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
Applicant’s arguments, see pages 1-10, filed 30 June 2026, with respect to 112 and 103 rejections have been fully considered and are persuasive in view of amendment. The 103 rejections of 30 June 2026 have been withdrawn.
The examiner has written 101 rejections for claims 1-20.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a neuromodulation system, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
analyze the ultrasound image data to determine and update a percent visibility of the target region within the ultrasound image data over time, wherein the percent visibility corresponds to a proportion of the target region that is present within a path of the imaging beam;
compare, in real-time, the percent visibility of the target region to a threshold target region visibility specific to a treatment protocol being administered to the subject; based on the comparison:
when the percent visibility of the target region meets or exceeds the threshold target region visibility, apply the neuromodulating energy dose to the target region in the subject via the therapy ultrasound beam emitted by the ultrasound energy application device,
when the percent visibility of the target region is below the threshold target region visibility, cause or prompt a remediating act to be performed.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image with a target region, and calculate percent visibility by targe region (number of pixels or areas) divided by total pixels in the image or imaging beam/path, and multiply by 100, according to mathematical formula of percentage, and comparing the calculated percent visibility to a known value (Visual comparison of the numbers) and when the calculated percent visibility is higher than the known value, turning on the energy source to start the neuromodulation by activating a switch, and when the percent visibility is lower, one can provide a verbal or written direction to provide a remediating act.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing a target region in image (spotting a specific region in the brain), evaluating whether the specific region is visible by calculating specific region pixels/areas divided by total image pixels/imaging path by known mathematical formula for percentage (calculation can be done by plugging the numbers into known formula using pen and paper), and comparing calculated value to either turn on or off the treatment (judgement and draw a conclusion). These steps can all be performed mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“an ultrasound energy application device configured to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;” and “wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject”
a controller configured to receive, in response to transmission of the imaging beam, real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;
This claim elements of an ultrasound device for imaging and therapy and generating image data via reconstructions are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the controller itself, just simply gathering ultrasound image data which is a necessary precursor for all uses of the recited abstract idea since no determination of visibility, comparison, determination of target region, and subsequent decision can be performed without first gathering necessary image data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
“an ultrasound energy application device configured to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;” and “wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject”
a controller configured to receive, in response to transmission of the imaging beam, real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;
The above-identified additional element, “A controller” is generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a controller as a processor ([0044]), generically described without structure.
Accordingly, in light of applicant’s specification, the claimed term controller is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
With “an ultrasound energy device,” this element represents well-understood, routine, conventional activity because of US patent publication Burdette et al. (US 2023/0095465) describes ultrasound transducers comprising conventional ultrasound imaging array and the therapy transducer ([0106] and [0123]) and such a configuration would partial overlap of imaging beam with therapy beam path (Figure 10).
Therefore, the examiner concludes that an ultrasound energy application generating both an imaging beam and therapy beam is common use in neuromodulating procedures and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 1 is ineligible.
Claims 2-6 and 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intraluminal imaging system, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claims 2-10 recite the limitations:
Of claim 2, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on an effectiveness threshold.
Of claim 3, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on a safety criterion.
Of claim 4, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on a therapy dose criterion.
Of claim 5, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on one or more specific features of the target region specified by the treatment protocol being visible in the ultrasound image data.
Of claim 6, wherein the one or more specific features of the target region comprise a porta hepatis.
Of claim 9, wherein the remediating act comprises one or both of repositioning or reorienting the ultrasound energy application device.
Of claim 10, wherein remediating act comprises performing an electronic adaptation of the ultrasound energy application device.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of before treatment begins, analyzing neuromodulating energy dose in reviewing conditions of efficacy, safety and therapy dose, and determining features of target region in the image to be present, by observing a porta hepatis presence in the image by visually observing the image, which can be conducted by mentally performing comparison, evaluation, and conclusion using efficacy, safety and therapy dose appropriate for the treatment. The appropriate action to be followed such as reposition, reorientation of the device and an electronic adaptation is recited as “cause or prompt a remediating act to be performed” as set froth in claim 1, thus is not actual performing but can be a written instruction to be followed.
