DETAILED ACTION
This office action is in response to the communication received on 09/17/2025 concerning application no. 18/304,471 filed on 04/21/2023.
Claims 1-18 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Regarding the 101 rejection, Applicant argues “The Examiner is of the position that the claims encompass steps that can be performed in the mind and thus are directed to an abstract idea. Applicant respectfully disagrees. However, to accelerate prosecution to grant, independent claim 1 is amended to add clarifying language which makes it clear that none of elements (a) through (f) can be practically performed in the human mind. Therefore, the present claims are not directed to an abstract idea. The present claims thus recite patent eligible subject matter.”
Examiner respectfully disagrees. Contrary to Applicant’s arguments not all elements (a) through (f) are assessed under Step 2A, Prong 1. Rather, the claim as a whole is assessed with the inclusion of the additional elements. Applicant’s argument that the present claims are not directed to an abstract idea are conclusory and without support. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).”
Examiner respectfully maintains the rejection.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings were received on 09/17/2025. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “applying a localization computing process to at least portions of the series of successive ultrasound images, the localization computing process being configured such that the position that results from the localization computing process has a precision, the precision being a distance value, that is inferior to the wavelength of the ultrasonic waves”. This is understood to be a computer-implemented functional limitation which requires disclosure of the underlying algorithm(s) for obtaining the result in order to comply with the written description requirement. See MPEP § 2161.01(I). The specification does not disclose the computing process tob at least portions of the images where that computing process is configured to have a precision. The specification fails to disclose any steps, considerations, weighting, or factors for the performance of a computing process. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 1 recites “a precision, the precision being a distance value, that is inferior to the wavelength of the ultrasonic waves”. While the specification discloses a precision inferior to the wavelength of the ultrasonic waves in the abstract, paragraphs 0006, 0050, 0065, and 0072, it does not disclose that precision being a distance value. The specification provides no disclosure of a distance value or its implementation in a precision determination. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
Recites “a precision, the precision being a distance value, that is inferior to the wavelength of the ultrasonic waves”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner a distance value of a position of a contrast agent is assessed with respect to the wavelength of a wave.
Applicant is encouraged to provide consistent and clear language.
Recites “(f) generating an at least one 2D backscattering amplitude image, comprising pixels, the generating including a 2D backscattering amplitude image processing comprising computing, for each of the pixels, a value representative of the step (d) generated measured backscattering amplitude of the detected at least one isolated ultrasound contrast agent in said pixel”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if this is referring to the generation of an image distinct from the already generated images of step (c) that are detected in steps (d) and (e) or referring to the same generation. If it is attempting to establish an additional generation of an image, it would be unclear what the distinction is as the ultrasound image in step (c) is representative of the amplitude information of all that is in the ultrasound imaging systems field of view. Furthermore, it is unclear what the step (d) value representative is as the step (d) provides for the detection of the contrast agent.
Applicant is encouraged to provide consistent and clear language.
Claim 2 is indefinite for the following reasons:
Recites “step (f) computing the value is configured to compute the value as an average”. This claim element is indefinite. It would be unclear if the claim is establishing that the value is used to generation another value that is the average or is attempting to narrow the value itself as an average. It would be unclear to one with ordinary skill in the art what the scope of the claim element is as in its present form, the claim element is grammatically incorrect.
Applicant is encouraged to provide consistent and clear language.
Claim 5 is indefinite for the following reasons:
Recites “a 2D backscattering amplitude image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “2D backscattering amplitude image” is the same as the “2D backscattering amplitude image” established in claim 1 or is a separate and distinct feature. If it the same as the “said image generated in step (f)” appears to indicate, then claim is encouraged to remove redundant language.
Applicant is encouraged to provide consistent and clear language.
Claim 6 is indefinite for the following reasons:
Recites “the width”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the ultrasound beam”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the direction Y”. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is indefinite for the following reasons:
Recites “the position y”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the imaging plane”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the direction Y”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the width”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the ultrasound beam”. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is indefinite for the following reasons:
Recites “the position y”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the imaging plane”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the imaging plane”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art which of the “plurality of parallel ultrasound imaging planes XZ” are being referred to or if it the imaging plane is referring to a different imaging plane from the plurality.
Applicant is encouraged to provide consistent and clear language.
Claim 11 is indefinite for the following reasons:
Recites “a simulated value”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how the width can be a simulated value as the claims establish the performance of “a method for imaging vascular activity at a microscopic scale in at least one area of a vascular network of an organ, the organ being of a human or animal, and the at least one area including one more isolated ultrasound contrast agents” and require the transmission of ultrasound waves for the generation of ultrasound images and tracking of the isolated ultrasound agent at a given position. That is, the claims establish actual experimental performance and it would be unclear how the transmission can be simulated as it would conflict with earlier elements of the claim.
Applicant is encouraged to provide consistent and clear language.
