unit (5) generates correction information on a received signal for reducing the influence of frequency dependent attenuation and supplies the corrected information to the reception circuit (4) for correcting ([0041]). Sato teaches the color Doppler processing system (7) obtains a IQ signal that is corrected for frequency dependent attenuation (FDA) and detects a Doppler signal [i.e. Doppler frequency shift] from the corrected IQ signal ([0090]). Sato therefore teaches wherein the measure of frequency content is taken after correction for frequency dependent attenuation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to first correct for frequency-dependent attenuation as taught by Sato (Fig. 1, [[0039], [0041], [0090]). By correcting for frequency-dependent attenuation, signal-to-noise ratio is improved and thus more accurate measures of frequency, flow, and/or velocity may be estimated.
Regarding claim 35, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach wherein the measure of frequency content is taken after correction for frequency dependent attenuation.
In an analogous method including incorporating of color into an image field of endeavor, Sato teaches such a feature. Sato teaches an ultrasonic apparatus (1) including a reception circuit (4), a frequency dependent attenuation (FDA) measuring unit (5), and a color Doppler processing system (7) Fig. 1, [0034]). Sato teaches the reception circuit (4) obtains corrected information from the FDA measuring unit (5) and supplies a corrected IQ signal to a B-mode processing system (6) and the color Doppler processing system (7) (Fig. 1, [0039]). Sato teaches the FDA measuring unit (5) generates correction information on a received signal for reducing the influence of frequency dependent attenuation and supplies the corrected information to the reception circuit (4) for correcting ([0041]). Sato teaches the color Doppler processing system (7) obtains a IQ signal that is corrected for frequency dependent attenuation (FDA) and detects a Doppler signal [i.e. Doppler frequency shift] from the corrected IQ signal ([0090]). Sato therefore teaches wherein the measure of frequency content is taken after correction for frequency dependent attenuation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to first correct for frequency-dependent attenuation as taught by Sato (Fig. 1, [0039], [0041], [0090]). By correcting for frequency-dependent attenuation, signal-to-noise ratio is improved and thus more accurate measures of frequency, flow, and/or velocity may be estimated.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gauthier (US20110263985) in view of Martin (US20120116218) as applied to claim 25 above, and further in view of Srinivasan (US20090306513).
Regarding claim 28, Gauthier in view of Martin teaches the invention as claimed above in claim 25.
However, Gauthier fails to teach the invention further comprising: generating and reporting at least one statistic about the region of interest based on the comparison.
In an analogous method including incorporating of color into an image field of endeavor, Srinivasan teaches such a feature. Srinivasan teaches the change [i.e. comparison] in frequency between two samples for the same location at different times indicates a [blood] flow velocity ([0034]). Srinivasan teaches flow data is estimated by a flow or Doppler estimator (22) which estimates a Doppler shift frequency [i.e. comparison of frequency content] and velocity is calculated from the Doppler shift frequency ([0062-0063]). Srinivasan further teaches wherein a statistic is computed for a plurality of locations [i.e. regions of interest] from the flow data [i.e. based on the comparison] such as a mean, standard deviation, or combination thereof (Claims 6 & 7, [0041-0042], [0047]). Srinivasan further teaches displaying display values [i.e. reporting] which are determined from the statistics associated with the flow data ([0071]) Srinivasan therefore teaches generating and reporting at least one statistic about a region of interest based on a comparison of a measure of frequency content.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to generate and report statistics about the region of interest based on the comparison as taught by Srinivasan (Claims 6 & 7, [0041-0042], [0047], [0062-0063]). The statistics may be used to determine display values for flow imaging and may also fill-in holes in flow data and improve color sensitivity as recognized by Srinivasan (Abstract, [0006], [0043]).
Regarding claim 29, Gauthier in view of Martin and Srinivasan teaches the invention as claimed above in claim 28.
However, Gauthier fails to teach wherein the at least one statistic is generated by calculating at least one of a mean and standard deviation of output channels, and measures of first and second order statistics.
In an analogous method including incorporating of color into an image field of endeavor, Srinivasan teaches such a feature. Srinivasan teaches the change in frequency between two samples for the same location at different times indicates a flow velocity ([0034]). Srinivasan teaches flow data is estimated by a flow or Doppler estimator (22) which estimates a Doppler shift frequency and velocity is calculated from the Doppler shift frequency ([0062-0063]). Srinivasan further teaches wherein a statistic is computed for a plurality of locations [i.e. regions of interest] from the flow data [i.e. based on the comparison] such as a mean, standard deviation, or combination thereof (Claims 6 & 7, [0041-0042], [0047]). Srinivasan further teaches wherein the output of filtered flow data is used to determine flow/display values using statistical information (Fig. 1) and wherein a processor (24) receives the filtered flow data from the output channel of an estimator (22) to determine display values using statistics (Fig. 4, [0070-0071]). Srinivasan therefore teaches wherein the at least one statistic is generated by calculating at least one of a mean and standard deviation of output channels, and measures of first and second order statistics.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Gauthier to calculate a mean and standard deviation from the flow data as taught by Srinivasan (Claims 6-7, [0041-0042]). The mean value may give a representative measure of overall blood flow in a vessel, and standard deviation (SD) may measure the variability of the flow; a high SD may indicate turbulent flow and low SD may suggest stable flow.
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 TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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