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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3rd November, 2025 has been entered.
Response to Amendment
This action is in response to the amendment filed on 3rd November, 2025. Claims 1, 3, and 13-14 have been amended. Claim 19 has been cancelled. Claims 1-18 and 20-21 remain rejected in the application.
Response to Arguments
Applicant's arguments with respect to Claims 1, 14, and 21 filed on 3rd November, 2025, with respect to the rejection under 35 U.S.C. § 103, regarding that the prior art does not teach the limitation(s): "determining whether the volume of the marked mass is less than a threshold volume of mass" has been fully considered, but are moot because of new grounds for rejection. It has now been taught by the combination of Geri and Breskin.
Regarding arguments to Claims 2-13, 15-18, and 20, they directly/indirectly depend on independent Claims 1, 14, and 21 respectively. Applicant does not argue anything other than independent Claims 1, 14, and 21. The limitations in those claims, in conjunction with combination, was previously established as explained.
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.
Claims 1-2, 8, 10-14, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin.
Regarding Claim 1, Geri discloses a method, performed by a processing device, (Geri, [0086]: teaches a real-time tracking and feedback system to track the location and orientation of a surgical instrument, which is sent to a surgical simulating system) comprising:
constructing a three-dimensional (3D) anatomy model including one or more blood vessels associated with a marked mass for removal (Geri, [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips, that can be used on the 3D model, such as placing aneurysm clips on blood vessels; [0082]: teaches generating anatomical structures using a Tissue Paint/Magic Tissue Wand algorithm as new created structures, where the new created structures can be rendered in a volume and/or mesh/polygon rendering/reconstruction <read on constructing 3D anatomy model>; [0084]: teaches presenting a marked region of tissue <read on marked mass for removal> in any selected visual characteristics of color from a library of available colors and transparency levels);
selecting a first position for a first surgical clip to be applied to the one or more blood vessels (Geri, [0042]: teaches the SNAP system automatically marking regions of interest within an anatomical structure <read on selecting first position>, where "such anatomical structure may include fiber track, nerves, vessels <read on first blood vessel>, arteries etc."; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on first surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels);
using the 3D anatomy model and the first position to determine a first region including a volume of the marked mass and surrounding [[healthy]] tissue occluded by the first surgical clip (Geri, [0086]: teaches after applying an aneurysm clip on an aneurysm, "the system allows the surgeon to rotate the simulated image/model <read on 3D model> that is princely oriented as the real anatomical structure based on the tracking, and observe and evaluate the location <read on first position> and efficacy of the placed implant"; [0079]: teaches when placing aneurysm clips at blood vessels, blood flow gets blocked <read on first surgical clip occluding volume>; [0082]: teaches applying a Magic Tissue Paint/Tissue Wand algorithm to generate a newly created structure, which is a volume and/or mesh/polygon rendering/reconstruction of a selected region <read on first region>);
[[determining whether the volume of the marked mass is less than a threshold volume of mass;]]
[[responsive to determining that the volume of the marked mass is less than the threshold volume of mass,]] selecting a second position for a second surgical clip to be applied (Geri, [0042]: teaches the SNAP system automatically marking regions of interest within an anatomical structure <read on selecting second position>, where "such anatomical structure may include fiber track, nerves, vessels <read on second blood vessel>, arteries etc."; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on second surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels; Note: it should be noted that the plurality of points, surgical clips, and blood vessels are being interpreted as the first and second positions, the first and second surgical clips, and the first and second blood vessels respectively) and
using the 3D anatomy model, the first position, and the second position to determine a cumulative region that comprises the first region and a second region occluded by the first surgical clip and the second surgical clip, respectively (Geri, [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on both surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels <read on first and second positions>, which results in blood flow getting blocked <read on both surgical clips occluding cumulative region>; [0085]: teaches generating a newly created structure <read on determine cumulative region comprising first and second regions> with the Tissue Paint or Magic Tissue Wand algorithm with mechanical properties/characteristics, where "a mechanical model of a specific tissue can be coupled to the new created structure and therefore, the new created structure will inherent such mechanical properties and will react, dynamically and statically according to those mechanical properties," such as soft tissue reacting realistically to applied forces); and
displaying the 3D anatomy model including the first position for the first surgical clip and the second position for the second surgical clip (Geri, [0086]: teaches the system allowing the surgeon to rotate the simulated model after the surgeon applied implements within the anatomical structure, such as aneurysm clips <read on first and second surgical clips> applied on aneurysms or blood vessels <read on first and second positions>).