Claim 13 is indefinite for the following reasons:
Recites “the positioning”. There is insufficient antecedent basis for this limitation in the claim.
Recites “a first backscattering amplitude image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “first backscattering amplitude image” is the same as the “plurality of 2D parallel backscattering amplitude images” established in claim 6 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a second backscattering amplitude image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “second backscattering amplitude image” is the same as the “plurality of 2D parallel backscattering amplitude images” established in claim 6 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the imaging plane associated to the first backscattering amplitude image”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the imaging plane associated to the second backscattering amplitude image”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is indefinite for the following reasons:
Recites “(ii) computing the velocity Vxz of the ultrasound contrast agents belonging to said selected blood vessel; (ii) obtaining the backscattering amplitude profile along a centerline of said selected blood vessel”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing the same step two, two alternative step twos, or if the second step two is a typographical error and is intended to be a step three.
Applicant is encouraged to provide consistent and clear language.
Claim 18 is indefinite for the following reasons:
Recites “a vascular network”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “vascular network” is the same as the “vascular network” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 and 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method for imaging vascular activity at a microscopic scale in at least one area of a vascular network of an organ, the organ being of a human or animal, and the at least one area including one more isolated ultrasound contrast agents and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “(c) generating, by an image-generating processing of the set of raw data, a series of successive ultrasound images; (d) detecting from the series of successive ultrasound images, at least one isolated ultrasound contrast agent, wherein the detecting includes generating a measured backscattering amplitude of the detected at least one isolated contrast agent; (e) localizing a position of said at least one isolated ultrasound contrast agents by applying a localization computing process to at least portions of the series of successive ultrasound images, the localization computing process being configured such that the position that results from the localization computing process has a precision, the precision being a distance value, that is inferior to the wavelength of the ultrasonic waves; and (f) generating an at least one 2D backscattering amplitude image, comprising pixels, the generating including a 2D backscattering amplitude image processing comprising computing, for each of the pixels, a value representative of the step (d) generated measured backscattering amplitude of the detected at least one isolated ultrasound contrast agent in said pixel”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the generation of images according to raw data and the detection of a contrast agent in the images that is then localized and the generation of images according to the pixel values with respect to the contrast agent. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “(a) transmitting, from an array of ultrasonic transducers extending along at least one direction, a series of ultrasonic waves, the transmitting having a configuration wherein the series of ultrasonic waves: i) has a wavelength and propagates in at least one propagation direction that is both perpendicular to the at least one direction of the array of transducers and is toward the at least one area, and ii) arrives in the at least one area as a series of successive incident ultrasonic waves, having an incidence configuration producing, from the at least one area, backscattered ultrasonic waves that propagate in a backscatter direction that is toward the array of transducers, and arrive at one or more of the transducers in the array of transducers, as transducer-received backscattered ultrasonic waves; (b) acquiring by said array of transducers, responsive to the transducer-received backscattered ultrasonic waves, a set of raw data”. The transmission and acquisition of reflected ultrasound is a data gathering step which is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the step (f) computing the value is configured to compute the value as an average of the measured backscattering amplitude of all isolated ultrasound contrast agents detected in said pixel”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the averaging of amplitude information for a contrast agent detected in a pixel. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the value computed in step (f) corresponds to a function of the backscattering amplitude of the at least one isolated ultrasound contrast agents detected in said pixel”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to computing a value of amplitude information for a contrast agent detected in a pixel. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising a tracking step that includes a tracking of at least one isolated ultrasound contrast agent detected across several ultrasound images generated in step (c) and a computing, based on a spacing between and a time difference between the ultrasound images in the several ultrasound images, of the at least one ultrasound contrast agents to trajectory and its speed”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the tracking of a contrast agent for the determination of speed and trajectory based on the difference between the ultrasound images. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 5 recites the following elements: “wherein the array of ultrasonic transducers is a 1D array extending along one direction X and the incident ultrasonic waves being propagated in a direction Z perpendicular to the array of transducers, said image generated in step (f) is a 2D backscattering amplitude image”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 5 rejection.
