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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Amendment
Currently claims 1-21 are pending.
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 1-21 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 system, and is therefore a machine.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “processing the set of images as the set of images are collected using the trained AI model to identify, in real-time, the deployed biopsy marker based in the set of images based on the second data set”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
In addition, the claim recites the limitation “using the first data set to train an artificial intelligence (AI) model”.
This limitation, as drafted, is a process step that, under BRI, also encompasses mathematical concepts that can be performed mentally. The training of the AI model requires specific mathematical calculations to perform the training of the AI model, and therefore encompasses mathematical concepts.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “A system comprising: an ultrasound imaging device; a display, wherein images captured by the ultrasound imaging device are displayed on the display at least one processor; and memory coupled to the at least one processor, the memory comprising computer executable instructions that, when executed by the at least one processor, performs a method comprising: receiving a first data set for one or more biopsy markers, wherein the first data set comprises at least one of: marker identification information, marker property information, marker image data, marker location, or supplemental marker information; receiving a second data set for a deployed biopsy marker; collecting, using the ultrasound imaging device, a set of images for a site of the deployed biopsy marker; providing the second data set to the trained Al model; and using the trained Al mode; and generating, on the display in real-time with processing the set of images, in response to identifying in real-time the deployed biopsy marker, the one or more images of the set of images including an indication the deployed biopsy marker has been identified”. The steps “receiving a first data set for one or more biopsy markers”, “receiving a second data set for a deployed biopsy marker”, “collecting”, and “providing the second data set to the trained AI model” are merely data gathering and output recited at a high level of generality. Further, the “generating, on the display” step is also considered insignificant post solution activity. This step merely presents the result of the abstract data analysis, and does not integrate the abstract idea into a practical application as it constitutes the presentation of information. Thus these steps are insignificant extra-solution activity. See MPEP 2106.05(d). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. See MPEP 2106.05.
The judicial exception of “using the trained AI model to identify, in real-time, the deployed biopsy marker in the set of images based on the second set” is performed “using the trained AI model”. The trained AI model is used to generally apply the abstract idea without placing any limits on how the trained AI model functions. Rather, these limitations only recite the outcome of the “identify” step and do not include any details about how the “identify” step is accomplished. See MPEP 2106.05(f).
Further, the ultrasound imaging device and display do not integrate a judicial exception into a practical application as they generally link the use of the judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h).
The recitation of “using a trained AI” in the limitation also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using a trained AI model” limits the identified judicial exceptions “identify, in real-time, the deployed biopsy marker based on the second data set”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 1 rejection.
Step 2A Prong 2: No, the claim recites “wherein the marker property information comprises at least one of shape, size, texture, type, manufacturer, surface reflection, material, composition, or frequency signature”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 2.
Step 2A Prong 1:Yes, the claim recites the limitation “correlate a shape of the one or more biopsy markers with corresponding marker identification information for the one or more biopsy markers.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “wherein training the Al model comprises enabling the Al model”.
The judicial exception of “wherein training the Al model comprises enabling the Al model” is performed using the AI model.
The recitation of using an AI model in the limitation merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “training the AI Model” limits the identified judicial exceptions “correlate a shape of the one or more biopsy markers with corresponding marker identification information for the one or more biopsy markers”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1:Yes, for the same reasons put forth in claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “wherein training the Al model comprises at least one of generating a 3D model of the one or more biopsy markers, or collecting one or more 2D images for the one or more biopsy markers”.
The judicial exception of “generating a 3D model of the one or more biopsy markers, or collecting one or more 2D images for the one or more biopsy markers” is performed using the AI model. The steps “generating a 3D model…” and “collecting one or more 2D images…” are merely data gathering and output recited at a high level of generality, and are thus insignificant extra-solution activity. See MPEP 2106.05(g). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The recitation of using an AI model in the limitation merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “training the AI Model” limits the identified judicial exceptions “generating a 3D model of the one or more biopsy markers, or collecting one or more 2D images for the one or more biopsy markers”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 1 rejection.
Step 2A Prong 2: No, the claim recites “wherein the deployed biopsy marker is one of the one or more biopsy markers used to train the Al model”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 1 rejection.
Step 2A Prong 2: No, the claim recites “wherein the second data set comprises at least one of: a name, a shape, or a product identifier for the deployed biopsy marker”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 1 rejection.
Step 2A Prong 2: No, the claim recites “wherein the second data set is collected from at least one of: a radiology report or a patient record”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2A Prong 1:Yes, for the same reasons put forth in claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “wherein the trained Al model is implemented by an imaging device configured to collect one or more images relating to the site of the deployed biopsy marker”.
The judicial exception of “collect one or more images relating to the site of the deployed biopsy marker” is performed using the AI model. The steps “collect one or more images relating to the site of the deployed biopsy marker” are merely data gathering and output recited at a high level of generality, and are thus insignificant extra-solution activity. See MPEP 2106.05(g). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The recitation of using an AI model in the limitation merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “training the AI Model” limits the identified judicial exceptions “collect one or more images relating to the site of the deployed biopsy marker”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 1.