However, Geri does not expressly disclose
using the 3D anatomy model and the first position to determine a first region including a volume of the marked mass and surrounding healthy tissue occluded by the first surgical clip;
determining whether the volume of the marked mass is less than a threshold volume of mass; and
responsive to determining that the volume of the marked mass is less than the threshold volume of mass, selecting a second position for a second surgical clip to be applied.
Breskin discloses
using the 3D anatomy model and the first position to determine a first region including a volume of the marked mass and surrounding healthy tissue occluded by the first surgical clip (Breskin, [0177]: teaches treating abnormal tissue that is surrounded by healthy tissue);
determining whether the volume of the marked mass is less than a threshold volume of mass (Breskin, [0241]: teaches a detected lesion volume <read on marked mass volume> threshold being less than
0.064
c
m
3
<read on threshold volume of mass> for a specific Gleason grade, such as (5+4)); and
responsive to determining that the volume of the marked mass is less than the threshold volume of mass, selecting a second position for a second surgical clip to be applied (Breskin, [0241]: teaches a detected lesion volume <read on marked mass volume> threshold being less than
0.064
c
m
3
<read on threshold volume of mass> for a specific Gleason grade, such as (5+4)).
Breskin is analogous art with respect to Geri because they are from the same field of endeavor, namely treating cancerous tissue. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize scores, such as Gleason scores, for determining the severity of cancerous regions as taught by Breskin into the teaching of Geri. The suggestion for doing so would allow the system to determine how much of the surrounding healthy tissue should be removed for a safe and effective procedure, thereby improving the overall safety of the system. Therefore, it would have been obvious to combine Breskin with Geri.
Regarding Claim 14, Geri discloses a system (Geri, [0052]: teaches a system) comprising:
a display (Geri, [0052]: teaches the system being connected "to a high-resolution 3D display 40 on which the surgeon can monitor the operation and activity of the various tools 32, 34, and 36"), and
a processor, configured to (Geri, [0055]: teaches the computer system including a processor/controller(s)):
obtain a three-dimensional (3D) model of a patient including one or more blood vessels and a mass that is marked for removal (Geri, [0075]: teaches a Surgery Navigation Advanced Platform (SNAP) displaying "patient specific dynamic and interactive 3D models <read on obtaining 3D model of patient> with real time navigation data"; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips, that can be used on the 3D model, such as placing aneurysm clips on blood vessels; [0084]: teaches presenting a marked region of tissue <read on marked mass for removal> in any selected visual characteristics of color from a library of available colors and transparency levels);
determine a first position of a first surgical clip to be applied to a first blood vessel (Geri, [0042]: teaches the SNAP system automatically marking regions of interest within an anatomical structure <read on determine first position>, where "such anatomical structure may include fiber track, nerves, vessels <read on first blood vessel>, arteries etc."; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on first surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels);
using the 3D model and the first position to determine a first region including a volume of the mass and surrounding [[healthy]] tissue occluded by the first surgical clip (Geri, [0086]: teaches after applying an aneurysm clip on an aneurysm, "the system allows the surgeon to rotate the simulated image/model <read on 3D model> that is princely oriented as the real anatomical structure based on the tracking, and observe and evaluate the location <read on first position> and efficacy of the placed implant"; [0079]: teaches when placing aneurysm clips at blood vessels, blood flow gets blocked <read on first surgical clip occluding volume>; [0082]: teaches applying a Magic Tissue Paint/Tissue Wand algorithm to generate a newly created structure, which is a volume and/or mesh/polygon rendering/reconstruction of a selected region <read on first region>);
[[determine whether the volume of the mass is less than a threshold volume of mass;]]