Claim 6 recites the following elements: “wherein the steps (a) to (f) are repeated for a plurality of parallel ultrasound imaging planes XZ spaced from each other within the width of the ultrasound beam along the direction Y to generate a plurality of 2D parallel backscattering amplitude images”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “(i) generating a spatial variation of the backscattering amplitude for said at least one tracked isolated contrast agent as a function of the position y of the imaging plane along the direction Y within the width of the ultrasound beam; (ii) computing the position y of said at least one tracked isolated contrast agent by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of the at least one isolated contrast agent being the position of the maximum of the spatial variation of backscattering amplitudes; and (iii) computing the velocity components Vx, Vy and VZ along respectively the three directions X, Y, Z for said at least one tracked isolated ultrasound contrast agent”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the generation of a spatial variation and the computation of the position that is fitted and the computation of the velocity components according to the three dimensions. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “(i) generating a spatial variation of the backscattering amplitude for each pixel as a function of the position y of the imaging planes along the direction Y within the width of the ultrasound beam; (ii) computing the position y of each pixel by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of each pixel being the position of the maximum of the variation of backscattering amplitudes; and (iii) computing three velocity components Vx, Vy and Vz along respectively the three directions X, Y, Z for each pixel”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the generation of a spatial variation and the computation of the position that is fitted and the computation of the velocity components according to the three dimensions. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the fitting function is a Gaussian function:
a
×
e
-
2
(
y
-
y
0
w
)
, a being the backscattering amplitude, w being the width of the ultrasound beam along the direction Y, and yo being the position of the maximum of the variation of backscattering amplitudes”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to using a Gaussian fitting function to determine an output. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 9 rejection.
Claim 10 recites the following elements: “wherein the width w of the ultrasound beam along the direction Y is an experimental value”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 10 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 9 rejection.
Claim 11 recites the following elements: “wherein the width w of the ultrasound beam along the direction Y is a simulated value”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 11 is ineligible.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 6 rejection.
Claim 12 recites the following elements: “wherein the plurality of parallel ultrasound imaging planes are obtained by moving the 1 D array of ultrasonic transducers along a direction Y perpendicular to the ultrasound imaging plane (x, z) within the width (w) of the ultrasound beam”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 12 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 14 recites the following elements: “further comprising a step of generating an at least 2D ultrasound localization microscopy (ULM) image of the at least one area is generated by attributing for each pixel a number of ultrasound contrast agents detected in said pixel”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 14 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “(i) selecting said at least one blood vessel in the at least one backscattering amplitude image; (ii) computing the velocity Vxz of the ultrasound contrast agents belonging to said selected blood vessel; (ii) obtaining the backscattering amplitude profile along a centerline of said selected blood vessel; (iii) computing the angle 0 between the backscattering amplitude profile along the selected blood vessel centerline and its projection on the ultrasound imaging plane; and (iv) computing a corrected velocity for each ultrasound contrast agents belonging to said selected vessel using said computed angle : Vcorr = Vxz/cosθ”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the selection of a vessel and assessing the velocity and the centerline and its angular relationship to perform a correction for the velocity. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 15 is ineligible.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the step of generating a series of successive 2D ultrasound images from said raw data comprises a step of filtration to discriminate the ultrasound signal of the individual ultrasound contrast agents from a tissue signal”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to filtering contrast agent signal data from tissue signals. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 16 is ineligible.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein at least one vascular parameter is extracted from the measured backscattering amplitudes, said one vascular parameter being chosen in the group comprising: blood flow, blood velocity, blood volume, blood pressure and any combination thereof”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of a vascular parameter. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 17 is ineligible.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising an automatic segmentation step of the vessels in at least one area of a vascular network from the at least 2D backscattering amplitude image and wherein at least one dimensional parameter of the vessels is quantified from the segmentation step”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the segmentation of a vascular network from the image and the quantification of the parameters of the vessel. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 18 is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134).
Regarding claim 1, Foiret teaches a method for imaging vascular activity at a microscopic scale in at least one area of a vascular network of an organ, the organ being of a human or animal, and the at least one area including one more isolated ultrasound contrast agents, the method including:
(a) transmitting, from an array of ultrasonic transducers extending along at least one direction, a series of ultrasonic waves, the transmitting having a configuration wherein the series of ultrasonic waves (Page 9 teaches all data was acquired with a programmable ultrasound system and imaging was performed with a 128-element compact linear array and transmission is at 0 degrees. A stack of 40000 frames was recorded in 133 s after the bolus injection of MBs into the tail vein of the animal. See Fig. 1):
i) has a wavelength and propagates in at least one propagation direction that is both perpendicular to the at least one direction of the array of transducers and is toward the at least one area, and ii) arrives in the at least one area as a series of successive incident ultrasonic waves, having an incidence configuration producing, from the at least one area, backscattered ultrasonic waves that propagate in a backscatter direction that is toward the array of transducers, and arrive at one or more of the transducers in the array of transducers, as transducer-received backscattered ultrasonic waves (Page 9 teaches all data was acquired with a programmable ultrasound system and imaging was performed with a 128-element compact linear array and transmission is at 0 degrees. A stack of 40000 frames was recorded in 133 s after the bolus injection of MBs into the tail vein of the animal. The delay between successive transmissions was minimized with a pulse repetition frequency of 28.5 kHz and frame rate of 300 Hz. See Fig. 1. Fig. 6 shows received echo);
(b) acquiring by said array of transducers, responsive to the transducer-received backscattered ultrasonic waves, a set of raw data (Page 10 teaches image reconstruction. See Fig. 1);
(c) generating, by an image-generating processing of the set of raw data, a series of successive ultrasound images (Page 9 teaches a stack of 40000 frames was recorded in 133 s after the bolus injection of MBs into the tail vein of the animal);
(d) detecting from the series of successive ultrasound images, at least one isolated ultrasound contrast agent, wherein the detecting includes generating a measured backscattering amplitude of the detected at least one isolated contrast agent (Abstract teaches that individual microbubbles (MBs) are detected and tracked within the vasculature. Pages 1-2 teach that the center of each MB is localized on a sub-wavelength grid and that it facilitates the reconstruction of the image of the vasculature. This form of imaging is ULM. Fig. 6 shows the density of the regions of interest and the received echo);
(e) localizing a position of said at least one isolated ultrasound contrast agents by applying a localization computing process to at least portions of the series of successive ultrasound images, the localization computing process being configured such that the position that results from the localization computing process has a precision, the precision being a distance value, that is inferior to the wavelength of the ultrasonic waves (Pages 1-2 teach that the center of each MB is localized on a sub-wavelength grid and that it facilitates the reconstruction of the image of the vasculature. This form of imaging is ULM. Page 3 teaches that the distances is smaller than the elevation beam width).