Step 2, Prong 1: Yes, the claim recites the limitation “evaluating, by the trained Al model in real-time, the set of images to detect a shape identified by the second data set, wherein the evaluating includes the use of an image comparison algorithm.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “wherein using the trained Al model to identify the deployed biopsy marker comprises: collecting, using the imaging device, a set of images for the site of the deployed biopsy marker; providing the set of images to the trained Al model;”. The steps “collecting…”and “providing…” are merely data gathering and output recited at a high level of generality, and are thus insignificant extra-solution activity. See MPEP 2106.05(g). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The judicial exception of “evaluating, by the trained Al model in real-time, the set of images to detect a shape identified by the second data set, wherein the evaluating includes the use of an image comparison algorithm” is performed through the “use of an image comparison algorithm”. The image comparison algorithm is used to generally apply the abstract idea without placing any limits on how image comparison algorithm functions. Rather, these limitations only recite the outcome of “evaluating” and do not include any details about how the “evaluating” is accomplished. See MPEP 2106.05(f).
The recitation of “using a trained AI” in the limitation also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using a trained AI model” limits the identified judicial exceptions “identify, in real-time, the deployed biopsy marker based on the second data set”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar 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. In the light above, claim 9 is ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 19.
Step 2, Prong 1: Yes, the claim recites the limitation “when the image comparison algorithm detects the shape in the set of images, an indication of the detected shape is generated.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2, Prong B: No, the claim does not recite additional elements. In the light above, claim 10 is ineligible
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 11.
Step 2A Prong 1:Yes, for the same reasons put forth in claim 11.
Step 2A Prong 2: No, the claim recite the following additional elements “wherein generating the indication of the detected shape comprises at least one of: highlighting the detected shape in the set of images, playing an audio clip, displaying an arrow pointing to the detected shape in the set of images, or encircling the detected shape in the set of images”.
These limitations are merely data gathering and output recited at a high level of generality. Thus the steps are insignificant extra-solution activity. See MPEP 2106.05(d). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 is ineligible.
Applicant is recommended to expand how these indications are affected by the inventive concept or the results of these indications on the inventive concept in order to overcome the 35 U.S.C. 101 rejections.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes- the claim recites a method, and is therefore a process.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “based on the second data set, using the Al component to identify the biopsy marker in the set of images of the deployment site in real-time.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
The claim additionally recites the limitation, “wherein the first data is used to train the Al component to detect the biopsy marker when the biopsy marker is deployed in a deployment site”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “A method comprising: receiving, by an imaging system, a first data set for a biopsy marker, wherein the first data set comprises a shape description of the biopsy marker and an identifier for the biopsy marker; providing the first data set to an artificial intelligence (Al) component associated with the imaging system; receiving, by an imaging system, a second data set for the biopsy marker, wherein the second data set comprises at least one of the shape description of the biopsy marker or the identifier for the biopsy marker; providing the second data set to the Al component; receiving, by the imaging system, a set of images of the deployment site; processing, by the imaging system, the set of images as the set of images are acquired by: providing the second data set and the set of images of the deployment site to the AI component”, and generating, on the display in real-time with processing the set of images, in response to identifying in real-time the deployed biopsy marker, the one or more images of the set of images including an indication the deployed biopsy marker has been identified.”
The steps “receiving, by an imaging system, a first data set for a biopsy marker, wherein the first data set comprises a shape description of the biopsy marker and an identifier for the biopsy marker”, “providing the first data set to an artificial intelligence (Al) component associated with the imaging system”, “receiving, by an imaging system, a second data set for the biopsy marker, wherein the second data set comprises at least one of the shape description of the biopsy marker or the identifier for the biopsy marker”, “providing the second data set to the AI component”, “receiving, by the imaging system, a set of images of the deployment site” , and “providing the second data set and the set of images of the deployment site to the AI component” are merely data gathering and output recited at a high level of generality, and are thus insignificant extra-solution activity. Further, the “generating, on the display in real-time with processing the set of images” step is also considered insignificant post solution activity. This step merely presents the result of the abstract data analysis, and does not integrate the abstract idea into a practical application as it constitutes the presentation of information. See MPEP 2106.05(g). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The judicial exception of “identify the biopsy marker in the set of images of the deployment site in real-time.” is performed “using the AI component”. The trained AI component is used to generally apply the abstract idea without placing any limits on how the trained AI model functions. Rather, these limitations only recite the outcome of the “identify” step and do not include any details about how the “identify” step is accomplished. See MPEP 2106.05(f).
The recitation of “using the AI component” in the limitation also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using the AI component” limits the identified judicial exceptions “identify the biopsy marker in the set of images of the deployment site in real-time”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Further, the ultrasound imaging device and display do not integrate a judicial exception into a practical application as they generally link the use of the judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 12.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 12 rejection.
