DETAILED ACTION
This office action is in response to the communication received on 10/13/2025 concerning application no. 18/633,375 filed on 04/11/2024.
Claims 1-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on 10/13/2025 is acknowledged. This is found persuasive.
Claims 15-20 are rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 10/13/2025 is hereby withdrawn.
Drawings
The drawings are objected to because:
The drawings (Fig. 9) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
Recites “displaying a desired 2D view of the first image volume on a display device, the desired 2D view one of: a 3D rendered view of the first image volume, using the defined slice plane as a crop plane”. This claim element is indefinite. It would be unclear in what manner the display of a 3D would be the display of a desired 2D view. Three-dimensional data is the display of all three dimensions while 2D view is the display of two dimensions.
Applicant is encouraged to provide consistent and clear language.
Recites “using the defined slice plane as a crop plane”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is attempting to establish that the singular slice is extracted from the 3D view and therefore solely a 2D plane is shown. It is further unclear if the slice plane is isolated or extracted with respect to the 3D view.
Applicant is encouraged to provide consistent and clear language.
Claim 9 is indefinite for the following reasons:
Recites “an additional point in the second image volume”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what was the initial point in the second image volume such that the instant element is the additional point.
Applicant is encouraged to provide consistent and clear language.
Claim 13 is indefinite for the following reasons:
Recites “further comprising performing the MPR in response to the delivery catheter not being visible in a displayed view of the second image volume, to maintain the delivery catheter within the displayed view”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the state of the delivery catheter is. The initial element establishes that it is not visible in the displayed view. The later element establishes that MPR is performed to maintain the catheter in the displayed view. It would be unclear to one with ordinary skill in the art if the catheter is in the displayed view and being maintained as such or not present in the displayed view.
Applicant is encouraged to provide consistent and clear language.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 claims recite a method for performing multiplanar reformation (MPR) on an image volume generated via an interventional imaging system and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “during an image-guided interventional procedure performed by an operator of the interventional imaging system on a patient: defining a slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the defining of a slice of the first image plane according to the pose data of the ultrasound system, a delivery catheter, and a fluoroscopy system. 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: “receiving a first image volume from a probe of an ultrasound system of the interventional imaging system; receiving a first set of position and orientation data from a first sensor located in the probe; receiving a second set of position and orientation data from a second sensor located in a delivery catheter; receiving a third set of position and orientation data from a fluoroscopy imaging system; and displaying a desired 2D view of the first image volume on a display device, the desired 2D view one of: a 3D rendered view of the first image volume, using the defined slice plane as a crop plane; an MPR of the first image volume at a location of the slice plane”. Reception of the image volume and the pose data is a data gathering step that is a form of a pre-solution insignificant activity. The display of the desired 2D view is a display step that merely amounts to a post-solution insignificant activity.
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 - 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 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein defining the slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data further comprises defining the slice plane based on the second set of position and orientation data, wherein the slice plane has an orientation either aligned with or perpendicular to the orientation of the second sensor”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to defining the slice plane according to the pose information and using multiple data sets so that the desired slice plane is aligned with or perpendicular to the orientation of the sensor of the delivery catheter. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein defining the slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data further comprises defining the slice plane at a position based on the second set of position and orientation data, and at an orientation based on the third set of position and orientation data, the orientation either aligned with or perpendicular to an X-ray beam of the fluoroscopy imaging system”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to def9ining the slice plane according to the pose data and according to multiple data sets and orientation information such that the orientation is aligned with or perpendicular to the fluoroscopy system. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “where a plurality of the desired 2D views are generated concurrently”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to concurrent defining and generation of 2D views. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “performing MPR on the second image volume based on the second set of position and orientation data to generate a second desired 2D view of the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance on a second image volume according to a second pose data set for the generation of a second desired 2D view of the image volume. 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: “receiving a second image volume acquired prior to the interventional procedure from a supplementary imaging system of the interventional imaging system; and displaying the second desired 2D view of the second image volume on the display device; wherein the supplementary imaging system one of: a computed tomography (CT) system; a magnetic resonance imaging (MRI) system; and a second ultrasound imaging system”. Reception of the image volume via a supplementary system is a data gathering step is a form of a pre-solution insignificant activity. Display of the 2D view is a display step that merely amounts to a post-solution insignificant activity.