However, Foiret is silent regarding a method, (f) generating an at least one 2D backscattering amplitude image, comprising pixels, the generating including a 2D backscattering amplitude image processing comprising computing, for each of the pixels, a value representative of the step (d) generated measured backscattering amplitude of the detected at least one isolated ultrasound contrast agent in said pixel.
In an analogous imaging field of endeavor, regarding contrast agent tracking, Averkiou teaches a method, (f) generating an at least one 2D backscattering amplitude image, comprising pixels, the generating including a 2D backscattering amplitude image processing comprising computing, for each of the pixels, a value representative of the step (d) generated measured backscattering amplitude of the detected at least one isolated ultrasound contrast agent in said pixel (Paragraphs 0023-24 teaches the assessment of the contrast agent as it builds to a maximum amplitude. This value is assessed for each pixel in each of the images. This is thresholded and used as confirmation of the flow of the contrast agent. Paragraph 0025 teaches that this amplitude is the basis of the generation of the image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Foiret with Averkiou’s teaching of pixel-based analysis of the amplitude for image generation. This modified method would allow the user to improve the spatial correlation (Paragraph 0004 of Averkiou). Furthermore, the modification can assist in the evaluation of stroke (Paragraph 0001 of Averkiou).
Regarding claim 2, modified Foiret teaches the method in claim 1, as discussed above.
However, Foiret is silent regarding a method, wherein the step (f) computing the value is configured to compute the value as an average of the measured backscattering amplitude of all isolated ultrasound contrast agents detected in said pixel.
In an analogous imaging field of endeavor, regarding contrast agent tracking, Averkiou teaches a method, wherein the step (f) computing the value is configured to compute the value as an average of the measured backscattering amplitude of all isolated ultrasound contrast agents detected in said pixel (Paragraph 0005 teaches that the intensity signals can be averaged for the mean intensity contrast agent signal within the ROI).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Foiret with Averkiou’s teaching of averaging the amplitude information of the contrast agents. This modified method would allow the user to improve the spatial correlation (Paragraph 0004 of Averkiou). Furthermore, the modification can assist in the evaluation of stroke (Paragraph 0001 of Averkiou).
Regarding claim 3, modified Foiret teaches the method in claim 1, as discussed above.
However, Foiret is silent regarding a method, wherein the value computed in step (f) corresponds to a function of the backscattering amplitude of the at least one isolated ultrasound contrast agents detected in said pixel.
In an analogous imaging field of endeavor, regarding contrast agent tracking, Averkiou teaches a method, wherein the value computed in step (f) corresponds to a function of the backscattering amplitude of the at least one isolated ultrasound contrast agents detected in said pixel (Paragraphs 0023-24 teaches the assessment of the contrast agent as it builds to a maximum amplitude. This value is assessed for each pixel in each of the images. This is thresholded and used as confirmation of the flow of the contrast agent. Paragraph 0025 teaches that this amplitude is the basis of the generation of the image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Foiret with Averkiou’s teaching of pixel-based analysis of the amplitude for image generation. This modified method would allow the user to improve the spatial correlation (Paragraph 0004 of Averkiou). Furthermore, the modification can assist in the evaluation of stroke (Paragraph 0001 of Averkiou).
Regarding claim 4, modified Foiret teaches the method in claim 1, as discussed above.
Foiret further teaches a method, further comprising a tracking step that includes a tracking of at least one isolated ultrasound contrast agent detected across several ultrasound images generated in step (c) and a computing, based on a spacing between and a time difference between the ultrasound images in the several ultrasound images, of the at least one ultrasound contrast agents to trajectory and its speed (Abstract teaches the tracking of the MBs and the blood velocity is estimated by tracking the MBs. Page 3 teaches tracking over a period of time. Fig. 4 shows the velocity and direction of the in-plane microvascular flow represented by individual trajectories of MBs. Also, see Figs. 1 and 5).