[[responsive to determining that the volume of the marked mass is less than the threshold volume of mass,]] determine a second position of a second surgical clip to be applied to a second blood vessel (Geri, [0042]: teaches the SNAP system automatically marking regions of interest within an anatomical structure <read on determine second position>, where "such anatomical structure may include fiber track, nerves, vessels <read on second blood vessel>, arteries etc."; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on second surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels; Note: it should be noted that the plurality of points, surgical clips, and blood vessels are being interpreted as the first and second positions, the first and second surgical clips, and the first and second blood vessels respectively) and
use the 3D model, the first position, and the second position to determine a cumulative region occluded by both surgical clips (Geri, [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips <read on both surgical clip>, that can be used on the 3D model, such as placing aneurysm clips on blood vessels <read on first and second positions>, which results in blood flow getting blocked <read on both surgical clips occluding cumulative region>; [0085]: teaches generating a newly created structure <read on determine cumulative region> with the Tissue Paint or Magic Tissue Wand algorithm with mechanical properties/characteristics, where "a mechanical model of a specific tissue can be coupled to the new created structure and therefore, the new created structure will inherent such mechanical properties and will react, dynamically and statically according to those mechanical properties," such as soft tissue reacting realistically to applied forces); and
present, to the display, the 3D model of the patient including a visual indication of the second region and the mass (Geri, [0044]: teaches the SNAP system providing a visual indication of a marked anatomical structure, such as changes in color <read on visual indication of second region and mass>, which can act as guidance or warnings for the surgeon; [0097]: teaches the surgeon generating "a hazard <read on visual indication of second region and mass> regarding the threshold related to the proximity and orientation indication based on calculation of proximity of the surgery instrument and/or a pointer/market to a specific anatomical structure").
However, Geri does not expressly disclose
using the 3D model and the first position to determine a first region including a volume of the mass and surrounding healthy tissue occluded by the first surgical clip;
determine whether the volume of the mass is less than a threshold volume of mass;
responsive to determining that the volume of the marked mass is less than the threshold volume of mass, determine a second position of a second surgical clip to be applied to a second blood vessel.
Breskin discloses
using the 3D model and the first position to determine a first region including a volume of the mass and surrounding healthy tissue occluded by the first surgical clip (Breskin, [0177]: teaches treating abnormal tissue that is surrounded by healthy tissue);
determine whether the volume of the mass is less than a threshold volume of mass (Breskin, [0241]: teaches a detected lesion volume <read on marked mass volume> threshold being less than
0.064
c
m
3
<read on threshold volume of mass> for a specific Gleason grade, such as (5+4));
responsive to determining that the volume of the marked mass is less than the threshold volume of mass, determine a second position of a second surgical clip to be applied to a second blood vessel (Breskin, [0241]: teaches a detected lesion volume <read on marked mass volume> threshold being less than
0.064
c
m
3
<read on threshold volume of mass> for a specific Gleason grade, such as (5+4)).
Breskin is analogous art with respect to Geri because they are from the same field of endeavor, namely treating cancerous tissue. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize scores, such as Gleason scores, for determining the severity of cancerous regions as taught by Breskin into the teaching of Geri. The suggestion for doing so would allow the system to determine how much of the surrounding healthy tissue should be removed for a safe and effective procedure, thereby improving the overall safety of the system. Therefore, it would have been obvious to combine Breskin with Geri.