Step 2A Prong 2: No, the claim recites “generating an image of the identified biopsy marker; and displaying the image on a display device”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 13 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 13.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 13 rejection.
Step 2A Prong 2: No, the claim recites “wherein generating the image comprises using an image enhancement technique to enhance at least a portion of the image”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 14 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 14.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 14 rejection.
Step 2A Prong 2: No, the claim recites “wherein the image enhancement technique comprise at least one of: modifying a brightness of the portion of the image, modifying a size of the portion of the image, modifying a color of the portion of the image, outlining the portion of the image, or incorporating a 2D or 3D symbol representing the portion of the image”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 15 is ineligible.
Applicant is recommended to expand how these indications are affected by the inventive concept or the results of these indications on the inventive concept in order to overcome the 35 U.S.C. 101 rejections.
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: Yes, for the same reasons put forth in claim 13.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 13 rejection.
Step 2A Prong 2: No, the claim recites “wherein the image enhancement technique comprise at least one of: modifying a brightness of the portion of the image, modifying a size of the portion of the image, modifying a color of the portion of the image, outlining the portion of the image, or incorporating a 2D or 3D symbol representing the portion of the image”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 16 is ineligible.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 14.
Step 2A Prong 1: Yes, the claim recites the limitation “using the Al component to identify the biopsy marker in the set of images comprises using one or more image matching techniques to match an image representation of the biopsy marker to data in the set of images.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim does not recite additional claim elements.
Step 2B, Inventive Concept: No, similar 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. In light of the above, claim 17 is ineligible.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 17.
Step 2A Prong 1: Yes, the claim recites the limitation “when a match between the image representation of the biopsy marker and the data in the set of images is detected.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “an indication of the match is provided by the imaging system.”
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No, similar 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. In light of the above, claim 18 is ineligible.
Claim 19 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 method, and is therefore a process.
Step 2A, Prong 1, Judicial Exception: Yes, the claim additionally recites the limitation, “wherein the Al component is trained to detect the biopsy marker when the biopsy marker is deployed in a deployment site”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
The claim recites the limitation “comparing, by the AI component, the one or more images to the images to the received characteristics; and based on the comparison, identifying, by the Al component, the biopsy marker in the one or more images of the deployment site in real-time.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation (BRI), fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. 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, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites the following additional elements “A method comprising: receiving, by an imaging system, characteristics for a biopsy marker, wherein the characteristics comprise at least two of: a shape description of the biopsy marker, an image of the biopsy marker, or an identifier for the biopsy marker; providing the received characteristics to a trained artificial intelligence (AI) component associated with the imaging system; receiving, by the imaging system, one or more images of the deployment site; processing, by the imaging system, the one or more images of the deployment site as the one or more images are acquired by: providing the one or more images to the trained Al component; comparing, by the trained Al component, the one or more images to the received characteristics”. Further, the “generating, on the display in real-time with processing the one or more images” step is also considered insignificant post solution activity. This step merely presents the result of the abstract data analysis, and does not integrate the abstract idea into a practical application as it constitutes the presentation of information.
The steps are merely data gathering and output recited at a high level of generality, and are thus insignificant extra-solution activity. See MPEP 2106.05(g). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The judicial exception of “identifying, by the Al component, the biopsy marker in the one or more images of the deployment site in real-time” is performed “by the AI component”. The trained AI component is used to generally apply the abstract idea without placing any limits on how the trained AI model functions. Rather, these limitations only recite the outcome of the “identify” step and do not include any details about how the “identify” step is accomplished. See MPEP 2106.05(f).
The recitation of “the AI component” in the limitation also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element of “the AI component” limits the identified judicial exceptions “identifying, by the Al component, the biopsy marker in the one or more images of the deployment site in real-time”, this type of limitation merely confines the use of the abstract idea to a particular technological environment (neural networks) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Further, the ultrasound imaging device and display do not integrate a judicial exception into a practical application as they generally link the use of the judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h).
Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO), and the claim is directed to the judicial exception. (Step 2A: YES).
Step 2B, Inventive Concept: No, similar to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 19 is ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 19.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 19 rejection.
Step 2A Prong 2: No, the claim recites “wherein the one or more images of the deployment site are exported to an alternative imaging system”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 20 is ineligible.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Yes, for the same reasons put forth in claim 20.
Step 2A Prong 1: Judicial Exceptions are discussed above in the claim 20 rejection.
Step 2A Prong 2: No, the claim recites “wherein the one or more images of the deployment site are exported to an alternative imaging system”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post solution activities and do no integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B: No, similarly to Step 2A, Prong 2, the additional claim elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 221 is ineligible.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 4-6, 8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al., (US20210038921A1) in view of Zvuloni et al., (US20130090554A1) and further in view of Rulkov et al., (US 20210128268 A1).