Regarding claim 5, modified Foiret teaches the method in claim 1, as discussed above.
However, Foiret is silent regarding a method, wherein the array of ultrasonic transducers is a 1D array extending along one direction X and the incident ultrasonic waves being propagated in a direction Z perpendicular to the array of transducers, said image generated in step (f) is a 2D backscattering amplitude image.
In an analogous imaging field of endeavor, regarding contrast agent tracking, Averkiou teaches a method, wherein the array of ultrasonic transducers is a 1D array extending along one direction X and the incident ultrasonic waves being propagated in a direction Z perpendicular to the array of transducers, said image generated in step (f) is a 2D backscattering amplitude image (Paragraph 0017 teaches that the array may be 1D and that the beam is aimed at the body that it is in contract with. Paragraph 0025 teaches that this amplitude is the basis of the generation of the image).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Foiret with Averkiou’s teaching of a 1D array that is used to generate amplitude images. This modified method would allow the user to improve the spatial correlation (Paragraph 0004 of Averkiou). Furthermore, the modification can assist in the evaluation of stroke (Paragraph 0001 of Averkiou).
Regarding claim 14, modified Foiret teaches the method in claim 1, as discussed above.
Foiret further teaches a method, further comprising a step of generating an at least 2D ultrasound localization microscopy (ULM) image of the at least one area is generated by attributing for each pixel a number of ultrasound contrast agents detected in said pixel (Pages 1-2 teach that the center of each MB is localized on a sub-wavelength grid and that it facilitates the reconstruction of the image of the vasculature. This form of imaging is ULM).
Regarding claim 16, modified Foiret teaches the method in claim 1, as discussed above.
Foiret further teaches a method, wherein the step of generating a series of successive 2D ultrasound images from said raw data comprises a step of filtration to discriminate the ultrasound signal of the individual ultrasound contrast agents from a tissue signal (Page 5 teaches that the MB echoes are filtered to eliminate stationary objects. Page 11 teaches that the filter is applied to assess the MBs and assess the flow while compensating for the non-integer values of the pixel positions after motion correction. See Figs. 3-4).
Regarding claim 17, modified Foiret teaches the method in claim 1, as discussed above.
Foiret further teaches a method, wherein at least one vascular parameter is extracted from the measured backscattering amplitudes, said one vascular parameter being chosen in the group comprising: blood flow, blood velocity, blood volume, blood pressure and any combination thereof (Abstract teaches the tracking of the MBs and the blood velocity is estimated by tracking the MBs. Page 3 teaches tracking over a period of time. Fig. 4 shows the velocity and direction of the in-plane microvascular flow represented by individual trajectories of MBs. Also, see Figs. 1 and 5).
Regarding claim 18, modified Foiret teaches the method in claim 1, as discussed above.
Foiret further teaches a method, further comprising an automatic segmentation step of the vessels in at least one area of a vascular network from the at least 2D backscattering amplitude image and wherein at least one dimensional parameter of the vessels is quantified from the segmentation step (Page 2 teaches that the segmentation is performed on the images upon tracking to study the vessels. Pages 4-5 teaches that the MBs facilitate the segmentation as they are used in relation to the small blood vessels. See Figs. 3-4).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134) further in view of Shandas et al. (PGPUB No. US 2008/0015440).
Regarding claim 6, modified Foiret teaches the method in claim 5, as discussed above.
However, the combination of Foiret and Averkiou is silent regarding a method, wherein the steps (a) to (f) are repeated for a plurality of parallel ultrasound imaging planes XZ spaced from each other within the width of the ultrasound beam along the direction Y to generate a plurality of 2D parallel backscattering amplitude images.
In an analogous imaging field of endeavor, regarding particle flow ultrasound monitoring, Shandas teaches a method, wherein the steps (a) to (f) are repeated for a plurality of parallel ultrasound imaging planes XZ spaced from each other within the width of the ultrasound beam along the direction Y to generate a plurality of 2D parallel backscattering amplitude images (Paragraph 0093 teaches the use of a 1D linear array. Paragraph 0211 teaches the performance of parallel beam scanning concept for improve the frame rate. See Fig. 51 where the transmission is in the third direction than the ultrasound probe position. Paragraph 0077 teaches generation of the velocity data with respect to amplitude echo images of the anatomy. Paragraph 0091 teaches that the lateral resolution of the images is defined by the beam width. Fig. 2 shows 2D images).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret and Averkiou with Shandas’s teaching of the performance of parallel beam imaging in a third direction. This modified method would allow the user to perform opaque microfluidic imaging measurement and take advantage of the harmonic radio frequency (RF) backscatter content of contrast agents (Paragraph 0068 of Shandas). Furthermore, the modification facilitates multi-component blood flow velocimetry for peripheral vascular imaging using Echo PIV (Paragraph 0070 of Shandas).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134) further in view of Shandas et al. (PGPUB No. US 2008/0015440) further in view of Heiles et al. (“Ultrafast 3D Ultrasound Localization Microscopy Using a 32 × 32 Matrix Array”, 2019).