Regarding Claim 21, Geri discloses a system (Geri, [0052]: teaches a system) comprising:
a display (Geri, [0052]: teaches the system being connected "to a high-resolution 3D display 40 on which the surgeon can monitor the operation and activity of the various tools 32, 34, and 36"), and
a processor, configured to (Geri, [0055]: teaches the computer system including a processor/controller(s)):
obtain a three-dimensional (3D) model of a patient including one or more blood vessels and a mass that is marked for removal (Geri, [0075]: teaches a Surgery Navigation Advanced Platform (SNAP) displaying "patient specific dynamic and interactive 3D models <read on obtaining 3D model of patient> with real time navigation data"; [0079]: teaches a virtual surgery scene with selectable surgery tools, such as aneurysm clips, that can be used on the 3D model, such as placing aneurysm clips on blood vessels; [0084]: teaches presenting a marked region of tissue <read on marked mass for removal> in any selected visual characteristics of color from a library of available colors and transparency levels);
determine, without user interference, a position of each of one or more surgical clips within the 3D model among a plurality of potential positions associated with the one or more blood vessels, [[to increase a volume of the mass that is included in a region of the 3D model]] (Geri, [0042]: teaches the SNAP system automatically marking anatomical structures using markers <read on determine position of surgical clips without user interference>, where "such anatomical structures may include fiber track, nerves, vessels <read on blood vessels>, arteries etc."; [0043]: teaches the markers being a target that a surgeon will navigate to <read on potential positions>, where "every marker that is being placed can be labeled, have a specific color, specific shape, etc."; [0089]: teaches the surgeon determining a simulated approach that will provide the best desired outcome, such as maximum tumor extraction), and
[[to reduce a volume of healthy tissue that is in the region, wherein]]
blood flow is restricted from the region based on the one or more blood vessels of the 3D model and the position of each of the one or more surgical clips (Geri, [0079]: teaches "aneurysm clips <read on position of surgical clips>, when placed at the vessel <read on blood vessel of 3D model>, blocks the blood flow <read on restricting blood flow from region>"); and
present, to the display, the 3D model of the patient including a visual indication of the region and the mass (Geri, [0044]: teaches the SNAP system providing a visual indication of a marked anatomical structure, such as changes in color <read on visual indication of second region and mass>, which can act as guidance or warnings for the surgeon; [0097]: teaches the surgeon generating "a hazard <read on visual indication of region and mass> regarding the threshold related to the proximity and orientation indication based on calculation of proximity of the surgery instrument and/or a pointer/market to a specific anatomical structure").
However, Geri does not expressly disclose
determine, without user interference, a position of each of one or more surgical clips within the 3D model among a plurality of potential positions associated with the one or more blood vessels, to increase a volume of the mass that is included in a region of the 3D model, and
to reduce a volume of healthy tissue that is in the region.
Breskin discloses
determine, without user interference, a position of each of one or more surgical clips within the 3D model among a plurality of potential positions associated with the one or more blood vessels, to increase a volume of the mass that is included in a region of the 3D model (Breskin, [0241]: teaches the value for certain Gleason grades correspond to a detected lesion area threshold, where the increasing the grades requires increasing the amount of tissue volume to remove; Note: it should be noted that Gleason grades are used to categorize types of cancerous cells, where the higher the score, the more aggressive the cancer cell is, which would require more surrounding tissue to remove), and
to reduce a volume of healthy tissue that is in the region (Breskin, [0177]: teaches treating an abnormal tissue region that is surrounded by healthy tissue <read on healthy tissue volume>, where the abnormal tissue is destroyed with relatively small damage <read on reduce healthy tissue volume in region> to the surrounding healthy tissue).
Breskin is analogous art with respect to Geri because they are from the same field of endeavor, namely treating cancerous tissue. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize scores, such as Gleason scores, for determining the severity of cancerous regions as taught by Breskin into the teaching of Geri. The suggestion for doing so would allow the system to determine how much of the surrounding healthy tissue should be removed for a safe and effective procedure, thereby improving the overall safety of the system. Therefore, it would have been obvious to combine Breskin with Geri.
Regarding Claim 2, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses
displaying a visual indication of the cumulative region and the marked mass (Geri, [0044]: teaches the SNAP system providing a visual indication of a marked anatomical structure, such as changes in color <read on displaying visual indication of second region and mass>, which can act as guidance or warnings for the surgeon).
Regarding Claim 8, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses wherein the threshold volume of mass is
obtained from a configurable setting (Geri, [0097]: teaches measuring an aneurysm size by virtual marking 330 and 335, with the resulting measurement shown in window 337 <read on obtain threshold volume of mass from configurable setting>, where the measurement is modifiable as shown in FIG. 15).