Regarding claim 1, Nguyen teaches a system comprising (Abstract a system for guiding radiation therapy system):
at least one processor (fig. 1 computer 30 with processors [0065]); and
a memory coupled to the at least one processor, the memory comprising computer executable instructions that, when executed by the at least one processor, performs a method comprising (fig. 1 computer 30 has memory that is capable of performing instructions [0065] and [0045]):
receiving a first data set for one or more markers ([0074] training images include markers), wherein the first data set comprises at least one of: marker image data ([0074] training images include markers).;
using the first data set to train an artificial intelligence (Al) model ([0071] a CNN is used to detect fiducial markers in kilovoltage images [0073]-[0074] training the CNN uses the training images);
receiving a second data set for a deployed marker (fig. 3 at step 304, the image is captured by the imaging system 16 [0090]);
collecting, using the imaging device, a set of images for a site of the deployed marker ([0096] there are multiple images that are received, and [0086] are of the position of the marker );
providing the second data set and the set of images for a site to the trained Al model ([0095] the image is classified by the trained CNN and the process repeated until all the images of the site are searched); and
processing the set of images as the set of images are collected using the trained Al model to identify, in real-time, the deployed biopsy in one or more images of the set of images marker based on the second data set ([0095] the image is classified as either marker or marker; [0014] the marker may be tracked in real time which means the set of image are processed in real-tiome).
However, Nguyen is silent regarding an ultrasound imaging device; a display, wherein images captured by the ultrasound imaging device are displayed on the display; the marker being a biopsy marker.
In the same marker field of endeavor, Zvuloni teaches an ultrasound imaging device ([0173] the imaging modality may be an ultrasound probe); a display, wherein images captured by the ultrasound imaging device are displayed on the display ([0176] display 114a displays the first images 89 a, which are the images captured by the ultrasound imaging modality ([0173]); a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers and display of Nguyen with the biopsy fiducial markers and display of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]). In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging system of Nguyen with the ultrasound system of Zvuloni, as both inventions relate to the imaging of markers, and would yield the predictable result of a system that uses ultrasound to image markers and process those markers to one of ordinary skill. Indeed, Zvuloni uses different imaging modalities such as ultrasound and x-ray interchangeably (see Zvuloni [0173]). One of ordinary skill would be able to make such a substitution, and the results of Nguyen using an ultrasound imaging system are reasonably predictable.
However, the combination of references are silent regarding generating on the display in real-time with processing the one or more, the one or more images of the set of images including an indication the deployed biopsy marker has been identified.
In the same marker imaging field of endeavor, Rulkov teaches generating on the display in real-time with processing the set of images ([0091] the surgeon may observe the display in real time), the one or more images of the set of images including an indication the deployed biopsy marker has been identified (fig. 1 the system identifies which mark is currently being localized by changing a color [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the identifying marker step of modified Nguyen with the next step of including an indication of the identified markers by coloring them as taught by Rulkov, as this would help facilitate planning a procedure by helping the surgeon identify the location of the markers and therefore the lesions (see Rulkov [0083]-[0084]).
Regarding claim 4, modified Nguyen teaches the system of claim 1, wherein Nguyen further teaches wherein training the Al model comprises at least one of collecting one or more 2D images for the one or more biopsy markers ([0074] the training images are 2 dimensional with dimensions of 1024x768 pixels and contain markers).
Regarding claim 5, modified Nguyen teaches the system of claim 1, wherein Nguyen further teaches wherein the deployed biopsy marker is one of the one or more biopsy markers used to train the Al model ([0080]-[0081] the CNN were trained with cylindrical gold fiducial markers and the deployed markers were also the gold fiducial markers).
Regarding claim 6, modified Nguyen teaches the system of claim 1, wherein the second data set comprises at least one of a shape ([0090] the image captured by the imaging system would have a shape of the fiducial marker).
Regarding claim 8, modified Nguyen teaches the system of claim 1, wherein Nguyen further teaches wherein the trained Al model is implemented by an imaging device configured to collect one or more images relating to the site of the deployed marker (fig. 1 imaging system 16 captures the kV image, that includes the deployed fiducial marker site [0090]).
However, Nguyen is silent regarding the marker being a biopsy marker.
In the same marker field of endeavor, Zvuloni teaches a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of Nguyen with the biopsy fiducial markers of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]).