Regarding claim 7, Foiret teaches the method in claim 4, as discussed above.
However, the combination of Foiret and Averkiou is silent regarding a method, further comprising a computation speed step for the at least one tracked isolated ultrasound agent at a given position (x, z) comprising the following steps:
(i) generating a spatial variation of the backscattering amplitude for said at least one tracked isolated contrast agent as a function of the position y of the imaging plane along the direction Y within the width of the ultrasound beam;
(ii) computing the position y of said at least one tracked isolated contrast agent by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of the at least one isolated contrast agent being the position of the maximum of the spatial variation of backscattering amplitudes; and
(iii) computing the velocity components Vx, Vy and VZ along respectively the three directions X, Y, Z for said at least one tracked isolated ultrasound contrast agent.
In an analogous imaging field of endeavor, regarding particle flow ultrasound monitoring, Shandas teaches a method, further comprising a computation speed step for the at least one tracked isolated ultrasound agent at a given position (x, z) comprising the following steps:
(i) generating a spatial variation of the backscattering amplitude for said at least one tracked isolated contrast agent as a function of the position y of the imaging plane along the direction Y within the width of the ultrasound beam (Paragraph 0093 teaches the use of a 1D linear array. Paragraph 0211 teaches the performance of parallel beam scanning concept for improve the frame rate. See Fig. 51 where the transmission is in the third direction than the ultrasound probe position. Paragraph 0077 teaches generation of the velocity data with respect to amplitude echo images of the anatomy. Paragraph 0091 teaches that the lateral resolution of the images is defined by the beam width. Fig. 2 shows 2D images).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret and Averkiou with Shandas’s teaching of the control of spatial variation according to the consideration of beam width. This modified method would allow the user to perform opaque microfluidic imaging measurement and take advantage of the harmonic radio frequency (RF) backscatter content of contrast agents (Paragraph 0068 of Shandas). Furthermore, the modification facilitates multi-component blood flow velocimetry for peripheral vascular imaging using Echo PIV (Paragraph 0070 of Shandas).
However, Shandas is silent regarding a method, (ii) computing the position y of said at least one tracked isolated contrast agent by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of the at least one isolated contrast agent being the position of the maximum of the spatial variation of backscattering amplitudes; and
(iii) computing the velocity components Vx, Vy and VZ along respectively the three directions X, Y, Z for said at least one tracked isolated ultrasound contrast agent.
In an analogous imaging field of endeavor, regarding ultrasound microscopy of a contrast agent, Heiles teaches a method, (ii) computing the position y of said at least one tracked isolated contrast agent by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of the at least one isolated contrast agent being the position of the maximum of the spatial variation of backscattering amplitudes (Page 2008 teaches the assessment of the maximum velocity and the tracking of the MBs. After microbubbles positions are measured and stored, a tracking algorithm is implemented where the number of particles in each frame are assessed over a period of time. This is used to assess the trajectory and mean path is defined as the streamline going from beginning to end of the field of view that is exactly centered in each direction (z, x, y). The velocity components in three dimensions are computed and used to formulate the total velocity. See Figs. 2-8); and
(iii) computing the velocity components Vx, Vy and VZ along respectively the three directions X, Y, Z for said at least one tracked isolated ultrasound contrast agent (Page 2008 teaches the assessment of the maximum velocity and the tracking of the MBs. After microbubbles positions are measured and stored, a tracking algorithm is implemented where the number of particles in each frame are assessed over a period of time. This is used to assess the trajectory and mean path is defined as the streamline going from beginning to end of the field of view that is exactly centered in each direction (z, x, y). The velocity components in three dimensions are computed and used to formulate the total velocity. See Figs. 2-8).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret, Averkiou, and Shandas with Heiles’s teaching of tracking of the MBs in multiple dimensions. This modified method would allow the user to improve image quality to be able to see the MBs (Page 2012 of Heiles). Furthermore, the modification delivers volumes with enhanced resolution in the three dimensions compared to conventional 3D B-mode imaging within acceptable acquisition times (Page 2014 of Heiles).
Regarding claim 8, modified Foiret teaches the method in claim 6, as discussed above.