These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining appropriate neuromodulating energy dose after reviewing efficacy, safety, and therapy dose and observing porta hepatis in the image prior to actual treatment and plan to make a change in position and electronic adaptation of the device. These steps can all be performed mind with aid of a pen and paper. and distal frames can be performed by observation and opinion of physician.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claims 2-6 recite the following additional elements:
A controller configured to
The use of a controller is recited for performing the mental process set forth above and does not integrate the subtract mental process into a practical application. These are generic hardware/software components invoked merely as a tool to perform the subtract steps and does not add meaningful limitations. The claims do not specify any configuration or improvement in the processor/computer itself, just simply gathering ultrasound image data which is a necessary precursor for all uses of the recited abstract idea since no determination of visibility, comparison, determination of target region, and subsequent decision can be performed without first gathering necessary image data.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception, as a controller is directed to “apply it” as discussed in STEP 2A PRONG TWO.
The above-identified additional element, “a controller” is generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a controller as a processor ([0044]), generically described without structure.
Accordingly, in light of Applicant’s specification, the claimed term controller is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
For these reasons, there is no invention concept in the claims.
In light of the above, claims 2-6 and 9-10 are ineligible.
Claims 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial exception are discussed above in the claim 1 rejection.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite
Of claim 7, wherein the ultrasound energy application device comprises: image transducers configured to acquire the ultrasound image data; and therapy transducers configured to the therapy ultrasound beam.
Of claim 8, wherein the ultrasound energy application device comprises: transducers configured to both emit both an imaging beam to acquire the ultrasound image data and the therapy ultrasound beam.
With respect to claim 7, this element represents well-understood, routine, conventional activity because of US patent publication Burdette et al. (US 2023/0095465) describes ultrasound transducers comprising conventional ultrasound imaging array and the therapy transducer ([0106] and [0123]) and such a configuration would partial overlap of imaging beam with therapy beam path (Figure 10).
Therefore, the examiner concludes that an ultrasound energy application comprising imaging transducer and therapy transducer is common use in neuromodulating procedures and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 7 is ineligible.
With respect to claim 8, this element represents well-understood, routine, conventional activity because of US patent publication Seip et al. (US 2008/0039724) describes conventional single crystal ultrasonic transducers use a single crystal for both imaging and HIFU treatment ([0008]).
Therefore, the examiner concludes that an ultrasound energy application single transducer for both imaging and therapy beams is common use in neuromodulating procedures and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 8 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a neuromodulation method, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 11 recites the limitations:
analyzing the ultrasound image data to determine and update a percent visibility of a target region within the ultrasound image data over time, wherein the percent visibility corresponds to a proportion of the target region that is present within a path of the imaging beam;
comparing, in real-time, the percent visibility of the target region to a threshold target region visibility specific to a treatment protocol being administered to the subject;
based on the comparison:
when the percent visibility of the target region meets or exceeds the threshold target region visibility, applying a neuromodulating energy dose to the target region in the subject via [[a]] the therapy ultrasound beam emitted by the ultrasound energy application device, wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject;
when the percent visibility of the target region is below the threshold target region visibility, causing or prompting a remediating act to be performed.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and the mathematical calculations as it recites steps of observing the image with a target region, and calculate percent visibility by targe region (number of pixels or areas) divided by total pixels in the image or imaging beam/path, and multiply by 100, according to mathematical formula of percentage, and comparing the calculated percent visibility to a known value (visual comparison of the numbers) and when the calculated percent visibility is higher than the known value, turning on the energy source to start the neuromodulation, and when the percent visibility is lower, provide verbal direction to provide a remediating act.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion) and mathematical calculation”. A human, such as surgeon and/or physician, could mentally perform tasks of observing a target region in image (spotting a specific region in the brain), evaluating whether the specific region is visible by calculating specific region pixels/areas divided by total image pixels/imaging path by known mathematical formula for percentage (calculation can be done by plugging the numbers into known formula using pen and paper), and comparing calculated value to either turn on or off the treatment (judgement and draw a conclusion). These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“operating an ultrasound energy application device to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;”
receiving, in response to transmission of the imaging beam real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;
“wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject”
This claim elements of an ultrasound device for imaging and therapy and generating image data via reconstructions are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the controller itself, just simply gathering ultrasound image data which is a necessary precursor for all uses of the recited abstract idea since no determination of visibility, comparison, determination of target region, and subsequent decision can be performed without first gathering necessary image data.
