DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Regarding claim objections
Examiner notes that the previously set forth claim objections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112(a)
Examiner notes that the previously set forth 112(a) rejections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 101
Applicant's arguments filed 07/31/2026 have been fully considered but they are not persuasive. For example, applicant argues “amended claim 6 now recites, in part, ‘calculating tissue displacements during MR-ARFI pulses based on pressure levels within the range of pressure levels’ and ‘determining unknown acoustic intensities based on the tissue displacements using a forward model relating acoustic pressure to MR-ARFI displacement” and points to [0085]-[0087] of the originally filed specification to show that “calculating tissue displacements during MR-ARFI pulses involves complex physics-based computational modeling of acoustic radiation force interactions with tissue” (REMARKS pg. 9). Examiner respectfully disagrees in that the claim does not provide any specific nexus between the calculating of tissue displacements in the claim to any of the disclosed complex physics-based computational modeling of acoustic radiation force interactions with tissue such as the argued solving of the Cauchy momentum equation with models, finite element methods, and time-resolved simulations of tissue response to acoustic radiation force. In other words, the claim merely recites calculating tissue displacements during MR-ARFI pulses based on pressure levels within a range of pressure levels, but does not recite the specific nature of the calculating nor how it is based on the pressure levels. Rather, the broadest reasonable interpretation of the claim includes calculating displacement during MR-ARFI based on pressure levels which may merely use detected signals in response to ARFI pulses (i.e. calculation of real displacements occurring during MR-ARFI in response to ARFI pulses which is therefore based on pressure levels).
Applicant further points to [0035] of the originally filed specification to show that “determining unknown acoustic intensities using a forward model relating acoustic pressure to MR-ARFI displacement requires sophisticated numerical simulation that relates pressure fields to tissue displacements through comprehensive forward modeling. (REMARKS pg. 10). Examiner respectfully disagrees in that there is no nexus between the supposed comprehensive forward modeling which requires “sophisticated numerical simulation” that relates pressure fields to tissue displacements and the current claim language. The claims are broad and merely recite determining unknown acoustic intensities based on the tissue displacements using a forward model relating acoustic pressure to MR-ARFI displacement, without requiring any specifics of how the determination uses the forward model (which is considered to be merely use of a generic computer) and how the forward model relates acoustic pressure to MR-ARFI displacement which would amount to any specific numerical simulation or comprehensive forward modeling as argued by applicant.
Applicant further argues “the claims are not merely applying generic calculations on a generic computer but are tied to the specific and specially designed technological context of MR-ARFI imaging with ultrasound transducers” (REMARKS pg. 10) Applicant’s arguments appear to be directed specifically toward claims 15 and 21, however, as noted below, claims 15 and 21 are considered withdrawn as being directed towards different embodiments than claim 6. Nonetheless, it is noted that although claim 6 alludes to MR-ARFI imaging with ultrasound transducers, it is noted that no such imaging is required and even so MR-ARFI merely ties the judicial exception recited in claim 6 toward the technological field of MR-ARFI and such recitations of MR-ARFI do not integrate the judicial exception of claim 6 into a practical application nor does it amount to significantly more than the judicial exception.
For at least these reasons, applicant’s arguments with respect to 101 are not found persuasive.
Regarding 35 U.S.C. 112(b)
Examiner notes that while some 112(b) rejections are withdrawn in view of the amendments to the claims, applicant does not provide any arguments nor amendments which would fully address the previously set forth 112(b) rejections (e.g. with respect to claim 6 “accessing parameters….”, claims 7-10, and 13 see below rejection for more detail). Such 112(b) rejections which are not specifically addressed via arguments/amendments are therefore maintained.
New 112(b) rejections are further necessitated by amendment.
Regarding prior art
Applicant’s arguments with respect to claim 6 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.
Election/Restrictions
Currently amended claims 15-21 are directed to an invention that is independent or distinct from the elected invention originally claimed for the following reasons:
This application contains claims directed to the following patentably distinct species:
Species A (identified as corresponding to original claim 6) – a first embodiment in which acoustic intensities are determined based on displacements as depicted in at least fig. 3 and disclosed in at least [0010] as one aspect of an invention and further in [0086]-[00125].
Species B (identified as corresponding to amended claims 15-21) – a second embodiment in which an MR-ARFI image is generated using tissue displacements and MR-ARFI image data is acquired from the subject, back propagation of derivatives occurs to select updated parameters of the focused ultrasound transducer or the tissue medium, and correction measures are selected using the updated parameters as depicted in at least fig. 4A and disclosed in at least [0012] as another aspect and further in [00127]-[00132].