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 - 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “performing the MPR on the second image volume to generate the second desired 2D view based on the second set of position and orientation data, and not using the first set of position and orientation data”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performance of MPR according to the second pose data and the exclusion of the first pose data. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising receiving a template selected by the operator that defines the second desired 2D view, and performing the MPR based on the second set of position and orientation data of the second sensor in accordance with the template”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to the operator selected template for a 2D view. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 7 rejection.
Claim 8 recites the following elements: “wherein the template is selected by the operator via a menu displayed on the display device”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising performing the MPR based on the first set of position and orientation data of the first sensor, the second set of position and orientation data of the second sensor, and an additional point in the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to the pose data and an additional element. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the additional point in the second image volume is an anatomical landmark selected by the operator”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to the pose data and an additional element according to the anatomical landmark selected by the operator. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the additional point in the second image volume is set”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to the pose data and an additional element. 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: “automatically by an image processing system of the interventional imaging system”. The use of processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 inventive concept in the claim. In light of the above, claim 11 is ineligible.
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 claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “performing the MPR on a first plane of the second image volume, where the delivery catheter is centered in the first plane, based on the second set of position and orientation data of the second sensor; performing the MPR on a second plane of the second image volume that is perpendicular to a tip of the delivery catheter, based on the second set of position and orientation data of the second sensor; performing the MPR on a third plane of the second image volume that is parallel to the tip of the delivery catheter, along an orientation of the delivery catheter, based on the second set of position and orientation data of the second sensor; performing the MPR on a fourth plane of the second image volume in which an intravascular device placed within the patient using the delivery catheter is centered, based on a fourth set of position and orientation data of a third sensor included in the device; performing the MPR on a fifth plane of the second image volume, the fifth plane defined by the orientation of the delivery catheter and a position of a selected anatomical landmark, based on the second set of position and orientation data of the second sensor; and performing the MPR on a sixth plane of the second image volume, the sixth plane defined by the second set of position and orientation data of the second sensor, the fourth set of position and orientation data of the third sensor, and the selected anatomical landmark”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performance of a series of MPR on multiple planes according to pose data and select anatomical landmarks. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising performing the MPR in response to the delivery catheter not being visible in a displayed view of the second image volume, to maintain the delivery catheter within the displayed view”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance to ensure that the catheter is within the displayed view. 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 does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising inserting a computer-aided design (CAD) model of the delivery catheter into the second image volume, and adjusting a size, position, and orientation of the CAD model to cover and replace a depiction of the delivery catheter in the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the adjustment of a model to cover and replace a delivery catheter depiction. 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: “computer-aided design (CAD) model”. The use of a processor for the modeling and adjustment does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “perform multiplanar reformation (MPR) on a second image volume acquired prior to the transcatheter therapy task from the supplementary imaging system, based on at least one of the first position and orientation and the second position and orientation, to generate a desired 2D view of the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance on a second image volume from pre-operative data with respect to pose information for the generation of a 2D view. 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: “an ultrasound probe including a first sensor that measures a first position and orientation of the first sensor; a delivery catheter including a second sensor that measures a second position and orientation of the second sensor; a supplementary imaging system; and an image processing system including a processor and a memory including instructions that when executed, cause the processor to: during a transcatheter therapy task performed on a patient by an operator of the interventional imaging system: receive a first image volume acquired via the ultrasound probe; display the desired 2D view of the second image volume on a display device”. Pose data from the ultrasound probe, delivery system, and imaging via the supplementary imaging system is a data gathering step that is a form of a pre-solution insignificant activity. Display of view is a display step which merely amounts to a post-solution insignificant activity. The use of a processor and memory does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 inventive concept in the claim. In light of the above, claim 15 is 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 claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “perform the MPR in accordance with the template”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to a template. 