However, the combination of Foiret and Averkiou is silent regarding a method, further comprising a computation speed step for each pixel at a given position (x, z) comprising the following steps:
(i) generating a spatial variation of the backscattering amplitude for each pixel as a function of the position y of the imaging planes along the direction Y within the width of the ultrasound beam;
(ii) computing the position y of each pixel by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of each pixel being the position of the maximum of the variation of backscattering amplitudes; and
(iii) computing three velocity components Vx, Vy and Vz along respectively the three directions X, Y, Z for each pixel.
In an analogous imaging field of endeavor, regarding particle flow ultrasound monitoring, Shandas teaches a method, further comprising a computation speed step for each pixel at a given position (x, z) comprising the following steps:
(i) generating a spatial variation of the backscattering amplitude for each pixel as a function of the position y of the imaging planes along the direction Y within the width of the ultrasound beam (Paragraph 0093 teaches the use of a 1D linear array. Paragraph 0211 teaches the performance of parallel beam scanning concept for improve the frame rate. See Fig. 51 where the transmission is in the third direction than the ultrasound probe position. Paragraph 0077 teaches generation of the velocity data with respect to amplitude echo images of the anatomy. Paragraph 0091 teaches that the lateral resolution of the images is defined by the beam width. Fig. 2 shows 2D images).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret and Averkiou with Shandas’s teaching of the control of spatial variation according to the consideration of beam width. This modified method would allow the user to perform opaque microfluidic imaging measurement and take advantage of the harmonic radio frequency (RF) backscatter content of contrast agents (Paragraph 0068 of Shandas). Furthermore, the modification facilitates multi-component blood flow velocimetry for peripheral vascular imaging using Echo PIV (Paragraph 0070 of Shandas).
However, Shandas is silent regarding a method, (ii) computing the position y of each pixel by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of each pixel being the position of the maximum of the variation of backscattering amplitudes; and
(iii) computing three velocity components Vx, Vy and Vz along respectively the three directions X, Y, Z for each pixel.
In an analogous imaging field of endeavor, regarding ultrasound microscopy of a contrast agent, Heiles teaches a method, (ii) computing the position y of each pixel by fitting a function on the spatial variation of the measured backscattering amplitude, the position y of each pixel being the position of the maximum of the variation of backscattering amplitudes (Page 2008 teaches the assessment of the maximum velocity and the tracking of the MBs. After microbubbles positions are measured and stored, a tracking algorithm is implemented where the number of particles in each frame are assessed over a period of time. This is used to assess the trajectory and mean path is defined as the streamline going from beginning to end of the field of view that is exactly centered in each direction (z, x, y). The velocity components in three dimensions are computed and used to formulate the total velocity. See Figs. 2-8); and
(iii) computing three velocity components Vx, Vy and Vz along respectively the three directions X, Y, Z for each pixel (Page 2008 teaches the assessment of the maximum velocity and the tracking of the MBs. After microbubbles positions are measured and stored, a tracking algorithm is implemented where the number of particles in each frame are assessed over a period of time. This is used to assess the trajectory and mean path is defined as the streamline going from beginning to end of the field of view that is exactly centered in each direction (z, x, y). The velocity components in three dimensions are computed and used to formulate the total velocity. See Figs. 2-8).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret, Averkiou, and Shandas with Heiles’s teaching of tracking of the MBs in multiple dimensions. This modified method would allow the user to improve image quality to be able to see the MBs (Page 2012 of Heiles). Furthermore, the modification delivers volumes with enhanced resolution in the three dimensions compared to conventional 3D B-mode imaging within acceptable acquisition times (Page 2014 of Heiles).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134) further in view of Shandas et al. (PGPUB No. US 2008/0015440) further in view of Kadokura et al. (PGPUB No. US 2010/0217125).
Regarding claim 12, modified Foiret teaches the method in claim 6, as discussed above.
However, the combination of Foiret, Averkiou, and Shandas is silent regarding a method, wherein the plurality of parallel ultrasound imaging planes are obtained by moving the 1D array of ultrasonic transducers along a direction Y perpendicular to the ultrasound imaging plane (x, z) within the width (w) of the ultrasound beam.
In an analogous imaging field of endeavor, regarding the ultrasound monitoring of blood flow, Kadokura teaches a method, wherein the plurality of parallel ultrasound imaging planes are obtained by moving the 1D array of ultrasonic transducers along a direction Y perpendicular to the ultrasound imaging plane (x, z) within the width (w) of the ultrasound beam (Paragraph 0158 teaches that the probe can have the elements arranged in 1D. See Fig. 2. Paragraphs 0191-97 teaches the control of the movement direction and speed of the ultrasound probe for the ultrasound acquisition with respect to the target. See Fig. 9).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret, Averkiou, and Shandas with Kadokura’s teaching of moving the probe in the y-direction. This modified method would allow the user to accurately measure the elasticity characteristic of a blood vessel (Paragraph 0021 of Kadokura). Furthermore, the modification can improve the measurement precision of ultrasonic diagnostic apparatuses (Paragraph 0009 of Kadokura).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134) further in view of Shandas et al. (PGPUB No. US 2008/0015440) further in view of Ribes et al. (PGPUB No. US 2016/0113632).