The species are independent or distinct because species A is directed to using the displacements to calculate acoustic intensities and interpolation thereof and species B is directed to using the displacements to generate an MR-ARFI image, backpropagate derivatives, select updated parameters using the derivatives, and select corrective measures based on the updated parameters. In addition, these species are not obvious variants of each other based on the current record.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Species A requires a search strategy involving at least CPC and text queries related to accessing parameters of an ultrasound transducer, calculating tissue displacements based on pressure; and determining unknown intensities based on the displacements which are not required of the search strategy for species B and Species B requires a search strategy involving at least CPC and text queries related to accessing a model of a focused ultrasound transducer and/or a tissue medium controlling the focused ultrasound transducer to acquire -MR-ARFI image data, calculating pressure fields generated by the focused ultrasound transducer, calculating tissue displacements using the pressure fields, generating an MR-ARFI image using the tissue displacements and MR-ARFI image data, back-propagating derivatives, selecting updated parameters, and selecting corrective measures which are not required for the search strategy of species A.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 15-21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 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 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 “relating acoustic pressure to MR-ARFI displacement”. It is unclear if the acoustic pressure is or is included in the range of pressure level or if this is different acoustic pressure and additionally unclear if the MR-ARFI displacement is the same as or included in the tissue displacements or if this is different displacements. In other words, since the limitation does not clearly link the acoustic pressure or MR-ARFI displacement to any of the previously recited pressure levels or displacement it is not clear what the relationship between relating acoustic pressure to MR-ARFI displacement with respect to the determination of acoustic intensities is.
Claim 6 recites the limitation “determining unknown acoustic intensities based on the tissue displacements using a forward model relating acoustic pressure to MR-ARFI displacement”. The limitation is unclear as to how determining unknown acoustic intensities uses a forward model relating acoustic pressure to MR-ARFI displacement. In other words, the claim does not make clear how the forward model relating acoustic pressure to MR-ARFI displacement is possibly used in determining unknown acoustic intensities as there is no explicit nor implicit recitation of the connection between the unknown acoustic intensities, the acoustic pressure and the MR-ARFI displacement. Examiner notes that while a person may recognize that calculating or determining tissue displacements may use such a forward model (e.g. relating the pressure levels to displacements) and such an interpretation appears to be supported by applicant’s specification in at least [0035], this is not made clear by the claim as the calculating of tissue displacements is a separate step and determining the unknown acoustic intensities is based on the tissue displacements previously recited.
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 “use a finite element method (FEM) to calculate the tissue displacements”. It is unclear if the finite element method (FEM) is the same as or included in the forward model relating acoustic pressure to MR-ARFI displacements or if this is a different method which is separate/distinct from the forward model. If applicant intends for the FEM to be separate/distinct, it is not clear what is or is not included in the forward model. Specifically, applicant’s originally filed specification appears to describe the FEM in a manner which relates acoustic pressure to MR-ARFI displacement in at least [0084] and [0087] calculating tissue displacements using the pressure fields, thus it appears that the finite element method (FEM) solver is the same as or at least included in the forward model, however, the claim language does not make this clear. For examination purposes, it ahs been interpreted that they may be the same or different, 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.
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.).
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 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 an ultrasound transducer configured to generate a range of pressure levels”, “calculating tissue displacements during MR-ARFI pulses based on pressure levels within the range of pressure levels” and “determining unknown acoustic intensities based on the tissue displacements” and “relating acoustic pressure to MR-ARFI displacement”. 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 (e.g. displacement/sensor data of the pulses), and determine unknown intensities via observation/evaluation of data as well as relating acoustic pressure to MR-ARFI displacement. 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
Using a forward model
The additional elements in the cited independent claim are not found to integrate the judicial exception into a practical application. In this case, a processor and the forward model amouns 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 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)
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) 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.
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.
Claims 6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreign Zou et al. (CN 115192927 A), hereinafter Zou. Examiner notes that citations to Zou are with respect to the translated copy provided herein.
