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 .
Election/Restrictions
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/09/2026.
Applicant's election with traverse of Invention II in the reply filed on 03/09/2026 is acknowledged. The traversal is on the ground(s) that “the Office has not met its procedural burden in establishing distinctiveness and serious search/examination burden” (REMARKS pg. 7) and “the Office has not only failed to identify whether there would be a serious search burden, a serious examination burden, or both, but the Office has also failed to provide any explanation, let alone the required appropriate explanation outlined in MPEP 808.02. Rather, the office has simply stated that ‘the inventions require a different field of search….” (REMARKS pg. 9). This is not found persuasive because examiner explicitly sets forth in the restriction requirement mailed on 02/06/2026 pg. 7 an explanation of the serious search burden. Such explanation includes an explanation that that the search strategies for each of the set forth inventions include features that would not be required in the search strategies of the remaining inventions. Specifically, examiner noted that the search strategy for Invention II would require at least CPC and text queries related to accessing parameters of an ultrasound transducer configured to generate a range of pressure levels, calculating displacements during MR-ARFI pulses based on the generated pressure levels and determining unknown intensities which are not required of the search strategy for Invention I and the search strategy for Invention I would require at least CPC and text queries related to converting simulations or measurements of a pressure field to force, delivering the force to a model to calculate dynamic tissue displacements in tissue and delivering the dynamic tissue displacement to control operation of an MR-ARFI process which are not required of Invention II.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 6, 12, and 21 are objected to because of the following informalities:
In claim 6, “accessing parameters of ultrasound transducer” should read –accessing parameters of an ultrasound transducer—
Claims 8-10, 11, and 15-21 recite the limitation “wherein the processor is configured to” or “wherein the processor is further configured to”, however, the claimed invention is directed towards a computer readable medium storing instructions that cause the processor to perform steps. Examiner recommends amending the claim to clearly tie the functions of the processor to the instructions stored in the claimed medium for enhanced clarity as to the scope of the claims such that the functional steps the steps performed by the processor are a result of the instructions. Such an amendment would be to recite “wherein the instructions cause (or further cause) the processor to carry out the steps of….” or similar.
In claim 12, “the lookup table includes uses minimum…” is recited. Examiner notes that includes uses is improper and applicant should amend the claims to more clearly define whether the lookup table includes the minimum, middle, or maximum displacements or uses minimum, middle, or maximum displacements.
In claim 21 “solver to calculating tissue displacements” should read –solver to calculate tissue displacements—.
Appropriate correction is required.
Claim Interpretation
Claim 8 recites the limitation “to calculate the displacements during MR-ARFI pulses”. The limitation is directed towards intended use of the finite element method (FEM). Limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. Examiner therefore notes that any prior art teaching a processor configured to a use a finite element method in which the finite element method would be capable of being used to calculate the displacements during MR-ARFI pulses would read on the claimed invention.
Claim 9 recites the limitation “to perform calculations over a radially symmetric slice around focus nodes”. The limitation is directed towards intended use of the finite element method (FEM). Limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. Examiner therefore notes that any prior art teaching a processor configured to a use a finite element method in which the finite element method would be capable of being used to perform calculations over a radially symmetric slice around focus notes would read on the claimed invention.
Claim 11 recites the limitation “to determine the unknown intensities”. The limitation is directed towards intended use of the lookup table. Limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. Examiner therefore notes that any prior art teaching a processor configured access a lookup table in which the lookup table would be capable of being used to determine the unknown intensities would read on the claimed invention.
Claim 19 recites the limitation “to create an updated MR-ARFI image”. The limitation is directed towards intended use of the MR-ARFI image. Limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. Examiner therefore notes that any prior art teaching a processor configured calculate the MR-ARFI image in which the MR-ARFI image would be capable of being used to create an updated MR-ARFI image would read on the claimed invention.
Claim 21 recites the limitation “to calculating tissue displacements using the pressure fields”, “to backpropagate derivatives with respect to parameters”, “to select updated parameters”, “to select corrective measures that refocuses an ultrasound beam”. The limitations are directed towards intended use of the displacements, the MR-ARFI image, the derivatives, and the updated parameters respectively. Limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. Examiner therefore notes that any prior art teaching a processor configured calculate displacements, use the MR-ARFI image, use the derivatives, and use the updated parameters in which the displacements, MR-ARFI image, derivatives, and updated parameters would be capable of being used to calculate tissue displacements, backpropagate derivatives, select updated parameters and select corrective measures, respectively, would read on the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 6-13 and 15-21 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 6 recites the limitation “accessing parameters of ultrasound transducer configured to generate a range of pressure levels”. It is unclear if the range of pressure levels are the same parameters that are accessed or if these are different parameters of the ultrasound transducer. In other words, a range of pressure levels is understood to be a parameter of the ultrasound transducer, thus it is unclear if the accessing of parameters is or includes accessing the range of pressure levels or if this is a different/distinct element.
Claim 6 recites the limitation “calculating displacements during MR-ARFI pulses based on the generated pressure levels”. The limitation is first unclear what the displacements are of (e.g. displacements between transducer, tissue displacements, focal displacements, or any other displacements). Furthermore, “the generated pressure levels” lacks sufficient antecedent basis as there is no recitation of generating pressure levels as the claim previously recites that an ultrasound transducer is configured to generate a range of pressure levels, but does not actually recite generating pressure levels and is further unclear if the generated pressure levels are the range of pressure levels, pressure levels therein, or some other generated pressure levels. For examination purposes, it has been interpreted to mean any displacements and based on any generated pressure levels, however, clarification is required.
Claim 6 recites the limitation “determining unknown intensities based on the displacements”. It is unclear what does and does not constitute “intensities”. In other words, it is not explicitly clear what the intensities are with respect to. For examination purposes, it has been interpreted to mean any intensities (e.g. levels, magnitudes, values, amplitudes, etc.), however, clarification is required.