Regarding claim 19, Nguyen teaches a method comprising ([0071] method for training and using AI model):
receiving, by an imaging system, characteristics for a marker ([0074] AI model is trained with kV images, which include characteristics of a marker), wherein the characteristic comprises at least two of: a shape description of the biopsy marker and an image of the biopsy marker ([0080] the Cylindrical Shaped Marker Data are used to train the AI model, which includes the shape (cylindrical or arbitrary) and the [0074] kV image))
providing the received characteristics to a trained artificial intelligence (Al) component associated with the imaging system, wherein the trained Al component is trained to detect the marker when the marker is deployed in a deployment site ([0074] the kV images are used to train the AI model, and would have markers that are deployed at a deployment site (see [0080]; [0095] the image is classified by the trained CNN);
receiving, by the imaging system, one or more images of the deployment site ([0090] a kV image is captured by imaging system 16; [0093] the images include where the markers are);
processing, by the imaging system, one or more images of the deployment site as the one or more images are acquired by ( [0045] processor receives image of target area and analyses the images [0095] the CNN classifies them as marker or background):
providing the one or more images to the trained Al component ([0094]-[0095] the image is fed to the CNN, which is trained);
comparing, by the trained AI component, the one or more images to the received characteristics ([0095] the CNN classifies the normalized images. Since the CNN is trained by the training images as taught in [0074] and [0080], the CNN is indirectly comparing the training images to the images of the normalized images of [0095]);
based on comparison, identifying, by the AI component the marker in at least one of the set of images of the deployment site in real-time ([0095] the CNN classifies them as marker or background[0014] the marker may be tracked in real time).
However, Nguyen is silent regarding the marker being a biopsy marker, and using an ultrasound imaging device.
In the same marker field of endeavor, Zvuloni teaches a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]), and using an ultrasound imaging device ([0173] the imaging modality may be an ultrasound probe);.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers and display of Nguyen with the biopsy fiducial markers and display of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]). In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging system of Nguyen with the ultrasound system of Zvuloni, as both inventions relate to the imaging of markers, and would yield the predictable result of a system that uses ultrasound to image markers and process those markers to one of ordinary skill. Indeed, Zvuloni uses different imaging modalities such as ultrasound and x-ray interchangeably (see Zvuloni [0173]). One of ordinary skill would be able to make such a substitution, and the results of Nguyen using an ultrasound imaging system are reasonably predictable.
However, the combination of references are silent regarding generating on the display in real-time with processing the one or more, the one or more images of the set of images including an indication the deployed biopsy marker has been identified.
In the same marker imaging field of endeavor, Rulkov teaches generating on the display in real-time with processing the one or more images ([0091] the surgeon may observe the display with the model in real-time), the one or more images of the set of images including an indication the deployed biopsy marker has been identified (fig. 1 the system identifies which mark is currently being localized by changing a color [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the identifying marker step of modified Nguyen with the next step of including an indication of the identified markers by coloring them as taught by Rulkov, as this would help facilitate planning a procedure by helping the surgeon identify the location of the markers and therefore the lesions (see Rulkov [0083]-[0084]).
Claims 2 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni and Rulkov as applied to claim 1 and 8 above, respectively, and further in view of Henry et al., (US20220000491A1).
Regarding claim 2, modified Nguyen teaches the system of claim 1, but fails to explicitly disclose wherein the marker property information comprises at least one of shape.
In the same position marker field of endeavor, Henry teaches wherein the marker property information comprises at least one of shape ([0087] “Each marker has a predefined size, shape and pattern. The algorithm knows the shape, the size and optionally the pattern of the marker.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the first data set of modified Nguyen to include the shape of the marker property information as taught by Henry, as this improves its position and its orientation in a reference frame for each image acquisition (see Henry [0088]).
Regarding claim 9, modified Nguyen teaches the system of claim 8, wherein Nguyen further teaches wherein using the trained Al model to identify the deployed biopsy marker comprises ([0071] a CNN is used to detect fiducial markers in kilovoltage images [0073]-[0074] training the CNN uses the training images): providing the set of images to the trained Al model ([0074] the images are used to train the CNN); and evaluating, by the trained Al model in real-time, the set of images to detect identified by the second data set ([0095] the image is classified as either marker or marker; [0014] the marker may be tracked in real time).
However, Nguyen is silent regarding the marker being a biopsy marker.
In the same marker field of endeavor, Zvuloni teaches a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of Nguyen with the biopsy fiducial markers of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]).
However the combination of references still fails explicitly disclose detecting a shape, wherein the evaluating includes the use of an image comparison algorithm.
In the same marker field of endeavor, Henry teaches detecting a shape ([0087] the image detects the shape of the marker), wherein the evaluating includes the use of an image comparison algorithm ([0087] the algorithm compares the digital representative of the stored elements, and compares it to the shape of the marker on the image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the first data set of modified Nguyen to include the shape comparison as taught by Henry, as this improves its position and its orientation in a reference frame for each image acquisition (see Henry [0088]).
Regarding claim 10, modified Nguyen teaches the system of claim 9, but fails to explicitly disclose when the image comparison algorithm detects the shape in the set of images.
However, in the same image comparison field of endeavor, Henry teaches detecting the shape in the set of images, ([0087] the image detects the shape of the marker),).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the first data set of modified Nguyen to include the shape comparison as taught by Henry, as this improves its position and its orientation in a reference frame for each image acquisition (see Henry [0088]).
However the combination of reference is silent regarding an indication of the detected marker is generated.