These additional elements, taken individually or in combination, merely amount to insignificant pre-solution and post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite
“operating an ultrasound energy application device to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;”
“receiving, in response to transmission of the imaging beam real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;”
The element of “operating an ultrasound energy application device” represents well-understood, routine, conventional activity because of US patent publication Burdette et al. (US 2023/0095465) describes ultrasound transducers comprising conventional ultrasound imaging array and the therapy transducer ([0106] and [0123]) and such a configuration would partial overlap of imaging beam with therapy beam path (Figure 10).
Therefore, the examiner concludes that an ultrasound energy application generating both an imaging beam and therapy beam is common use in neuromodulating procedures and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception.
The element of “receiving” is recited and described in specification to be performed by controller ([0006]). Per applicant’s specification, applicant describes a controller as a processor ([0044]), generically described without structure.
The above-identified additional element, “ receiving by a controller” is generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Accordingly, in light of Applicant’s specification, the claimed term controller is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
In light of the above, claim 11 is ineligible.
Claims 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a neuromodulating method, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claims 2-10 recite the limitations:
Of claim 12, further comprising: prior to applying the neuromodulating energy dose to the target region, performing a further determination that the neuromodulating energy dose can be applied to the target region based on one or more specific features of the target region specified by the treatment protocol being visible in the ultrasound image data.
Of claim 13, wherein the one or more specific features of the target region comprise a porta hepatis.
Of claim 14, wherein the remediating act comprises one or both of repositioning or reorienting the ultrasound energy application device.
Of claim 15, wherein remediating act comprises performing an electronic adaptation of the ultrasound energy application device.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of before treatment begins, determining features of target region in the image to be present, by observing a porta hepatis presence in the image by visually observing the image, which can be conducted by mentally performing comparison, evaluation, and conclusion to perform therapy dose appropriate for the treatment. The appropriate action to be followed such as reposition, reorientation of the device and an electronic adaptation is recited as “cause or prompt a remediating act to be performed” as set forth in claim 1, thus is not actual performing steps but can be a written instruction to be followed.
These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining appropriate neuromodulating energy dose after reviewing efficacy, safety, and therapy dose and observing porta hepatis in the image prior to actual treatment and plan to make a change in position and electronic adaptation of the device. These steps can all be performed in the mind with aid of a pen and paper. and distal frames can be performed by observation and opinion of physician.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claims 12-15 do not recite additional limitations and therefore, does not integrate the subtract mental process into a practical application.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no invention concept in the claims.
In light of the above, claims 12-15 are ineligible.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites one or more tangible, machine-readable media storing processor-executable routines, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 16 recites the limitations:
analyzing the ultrasound image data to determine and update a percent visibility of a target region within the ultrasound image data over time, wherein the percent visibility corresponds to a proportion of the target region that is present within a path of the imaging beam;
comparing, in real-time, the percent visibility of the target region to a threshold target region visibility specific to a treatment protocol being administered to the subject;
based on the comparison:
when the percent visibility of the target region meets or exceeds the threshold target region visibility, applying a neuromodulating energy dose to the target region in the subject via the therapy ultrasound beam emitted by the ultrasound energy application device, wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject;
when the percent visibility of the target region is below the threshold target region visibility, causing or prompting a remediating act to be performed.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical calculation as it recites steps of observing the image with a target region, and calculate percent visibility by targe region (number of pixels or areas) divided by total pixels in the image or imaging beam/path, and multiply by 100, according to mathematical formula of percentage, and comparing the calculated percent visibility to a known value (visual comparison of the numbers) and when the calculated percent visibility is higher than the known value, turning on the energy source to start the neuromodulation, and when the percent visibility is lower, provide verbal direction to provide a remediating act.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion) and mathematical calculation”. A human, such as surgeon and/or physician, could mentally perform tasks of observing a target region in image (spotting a specific region in the brain), evaluating whether the specific region is visible by calculating specific region pixels/areas divided by total image pixels/imaging path by known mathematical formula for percentage (calculation can be done by plugging the numbers into known formula using pen and paper), and comparing calculated value to either turn on or off the treatment (judgement and draw a conclusion). These steps can all be performed mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“One or more tangible, machine-readable media storing processor-executable routines, wherein the processor-executable routines, when executed by a processor, causes acts to be performed comprising:”
“operating an ultrasound energy application device to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;”
receiving, in response to transmission of the imaging beam real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;
“wherein the path of the imaging beam at least partially overlaps a path of the therapy ultrasound beam within the subject”
This claim elements of an ultrasound device for imaging and therapy and generating image data via reconstructions are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the processor and its storage itself, just simply gathering ultrasound image data which is a necessary precursor for all uses of the recited abstract idea since no determination of visibility, comparison, determination of target region, and subsequent decision can be performed without first gathering necessary image data.