Claim 7 recites the limitation “configured to generate pressure levels ranging from .27 to 2.70 MPa”. The limitation is unclear as to whether the pressure levels are the same as the range of pressure levels, a subset thereof, or a separate/distinct pressure levels (e.g. the ultrasound transducer is configured to generate multiple ranges of pressure levels). For examination purposes, it has been interpreted to mean the range of pressure levels is or includes pressure levels ranging from .27 to 2.70 MPa, however, clarification is required.
Claim 8 recites the limitation “during MR-ARFI pulses”. It is unclear if this is the same MR-ARFI pulses or if these are different MR-ARFI pulses. For examination purposes, it has been interpreted to mean any MR-ARFI pulses, however, clarification is required.
Claims 8-10, 11, and 15-21 recite the limitation “wherein the processor is (further) configured to” and recites corresponding functions of the processor. Examiner notes that the independent claim 6 is directed to a storage medium having instructions stored thereon that, when executed by a processor, cause the processor to carry out steps… and it is therefore unclear how the processor configuration ties to the instructions stored on the storage medium. In other words, it is unclear as to whether the corresponding functions of the processor are caused by the instructions stored on the computer storage medium as claimed or if these are different functions of the processor that are not tied to the steps carried out by the processor in response to the instructions. For examination purposes, it has been interpreted that the instructions cause the processor to carry out steps which correspond to the functions of the processor recited in these claims, however, clarification is required. Examiner recommends amending the claims to recite that the instructions cause the processor to further carry out steps or similar in order to enhance clarity as to the specific correspondence between the claimed instructions and the processor functions.
Claim 9 recites the limitation “to perform calculations”. It is unclear if the calculations are the same as the displacement calculations or different calculations. For examination purposes, it has been interpreted to mean any calculations, however, clarification is required.
Claim 10 recites the limitation “a timestep of 5x10-5 seconds”. The limitation is unclear as to what 5x10-5 seconds means. For examination purposes, it has been interpreted to mean any time step that includes 5 seconds, however, clarification is required.
Claim 13 recites the limitation ”wherein the unknown intensities are determined at middle points”. It is unclear what is meant by “middle points” (e.g. middle points of tissue, middle points, of an image, middle points of intensity, etc.).
Claims 15 and 21 recite the limitation “a focused ultrasound transducer”. It is unclear if this is the same ultrasound transducer of claim 6 or if this is a different ultrasound transducer. For examination purposes, it has been interpreted to mean either the same or different ultrasound transducer, however, clarification is required.
Claims 15 and 21 recite the limitation “control a focused ultrasound transducer”. It is unclear if this is either of the previously recited ultrasound transducers or if this is a different ultrasound transducer. For examination purposes, it has been interpreted to mean any focused ultrasound transducer, however, clarification is required.
Claims 15 and 21 recite the limitation “the focused ultrasound transducer” in multiple instances. It is unclear which of the previously recited focused ultrasound transducers the limitation is referring to. For examination purposes, it has been interpreted to mean any of the previously recited ultrasound transducers, however, clarification is required.
Claims 15 and 25 recites the limitation “pressure fields”. It is unclear if the pressure fields are the same as or different from the pressure levels or range of pressure levels recited in claim 6. For examination purposes, it has bene interpreted to mean they are the same or different, however, clarification is required.
Claim 15 recites the limitation “calculate tissue displacements using the pressure fields using a model to calculate the displacements”. It is unclear if the tissue displacements are the same as the displacements or if they are merely a first calculation of tissue displacements to calculate some other displacements. For examination purposes, it has been interpreted that they may be the same or different, however, clarification is required.
Claim 15 recites the limitation “using a model”. It is unclear if the model is the same as or different form the model of the focused ultrasound transducer and a tissue medium or if this is a different model. In other words, it is unclear if the tissue displacements are calculated using the model of the focused ultrasound transducer and tissue medium or if this is a different model that is used. For examination purposes, it has been interpreted to mean any model, however, clarification is required.
Claims 15 and 21 recite the limitation “generate an MR-ARFI image using the tissue displacements and MR-ARFI image data acquired from the subject”. It is unclear first if the limitation intends to mean that an MR-ARFI image is generated using both the tissue displacements and MR-ARFI image data or if the limitation intends to mean generate an MR-ARFI image and generate MR-ARFI image data. It is further unclear if the MR-ARFI image data is the same as or different from the MR-ARFI image data recited previously. For examination purposes, it has been interpreted to mean any of the above interpretations, however, clarification is required.
Claim 15 recite the limitation “using the MR-ARFI image, backpropagate derivatives with respect to parameters of the focused ultrasound transducer or the tissue medium back from the inputs to the model”. The limitation is unclear for a plurality of reasons. First, it is unclear what is meant by backpropagate derivatives with respect to parameters of the focused ultrasound transducers and how this is done, it is unclear what derivatives with respect to parameters of the focused ultrasound transducer are and if the parameters of the focused ultrasound transducer are the same as the accessed parameters of claim 6 or if these are different parameters. Furthermore, it is unclear what is meant by “back from the inputs to the model” and what the limitation is referring to (e.g. are the derivatives backpropagated back from the inputs to the model, are the parameters of the focused ultrasound transducer or the tissue medium “back” from the inputs to the model, or some other meaning?) . Finally, there is insufficient antecedent basis for “the inputs to the model” and it is therefore unclear what the inputs to the model are. Finally, it is unclear if the model refers to the model of the focused ultrasound transducer and tissue medium or the model used to calculate displacements. For examination purposes, it has been interpreted to mean backpropagate derivatives, however, clarification is required.
