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 .
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/11/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an ultrasound output unit” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses the specific structure for this unit on page 13.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-8 are drawn to a method and claims 9-15 are drawn to an apparatus, each of which is within the four statutory categories. Claims 1-15 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method for operating an apparatus for destroying biological tissue operated by at least one processor, the method comprising:
1) acquiring learning data including information on characteristics of biological tissue, a pressure of focused ultrasound, a variable acoustic pressure application time point, and a range of destruction of the biological tissue;
a) training 2) a model such that, when the learning data is input, a pressure of focused ultrasound, a variable acoustic pressure application time point, and a number of pulses are output depending on the characteristics of the biological tissue and the range of destruction of the biological tissue; and
3) setting a pressure of focused ultrasound, a variable acoustic pressure application time point, and a number of pulses, which are used to destroy target biological tissue, when a medical image comprising the target biological tissue is input into b) the trained model.
Claim 1 recites, in part, performing the steps of 1) acquiring learning data including information on characteristics of biological tissue, a pressure of focused ultrasound, a variable acoustic pressure application time point, and a range of destruction of the biological tissue, using 2) a model such that, when the learning data is input, a pressure of focused ultrasound, a variable acoustic pressure application time point, and a number of pulses are output depending on the characteristics of the biological tissue and the range of destruction of the biological tissue, and 3) setting a pressure of focused ultrasound, a variable acoustic pressure application time point, and a number of pulses, which are used to destroy target biological tissue, when a medical image comprising the target biological tissue is input into the model. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, a person can adjust settings based on an output of a module using data.
Claim 9 recites an apparatus for destroying biological tissue, the apparatus comprising:
c) an ultrasound output unit configured to output a focused ultrasound; and
d) a processor configured to 4) control a pressure of the focused ultrasound and a variable acoustic pressure application time point, wherein
the processor 5) sets the variable acoustic pressure application time point or the variable acoustic pressure application time points at which the pressure of the focused ultrasound is lowered to be different depending on characteristics of target biological tissue, the pressure of the focused ultrasound, and a range of destruction of biological tissue.
Claim 9 recites, in part, performing the steps of 4) control a pressure of the focused ultrasound and a variable acoustic pressure application time point and 5) sets the variable acoustic pressure application time point or the variable acoustic pressure application time points at which the pressure of the focused ultrasound is lowered to be different depending on characteristics of target biological tissue, the pressure of the focused ultrasound, and a range of destruction of biological tissue. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, a person can input settings into an ultrasound device to control the device’s operation.
Depending claims 2-8 and 10-15 include all of the limitations of claims 1 and 9, and therefore likewise incorporate the above described abstract idea. Depending claims 2-5 add additional, functional steps to the claims, claims 6-7 are directed to additional training language but in a manner which does not add upon the claims from which they depend upon, claim 8 adds additional steps and an additional element of retraining the model (which is further addressed below in Prong Two), claim 10 adds a training step similar to the training step of claim 1, claims 11-12 add additional, functional steps to the claims, claims 13-14 are similar to claims 6-7 above, and claim 15 is similar to claim 8 above. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-8 and 10-15 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 9 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of –a) training a model, using b) the trained model, c) an ultrasound output unit configured to output a focused ultrasound, d) a processor, and e) retraining the model (from claims 8 and 15) to perform the claimed steps.
The a) training a model, using b) the trained model, and e) retraining the model in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic machine learning components (see: MPEP 2106.05(f)).
Additionally, the c) ultrasound output unit configured to output a focused ultrasound in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic components (see: MPEP 2106.05(f)).
In addition, the c) ultrasound output unit configured to output a focused ultrasound in these steps also adds insignificant extra-solution activity to the abstract idea which amounts to insignificant application, see MPEP 2106.05(g).
Lastly, the d) processor in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that it amounts to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification for a lack of description for anything but what may be considered as generic computing components for this element, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) training a model, using b) the trained model, c) an ultrasound output unit configured to output a focused ultrasound, d) a processor, and e) retraining the model to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) or mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention determines settings utilizing a) training a model, using b) the trained model, d) a processor, and e) retraining the model and applies those settings using c) an ultrasound output unit configured to output a focused ultrasound thus these components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer, using machine learning, and using an ultrasound unit.
Lastly, the c) ultrasound output unit configured to output a focused ultrasound, in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives setting data, and transmits the data to an ultrasound unit.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-15 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over W.O. 2020/162989 to Starns in view of U.S. 2019/0307472 to Lu et al.