Regarding claim 6,
Zou discloses a non-transitory computer storage medium having instructions stored thereon that, when executed by a processor (pg. 10 third to last paragraph and second to last paragraph which discloses The present application also provides a computer-readable storage medium on which a computer program is stored, and when the computer program is executed by a processor, implements the aforementioned method for measuring the distribution of acoustic absorption energy in biological tissue. The computer-readable storage medium may be included in the electronic device described in the above embodiments, or may exist alone without being assembled into the electronic device and specific examples of computer readable storage media may include portable computer disks, hard disks, etc.), cause the processor to carry out steps comprising:
accessing parameters of an ultrasound transducer configured to generate a range of pressure levels (at least fig. 4 (410) and corresponding disclosure in at least pg. 7 third to last paragraph. See also pg. 9 which discloses the acoustic radiation force is calculated according to formula (VIII) and pg. 4 which discloses the method of the application is based on self-attribute of focused ultrasound, at the focus, it will generate a sound radiation force along the sound propagation direction, and maximum at the focal region. Examiner notes that the sound radiation force F, frequency of the ultrasound field, etc. are considered parameters of an ultrasound transducer configured to generate a range of pressure levels, where the ultrasound transducer is not considered a part of the claimed invention, but rather intended to be used with the claimed invention and the sound radiation force F and frequency of an ultrasound field are parameters which are necessarily of an ultrasound transducer which would be necessary in order to produce such a radiation force/ultrasound field);
calculating tissue displacements during MR-ARFI pulses based on pressure levels within the range of pressure levels (at least fig. 3 (320) and corresponding disclosure in at least pg. 7 and/or at least fig. 4 (S440) and corresponding disclosure in at least pg. 9 where it is noted that the displacements are based on the ultrasonic irradiation/actual sound intensity distribution, ultrasonic frequency information, etc, thus based on any pressure levels within the range of pressure levels in its broadest reasonable interpretation. Examiner further notes that during MR-ARFI pulses is considered intended use and the computer-readable medium functions to calculate tissue displacements in any case including during MR-ARFI pulses where during MR-ARFI pulses merely refers to a time-frame. Examiner further notes that the disclosure of Zou is directed toward acoustic radiation force impulses as disclosed in pg. 4, thus would function to calculate tissue displacements during any ARF pulses (thus including MR-ARFI pulses));
and determining unknown acoustic intensities based on the tissue displacements using a forward model relating acoustic pressure to MR-ARFI displacement (at least fig. 1 (S140) and corresponding disclosure in at least pg. 5, where the sound field distribution prediction model is considered a forward model relating acoustic pressure to ARF (thus MR-ARFI) displacement see also pg. 5 disclosing intensity prediction uses a forward model (F(x,y)) where F(x,y) (i.e. acoustic radiation force as disclosed in at least pg. 10) and I(0) is the medium displacement data).
Regarding claim 8,
Zou further discloses wherein the instructions further cause the processor to use a finite element method (FEM) to calculate the tissue displacements during MR-ARFI pulses (pg. 9 which discloses Step S520: Calculate the theoretical medium displacement data according to the acoustic radiation force, the viscosity coefficient information and the elastic coefficient information. Specifically, according to the transient dynamic analysis of the finite element simulation analysis method, the theoretical displacement of the biological tissue phantom or isolated biological tissue under the action of the acoustic radiation force is calculated).
Regarding claim 9,
Zou further discloses wherein the instructions further cause the processor 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 instructions cause the processor to use the FEM to calculate the tissue displacements and is therefore considered capable of being used to perform calculations over a radially symmetric slice around focus nodes).
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 Zou in view of Konofagou et al. (US 20210283428 A1), hereinafter Konofagou.
Regarding claim 7,
Zou teaches the elements of claim 6 as previously stated. Examiner notes that as noted above, the ultrasound transducer is not positively recited as part of the claimed invention, thus Zou teaches the requirements of the claimed invention.
Alternatively, since Zou fails to explicitly teach specifics regarding the ultrasound transducer, Zou fails to explicitly teach wherein the transducer is a 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 Zou 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]).
Additionally/alternatively, such a modification amounts to merely a simple substation of one known ultrasound transducer for another yielding predictable results with respect to focused ultrasound generation thereby rendering the claim obvious (MPEP 2143).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zou 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 10,
Zou teaches the elements of claim 9 as previously stated. Zou fails to explicitly teach wherien the instructions further cause the processor to use the FEM with a Poisson’s ratio of .49, a Young’s modulus of 2000Pa, and a timestep of 5x10-5s.
Nonetheless, Palmeri, in a similar field of endeavor involving acoustic radiation force 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)., wherein 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)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Zou, as currently modified, to include using the FEM with a Poisson’s ratio of .49 as taught by Palmeri in order to provide for simulation of dynamic displacement. Furthermore such a modification amounts to merely routine optimization of the Poisson’s ratio and Young’s modulus of an FEM to yield predictable results with respect to ARFI displacement calculation absent criticality in the claimed values in applicant’s originally filed specification (MPEP 2144).
Zou, 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 Zou in view of Gallippi et al. (US 20210294677 A1), hereinafter Gallippi.
Regarding claim 11,
Zou teaches the elements of claim 1 as previously stated. Zou further teaches wherein the instructions further cause the processor to access a training set to determine the unknown intensities (pg. 3 which discloses compare the actual medium displacement data corresponding to the biological tissue phantom or the isolated biological tissue with the theoretical medium displacement data, select the theoretical medium displacement data and corresponding theoretical sound intensity distribution data that meet the preset conditions from the data set and pg. 4 disclsing the construction of a training data set and pg. 4 disclosing selecting the theoretical medium displacement data and corresponding theoretical sound intensity distribution data that meet the preset conditions from the data set and construct a training program set).
While it is noted that a training set having theoretical medium displacement data and corresponding theoretical sound intensity distribution data would appear to at least act as a look-up table, a look-up table is not explicitly taught by Zou.
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 Zou to include accessing a look-up table as taught by Gallippi in order to make provide a simple database of entries including theoretical displacement profiles and corresponding theoretical sound intensity distribution data to thereby allow for easy prediction of the sound intensity distribution data of Zou accordingly.
Regarding claim 12,
Gallippi, as applied to claim 11 above, further teaches wherein the lookup table 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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