Claim 18 recites the limitation “calculate tissue displacements by simulation a response of the tissue medium to the forces calculated”. It is unclear if the tissue displacements are the same as or different from the tissue displacements recited previously or the displacements recited in claim 6, or if these are different tissue displacements. For examination purposes, it has been interpreted to mean any tissue displacements, however, clarification is required.
Claim 19 recites the limitation “calculate the MR-ARFI image by encoding the tissue displacements into the MR-ARFI image to create an updated MR-ARFI image”. The limitation as a whole is unclear. For example, it is unclear if the calculating of the MR-ARFI image is the same as the generating of claim 15, unclear which tissue displacements the limitation is referring to, and unclear how the MR-ARFI image is created by encoding the tissue displacements into the MR-ARFI image as this appears to have redundant/circular meaning. In other words, it is unclear how an image is created by encoding displacements into the image (which implies an already created image). For examination purposes, it has been interpreted to mean that the processor is configured to create and updated MR-ARFI image, however, clarification is required.
Claim 21 recites the limitation “calculate displacements during MR-ARF pulses using a finite element method (FEM) solver to calculating tissue displacements”. The limitation is unclear as to whether either of the displacements or tissue displacements are the same as or different from the previously recited displacements of claim 6. For examination purposes, it has been interpreted that they may be the same or different, however, clarification is required.
Claim 21 recites the limitation “use the MR-ARFI image to backpropagate derivatives with respect to parameters of the focused ultrasound transducer or the tissue medium back from the inputs to the FEM solver”. The limitation is unclear for a plurality of reasons. First, it is unclear what is meant by backpropagate derivatives with respect to parameters of the focused ultrasound transducers and how this is done, it is unclear what derivatives with respect to parameters of the focused ultrasound transducer are and if the parameters of the focused ultrasound transducer are the same as the accessed parameters of claim 6 or if these are different parameters. Furthermore, it is unclear what is meant by “back from the inputs to the model” and what the limitation is referring to (i.e. are the derivatives back propagated back from the inputs to the FEM solver are the parameters of the transducer or tissue medium considered to be back from the model. Finally, there is insufficient antecedent basis for “the inputs to the FEM solver” and it is therefore unclear what the inputs to the FEM solver are. For examination purposes, it has been interpreted to mean backpropagate derivatives, however, clarification is required.
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 6-13 and 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claim 6 is found to recite a judicial exception (i.e. abstract idea). In this instance, claim 6 recites the limitations “accessing parameters of ultrasound transducer configured to generate a range of pressure levels”, “calculating displacements during MR-ARFI pulses based on the generated pressure levels” and “determining unknown intensities based on the displacements”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of accessing information, calculating, and determining which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably access parameters (e.g. position, location, frequency, etc.) of an ultrasound transducer via observation/evaluation, calculate displacements during MR-ARFI pulses based on the generated pressure levels via observation/evaluation of data, and determine unknown intensities via observation/evaluation of data. Examiner notes that with the exception of generic computer-implemented steps (e.g. a processor recited in claim 6), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
A processor
Accessing parameters of ultrasound transducer configured to generate a range of pressure levels
The additional element(s) in the cited independent claim(s) are not found to integrate the judicial exception into a practical application. In this case, a processor amounts to merely a generic computer for performing the judicial exception and accessing parameters of ultrasound transducer is alternatively interpreted as an additional element which amounts to mere data gathering. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claim 6 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above the additional elements amount to merely a generic computer and data gathering. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 7-13 and 15-20 further limit the abstract idea of independent claim 6. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
Access a look-up table (claim 11)
Access a model of a focused ultrasound transducer and a tissue medium (claim 15)
Calculate pressure fields (claim 15)
Calculate tissue displacements using the pressure fields using a model (claim 15)
Using the MR-ARFI image, backpropagate derivatives with respect to parameters of the focused ultrasound transducer (claim 15)
Using the derivatives, select updated parameters of the focused ultrasound transducer (claim 15)
Using the updated parameters, select corrective measures (claim 15)
Convert the pressure fields to forces (claim 17)
Calculate tissue displacements by simulating a response of the tissue medium to the forces calculated (claim 18)
Adjust parameters of the focused ultrasound transducer (claim 20) based on a comparison...
The cited limitation(s), under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably access a lookup table, access a model, calculate pressure fields, calculate tissue displacements, backpropagate derivatives with respect to parameters, select updated parameters, and select corrective measures convert pressure fields to forces, calculate tissue displacements by simulating data, adjust parameters via selection/determination of updated parameters based on a comparison. Examiner notes that with the exception of generic computer-implemented steps (e.g. i.e. the processor), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 7-13 and 15-20 present additional elements which only further narrow the judicial exceptions (e.g. claim 7 which merely narrows the ultrasound transducer which is not found to have any particular relationship to the judicial exception at this time, claim 8 which merely recites using a finite element method to calculate the displacements where a finite element method is well-understood, routine, and conventional in numerical calculations and is merely recited with an intended use of calculating the displacements, claims 9 and 10 which merely further narrow the FEM with no direct tie to the judicial exception, claims 12-13 which further narrow the lookup table and unknown intensities, claim 15 which recites controlling a focused ultrasound transducer to acquire MR-ARFI image data which amounts to mere data gathering, and claim 16 which further narrows the pressure fields calculation to be by simulating the propagation of ultrasound waves) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
Examiner notes that claim 21 is found to be patent eligible as it requires specific use of a differentiable acoustic solver and calculating displacements during MR-ARFI pulses using a finite element method (FEM solver). Such additional elements when considered in combination with the judicial exception are found to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112(a)
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 15-21 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.