As per claim 1, Starns teaches a method for operating an apparatus for destroying biological tissue operated by at least one processor, the method comprising:
--acquiring learning data including information on characteristics of biological tissue, (see: page 11, lines 1-14 where there is acquiring of images with metadata associated with the type of tissue being subjected to ultrasound) a pressure of focused ultrasound, (see: page 6, lines 5-10 where there is a determination if more or less pressure is needed, thus there is a determination of a current pressure) and a range of the biological tissue; (see: page 1, lines 30-39 where images are being received. The images provide the range of destruction)
--training a model such that, when the learning data is input, a pressure of focused ultrasound, and other information (see: page 2, lines 12-32 where pressure and other parameters for the ultrasound recommendations are being outputted) are output depending on the characteristics of the biological tissue and the range of the biological tissue; (see: page 2, lines 12-32 where there is reception of input information in order to train a model and then there is output of feedback. The inputted data includes the metadata characteristics above as well as the image surface area which is the basis for the range) and
--setting a pressure of focused ultrasound, and other information when a medical image comprising the target biological tissue is input into the trained model (see: page 2, lines 12-32 where a pressure recommendation is being outputted when a target tissue is inputted into the training model via imaging).
Starns may not further, specifically teach:
1) --acquiring learning data including information on a variable acoustic pressure application time point,
2) --a range of destruction of the biological tissue;
3) --other information as a variable acoustic pressure application time point, and a number of pulses; and
4) --setting parameters which are used to destroy target biological tissue.
Lu et al. teaches:
1) --acquiring learning data including information on a variable acoustic pressure application time point, (see: FIGS. 9(a)-(f) and paragraphs [0035] and [0038] where there is a time point where there is a change between frequencies)
2) --a range of destruction of the biological tissue; (see: paragraph [0043] where there is histotripsy for tissue destruction and paragraph [0051] where there is a target tissue and its size)
3) --other information as a variable acoustic pressure application time point, and a number of pulses; (see: FIGS. 9(a)-(f) and paragraphs [0035] and [0038] where there is a time point where there is a change between frequencies. Also see: paragraph [0030] where there is a number of pulses) and
4) --setting parameters which are used to destroy target biological tissue (see: paragraph [0043] where there is histotripsy for tissue destruction and paragraph [0029] where there is a setting of parameters for this).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include 1) acquiring learning data including information on a variable acoustic pressure application time point and 4) set parameters which are used to destroy target biological tissue as taught by Lu et al. in the method of Starns since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Starns teaches of acquiring certain data and setting parameters for operating ultrasound device and adding more parameters and what type of device it is would maintain the same functionality of Starns, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 2) a range of destruction of the biological tissue and 3) a variable acoustic pressure application time point as taught by Lu et al. for the range of tissue and other information as disclosed by Starns since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Starns already teaches of using a range of tissue and other information thus one could substitute that range and other information for another range and other ultrasound information and achieve predictable results of using a range and other ultrasound information. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over W.O. 2020/162989 to Starns in view of U.S. 2019/0307472 to Lu et al. as applied to claim 1, and further in view of K.R. 102320038 B1 to Park et al.
As per claim 2, Starns and Lu et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach:
--after the setting,
--outputting a focused ultrasound at the set pressure of focused ultrasound to the target biological tissue, thereby destroying the target biological tissue, and
--controlling an acoustic pressure and intensity of the focused ultrasound to be lowered at the variable acoustic pressure application time point.
Park et al. teaches:
--after the setting,
--outputting a focused ultrasound at the set pressure of focused ultrasound to the target biological tissue, thereby destroying the target biological tissue, (see: paragraph [0016] where there is an outputting of this focused ultrasound to destroy tissue) and
--controlling an acoustic pressure and intensity of the focused ultrasound to be lowered at the variable acoustic pressure application time point (see: paragraph [0016] where the pressure and intensity are being lowered at a time point (when the second condition of tissue reaches a threshold value)).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to after the setting, outputting a focused ultrasound at the set pressure of focused ultrasound to the target biological tissue, thereby destroying the target biological tissue and controlling an acoustic pressure and intensity of the focused ultrasound to be lowered at the variable acoustic pressure application time point as taught by Park et al. in the method as taught by Starns and Lu et al. in combination with the motivation(s) of improving the precision of tissue removal (see: paragraph [0033] of Park et al.).
As per claim 3, Starns, Lu et al., and Park et al. in combination teaches the method of claim 2, see discussion of claim 2. Lu et al. further teaches a duty cycle is set to be 0.1% to 10% (see: paragraph [0040] where there is such a duty cycle).