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: “wherein the MPR is performed based on further instructions stored in the memory that when executed, cause the processor to: in response to the operator selecting a menu element displayed on the display device: display a menu of templates for performing the MPR; receive a selection of a template by the operator via the menu”. Selection of templates via an operator selection is a data gather step that is a form of a pre-solution insignificant activity. The use of processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “MPR on a first plane of the second image volume, where the delivery catheter is centered in the first plane, based on the second position and orientation of the second sensor; MPR on a second plane of the second image volume that is perpendicular to a tip of the delivery catheter, based on the second position and orientation of the second sensor; MPR on a third plane of the second image volume that is parallel to the tip of the delivery catheter, along an orientation of the delivery catheter, based on the second position and orientation of the second sensor; MPR on a fourth plane of the second image volume in which an intravascular device placed within the patient using the delivery catheter is centered, based on a third position and orientation of a third sensor included in the device; MPR on a fifth plane of the second image volume, the fifth plane defined by the orientation of the delivery catheter and a position of an anatomical landmark selected by the operator, based on the second position and orientation of the second sensor; MPR on a sixth plane of the second image volume, the sixth plane defined by the second position and orientation of the second sensor, the third position and orientation of the third sensor, and the selected anatomical landmark; and MPR on a seventh plane of the second image volume, the seventh plane defined by the second position and orientation of the second sensor and the first position and orientation of the first sensor”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to MPR performance according to one of pose data, landmarks, or imaging data sets. 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: “wherein the MPR is performed in accordance with the template based on further instructions stored in the memory, that when executed, cause the processor to perform one of”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 inventive concept in the claim. 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: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “insert a computer-aided design (CAD) model of the delivery catheter into the second image volume, and adjusting a size, position, and orientation of the CAD model to cover and replace a depiction of the delivery catheter in the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the adjustment of a model to cover and replace a delivery catheter depiction. 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: “wherein further instructions are stored in the memory, that when executed, cause the processor to…computer-aided design (CAD) model”. The use of a processor for the modeling and adjustment does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 inventive concept in the claim. 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 claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “during an image-guided interventional procedure performed by an operator of an interventional imaging system on a patient; inserting a computer-aided design (CAD) model of the delivery catheter into the second image volume, a size, position, and orientation of the CAD model adjusted to cover and replace the representation of the delivery catheter in the second image volume”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the adjustment of a model to cover and replace a delivery catheter depiction. 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: “acquiring a first image volume from a probe of an ultrasound system of the interventional imaging system; receiving a second image volume acquired from the patient prior to the interventional procedure via a supplementary imaging system of the interventional imaging system; receiving position and orientation data of a sensor located in a delivery catheter used in the interventional procedure, a representation of the delivery catheter included in the second image volume; and displaying a view of the second image volume on a display device, the view including the CAD model”. Acquisition of image volume and reception of the imaging data and the pose data is a data-gathering step is a form of a pre-solution insignificant activity. Display of the view is a display step that merely amounts to a post-solution insignificant activity. The use of a processor for the modeling and adjustment does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - 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 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 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 19 rejection.
Claim 20 recites the following elements: “wherein the supplementary imaging system one of: a computed tomography (CT) system; a magnetic resonance imaging (MRI) system; and a second ultrasound imaging system”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 20 is ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parthasarathy et al. (PGPUB No. US 2014/0187919).