Claims 15 and 21 recite limitations that are directed to a different embodiment than the embodiment of claim 6. For example, claim 6 recites the limitations “accessing parameters of ultrasound transducer configured to generate a range of pressure levels; calculating displacements during MR-ARFI pulses based on the generated pressure levels, and determining unknown intensities” which are directed to a first embodiment depicted in fig. 3B and disclosed in at least [0010] as one aspect of the invention and further disclosed in [0086]-[00125] and claims 15 and 21 recite the limitations “access a model of a focused ultrasound transducer and a tissue medium”, “control a focused ultrasound transducer to acquire MR-ARFI image data from an intended target through aberrations or imperfections”, “calculate pressure fields…”, “calculate tissue displacements using the pressure fields using a model…”, “generate and MR-ARFI image using the tissue displacements”, “… backpropagate derivatives…”, “select updated parameters of the focused ultrasound transducer..”, and “select corrective measures that refocuses an ultrasound beam…” which are directed a second embodiment depicted by fig. 4 and disclosed in at least [0012] as another aspect and further disclosed in at least [00127]-[00132]. Examiner notes that there is insufficient written description combining the methods of figs. 3B and 4. In other words, there is insufficient written description for a storage medium causes a processor to access both parameters and a model, calculate displacements using both generated range of pressure levels and the calculated pressure fields generated by the focused ultrasound transducer, generates an MR-ARFI image using the tissue displacements and determines unknown intensities based on the displacements in combination with selecting updated parameters of the focused ultrasound transducer or the tissue medium that fit the ARFI image data, and selecting corrective measures that refocuses an ultrasound beam using the updated parameters. It is therefore noted that the claims 15 and 21 as currently amended (i.e. to depend from claim 6) constitute new matter such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medan et al. (US 20110094299 A1), hereinafter Medan.
Regarding claim 6,
A non-transitory computer storage medium having instructions stored thereon that, when executed by a processor (at least fig. 2 (204 and/or 206) and corresponding disclosure in at least [0022]-[0023] and further discloses having suitable and conventional driver software installed. Examiner notes that a computer for performing the corresponding functions necessarily requires a non-transitory computer storage medium having instructions that cause the computer to function accordingly), cause the processor to carry out steps comprising:
accessing parameters of ultrasound transducer (at least fig. 3 (300 or any element thereof) and corresponding disclosure in at least [0026]) configured to generate a range of pressure levels ([0024] which discloses during the mapping procedure, the control station 204 sends control signals to the ultrasound transducer hardware 202 to vary one or more parameters affecting the focus properties and [0006] which discloses one or more focus-affecting parameters (such as the phase and/or amplitude of one or more transducer elements) are varied);
calculating displacements during MR-ARFI pulses based on the generated pressure levels ([0025] which discloses material displacement indicative of the intensity in the focus is computationally extracted from the images);
and determining unknown intensities based on the displacements (see at least fig. 5 in which intensities (e.g. intensities of displacement for display) are determined. See also [0025] which discloses For therapeutic applications involving targeted tissue destruction, for example, the focus quality may be measured in terms of a peak intensity or total power delivered (corresponding to an integrated intensity over the focus cross section) and claims 4-5 which disclose measuring an integral intensity of the force and measuring a peak intensity of the focus).
Claims 6 (alternatively) and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gallippi et al. (US 20210294677 A1), hereinafter Gallippi.
Regarding claim 6,
A non-transitory computer storage medium having instructions stored thereon that, when executed by a processor ([0042] which discloses a non-transitory computer readable medium stores software instructions that when executed by one or more processors of a system for quantitatively measuring a physical characteristic of a material, cause the system), cause the processor to carry out steps comprising:
accessing parameters of ultrasound transducer ([0010] which discloses the techniques presented herein utilize Acoustic Radiation Force (ARF) based ultrasound or other force-producing techniques to excite tissue or other materials, and record the resulting displacement of particular volumes or portions of the material over time) configured to generate a range of pressure levels ([0070] which discloses the interrogation subsystem 100 produces a sequence of one or more forces directed towards a material sample according to an interrogation profile that defines an amount, direction, and/or focal depth of each force in the sequence of forces, as well as the timing, duration, spacing, relaxation time, recovery time, etc., of each force in the sequence of forces.);
calculating displacements during MR-ARFI pulses based on the generated pressure levels ([0072] which discloses The displacement calculation subsystem 104 receives data produced by the motion dynamics observation subsystem 102 and calculates displacement of the sample and [0073] which discloses the measured displacements);
and determining unknown intensities based on the displacements ([0073] which discloses the physical parameter calculation subsystem 106 receives displacement information (e.g., the measured displacement) from the displacement calculation subsystem 104, as well as some or all of the interrogation profile received from the interrogation subsystem 100, and uses all or a portion of that information to calculate or derive a predicted value for one or more physical parameters. [0075] which discloses 0075] The physical parameter calculation subsystem 106 produces as output values of the physical parameters of the material sample, such as the elasticity/viscosity of the material sample, which it provides to the system output subsystem 108. In the embodiment illustrated in FIG. 1, the system output subsystem 108 produces a “heat map” showing the values of the measured parameter at different locations (depth, lateral distance from centerline) of the measured sample. Where the physical parameters and the pixel values of heat map are considered unknown intensities which are determined).
Regarding claim 11,
Galliippi further discloses wherein the processor is configured to access a look-up table to determine unknown intensities ([0011] which discloses resulting displacement profiles are compared to entries of a look-up table (LUT) of displacement profiles of samples with known elasticity/viscosity following a known interrogation profile to determine a best match and [0028] which discloses reporting a physical characteristic associated with the best matched LUT entry as being the predicted physical characteristic of the material samples and 0073] which discloses (e.g., the elasticity and viscosity of the LUT entry), examiner notes that elasticity and viscosity are considered unknown intensities in its broadest reasonable interpretation).