Regarding claim 13, modified Foiret teaches the method in claim 6, as discussed above.
However, the combination of Foiret, Averkiou, and Shandas is silent regarding a method, further comprising a correction step of the positioning of the 1D array of ultrasonic transducers by comparing a first backscattering amplitude image and a second backscattering so as the imaging plane associated to the first backscattering amplitude image coincides with the imaging plane associated to the second backscattering image.
In an analogous imaging field of endeavor, regarding probe control, Ribes teaches a method, further comprising a correction step of the positioning of the 1D array of ultrasonic transducers by comparing a first backscattering amplitude image and a second backscattering so as the imaging plane associated to the first backscattering amplitude image coincides with the imaging plane associated to the second backscattering image (Paragraph 0006 teaches the use of a 1D probe. Paragraph 0019 teaches that the probe motion can be corrected according to comparison between the desired motion and the actual motion of the probe. Paragraphs 0015-16 teaches that the ultrasound data is compared to reference images or previous images to assess sufficiency of the imaging).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret, Averkiou, and Shandas with Ribes’s teaching of comparing images for probe motion. This modified method would allow the user to ensure proper quality during image acquisition (Abstract of Ribes). Furthermore, the modification can be greatly improved by a volume visualization and an accurate volume estimation (Paragraph 0003 of Ribes).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Foiret et al. (“Ultrasound localization microscopy to image and assess microvasculature in a rat kidney”, 2017) in view of Averkiou et al. (PGPUB No. US 2016/0343134) further in view of Shandas et al. (PGPUB No. US 2008/0015440) further in view of Dentinger et al. (PGPUB No. US 2012/0078106).
Regarding claim 15, modified Foiret teaches the method in claim 5, as discussed above.
However, the combination of Foiret, Averkiou, and Shandas is silent regarding a method, further comprising a quantification step of the corrected velocity for at least one vessel from said 2D backscattering amplitude image, said quantification step comprising:
(i) selecting said at least one blood vessel in the at least one backscattering amplitude image;
(ii) computing the velocity Vxz of the ultrasound contrast agents belonging to said selected blood vessel;
(ii) obtaining the backscattering amplitude profile along a centerline of said selected blood vessel;
(iii) computing the angle θ between the backscattering amplitude profile along the selected blood vessel centerline and its projection on the ultrasound imaging plane; and
(iv) computing a corrected velocity for each ultrasound contrast agents belonging to said selected vessel using said computed angle : Vcorr = Vxz/cosθ.
In an analogous imaging field of endeavor, regarding the ultrasound monitoring of blood flow, Dentinger teaches a method, further comprising a quantification step of the corrected velocity for at least one vessel from said 2D backscattering amplitude image, said quantification step comprising:
(i) selecting said at least one blood vessel in the at least one backscattering amplitude image (Paragraph 0031 teaches the automatic detection of vessels within the scan planes);
(ii) computing the velocity Vxz of the ultrasound contrast agents belonging to said selected blood vessel (Paragraph 0031 teaches the assessment of the velocity of the blood flow and the calculation of the flow rate);
(ii) obtaining the backscattering amplitude profile along a centerline of said selected blood vessel (Paragraph 0031 teaches the determination of a centerline);
(iii) computing the angle θ between the backscattering amplitude profile along the selected blood vessel centerline and its projection on the ultrasound imaging plane (Paragraph 0051 teaches that the centerline coincides with the velocity vector and can be used in the determination to find the rotation angles); and
(iv) computing a corrected velocity for each ultrasound contrast agents belonging to said selected vessel using said computed angle : Vcorr = Vxz/cosθ (Paragraph 0051 teaches that the centerline coincides with the velocity vector and can be used in the determination to find the rotation angles. The equations would allow one with ordinary skill in the art to reverse the relationship such that the velocity would be corrected accorded to a known angular value).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Foiret, Averkiou, and Shandas with Dentinger’s teaching of the determination and correction of velocity according to a centerline. While Dentinger is silent regarding the contrast agent, it would be obvious to one with ordinary skill in the art that the tracking of the blood vessels as discussed in Foiret would result in the assessment of the contrast agent velocity as it is present in the blood vessels. This modified method would allow the user to monitor the arterial parameters of the patient in real-time (Abstract of Dentinger). Furthermore, the modification allows for continuous non-invasive monitoring of patient parameters (Paragraph 0002 of Dentinger).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gu et al. (PGPUB No. US 2018/0185010): Teaches assessment of the pixel representation of the contrast agent according to amplitude.
Frinking et al. (PGPUB No. US 2009/0324030): Teaches assessment of the pixel representation of the contrast agent according to amplitude.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798