Regarding claim 1, Parthasarathy teaches a method for performing multiplanar reformation (MPR) on an image volume generated via an interventional imaging system (Abstract teaches the use of MPR for interventional procedure and the generation of volumetric ultrasound image data), the method comprising:
during an image-guided interventional procedure performed by an operator of the interventional imaging system on a patient (Paragraph 0003 teaches real time operability of the system. Paragraph 0006 teaches real time tool localization and generation of MPR views):
receiving a first image volume from a probe of an ultrasound system of the interventional imaging system (Paragraph 0022 teaches the generation of ultrasound volume data via a TEE probe);
receiving a first set of position and orientation data from a first sensor located in the probe (Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system);
receiving a second set of position and orientation data from a second sensor located in a delivery catheter (Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system);
receiving a third set of position and orientation data from a fluoroscopy imaging system (Paragraphs 0002-03 teach that the x-ray system can be fluoroscopic. Paragraphs 0038-45 teach x-ray imaging for tracking of the interventional tool);
defining a slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data (Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12); and
displaying a desired 2D view of the first image volume on a display device, the desired 2D view one of: a 3D rendered view of the first image volume, using the defined slice plane as a crop plane; an MPR of the first image volume at a location of the slice plane (Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
Regarding claim 2, Parthasarathy teaches the method in claim 1, as discussed above.
Parthasarathy further teaches a method, wherein defining the slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data further comprises defining the slice plane based on the second set of position and orientation data, wherein the slice plane has an orientation either aligned with or perpendicular to the orientation of the second sensor (Paragraph 0051 teaches that the MPR images are generated according to the catheter and its position sensor. Paragraph 00585 teaches that the sensor along the catheter is tracked according to the coordinate system and the sensor acts as a origin for the MPR image as shown in Fig. 7-9).
Regarding claim 4, Parthasarathy teaches the method in claim 1, as discussed above.
Parthasarathy further teaches a method, where a plurality of the desired 2D views are generated concurrently (Abstract teaches that the MPR imaging module generates two or more MPR images. MPR stands for multi-planar reconstruction).
Regarding claim 5, Parthasarathy teaches the method in claim 1, as discussed above.
Parthasarathy further teaches a method, further comprising:
receiving a second image volume acquired prior to the interventional procedure from a supplementary imaging system of the interventional imaging system; performing MPR on the second image volume based on the second set of position and orientation data to generate a second desired 2D view of the second image volume; and displaying the second desired 2D view of the second image volume on the display device; wherein the supplementary imaging system one of: a computed tomography (CT) system; a magnetic resonance imaging (MRI) system; and a second ultrasound imaging system (Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
Regarding claim 15, Parthasarathy teaches interventional imaging system, comprising:
an ultrasound probe including a first sensor that measures a first position and orientation of the first sensor (Paragraph 0022 teaches the generation of ultrasound volume data via a TEE probe. Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system);
a delivery catheter including a second sensor that measures a second position and orientation of the second sensor (Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system);
a supplementary imaging system (Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12); and
an image processing system including a processor and a memory including instructions that when executed, cause the processor to:
during a transcatheter therapy task performed on a patient by an operator of the interventional imaging system (Paragraph 0003 teaches real time operability of the system. Paragraph 0006 teaches real time tool localization and generation of MPR views):
receive a first image volume acquired via the ultrasound probe (Paragraph 0022 teaches the generation of ultrasound volume data via a TEE probe);
perform multiplanar reformation (MPR) on a second image volume acquired prior to the transcatheter therapy task from the supplementary imaging system, based on at least one of the first position and orientation and the second position and orientation, to generate a desired 2D view of the second image volume; display the desired 2D view of the second image volume on a display device (Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Shina (PGPUB No. US 2006/0036167).
Regarding claim 3, Parthasarathy teaches the method in claim 1, as discussed above.
However, Parthasarathy is silent regarding a method, wherein defining the slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data further comprises defining the slice plane at a position based on the second set of position and orientation data, and at an orientation based on the third set of position and orientation data, the orientation either aligned with or perpendicular to an X-ray beam of the fluoroscopy imaging system.
In an analogous imaging field of endeavor, regarding image processing, Shina teaches a method, wherein defining the slice plane of the first image volume based on at least one of the first set of position and orientation data, the second set of position and orientation data, and the third set of position and orientation data further comprises defining the slice plane at a position based on the second set of position and orientation data, and at an orientation based on the third set of position and orientation data, the orientation either aligned with or perpendicular to an X-ray beam of the fluoroscopy imaging system (Paragraph 0124 teaches that the vessel may be perpendicular to the x-ray imaging plane. Paragraph 0136 teaches that the IVUS slice can be centered and established to be perpendicular to the center line. Additionally slice orientation can be according to the position sensor or the x-ray imaging so that the axial position is defined).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Shina’s teaching of defining of the slice plane according to the x-ray beam. This modified method would allow the user to estimate 3D position as the object is restricted with respect to the blood vessel (Abstract of Shina). Furthermore, the modification enhances catheter positioning (Paragraph 0002 of Shina).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Rahn (PGPUB No. US 2009/0118609).