Regarding claim 12,
Gallippi further discloses wherein the lookup table includes uses minimum, middle, or maximum displacements and corresponding intensities as source points in calculations to interpolate unknown intensities ([0011] which discloses The LUT approach can also involve interpolating values that lie between the exact entries in the LUT. For example, if the LUT was constructed using 0, 5, 10, 15 Kilopascal (kPa) materials, and a sample of interest has a 7 kPa elasticity, both 5 and 10 kPa LUT entries will yield SAD scores that are high, and thus the value could be interpolated (as the SAD score-weighted average of 5 and 10, or some other approach to interpolation) the LUT approach can incorporate interpolation to predict values that lie between the exact LUT entries).
Regarding claim 13,
Gallippi further discloses wherein the unknown intensities are determined at middle points ([0011] which discloses the LUT approach can also involve interpolating values that lie between the exact entries in the LUT. For example, if the LUT was constructed using 0, 5, 10, 15 Kilopascal (kPa) materials, and a sample of interest has a 7 kPa elasticity, both 5 and 10 kPa LUT entries will yield SAD scores that are high, and thus the value could be interpolated (as the SAD score-weighted average of 5 and 10, or some other approach to interpolation).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Medan in view of Konofagou et al. (US 20210283428 A1), hereinafter Konofagou.
Regarding claim 7,
Medan further teaches wherein the transducer is a single element ultrasound transducer ([0006] which discloses one or more focus-affecting parameters (such as the phase and/or amplitude of one or more transducer elements) are varied)
Medan fails to explicitly teach the single element ultrasound transducer configured to generate pressure levels ranging from .27 to 2.70 MPa.
Nonetheless, Konofagou, in a similar field of endeavor involving acoustic radiation force imaging, teaches a single element ultrasound transducer ([0010] which discloses the FUS stimulation probe can be a single element FUS probe) configured to generate pressure levels ranging from .27 to 2.70 MPa ([0061] which discloses the peak negative pressure can range from about 0.5 MPa to about 11 MPa, from about 0.5 MPa to about 10 MPa, from about 0.5 MPa to about 9 MPa, from about 0.5 MPa to about 8 MPa, from about 0.5 MPa to about 7 MPa, from about 0.5 MPa to about 6 MPa, from about 0.5 MPa to about 5 MPa, from about 0.5 MPa to about 4 MPa, from about 0.5 MPa to about 3 MPa, from about 0.5 MPa to about 2 MPa, or from about 0.5 MPa to about 1 MPa. In non-limiting embodiments, the peak positive pressure can range from about 1 MPa to about 30 MPa, 1 MPa to about 25 MPa, 1 MPa to about 20 MPa, 1 MPa to about 15 MPa, 1 MPa to about 10 MPa, or 1 MPa to about 5 MPa. In non-limiting embodiments, the pulse duration can be about 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan to include a single element ultrasound transducer as taught by Konofagou in order to generate an acoustic radiation force and induce displacement as desired. Such a modification would allow for different combinations of ultrasound parameters (Konofagou [0061]) leading a person having ordinary skill in the art to achieve desired results with respect to the stimulation/treatment of the patient. Additionally/alternatively, such a modification amounts to merely a simple substation of one known transducer for another yielding predictable results with respect to focused ultrasound stimulation/treatment thereby rendering the claim obvious (MPEP 2143).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Medan in view of NPL Palmeri et al. (“A Finite-Element Method Model of Soft Tissue Response to Impulsive Acoustic Radiation Force”), hereinafter Palmeri.
Regarding claim 8,
Medan teaches the elements of claim 6 as previously stated. Medan fails to explicitly teach wherein the processor is configured to use a finite element method (FEM) to calculate the displacements during MR-ARFI pulses.
Palmeri, in a similar field of endeavor involving acoustic radiation forces evaluation, teaches using a finite element method (FEM) to calculate displacements during MR-ARFI pulses (pg. 1702 right column which discloses the dynamic displacement fields associated with ARFI imaging were modeled using FEM to solve the three-dimensional, weak-form equations of elastodynamics).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan to include using a finite element method as taught by Palmeri in order to allow for simulating dynamic displacement fields (Palmeri pg. 1702). Such a modification would provide for enhanced calibration in the system of Medan, by allowing for simulating the displacement results without having to apply the MR-ARFI pulses during calibration accordingly thereby enhancing the overall safety and efficiency of Medan.
Regarding claim 9,
Medan, as modified, teaches the elements of claim 8 as previously stated. Medan, as modified, further teaches wherein the processor is configured to use the FEM to perform calculations over a radially symmetric slice around focus nodes (Examiner notes that the limitation “to perform calculations over a radially symmetric slice around focus notes” is directed to intended use, where it is noted that the processor is configured to use the FEM for measuring displacements and is therefore considered capable of being used to perform calculations over a radially symmetric slice around focus nodes).
Regarding claim 10,
Medan, as modified, teaches the elements of claim 9 as previously stated. herein the processor is configured to use the FEM with a Poisson’s ratio of .49 (As (15) shows, varying v from 0.490 to 0.499 only varies the shear wave speed by approximately 0.003 m/s for materials with Young's moduli ranging from 1 to 100 kPa), and a young’s modulus of 2000 Pa (pg. 1708 right paragraph which discloses young's moduli ranging from 1 to 100 kPa)
Medan, as currently modified, fails to explicitly teach a timestep of 5x10-5s, however, it is noted that it would have been obvious to a person having ordinary skill in the art before the effective filing date to have used a timestep of 5x10-5s in the field of displacement measurement. Such a modification amounts to merely routine optimization of the time-step for the FEM to yield predictable results related to ARFI displacement calculation absent criticality of the claimed value in applicant’s originally filed specification (MPEP 2144).