The use of processor, storage and routines do not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. The processor and routines executable is recited in a high level of generality in the claim. Theses additional elements, taken individually or in combination merely amount to insignificant pre/post solution activities and do not integrate the judicial exception into a practical application.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite
“One or more tangible, machine-readable media storing processor-executable routines, wherein the processor-executable routines, when executed by a processor, causes acts to be performed comprising:”
“operating an ultrasound energy application device to generate both an imaging beam for imaging an anatomic region of a subject and a therapy ultrasound beam capable of delivering deliver a neuromodulating energy dose to a target region within the anatomic region of the in a subject;”
“receiving, in response to transmission of the imaging beam real-time ultrasound image data of an internal tissue of the subject, wherein the ultrasound image data depicts anatomical structures when reconstructed;”
The element of “operating ultrasound energy application device” represents well-understood, routine, conventional activity because of US patent publication Burdette et al. (US 2023/0095465) describes ultrasound transducers comprising conventional ultrasound imaging array and the therapy transducer ([0106] and [0123]) and such a configuration would partial overlap of imaging beam with therapy beam path (Figure 10).
Therefore, the examiner concludes that an ultrasound energy application generating both an imaging beam and therapy beam is common use in neuromodulating procedures and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception.
The element of “receiving” and “machine-readable media storing processor-executable routines” are recited and described in specification to be performed by controller ([0006]) and machine-readable media storing is only disclosed in claim 16. Per applicant’s specification, applicant describes a controller as a processor ([0044]), generically described without structure.
The above-identified additional element, “a controller” and “machine-readable media storing processor-executable routines” are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Accordingly, in light of Applicant’s specification, the claimed term controller and “machine-readable media storing processor-executable routines” are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller and “machine-readable media storing processor-executable routines”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
In light of the above, claim 16 is ineligible.
Claims 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite one or more tangible, machine-readable media, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claims 17-18 recite the limitations:
Of claim 17, prior to applying the neuromodulating energy dose to the target region, performing a further determination that the neuromodulating energy dose can be applied to the target region based on one or more specific features of the target region specified by the treatment protocol being visible in the ultrasound image data.
Of claim 18, wherein the one or more specific features of the target region comprise a porta hepatis.
Of claim 19, wherein the remediating act comprises one or both of repositioning or reorienting the ultrasound energy application device.
Of claim 20, wherein remediating act comprises performing an electronic adaptation of the ultrasound energy application device.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of before treatment begins, determining features of target region in the image to be present, by observing a porta hepatis presence in the image by visually observing the image, which can be conducted by mentally performing comparison, evaluation, and conclusion to perform therapy dose appropriate for the treatment. The appropriate action to be followed such as reposition, reorientation of the device and an electronic adaptation is recited as “cause or prompt a remediating act to be performed” as set forth in claim 16, thus is not actual performing steps but can be a written instruction to be followed.
These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining appropriate neuromodulating energy dose after reviewing efficacy, safety, and therapy dose and observing porta hepatis in the image prior to actual treatment and plan to make a change in position and electronic adaptation of the device. These steps can all be performed in the mind with aid of a pen and paper. and distal frames can be performed by observation and opinion of physician.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claims 17-18 recite additional elements as follows: “processor-executable routines, when executed by a processor, cause further acts to be performed.”
The use of processor, storage and routines do not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. The processor and routines executable is recited in a high level of generality in the claim. Theses additional elements, taken individually or in combination merely amount to insignificant pre/post solution activities and do not integrate the judicial exception into a practical application.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no invention concept in the claims.
In light of the above, claims 17-20 are ineligible.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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