Regarding claim 6, Parthasarathy teaches the method in claim 5, as discussed above.
However, Parthasarathy is silent regarding a method, further comprising: performing the MPR on the second image volume to generate the second desired 2D view based on the second set of position and orientation data, and not using the first set of position and orientation data.
In an analogous imaging field of endeavor, regarding image processing, Rahn teaches a method, further comprising: performing the MPR on the second image volume to generate the second desired 2D view based on the second set of position and orientation data, and not using the first set of position and orientation data (Paragraph 0069 teaches that MPR reconstruction may be performed according to the pre-operative images. The location of the catheter may be determined via an acoustic or magnetic sensor and the location and orientation of the catheter can be superimposed on the displayed images).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Rahn’s teaching of MPR according to the second image volume. This modified method would allow the user to improve the medical treatment of patients using ablation therapy (Paragraph 0001 of Rahn). Furthermore, the modification improve image quality (Paragraph 0032 of Rahn).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Rahn (PGPUB No. US 2009/0118609) further in view of Li et al. (PGPUB No. US 2024/0104732).
Regarding claim 7, modified Parthasarathy teaches the method in claim 6, as discussed above.
However, the combination of Parthasarathy and Rahn is silent regarding a method, further comprising receiving a template selected by the operator that defines the second desired 2D view, and performing the MPR based on the second set of position and orientation data of the second sensor in accordance with the template.
In an analogous imaging field of endeavor, regarding image processing, Li teaches a method, further comprising receiving a template selected by the operator that defines the second desired 2D view, and performing the MPR based on the second set of position and orientation data of the second sensor in accordance with the template (Paragraph 0053 teaches that the template includes information with the view names, anatomical features. Paragraphs 0057-59 teaches that the operator is able to designate the applicable view name through the interface as seen in Fig. 6. Paragraph 0095 teaches that this view is according to the transducer position. Paragraphs 0071-72 teach that the template selection provides the basis for the MPR generation according to the extracted features).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Parthasarathy and Rahn with Li’s teaching of use of a template for MPR. This modified method would allow the user to obtain a clear ultrasound image of the heart while avoiding impacts from the chest walls and the air inside the lung parts (Paragraph 0004 of Li). Furthermore, the modification addresses the issue of operational manipulation in an efficient manner (Paragraphs 0009-10 of Li).
Regarding claim 8, modified Parthasarathy teaches the method in claim 7, as discussed above.
However, the combination of Parthasarathy and Rahn is silent regarding a method, wherein the template is selected by the operator via a menu displayed on the display device.
In an analogous imaging field of endeavor, regarding image processing, Li teaches a method, wherein the template is selected by the operator via a menu displayed on the display device (Paragraph 0053 teaches that the template includes information with the view names, anatomical features. Paragraphs 0057-59 teaches that the operator is able to designate the applicable view name through the interface as seen in Fig. 6. Paragraph 0095 teaches that this view is according to the transducer position. Paragraphs 0071-72 teach that the template selection provides the basis for the MPR generation according to the extracted features).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Parthasarathy and Rahn with Li’s teaching of an operator selectable menu. This modified method would allow the user to obtain a clear ultrasound image of the heart while avoiding impacts from the chest walls and the air inside the lung parts (Paragraph 0004 of Li). Furthermore, the modification addresses the issue of operational manipulation in an efficient manner (Paragraphs 0009-10 of Li).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Fuerst et al. (PGPUB No. US 2021/0236233).
Regarding claim 9, Parthasarathy teaches the method in claim 5, as discussed above.