Claims 11-13 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Medan in view of Gallippi et al. (US 20210294677 A1), hereinafter Gallippi.
Regarding claim 11,
Medan teaches the elements of claim 6 as previously stated. Medan fails to explicitly teach wherein the processor is configured to access a lookup table to determine the unknown intensities.
Galliippi, in a similar field of endeavor involving MR-ARFI, teaches wherein a processor is configured to access a look-up table to determine unknown intensities ([0011] which discloses resulting displacement profiles are compared to entries of a look-up table (LUT) of displacement profiles of samples with known elasticity/viscosity following a known interrogation profile to determine a best match and [0028] which discloses reporting a physical characteristic associated with the best matched LUT entry as being the predicted physical characteristic of the material samples and 0073] which discloses (e.g., the elasticity and viscosity of the LUT entry), examiner notes that elasticity and viscosity are considered unknown intensities in its broadest reasonable interpretation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan to include accessing a look-up table as taught by Gallippi in order to make it possible to reasonably predict viscoelasticity of simulated and real phantoms (Gallippi [0128]) which minimal processing time an artifacts (Gallippi [0130]). Such a modification would therefore allow for quantitative measuring a physical characteristic of a material such as calculation of viscoelastic properties of the phantom or a subject of Medan therefore allowing for investigating media that are highly attenuating to shear waves such as muscle or imaging heterogenous tissues such as skeletal muscle ([0131]).
Regarding claim 12,
Gallippi, as applied to claim 11 above, further teaches wherein the lookup table includes uses minimum, middle, or maximum displacements and corresponding intensities as source points in calculations to interpolate unknown intensities ([0011] which discloses The LUT approach can also involve interpolating values that lie between the exact entries in the LUT. For example, if the LUT was constructed using 0, 5, 10, 15 Kilopascal (kPa) materials, and a sample of interest has a 7 kPa elasticity, both 5 and 10 kPa LUT entries will yield SAD scores that are high, and thus the value could be interpolated (as the SAD score-weighted average of 5 and 10, or some other approach to interpolation) the LUT approach can incorporate interpolation to predict values that lie between the exact LUT entries).
Regarding claim 13,
Gallippi, as applied to claim 12 above, further teaches wherein the unknown intensities are determined at middle points ([0011] which discloses the LUT approach can also involve interpolating values that lie between the exact entries in the LUT. For example, if the LUT was constructed using 0, 5, 10, 15 Kilopascal (kPa) materials, and a sample of interest has a 7 kPa elasticity, both 5 and 10 kPa LUT entries will yield SAD scores that are high, and thus the value could be interpolated (as the SAD score-weighted average of 5 and 10, or some other approach to interpolation).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Medan in view of NPL Phipps et al. (“Considerations for ultrasound exposure during transcranial MR acoustic radiation force imaging”), hereinafter Phipps and Sliwa et al. (US 20070204671 A1), hereinafter Sliwa.
Regarding claim 15,
Medan teaches the elements of claim 6 as previously stated.
Medan further teaches wherein the processor is further configured to:
Accessing a model of the tissue medium ([0010] which discloses providing a phantom and generating ultrasound focus and measuring the focus quality in the phantom)
control a focused ultrasound transducer ([0008] which discloses driving the plurality of transducer elements so as to generate an ultrasound focus and [0022] which discloses The drivers are controlled by a control station 204) to acquire MR-ARFI image data from an intended target through aberrations or imperfections ([0027] which discloses The material displacement may be visualized in an imaging plane 306 using an imaging techniques such as, e.g., magnetic-resonance-based acoustic radiation force imaging (MR-ARFI). In MR-based imaging methods, the object to be imaged (here, the phantom) is placed in a relatively uniform static magnetic field having a field strength of, typically, between about 1.5 and about 3.0 Tesla. Such a field may be generated, for example, by a large cylindrical electromagnet coil 308);
calculate tissue displacements using pressure fields and using a model to calculate the displacements during MR-ARFI pulses based on the generated pressure levels ([0025] which discloses material displacement indicative of the intensity in the focus is computationally extracted from the images and [0026] which discloses During the mapping procedure, the transducer 300 is driven so as to focus an ultrasound wave pulse into a phantom (i.e. model) 302, which comprises or consists of a material that responds to acoustic pressure in a detectable manner);
generate an MR-ARFI image using the tissue displacements and MR-ARFI image data acquired form the subject (see at least fig. 5 and corresponding disclosure in at least [0019] and [0030]);
select updated parameters of the focused ultrasound transducer or the tissue medium that fit the MR-ARFI image data ([0006] which discloses the focus-affecting parameter(s) are then set to values for which the focus quality is optimized. For example, the relative phases of the transducer elements may be fine-tuned one at a time to maximize the intensity at the focus); and
using the updated parameters, select corrective measures that refocuses an ultrasound beam from the focused ultrasound transducer to the intended target through the aberrations or imperfections ([0006] which discloses the focus-affecting parameter(s) are then set to values for which the focus quality is optimized. For example, the relative phases of the transducer elements may be fine-tuned one at a time to maximize the intensity at the focus)
Medan fails to explicitly teach accessing a model of a focused ultrasound transducer, calculate pressure fields generated by the focused ultrasound transducer in a tissue medium of the subject, calculate the tissue displacements using the pressure fields using a model, using the MR-ARFI image, backpropagate derivatives with respect to parameters of the focused ultrasound transducer or the tissue medium back from the inputs to the model; using the derivatives, select the updated parameters of the focused ultrasound transducer of the tissue medium that fit the MR-ARFI image data.