In the same marker imaging field of endeavor, Rulkov teaches an indication of the marker is generated (fig. 1 the system identifies which mark is currently being localized by changing a color [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the detecting shapes part of the algorithm of modified Nguyen with the step of including an indication of the identified markers by coloring them as taught by Rulkov, as this would help facilitate planning a procedure by helping the surgeon identify the location of the markers and therefore the lesions (see Rulkov [0083]-[0084]).
Regarding claim 11, modified Nguyen teaches the system of claim 10, but fails to explicitly disclose wherein generating the display indication of the detected shape comprises at least one of: highlighting the detected shape in the set of images.
In the same marker field of endeavor, Rulkov teaches wherein generating the display indication of the detected shape comprises at least one of: highlighting the detected shape in the set of images (fig. 1 the system identifies which mark is currently being localized by changing a color [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the detecting shapes part of the algorithm of modified Nguyen with the step of including an indication of the identified markers by coloring them as taught by Rulkov, as this would help facilitate planning a procedure by helping the surgeon identify the location of the markers and therefore the lesions (see Rulkov [0083]-[0084]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni and Rulkov as applied to claim 1 above, and further in view Daon et al., (US20220265387A1).
Regarding claim 3, modified Nguyen teaches the system of claim 1, wherein Nguyen further teaches training the AI model ([0073]-[0074] training the CNN uses the training images); but fails to explicitly disclose correlating a shape of the one or more biopsy markers with corresponding marker identification information for the one or more biopsy markers.
In the same imaging a marker field of endeavor, Daon teaches a shape of the one or more biopsy markers with corresponding marker identification information for the one or more biopsy markers ([0159] each marker has a unique shape/marking which may be used to identify a marker).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the AI training of modified Nguyen to include unique markers that correlate with an identity of a marker as taught by Daon, as this would advance the effectiveness of surgical procedures (see Daon [0003]). This would allow for users to more easily distinguish between different markers. One of ordinary skill in the art would understand that Daon’s teachings of the unique marker identifiers can be applied to the training of the AI model of modified Nguyen, resulting in the reading of the limitation wherein training the Al model comprises enabling the Al model to correlate a shape of the one or more biopsy markers with corresponding marker identification information for the one or more biopsy markers.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni as applied to claim 1 above, and further in view of Chan et al., (US20150324522A1).
Regarding claim 7, modified Nguyen teaches the system of claim 1, but fails to explicitly disclose wherein the second data set is collected from at least one of: a patient record.
In the same biopsy field of endeavor, Chan teaches wherein the second data set is collected from at least one of: a patient record ([0012] medical records can contain information regarding the biopsy marker, which may also include a body part image associated with the biopsy marker).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the second data set of modified Nguyen with the patient record of Chan, as this would allow for users to more easily conceptualize diagnoses and locations referenced in medical information (see Chan [0008]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Zvuloni et al., and in further view of Henry and Rulkov.
Regarding claim 12, Nguyen teaches a method comprising ([0071] method for training and using AI model):
receiving, by an imaging system, a first data set for a marker ([0074] AI model is trained with kV images), wherein the first data set comprises a shape description of the marker and an identifier for the marker ([0080] the Cylindrical Shaped Marker Data and the [0082] Arbitrarily Shaped Marker Data are used to train the AI model, which includes the shape (cylindrical or arbitrary) and the identifier(cylindrical or arbitrary))
providing the first data set to an artificial intelligence (Al) component associated with the imaging system, wherein the first data is used to train the Al component to detect the marker when the marker is deployed in a deployment site ([0074] the kV images are used to train the AI model, and would have markers that are deployed at a deployment site (see [0080]);
receiving, by an imaging system, a second data set for the marker ([0090] a kV image is captured by imaging system 16);
providing the second data set to the Al component ([0094]-[0095] the image is fed to the CNN);
receiving, by the imaging system, a set of images of the deployment site ([0095] the steps are repeated until the entire image tracking window has been searched);
processing, by the imaging system, the set of images as the set of images are acquired by ([0045] processor receives images of target area and analyses them; [0095] the CNN classifies them as marker or background; [0014] the marker may be tracked in real time):
providing the second data set and the set of imaging for a site to the trained Al model ([0095] the image is classified by the trained CNN and the process repeated until all the images of the site are searched);
based on the second data set, using the Al component to identify the marker in the set of images of the deployment site in real-time ([0095] the CNN classifies them as marker or background; [0014] the marker may be tracked in real time).
However, Nguyen is silent regarding the marker being a biopsy marker.
In the same marker field of endeavor, Zvuloni teaches a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of Nguyen with the biopsy fiducial markers of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]).
However the combination of references are silent regarding wherein the second data set comprises at least one of the shape descriptions of the biopsy marker.
However in the same marker field of endeavor, Henry teaches wherein the second data set comprises at least one of the shape descriptions of the biopsy marker (fig. 3 the fiducial markers are identified by the computer 15 by detecting the circular shape of the localizer 1 [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the second data set of modified Nguyen to include the shape comparison as taught by Henry, as this improves its position and its orientation in a reference frame for each image acquisition (see Henry [0088]).