Parthasarathy further teaches a method, further comprising performing the MPR based on the first set of position and orientation data of the first sensor, the second set of position and orientation data of the second sensor (Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
However, Parthasarathy is silent regarding a method, and an additional point in the second image volume.
In an analogous imaging field of endeavor, regarding image processing, Fuerst teaches a method, further comprising performing the MPR based an additional point in the second image volume (Paragraphs 0079-80 teach that the pre-operative image can be selected and provides the basis for an MPR view to be generated according to the that image. This image can be displayed and provides an inclusion of the anatomical view. Paragraph 0076 teaches that the landmarks can be user selected or that the landmark information can be automated via the system operation to associate that information to the pre-operative data can be called upon).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Fuerst’s teaching of MPR according to additional second image information. This modified method would allow the user to improve 3D display that enables the user to better visualize the surgical site during a surgical procedure performed with a surgical robotic system (Paragraph 0004 of Fuerst). Furthermore, the modification can provide a better understanding of patient anatomy and tool mobility (Paragraph 0027 of Fuerst).
Regarding claim 10, modified Parthasarathy teaches the method in claim 9, as discussed above.
However, Parthasarathy is silent regarding a method, wherein the additional point in the second image volume is an anatomical landmark selected by the operator.
In an analogous imaging field of endeavor, regarding image processing, Fuerst teaches a method, wherein the additional point in the second image volume is an anatomical landmark selected by the operator (Paragraphs 0079-80 teach that the pre-operative image can be selected and provides the basis for an MPR view to be generated according to the that image. This image can be displayed and provides an inclusion of the anatomical view. Paragraph 0076 teaches that the landmarks can be user selected or that the landmark information can be automated via the system operation to associate that information to the pre-operative data can be called upon).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Fuerst’s teaching of user selection. This modified method would allow the user to improve 3D display that enables the user to better visualize the surgical site during a surgical procedure performed with a surgical robotic system (Paragraph 0004 of Fuerst). Furthermore, the modification can provide a better understanding of patient anatomy and tool mobility (Paragraph 0027 of Fuerst).
Regarding claim 11, modified Parthasarathy teaches the method in claim 9, as discussed above.
However, Parthasarathy is silent regarding a method, wherein the additional point in the second image volume is set automatically by an image processing system of the interventional imaging system.
In an analogous imaging field of endeavor, regarding image processing, Fuerst teaches a method, wherein the additional point in the second image volume is set automatically by an image processing system of the interventional imaging system (Paragraphs 0079-80 teach that the pre-operative image can be selected and provides the basis for an MPR view to be generated according to the that image. This image can be displayed and provides an inclusion of the anatomical view. Paragraph 0076 teaches that the landmarks can be user selected or that the landmark information can be automated via the system operation to associate that information to the pre-operative data can be called upon).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Fuerst’s teaching of system automation. This modified method would allow the user to improve 3D display that enables the user to better visualize the surgical site during a surgical procedure performed with a surgical robotic system (Paragraph 0004 of Fuerst). Furthermore, the modification can provide a better understanding of patient anatomy and tool mobility (Paragraph 0027 of Fuerst).
Claim 16-17 is rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Li et al. (PGPUB No. US 2024/0104732).
Regarding claim 16, modified Parthasarathy teaches the interventional imaging system in claim 15, as discussed above.
However, Parthasarathy is silent regarding an interventional imaging system, wherein the MPR is performed based on further instructions stored in the memory that when executed, cause the processor to: in response to the operator selecting a menu element displayed on the display device: display a menu of templates for performing the MPR; receive a selection of a template by the operator via the menu; and perform the MPR in accordance with the template.