Park et al. further teaches wherein:
--in the destroying,
--the focused ultrasound has a nonlinear ultrasound waveform having a shock wave pressure of 40 MPa or higher or a pressure of a maximum positive pressure of 30 MPa or higher and a maximum negative pressure of -10 MPa or lower, (see: paragraph [0067] where there is a nonlinear waveform. Also see: paragraphs [0061] and [0069] where there is such positive and negative pressures)
--the focused ultrasound after controlling the intensity of the focused ultrasound to be at or below a set value has any one of linear and nonlinear ultrasound waveforms having a shock wave pressure of lower than 40 MPa or a pressure of a maximum positive pressure of 30 MPa or lower and a maximum negative pressure of -10 MPa or higher, (see: paragraph [0028] where there is intensity controlled to be at or below a set value lower than 40 MPa) and
--there are one or more pulses where a pulse duration is set to be 0.1 ms to 100 ms, (see: paragraph [0057] where there are values for pulse duration/length within this range) an ultrasound center frequency is set to be 0.1 MHz to 10 MHz, (see: paragraph [0057] where there are values for center frequency within this range) a pulse repetition frequency is set to be 0.1 MHz to 100 MHz (see: paragraph [0057] where there are values for repetition frequency within this range).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 2, and incorporated herein.
As per claim 4, Starns and Lu et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein:
--the setting involves setting a plurality of the variable acoustic pressure application time points to be after a time point at which vapor bubbles are generated in the target biological tissue due to an output of the focused ultrasound.
Park et al. teaches:
--the setting involves setting a plurality of the variable acoustic pressure application time points to be after a time point at which vapor bubbles are generated in the target biological tissue due to an output of the focused ultrasound (see: paragraph [0053] where different time points after the first condition is reached (after bubbling) can lead to different pressures being set).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein: the setting involves setting a plurality of the variable acoustic pressure application time points to be after a time point at which vapor bubbles are generated in the target biological tissue due to an output of the focused ultrasound as taught by Park et al. in the method as taught by Starns and Lu et al. in combination with the motivation(s) of improving the precision of tissue removal (see: paragraph [0033] of Park et al.).
As per claim 5, Starns, Lu et al., and Park et al. in combination teaches the method of claim 4, see discussion of claim 4. Park et al. further teaches wherein:
--a pressure of the focused ultrasound, which is output to the target biological tissue at each of the plurality of set variable acoustic pressure application time points, is controlled to be different (see: paragraph [0023] where the acoustic pressure is being controlled by the control unit to be different based on the tissue. Also see: paragraph [0053] where different time points after the first condition is reached (after bubbling) can lead to different pressures being set).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over W.O. 2020/162989 to Starns in view of U.S. 2019/0307472 to Lu et al. as applied to claim 1, and further in view of U.S. 2025/0356987 to Templeton.
As per claim 6, Starns and Lu et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein:
--the training the model involves training the model such that, when the learning data is input, the range of destruction of biological tissue is displayed according to the characteristics of the biological tissue, the pressure of the focused ultrasound, and the variable acoustic pressure application time point.
Templeton teaches:
--the training the model involves training the model such that, when the learning data is input, the range of destruction of biological tissue is displayed according to the characteristics of the biological tissue, the pressure of the focused ultrasound, and the variable acoustic pressure application time point (see: paragraph [0003] where there is reception of imaging data by a model and generation and displaying of ablation regions. Also see: paragraph [0087] where there is an overlay of ablation tissue and paragraph [0094] where there is training to recognize characteristics of a lesion. A trained model is using imaging data as well as characteristics data here in order to display the overlay. The characteristics data including pressure and time points was taught in the base references).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have the training the model involve training the model such that, when the learning data is input, the range of destruction of biological tissue is displayed according to the characteristics of the biological tissue, the pressure of the focused ultrasound, and the variable acoustic pressure application time point as taught by Templeton in the method as taught by Starns and Lu et al. in combination with the motivation(s) of improving medical outcomes (see: paragraph [0061] of Templeton).
As per claim 7, Starns, Lu et al., and Templeton in combination teaches the method of claim 6, see discussion of claim 6. Templeton further teaches:
--when a medical image of the target biological tissue is input, displaying the pressure of the focused ultrasound and the variable acoustic pressure application time point, which are used to destroy the target biological tissue, as well as a range of destruction of the target biological tissue in the medical image (see: paragraph [0087] where there is an overlay of ablation tissue data (range of destruction) on a medical image. The displayed data including pressure of the focused ultrasound and the variable acoustic pressure application time point was already taught in the base references).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
As per claim 8, Starns, Lu et al., and Park et al. in combination teaches the method of claim 2, see discussion of claim 2. The combination may not further, specifically teach:
--after the controlling the intensity to be lowered,
--acquiring a destruction image in which the target biological tissue is destroyed according to the setting,
--comparing a difference range between an actual destruction range extracted from the destruction image and a determined destruction range corresponding to the information on the range of destruction of the biological tissue, and
--retraining the model using the actual destruction range, the pressure of the focused ultrasound, the variable acoustic pressure application time point, and the characteristics of the biological tissue when the difference range exceeds a preset threshold range.