However, the combination of references are silent regarding generating on the display in real-time with processing the set of images, the one or more images of the set of images including an indication the deployed biopsy marker has been identified.
In the same marker imaging field of endeavor, Rulkov teaches generating on the display in real-time with processing the set of images ([0091] the surgeon can observe the model on the display in real time), the one or more images of the set of images including an indication the deployed biopsy marker has been identified (fig. 1 the system identifies which mark is currently being localized by changing a color [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the identifying marker step of modified Nguyen with the next step of including an indication of the identified markers by coloring them as taught by Rulkov, as this would help facilitate planning a procedure by helping the surgeon identify the location of the markers and therefore the lesions (see Rulkov [0083]-[0084]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Henry, and Rulkov as applied to claim 12 above, and further in view of Izmirli et al., (US20190328482A1).
Regarding claim 13, modified Nguyen teaches the method claim 12, but fails to explicitly disclose generating an image of the identified biopsy marker; and displaying the image on a display device.
In the same marker imaging field of endeavor, Izmirli teaches generating an image of the identified biopsy marker; and displaying the image on a display device (fig. 2 images of the fiducial markers are displayed on display 34 [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of modified Nguyen with the display of Izmirli, as both inventions relate to imaging markers, and would yield the predictable result of the an image processing system with a display to display a generated image of markers to one of ordinary skill in the art. One of ordinary skill in the art would be able make such a combination, and the results of the method of modified Nguyen using a display to display a generated image of the marker are reasonably predictable.
However, Nguyen is silent regarding the marker being a biopsy marker.
In the same marker field of endeavor, Zvuloni teaches a biopsy marker (fig. 15C fiducial marker are visible under clinical imaging modalities, enabling recording positions of sources of each biopsy sample taken, therefore these fiducial markers are biopsy markers [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of Nguyen with the biopsy fiducial markers of Zvuloni, as this would provide useful information with regards to the apparent positions of objects on an image (see Zvuloni [0030]).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Henry, and Izmirli as applied to claim 13 above, and further in view of Riley (US20120259230A1).
Regarding claim 14, modified Nguyen teaches the method of claim 13, but fails to explicitly disclose generating the image comprises using an image enhancement technique to enhance at least a portion of the image.
In a reference reasonably pertinent to the problem of image processing faced by the inventor, Riley teaches of generating the image comprises using an image enhancement technique to enhance at least a portion of the image (fig. 4 the fiducial marker may be displayed with different colors [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Nguyen with the colors of Riley, as this would provide clear references for adjusting color balances on a display (see Riley [0064]).
Regarding claim 15, modified Nguyen teaches the method of claim 14, but fails to explicitly disclose wherein the image enhancement technique comprise at least one of: modifying a color of the portion of the image.
In a reference reasonably pertinent to the problem of image processing faced by the inventor, Riley teaches wherein the image enhancement technique comprise at least one of: modifying a color of the portion of the image. (fig. 4 the fiducial marker may be displayed with different colors [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Nguyen with the colors of Riley, as this would provide clear references for adjusting color balances on a display (see Riley [0064]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Henry, Rulkov, and Izmirli as applied to claim 13 above, and further in view of Chan.
Regarding claim 16, modified Nguyen teaches the method of claim 13, but fails to explicitly disclose wherein generating the image comprises adding information associated with the marker to the image, the information comprising at least one of: marker attributes or a marker detection confidence score.
However in the same marker imaging field of endeavor, Kawagishi teaches wherein generating the image comprises adding information associated with the marker to the image, the information comprising at least one of: marker attributes ([0054] the mapping tool may overlay a symbol on a body part image, which the symbol is based on diagnosis data associated with the marker, thus giving the marker attributes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the second data set of modified Nguyen with the symbol overlay of Chan, as this would allow for user to more easily conceptualize diagnoses and locations referenced in medical information (see Chan [0008]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Henry, and Rulkov as applied to claim 14 above, and further in view of Yamada et al., (US20190111282A1).
Regarding claim 17, modified Nguyen teaches the method of claim 14, wherein Nguyen further teaches using the AI component to identify the biopsy marker in the set of images ([0095] the CNN classifies them as marker or background), but fails to explicitly disclose using one or more image matching techniques to match an image representation of the biopsy marker to data in the set of images.
In the same marker imaging field of endeavor, Yamada teaches using one or more image matching techniques to match an image representation of the biopsy marker to data in the set of images (fig. 3 the template image of the marker 29 is compared with the captured image [0043]; [0039] multiple images are taken).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the AI component of modified Nguyen to use the image matching technique of Yamada, as this would reduce the frequency of erroneous detection of an object to be tracked (see Yamada [0013]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Henry, Rulkov, and Yamada as applied to claim 17 above, and further in view of Kumagai
Regarding claim 18, modified Nguyen teaches the system of claim 17, but fails to explicitly disclose when a match between the image representation of the biopsy marker and the data in the set of images is detected, an indication of the match is provided by the imaging system.