In an analogous imaging field of endeavor, regarding image processing, Li teaches an interventional imaging system, wherein the MPR is performed based on further instructions stored in the memory that when executed, cause the processor to: in response to the operator selecting a menu element displayed on the display device: display a menu of templates for performing the MPR; receive a selection of a template by the operator via the menu; and perform the MPR in accordance with the template (Paragraph 0053 teaches that the template includes information with the view names, anatomical features. Paragraphs 0057-59 teaches that the operator is able to designate the applicable view name through the interface as seen in Fig. 6. Paragraph 0095 teaches that this view is according to the transducer position. Paragraphs 0071-72 teach that the template selection provides the basis for the MPR generation according to the extracted features).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Li’s teaching of an operator selectable menu for template based MPR. This modified method would allow the user to obtain a clear ultrasound image of the heart while avoiding impacts from the chest walls and the air inside the lung parts (Paragraph 0004 of Li). Furthermore, the modification addresses the issue of operational manipulation in an efficient manner (Paragraphs 0009-10 of).
Regarding claim 17, modified Parthasarathy teaches the interventional imaging system in claim 16, as discussed above.
Parthasarathy further teaches a interventional imaging system, wherein the MPR is performed in accordance with the template based on further instructions stored in the memory, that when executed, cause the processor to perform one of: MPR on a first plane of the second image volume, where the delivery catheter is centered in the first plane, based on the second position and orientation of the second sensor; MPR on a second plane of the second image volume that is perpendicular to a tip of the delivery catheter, based on the second position and orientation of the second sensor; MPR on a third plane of the second image volume that is parallel to the tip of the delivery catheter, along an orientation of the delivery catheter, based on the second position and orientation of the second sensor; MPR on a fourth plane of the second image volume in which an intravascular device placed within the patient using the delivery catheter is centered, based on a third position and orientation of a third sensor included in the device; MPR on a fifth plane of the second image volume, the fifth plane defined by the orientation of the delivery catheter and a position of an anatomical landmark selected by the operator, based on the second position and orientation of the second sensor; MPR on a sixth plane of the second image volume, the sixth plane defined by the second position and orientation of the second sensor, the third position and orientation of the third sensor, and the selected anatomical landmark; and MPR on a seventh plane of the second image volume, the seventh plane defined by the second position and orientation of the second sensor and the first position and orientation of the first sensor (Paragraph 0051 teaches that the MPR images are generated according to the catheter and its position sensor. Paragraph 00585 teaches that the sensor along the catheter is tracked according to the coordinate system and the sensor acts as a origin for the MPR image as shown in Fig. 7-9. Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al. (PGPUB No. US 2014/0187919) in view of Wang).
Regarding claim 18, modified Parthasarathy teaches the interventional imaging system in claim 15, as discussed above.
However, Parthasarathy is silent regarding an interventional imaging system, wherein further instructions are stored in the memory, that when executed, cause the processor to insert a computer-aided design (CAD) model of the delivery catheter into the second image volume, and adjusting a size, position, and orientation of the CAD model to cover and replace a depiction of the delivery catheter in the second image volume.
In an analogous imaging field of endeavor, regarding image processing, Wang teaches an interventional imaging system, wherein further instructions are stored in the memory, that when executed, cause the processor to insert a computer-aided design (CAD) model of the delivery catheter into the second image volume, and adjusting a size, position, and orientation of the CAD model to cover and replace a depiction of the delivery catheter in the second image volume (Paragraph 0017 teaches that the location and size of the anatomical structures is assessed and used to determine the selection and determination of the optimal type and size of a catheter for medical procedure performance for a specific patient. Paragraphs 0047-48 teaches that the specific anatomical feature can be assessed. The user may manipulate the plane for the desired point or location for display. Claim 6 teaches that the measurement that can be used can be distances or angles between anatomical features. Paragraph 0088 teaches the model can simulate the placement of the instrument with respect to the anatomy. See Fig. 18).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Wang’s teaching of CAD modeling with an anatomical model. This modified apparatus would allow the user to have improved selection of medical devices for use in procedures (Paragraph 0002 of Wang). Furthermore, the modification minimizes and eliminates the issues of percutaneous implantation of cardiac devices (Paragraphs 0003-05 of Wang).