Templeton teaches:
--after the controlling the intensity to be lowered,
--acquiring a destruction image in which the target biological tissue is destroyed according to the setting, (see: paragraph [0075] where there is reception of data from after the patient is treated)
--comparing a difference range between an actual destruction range extracted from the destruction image and a determined destruction range corresponding to the information on the range of destruction of the biological tissue, (see: paragraph [0248] where there is a comparison between a target and a prediction) and
--retraining the model using the actual destruction range, the pressure of the focused ultrasound, the variable acoustic pressure application time point, and the characteristics of the biological tissue when the difference range exceeds a preset threshold range (see: paragraph [0248] where there is training of a model using the difference between a target and a prediction and retraining based on utilization of an error signal/threshold).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to after the controlling the intensity to be lowered, acquire a destruction image in which the target biological tissue is destroyed according to the setting, compare a difference range between an actual destruction range extracted from the destruction image and a determined destruction range corresponding to the information on the range of destruction of the biological tissue, and retrain the model using the actual destruction range, the pressure of the focused ultrasound, the variable acoustic pressure application time point, and the characteristics of the biological tissue when the difference range exceeds a preset threshold range as taught by Templeton in the method as taught by Starns and Lu et al. in combination with the motivation(s) of improving medical outcomes (see: paragraph [0061] of Templeton).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0307472 to Lu et al. in view of K.R. 102320038 B1 to Park et al.
As per claim 9, Lu et al. teaches an apparatus for destroying biological tissue, the apparatus comprising:
--an ultrasound output unit configured to output a focused ultrasound; (see: paragraph [0004] where there is such an ultrasonic device) and
--a processor configured to control a pressure of the focused ultrasound and a variable acoustic pressure application time point, (see: paragraph [0049] where there is such a processor to control a pressure).
Lu et al. may not further, specifically teach:
--the processor sets the variable acoustic pressure application time point or the variable acoustic pressure application time points at which the pressure of the focused ultrasound is lowered to be different depending on characteristics of target biological tissue, the pressure of the focused ultrasound, and a range of destruction of biological tissue.
Park et al. teaches:
--the processor sets the variable acoustic pressure application time point or the variable acoustic pressure application time points at which the pressure of the focused ultrasound is lowered to be different depending on characteristics of target biological tissue, the pressure of the focused ultrasound, and a range of destruction of biological tissue (see: paragraphs [0016] and [0026] – [0027] where the pressure is being lowered at a time point (when the second condition of tissue reaches a threshold value) depending on the tissue, pressure, and the range of destruction).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have the processor set the variable acoustic pressure application time point or the variable acoustic pressure application time points at which the pressure of the focused ultrasound is lowered to be different depending on characteristics of target biological tissue, the pressure of the focused ultrasound, and a range of destruction of biological tissue as taught by Park et al. in the apparatus as taught by Lu et al. with the motivation(s) of improving the precision of tissue removal (see: paragraph [0033] of Park et al.).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0307472 to Lu et al. in view of K.R. 102320038 B1 to Park et al. as applied to claim 9, and further in view of W.O. 2020/162989 to Starns.
As per claim 10, Lu et al. and Park et al. in combination teaches the apparatus of claim 9, see discussion of claim 9. Lu et al., Park et al., and Starns in combination teaches claim 10 in a similar manner to claim 1.
As per claim 11, Lu et al., Park et al., and Starns in combination teaches the apparatus of claim 10, see discussion of claim 10. Lu et al., Park et al., and Starns in combination teaches claim 11 in a similar manner to claim 4.
As per claim 12, Lu et al., Park et al., and Starns in combination teaches the apparatus of claim 11, see discussion of claim 11. Lu et al., Park et al., and Starns in combination teaches claim 12 in a similar manner to claim 5.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0307472 to Lu et al. in view of K.R. 102320038 B1 to Park et al. further in view of W.O. 2020/162989 to Starns as applied to claim 12, and further in view of U.S. 2025/0356987 to Templeton.
As per claim 13, Lu et al., Park et al., and Starns in combination teaches the apparatus of claim 12, see discussion of claim 12. Lu et al., Park et al., Starns, and Templeton in combination teaches claim 13 in a similar manner to claim 6.
As per claim 14, Lu et al., Park et al., Starns, and Templeton in combination teaches the apparatus of claim 13, see discussion of claim 13. Lu et al., Park et al., Starns, and Templeton in combination teaches claim 14 in a similar manner to claim 7.
As per claim 15, Lu et al., Park et al., Starns, and Templeton in combination teaches the apparatus of claim 14, see discussion of claim 14. Lu et al., Park et al., Starns, and Templeton in combination teaches claim 13 in a similar manner to claim 8.
Conclusion
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