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Regarding Claim 10, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses wherein constructing a 3D anatomy model includes
obtaining one or more scans of a patient anatomy (Geri, [0039]: teaches the SNAP tool utilizing <read on obtaining> CR/MRI scans of the patient),
performing segmentation on the one or more scans to define structures of the patient anatomy (Geri, [0092]: teaches control segmentation, where images <read on scans> related to certain anatomical structures <read on patient anatomy> are displayed) including
the marked mass (Geri, [0092]: teaches the control segmentation only displaying soft tissue <read on marked mass>) and
the one or more blood vessels (Geri, [0092]: teaches the control segmentation only displaying vessels <read on blood vessels>).
Regarding Claim 11, the combination of Geri and Breskin discloses the method of Claim 10. Additionally, Geri further discloses wherein the one or more scans includes
a plurality of computerized tomography (CT) scans of the patient anatomy (Geri, [0039]: teaches the SNAP tool utilizing CR/MRI scans of the patient).
Regarding Claim 12, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses wherein displaying the 3D anatomy model includes
adjusting a view of the 3D anatomy model to show the first region in front of other structures in the 3D anatomy model, based on a selection of the first region (Geri, [0108]: teaches a tissue segmentation window being used to modify tissue-specific intensity ranges applied to patient data, where " one can adjust and customize the segmentation <read on adjusting view of 3D anatomy> to highlight the AVM Nidus, the draining veins, feeding arteries and the transverse sinuses for optimal visualization, while making the skull and less vital structures more transparent <read on first region being in front of other structures based on selection of first region>").
Regarding Claim 13, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses wherein displaying the 3D anatomy model includes
presenting the 3D anatomy on a portable device (Geri, FIG. 1B teaches the system including a display, which display a 3D anatomy model, that is mounted on stand 101, which is connected to mobile platform 107 <read on portable device>) and
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adjusting a view of the 3D anatomy model to show the first region or the second region in front of other structures in the 3D anatomy model, based on a tracked position of the portable device (Geri, [0108]: teaches a tissue segmentation window being used to modify tissue-specific intensity ranges applied to patient data, where " one can adjust and customize the segmentation <read on adjusting view of 3D anatomy> to highlight the AVM Nidus, the draining veins, feeding arteries and the transverse sinuses for optimal visualization, while making the skull and less vital structures more transparent <read on first region being in front of other structures>"; [0087]: teaches using a video system to track the location and movement of the real instrument <read on portable device>).
Regarding Claim 16, the combination of Geri and Breskin discloses the system of Claim 14. Additionally, Geri further discloses wherein
the display includes a stereoscopic display (Geri, [0052]: teaches the system being connected "to a high-resolution 3D display 40 <read on stereoscopic display> on which the surgeon can monitor the operation and activity of the various tools 32, 34, and 36").
Claims 3, 9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin as applied to Claims 1 and 14 above respectively, and further in view of Sorger et al. (US 20210236213 A1, previously cited), hereinafter referenced as Sorger.
Regarding Claim 3, the combination of Geri and Breskin discloses the method of Claim 1. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 3; however, Sorger discloses wherein
an order of selecting the first position and selecting the second position is based on the volume of the marked mass relative to a volume of the surrounding healthy tissue that is associated with each of the first position and the second position, respectively (Sorger, [0044]: teaches planning a medical procedure <read on order> of a given portion of tissue; [0055]: teaches identifying regions on the exterior of the target tissue 302, "where disease is present or where disease is separated from the exterior by an amount of healthy tissue <read on volume of surrounding healthy tissue> that is less than a minimum threshold"; [0050]: teaches the medical system 10 automatically identifying, marking, and recording fiducial features from the first intraoperative image 300).
Sorger is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely safer excising tumor procedures. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have the system follow a planned medical procedure for a given portion of tissue as taught by Sorger into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow the system to automatically identify healthy and cancerous regions, thereby speeding up the surgical procedure. Therefore, it would have been obvious to combine Sorger with Geri, in view of Breskin.
Regarding Claim 9, the combination of Geri and Breskin discloses the method of Claim 1. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 9; however, Sorger discloses wherein selecting the first position and the second position includes
enforcing a minimum distance between the marked mass and the first surgical clip, and between the marked mass and the second surgical clip (Sorger, [0037]: teaches maintaining the size of the incision <read on enforcing a minimum distance>; [0042]: teaches identifying surgical margins of excised tissue with no or minimal healthy cells between the cancerous or otherwise diseased cells <read on marked mass> and the margin <read on first and second surgical clips>).