However, in the same image comparison field of endeavor, Kumagai teaches when a match between the image representation of the biopsy marker and the data in the set of images is detected, an indication of the match is provided by the imaging system (fig. 4 the image comparison unit 55 compares the two images to calculate a match [0068]; the visual check result reception unit 56 receives an indication of a match or not match, which may be based on a matching degree value, such as 1.0 [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the image comparison algorithm of modified Nguyen with the image comparison unit of Kumagai, as both inventions relate to image processing, and would yield the predictable result of an image comparison algorithm comparing shapes, and an indication of the detected shape is generated to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such as combination, and the results of modified Nguyen incorporating the image comparison unit of Kumagai are reasonably predictable.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, and Rulkov as applied to claim 19 above, and further in view of Seip et al., (US20160317129A1).
Regarding claim 20, modified Nguyen teaches the method of claim 19, but fails to explicitly disclose wherein the one or more images of the deployment site are exported to an alternative imaging system.
In the same image processing field of endeavor, Seip teaches wherein the one or more images of the deployment site are exported to an alternative imaging system ([0050] the images of the fiducial markers may be transferred to [0051] an ultrasound image system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Nguyen to include another imaging system as taught by Seip, as this would help to provide a predictive treatment outcome value of STL treatments (see Seip [0068]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as modified by Zvuloni, Rulkov, and Seip as applied to claim 20 above, and further in view of Dyer et al., (US20170265947A1).
Regarding claim 21, modified Nguyen teaches the method of claim 20, but fails to explicitly disclose wherein the alternative imaging system is a multimodal device configured to perform real-time detection of the marker.
In the same marker field of endeavor, Dyer teaches the alternative imaging system is a multimodal device configured to perform real-time detection of the marker (fig. 23 the system 216 is obtains a real-time multi-modal image that can track a fiducial marker 212 [0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Nguyen with the multi-modal imaging system of Dyer, as this would help facilitate navigation of a medical procedure (see Dyer Abstract).
Response to Arguments
Applicant's arguments filed 12/22/2025 regarding the 35 U.S.C. 101 rejection have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 rejection of claim 1, Applicant has argued that the examiner has failed to account for the nature of ultrasound imaging and the stated purpose of the claimed invention. Specifically, while the claims do not relate to “any improvement of the display mechanism”, it provides significantly more than “generic display instruction” because the invention integrates advanced image processing with the ultrasound device to provide instant, actional feedback to the user during imaging procedure.
Examiner disagrees. The claim limitations merely state of a generic ultrasonic system that utilizes a generic AI component to enable generating on a display real time ultrasound images. In addition, real-time image acquisition is a known characteristic of ultrasound, and is therefore not an improvement that would allow the limitations to be integrated into a practical application. Having the processing perform in real time does not alter the actual process itself, as it does not recite any improvement to the image acquisition, such as resolution, buffering, processing architecture, etc. and as such, the limitations do not integrate the judicial exception into a practical application. Further, MPEP 2106.04(d) details how to integrate a judicial exception into a practical application, and further states that “ merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea” do not integrate a judicial exception into a practical application.
Applicant further points to example 47 claim 3 in the USPTO SME and indicates how training and applying the trained model to detect anomalies in real time network traffic and automatically executing remedial actions was found to be eligible.
Examiner disagrees with this comparison. Example 47 claim 3 was found to eligible because of the recitation of the automatic remedial actions that improve the functioning of a computer network, including dropping malicious packets in real time and blocking future traffic. In contrast, generating an indication on a display merely outputs information to a user and does not recite any type of such process that would result in an improvement in some way and thus fail to integrate the judicial exception into a practical application.
Applicant further argues against the 35 U.S.C. 103 rejection, and states the prior arts do not teach the amended limitations. Specifically, Applicant argues that Rulkov does not disclose any methods for processing medical images in real time with the use of trained AI models, and the second data set used for identifying such markers. Applicant further argues that Rulkov does not tech or suggest the generation of a real -time visual indication within a set of medical images to denote the identification of a biopsy marker.
Examiner disagrees. Rulkov has only been used to teach the display generating the model and markers so that the surgeon may observe it in real time ([0091]), and not the AI portion of the claim limitations. Instead, it is the combination of Nguyen and Rulkov that teach those limitations. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Further, Rulkov does indeed comprise enabling disclosure for overlaying real-time results onto images as they are acquired during a medical procedure as Rulkov teaches that the system may output an identifier for the marker such as changing the color ([0079]), and this marker which may be used during a biopsy and there is a biopsy marker, may be a part of a model that may be observed in real time by surgeons ([0091]). Therefore, Rulkov teaches the overlaying of real-time results onto images as they are acquired.
The remaining claims are rejected for substantially the same reason as above.
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798