Regarding claim 19, Parthasarathy teaches a method, comprising:
during an image-guided interventional procedure performed by an operator of an interventional imaging system on a patient (Paragraph 0003 teaches real time operability of the system. Paragraph 0006 teaches real time tool localization and generation of MPR views):
acquiring a first image volume from a probe of an ultrasound system of the interventional imaging system (Paragraph 0022 teaches the generation of ultrasound volume data via a TEE probe);
receiving a second image volume acquired from the patient prior to the interventional procedure via a supplementary imaging system of the interventional imaging system (Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12);
receiving position and orientation data of a sensor located in a delivery catheter used in the interventional procedure, a representation of the delivery catheter included in the second image volume (Paragraph 0049 teaches that the position of the probe and catheters be tracked via a sensor. Additionally shape sensing can be performed. Paragraphs 0050-51 teach 5-6 DOF and the use of a global coordinate system).
However, Parthasarathy is silent regarding a method, inserting a computer-aided design (CAD) model of the delivery catheter into the second image volume, a size, position, and orientation of the CAD model adjusted to cover and replace the representation of the delivery catheter in the second image volume; and displaying a view of the second image volume on a display device, the view including the CAD model.
In an analogous imaging field of endeavor, regarding image processing, Wang teaches a method, inserting a computer-aided design (CAD) model of the delivery catheter into the second image volume, a size, position, and orientation of the CAD model adjusted to cover and replace the representation of the delivery catheter in the second image volume; and displaying a view of the second image volume on a display device, the view including the CAD model (Paragraph 0017 teaches that the location and size of the anatomical structures is assessed and used to determine the selection and determination of the optimal type and size of a catheter for medical procedure performance for a specific patient. Paragraphs 0047-48 teaches that the specific anatomical feature can be assessed. The user may manipulate the plane for the desired point or location for display. Claim 6 teaches that the measurement that can be used can be distances or angles between anatomical features. Paragraph 0088 teaches the model can simulate the placement of the instrument with respect to the anatomy. See Fig. 18).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Parthasarathy with Wang’s teaching of CAD modeling with an anatomical model. This modified method would allow the user to have improved selection of medical devices for use in procedures (Paragraph 0002 of Wang). Furthermore, the modification minimizes and eliminates the issues of percutaneous implantation of cardiac devices (Paragraphs 0003-05 of Wang).
Regarding claim 20, modified Parthasarathy teaches the method in claim 19, as discussed above.
Parthasarathy further teaches a method, wherein the supplementary imaging system one of: a computed tomography (CT) system; a magnetic resonance imaging (MRI) system; and a second ultrasound imaging system (Paragraphs 0034-35 teach that the target volume can have a preoperative scan that is overlaid with the ultrasound volume for targeting. This can be via an MRI or CT scan that provides the frame of reference and is fused with the volumetric scan to facilitate the MPR image analysis as seen in Fig. 9. Paragraphs 0026-27 teach the assessment of the interventional tool and the determination of the MPR according to the tool and performance of the MPR on the volumetric image data. The image data is visualized. Paragraph 0028 teaches that the MPR is continually updated. Paragraph 0024 teaches that the MPR can be integrated with the display device. See Fig. 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
John et al. (PGPUB No. US 2008/0177172): Teaches use of pre-operative landmarks for MPR.
Popovic et al. (PGPUB No. US 2019/0290247): Teaches overlay of pre-operative and interventional tools with ultrasound image data.
Thoranaghat et al. (PGPUB No. US 2016/0000518): Teaches tracking of an interventional tool with respect to volumetric image data.
Abe et al. (PGPUB No. US 2018/0242950): Teaches MPR performance with volumetric image data.
Cox et al. (PGPUB No. US 2018/0296185): Teaches planar image data with respect to a catheter tip and catheter pose.
Imagawa et al. (PGPUB No. US 2015/0272529): Teaches MPR according to a fluoroscopic image data set.
Sun et al. (PGPUB No. US 2008/0095421): Teaches MPR according to a fluoroscopic image data set.
Hall et al. (PGPUB No. US 2016/0331469): Teaches use of pre-operative landmarks for MPR.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798