Sorger is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely surgical operations of cancerous tissue. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have the system determine whether additional tissue should be removed around a tumor as taught by Sorger into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow the system to automatically minimize the amount of healthy tissue being removed, thereby reducing tissue damage. Therefore, it would have been obvious to combine Sorger with Geri, in view of Breskin.
Regarding Claim 20, the combination of Geri and Breskin discloses the system of Claim 14. Additionally, Geri further discloses wherein the processor is configured to
determine the first position and the second position by automatically selecting the first position and the second position such that the second region (Geri, [0042]: teaches the SNAP system automatically marking anatomical structures <read on automatically selecting first and second positions>, which "may include fiber track, nerves, vessels, arteries etc.") comprises
[[a highest ratio of volume of the mass relative to volume of healthy tissue that is included in the second region.]]
However, the combination of Geri and Breskin does not expressly disclose
a highest ratio of volume of the mass relative to volume of healthy tissue that is included in the second region.
Sorger discloses
a highest ratio of volume of the mass relative to volume of healthy tissue that is included in the second region (Sorger, [0055]: teaches diseased tissue being nearby the target tissue 302, where the amount of healthy tissue <read on healthy tissue volume> in the target tissue area <read on second region> is less than a minimum threshold amount <read on highest ratio of volume mass>).
Sorger is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely safer excising tumor procedures. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have the system follow a planned medical procedure for a given portion of tissue as taught by Sorger into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow the system to automatically identify healthy and cancerous regions, thereby speeding up the surgical procedure. Therefore, it would have been obvious to combine Sorger with Geri, in view of Breskin.
Claims 4-5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin as applied to Claims 1 and 14 above respectively, and further in view of Avisar (US 20150127316 A1, previously cited).
Regarding Claim 4, the combination of Geri and Breskin discloses the method of Claim 1. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 4; however, Avisar discloses
responsive to the volume of the marked mass satisfying the threshold volume of mass, not selecting the second position of the second surgical clip or any additional positions for any additional surgical clip (Avisar, [0109]: teaches selecting temporary clips from a Clips library; [0111]: teaches the surgeon removing the temporary clips and puncturing the aneurysm, indicating that no additional clips are required <read on not selecting additional positions for any additional surgical clip>; [0112]: teaches "inappropriate temporary clip placement will not stop the flow of blood into the aneurysm, whereas appropriate clip will cause the aneurysm to deflate or obliterate" and "improper management of the aneurysm will result in bleeding if temporary clips were not placed or not sufficiently placed"; [0123]: teaches modifying the length and angles of an aneurysm clip "to create a tailored designed clip that will best fit the patient's specific aneurysm's size <read on satisfying threshold volume of mass> and shape and the specific orientation of the approach/corridor to the aneurysm"; Note: it should be noted that a value being below the threshold volume of mass is being interpreted as satisfying the threshold).
Avisar is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely 3D modeling of organs and analysis. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to puncture an aneurysm in the 3D organ model after placing and removing an appropriate number of clips as taught by Avisar into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow for the surgeon to analyze each clip and determine if the current number of clips are sufficient to stop or minimize bleeding, thereby further reducing the risk of internal bleeding. Therefore, it would have been obvious to combine Avisar with Geri, in view of Breskin.
Regarding Claim 5, the combination of Geri and Breskin discloses the method of Claim 1. Additionally, Geri further discloses wherein the second region includes
an additional volume of the marked mass (Geri, [0097]: teaches the surgeon generating a hazard "regarding the threshold related to the proximity and orientation indication based on calculation of proximity of the surgery instrument and/or a pointer/market to a specific anatomical structure <read on second region>," such as measuring the remaining tumor <read on additional volume of marked mass> and distance from arteries), wherein
[[the method further comprises selecting an additional position for an additional surgical clip in response to a total volume of the marked mass that is included in the cumulative region of selected surgical clips not satisfying the threshold volume of mass and in response to one or more criteria not being satisfied.]]