Phipps, in a similar field of endeavor involving MR acoustic radiation force imaging, teaches accessing a model of a focused ultrasound transducer (pg. 8 which discloses the H115MR transducer was modeled in k-Wave and placed so that the geometric focus was approximately 1 cm past the inner surface of the skull fragment),
calculating pressure fields generated by the focused ultrasound transducer in a tissue medium of the subject (pg. 8 which discloses A GPU-accelerated 3D k-Wave simulation was run on a workstation PC HP Z820, Xeon E5, with 256 GB RAM, Hewlett Packard, Palo Alto, CA) with a 16 GB Nvidia Titan GPU (Nvidia, Santa Clara, CA). The maximum pressure was recorded for every voxel in the simulation grid), and calculating the tissue displacements using the pressure fields and using a model (pg. 9 which discloses sonications were performed at 802 kHz for 4.5 ms (3609 cycles) with an acoustic pressure (maximum free field of 2.81 MPa) that would not be expected to exceed a temperature increase greater than 1 °C or MI greater than 1.1 within the brain based on the previously described acoustic simulations and hydrophone experiments and pg. 9 which discloses in order to simulate the targeting of arbitrary brain regions with our optically tracked MR-ARFI pulse sequence, and to demonstrate the need to align the MR-ARFI MEGs with the FUS propagation direction via optical tracking, displacement images were acquired in an ex vivo agarose phantom designed to mimic brain tissue acoustic properties)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan to include accessing a model of a focused ultrasound transducer and calculating pressure fields as taught by Phipps in order to allow for simulating acoustic parameters within the tissue, such acoustic parameter simulations would allow for providing sonications which have desired acoustic pressures that would not expect to exceed dangerous temperatures in the tissue (pg. 9) thereby enhancing safety when performing ultrasound transmission.
Sliwa, in a similar field of endeavor involving focused ultrasound, teaches using a parameter image, backpropagating derivatives with respect to parameters of a focused ultrasound transducer or the tissue medium back from inputs to model, using the derivatives, select updated parameters of the focused ultrasound transducer that fit the parameter image data; and using the updated parameters, select corrective measures that refocuses an ultrasound beam from the focused ultrasound transducer to the intended target through aberrations or imperfections ([0015] which discloses back-calculating one or more characteristics of an acoustic beam that results in the at least one immersant parameter map generally includes the steps of: assuming values for the one or more characteristics; modeling behavior in the immersant of an acoustic beam having the assumed values, thereby generating at least one modeled parameter map; comparing the at least one modeled parameter map to the at least one immersant parameter map; and utilizing an optimization algorithm to refine the assumed values for the one or more characteristics. The process may be iteratively repeated until the difference between the modeled parameter map and the immersant parameter map is minimized)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan, as currently modified, to include backpropagating derivatives and using the derivatives as taught by Sliwa in order to allow for determining the three dimensional spatial and temporal characteristics of the acoustic field that is necessary to produce the observed displacements (Sliwa [0094]). Such a modification would provide the desirable ability to non-invasively and non-destructively characterize acoustic beams at high power and to model the behavior of high intensity focused ultrasound beams in three dimensions in real-time or near real-time (Sliwa [0009]), such a modification would thereby enhance the optimization of the acoustic parameters as desired by Medan.
Examiner notes that in the modified system the selected updated parameters would fit the MR-ARFI image data in the same manner as the immersant parameter map.
Regarding claim 16,
Medan, as modified, teaches the elements of claim 15 as previously stated. Phipps, as applied to claim 15 above further teaches wherein the processor is further configured to calculate the pressure fields by simulating the propagation of ultrasound waves from the focused ultrasound transducer through the tissue medium (pg. 8 which discloses A GPU-accelerated 3D k-Wave simulation was run on a workstation PC HP Z820, Xeon E5, with 256 GB RAM, Hewlett Packard, Palo Alto, CA) with a 16 GB Nvidia Titan GPU (Nvidia, Santa Clara, CA). The maximum pressure was recorded for every voxel in the simulation grid).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Medan, Phipps, and Sliwa, as applied to claim 15 above, and further in view of NPL Prieur et al. (“Modeling of the acoustic radiation force in elastography”), hereinafter Prieur.
Regarding claim 17,
Medan, as modified, teaches the elements of claim 15 as previously stated. Medan fails to explicitly teach wherein the processor is further configured to convert the pressure fields to forces.
Nonetheless, Prieur, in a similar field of endeavor involving acoustic radiation force modeling, (pg. 947 which discloses numerical simulations then show the spatial distribution of the force when using each formulation pg. 952 which discloses Figures 4 and 5 show the ARF field and amplitude using both formulations as well as the force amplitude on axis for all three formulations in the case ka¼7 and ka¼5, respectively. The on-axis force amplitudes are normalized with the maximum amplitude obtained using the second-order approximation. Pg. 956 which discloses the force is approximated parallel to the main propagation axis.6 This approximation was also made in our case and pg. 956 which discloses Note that in k Wave there is no formal way to input a volume force. It only takes stress components or particle velocities as inputs. However, as explained in the k-Wave user manual the input velocity is automatically scaled to a force per mass (m/s2) by multiplying it with the factor 2c0/Dxi where Dxi is the spatial step in the chosen direction. To get a volume force Fi as input, we can therefore use an input velocity equal to Fi=q0 ð Þ=2c0=Dxi ð Þ. See also pg. 958 disclosing the second order approximation formulation for force calculation relying on pressure (P) conversion).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan, as currently modified to include converting the pressure fields to forces as taught by Prieur in order to provide additional data regarding the acoustic field in ARFI. Such a modification further provides for acoustic field information in the z-direction such that tissue displacement may be correspondingly approximated in the z-direction accordingly.