However, the combination of Geri and Breskin does not expressly disclose
the method further comprises selecting an additional position for an additional surgical clip in response to a total volume of the marked mass that is included in the cumulative region of selected surgical clips not satisfying the threshold volume of mass and in response to one or more criteria not being satisfied.
Avisar discloses
the method further comprises selecting an additional position for an additional surgical clip in response to a total volume of the marked mass that is included in the cumulative region of selected surgical clips not satisfying the threshold volume of mass and in response to one or more criteria not being satisfied (Avisar, [0112]: teaches that insufficient placements of temporary clips would result in bleeding <read on selecting additional position for additional surgical clip>, indicating that additional clips should be applied <read on criteria not being satisfied>; Note: it should be noted that although not expressly stated, it is being interpreted that if a current amount of surgical clips does not stop bleeding, then one skilled in the art would be able to discern that more surgical clips are required to stop the bleeding, indicating that the total number of clips used was insufficient for a larger tumor, which is being interpreted as not satisfying the threshold volume of mass).
Avisar is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely 3D modeling of organs and analysis. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to puncture an aneurysm in the 3D organ model after placing and removing an appropriate number of clips as taught by Avisar into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow for the surgeon to analyze each clip and determine if the current number of clips are sufficient to stop or minimize bleeding, thereby further reducing the risk of internal bleeding. Therefore, it would have been obvious to combine Avisar with Geri, in view of Breskin.
Regarding Claim 17, the combination of Geri and Breskin discloses the system of Claim 14. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 17; however, Avisar discloses wherein the processor is configured to
determine the first position or the second position by obtaining user input indicating the first position or the second position on a portion of the first blood vessel or a portion of the second blood vessel, respectively (Avisar, [0117]: teaches a CA-SRP including "a search engine that allows the surgeon to locate an aneurysm clip that matches the patient specific aneurysm and vessels 3 dimensional geometrical structure <read on determine first or second positions>," where "a graphic user interface allows the surgeon the option to work with a 3 dimensional model of an aneurysm clip <read on obtaining user input> and to design its own clip to match the patient specific aneurysm and vessels 3 dimensional geometrical structures <read on indicating first or second positions on portion of first or second blood vessels respectively>"; Note: it should be noted that it is common in the art for GUIs to visually indicate selected items, such as a bolded outline or highlighting said selected item(s), which is being interpreted as indicating positions).
Avisar is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely 3D modeling of organs and analysis. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have a surgeon read the input of the surgeon during simulation as taught by Avisar into the teaching of Geri, in view of Breskin. The suggestion for doing so would allow the surgeon to interact with the simulation, thereby providing training exercises in preparation for future surgical procedures. Therefore, it would have been obvious to combine Avisar with Geri, in view of Breskin.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin, and further in view of Avisar (US 20150127316 A1, previously cited) as applied to Claim 5 above respectively, and further in view of Kopel et al. (US 20240024029 A1, previously cited), hereinafter referenced as Kopel.
Regarding Claim 6, the combination of Geri, Breskin, and Avisar discloses the method of Claim 5. The combination of Geri, Breskin, and Avisar does not expressly disclose the limitations of Claim 6; however, Kopel discloses wherein
the one or more criteria include a maximum number of allowed surgical clips (Kopel, [0117]: teaches a surgeon applying surgical aneurysm clips that are fitted specifically for a given patient's aneurysm and surrounding blood vessels, which includes determining the length of each aneurysm clip length, clip shape, and number of clip holes <read on maximum number of allowed surgical clips>).
Kopel is analogous art with respect to the combination of Geri, Breskin, and Avisar because they are from the same field of endeavor, namely analyzing and modeling CT scans for tumor excising procedures. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to determine the properties for each surgical clip for an affected region as taught by Kopel into the combined teaching of Geri, Breskin, and Avisar. The suggestion for doing so would result in fewer and more precise surgical clips to be applied, thereby reducing possible errors and improving safety. Therefore, it would have been obvious to combine Kopel with the combination of Geri, Breskin, and Avisar.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin, and further in view of Avisar (US 20150127316 A1, previously cited) as applied to Claim 5 above respectively, and further in view of Sorger et al. (US 20210236213 A1, previously cited), hereinafter referenced as Sorger.