Regarding claim 18,
Medan, as modified, teaches the elements of claim 17 as previously stated. Prieur further teaches wherein the processor to configured to calculate tissue displacements by simulating a response of the tissue medium to the forces calculated (pg. 956 which discloses using the fields of ARF computed with the three methods described above, the obtained displacements along the z direction are shown in Fig. 9 at three distinct times)
Regarding claim 19,
Medan, as modified, teaches the elements of claim 18 as previously stated. Medan further teaches wherein the processor is configured to calculate the MR-ARFI image by encoding the tissue displacements into the MR-ARFI image ([0030] which discloses an example of an MR-ARFI image of the ultrasound focus region is shown in fig. 5. As showng the displacement with respect to the equilibrium position varies between about -1 micron and 5 microns as indicated in the color-coding of the image) to create an updated MR-ARFI image ([0030] which discloses the acoustic field intensity, in turn, is maximized when the elements of the ultrasound transducer emit acoustic waves that are all in phase at the focus position. If a transducer element is out of phase with respect to the others, the focus intensity in the center decreases. This relationship can be exploited to optimize the focus, and thus to map and adjust the transducer elements. Examiner therefore notes that the creation of the MR-ARFI image is to create an updated MR-ARFI image during optimization of the focus)
Regarding claim 20,
Medan, as modified, teaches the elements of claim 19 as previously stated. Medan, as currently modified, fails to explicitly teach wherein the processor is configured to adjust parameters of the focused ultrasound transducer or tissue medium based on a compairosn between the updated MR-ARFI image and the MR-ARFI image.
Nonetheless, Sliwa further teaches wherein the processor is further configured to adjust parameters of the focused ultrasound transducer or tissue medium based on a comparison between an updated image and an image ([0015] which discloses the step of back-calculating one or more characteristics of an acoustic beam that results in the at least one immersant parameter map generally includes the steps of: assuming values for the one or more characteristics; modeling behavior in the immersant of an acoustic beam having the assumed values, thereby generating at least one modeled parameter map; comparing the at least one modeled parameter map to the at least one immersant parameter map; and utilizing an optimization algorithm to refine the assumed values for the one or more characteristics. The process may be iteratively repeated until the difference between the modeled parameter map and the immersant parameter map is minimized).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Medan, as currently modified, to include backpropagating derivatives and using the derivatives as taught by Sliwa in order to allow for determining the three dimensional spatial and temporal characteristics of the acoustic field that is necessary to produce the observed displacements (Sliwa [0094]). Such a modification would provide the desirable ability to non-invasively and non-destructively characterize acoustic beams at high power and to model the behavior of high intensity focused ultrasound beams in three dimensions in real-time or near real-time (Sliwa [0009]), such a modification would thereby enhance the optimization of the acoustic parameters as desired by Medan.
Examiner’s note
As best understood, claim 21 is found to distinguish over the prior art, however, due to pending 112 issues, allowability is not determinable at this time.
Specifically regarding the prior art, Medan, Phipps, and Sliwa are the closest prior art of record. While Phipps teaches using a k-wave solver, this is not considered a differentiable acoustic solver as understood in the art. Furthermore, Medan, Phipps, and Sliwa fail to explicitly teach calculating displacements during MR-ARFI pulses using a finite element (FEM) solver to calculate tissue displacements using the pressure fields and generating an MR-ARFI image using the tissue displacements. Examiner notes that while there is prior art which teaches an FEM solver to calculate tissue displacements
Examiner notes that while there is prior art which teach using a differentiable acoustic solver such as Xue et al. (“Jax-FEM…”) and Stanziola et al. (“j-wave: an open source…”) which are both provided in applicant’s IDS and further prior art which teaches calculating displacements using an FEM solver such as Palmeri as cited above. Modifying Medan to include the features of Phipps, Sliwa, Stanziola/Xue, and Palmeri to teach all of the elements of claim 21 would not have been obvious to a person having ordinary skill in the art as they would have required impermissible hindsight reasoning. For these reasons, the combination of elements distinguishes over the prior art collectively.
Conclusion
Vortman (US 20160008633) teaches MR-ARFI to measure the tissue displacement resulting from acoustic pressure at the target, ultrasound detection to measure the intensity of the ultrasound that is reflected and following frequency optimization, the phase and/or amplitude settings of the phased-array transducer may be adjusted to optimize the focus for the selected frequency. Treatment may then commence at the optimum frequency and phase/amplitude settings in [0025].
Vortman (US 20210170204 A1) teaches adjusting parameter values of transducer elements based on an acoustic simulation ([0016])
Matsui (US 20210007713 A1) teaches determining an acoustic intensity of an acoustic field during ARFI pulses based on displacements ([0072] which discloses The method of the invention also relies on the fact that, if the displacement u and the viscoelastic model M are known, an inversion of the viscoelastic model M allows determination of the acoustic field intensity {right arrow over (i)})
Kohler (US 20160045771 A1) teaches is that the pressure field can be estimated via the radiation force that the HIFU exerts on the tissue. The local pressure field is also the mechanisms via which the HIFU heats the tissue. Hence, an estimate of the distribution of the pressure field will give an idea of the distribution of the heating that may result.
Ben-Ezra (US 20210045714 A1) teaches determining unknown intensities based on displacements during ARFI pulses ([0187] which discloses respective velocity amplitudes of the respective oscillating scatterers may be calculated based on the respective displacement amplitudes, and respective intensities of first acoustic field 22 in the region may be calculated based on the respective velocity amplitudes. [0191] which discloses once the displacement amplitude of the oscillation has been obtained, the velocity amplitude of the oscillation, and intensity at the location of the scatter may be calculated, and respective maps of first acoustic field 22 generated. [0027] which discloses based on the displacement amplitude, calculating a velocity amplitude of the oscillating scatterer and [0028] which discloses based on the velocity amplitude, calculating an intensity of the first acoustic field at a location of the oscillating scatterer and [0131] which discloses (b) generate a map of intensities of the first acoustic field on a portion of the sonogram corresponding to the region)
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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