Regarding Claim 7, the combination of Geri, Breskin, and Avisar discloses the method of Claim 5. The combination of Geri, Breskin, and Avisar does not expressly disclose the limitations of Claims 7; however, Sorger discloses wherein the one or more criteria include
a maximum volume of healthy tissue that is allowed in the cumulative region (Sorger, [0055]: teaches diseased tissue being nearby the target tissue 302 <read on marked mass>, where the amount of healthy tissue in the target tissue area is less than a minimum threshold amount <read on maximum volume of healthy tissue>; [0073]: teaches the medical system 10 marking "the region 702 in the tissue bed 304 that corresponds to a suspicious margin 402 marked in the ex vivo model 400", where the "region 702 represents an area of tissue bed where cancerous cells of the excised tissue 302 met the remaining tissue bed 304").
Sorger is analogous art with respect to the combination of Geri, Breskin, and Avisar because they are from the same field of endeavor, namely surgical operations of cancerous tissue. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have the system determine whether additional tissue should be removed around a tumor as taught by Sorger into the combined teaching of Geri, Breskin, and Avisar. The suggestion for doing so would allow the system to automatically minimize the amount of healthy tissue being removed, thereby reducing tissue damage. Therefore, it would have been obvious to combine Sorger with Geri, Breskin, and Avisar.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Geri et al. (US 20170035517 A1, previously cited), hereinafter referenced as Geri, in view of Breskin et al. (US 20100312072 A1), hereinafter referenced as Breskin as applied to Claim 14 above respectively, and further in view of Kopel et al. (US 20240024029 A1, previously cited), hereinafter referenced as Kopel.
Regarding Claim 15, the combination of Geri and Breskin disclose the system of Claim 14. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 15; however, Kopel discloses wherein
the display and the processor are integral to a tablet computer (Kopel, [0069]: teaches "workstation 701 may be a stationary computing device, such as a personal computer, or a portable computing device such as a tablet computer", where the "processor 704 may be coupled <read on integral> with memory 702, display 706, input device 710, output module 712, network interface 708, and imaging device 715").
Kopel is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely analyzing and identifying CT scans to simulate tumor extraction procedures. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have the workstation be a portable computing device as taught by Kopel into the teaching of Geri, in view of Breskin. The suggestion for doing so would result in the device containing less wires, thereby offering a more flexible training experience. Therefore, it would have been obvious to combine Kopel with Geri, in view of Breskin.
Regarding Claim 18, the combination of Geri and Breskin discloses the system of Claim 14. The combination of Geri and Breskin does not expressly disclose the limitations of Claim 18; however, Kopel discloses wherein the processor is further configured to
display a first volume of the second region that is associated with the mass that is marked for removal (Kopel, [0056]: teaches displaying the dimensions and volume of a tumor <read on first volume of second region>; [0041]: teaches the clinician marking the position of the tumor <read on marked for removal>, which generates a display indicator) and
a second volume of the second region that is associated with healthy tissue (Kopel, [0042]: teaches a margin 214 identifying a healthy tissue portion <read on second volume> of the 3D model).
Kopel is analogous art with respect to Geri, in view of Breskin because they are from the same field of endeavor, namely analyzing and identifying CT scans to simulate tumor extraction procedures. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to distinguish portions of the anatomy using colors as taught by Kopel into the teaching of Geri, in view of Breskin. The suggestion for doing so would aid the surgeon for quick identification for each diseased tissue, thereby assisting the abilities of the surgeon regarding safety and effectiveness. Therefore, it would have been obvious to combine Kopel with Geri, in view of Breskin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hurley et al. (US 20150324114 A1) discloses an interactive 3D surgical planning system; and
Fichtinger et al. (US 20160242855 A1) discloses a real-time surgical navigation system that generates an image of a tissue volume.
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/K.D.T./Examiner, Art Unit 2614
/KENT W CHANG/Supervisory Patent Examiner, Art Unit 2614