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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/05/2025 has been entered.
Response to Amendment
This communication is in response to the action filed on 11/05/2025.
Claims 1 and 12 are currently amended. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments filed on 11/05/2025 on pages 6-11, under REMARKS with respect to 35 U.S.C. 103 claim rejections to claims 1-20 have been fully considered and are persuasive. The rejections to the claims have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 in view of US 10,792,097 B2 (previously cited as EP 3,175,807 A1).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4, 8-15, and 19-20 are rejected under 35 § U.S.C. 103 as being obvious over WO 2007/092159 A2 to W, HUNDLEY (hereinafter “HUNDLEY”) in view of US 10,792,097 B2 to ZIV-ARI et al. (hereinafter “ZIV-ARI”), in further view of Initial Experience with a Novel Focused Ultrasound Ablation System for Ring Ablation Outside the Pulmonary Vein to MEININGER et al. (hereinafter “MEININGER”).
As per claim 1, HUNDLEY discloses A method comprising: receiving, by an evaluation engine executed by a processor (a method in which a cardiac imaging and modeling system receives data including points when processed by a heart evaluation model executed by a computer system comprising computing components such as a computer memory and processor; abstract; page 6, lines 4-33; page 7, lines 1-21; figure 2), a plurality of ablation points respective to cardiac tissue of a patient (a curve of the anatomical body part is drawn via points and placement of these points respective of the tissue being modeled and drawing a region of interest; page 12, lines 1-29; page 36, lines 10-34); determining, by the evaluation engine, an anatomical structural classification comprising anatomical locations (histograms of intensity voxels can allow for of cardiac tissues allow the system to determine a tissue type of the heart based on segmentation and data wherein the cardiac tissue evaluation system provides treatment options to the user and provides effective cardiac tissue treatment; figure 14; page 25, lines 4-32; page 30, lines 4-34; page 16, lines 1-29; page 21, lines 7-30). HUNDLEY fails to disclose in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue; and associating one or more segments of the left PV and right PV for the plurality of ablation points; updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation; and providing, by the evaluation engine, the anatomical locations in two separate circular rings around the left PV and the right PV associated with the plurality of ablation points including the one or more segments for the plurality of ablation points to support treatment of cardiac tissue.
ZIV-ARI discloses updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation (as seen in figure 2 a plurality of circular ablation points are made on the cardiac tissue of the subject and computes an ALCI ablation line contiguity index value in order to determine reconnection risks between a pair of given lesions via the value of the ALCI; abstract; fig 2; column 4, lines 24-60; column 6, lines 35-55; column 8, lines 21-64).
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 HUNDLEY to have updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation of ZIV-ARI reference. The Suggestion/motivation for doing so would have been to provide the advantage of determining the ALCI value to determine risk of reconnection of the arrhythmic pathway between a given pair of lesions increases with decreasing ALCI. As noted earlier, processor 40 in system 20 records the ablation site locations (center points 74 marked in FIG. 2) and ablation parameters applied at each site and automatically computes the ALCI values, either in real time during a procedure or retrospectively, and thus provides an assessment of ablation line quality as suggested by ZIV-ARI at column 8, lines 26-38. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine ZIV-ARI with HUNDLEY to obtain the invention as specified in claim 1.
MEININGER discloses in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue (a system and associated method for providing focused ultra sound ablation to the heart tissue of a patient to specific point the anatomical locations for ablation chosen using an anatomically based approach comprise the delivery of anatomically directed circumferential ablation lesions outside of the pulmonary vein in order to create electrical isolation of the pulmonary vein and as seen in figure 4 comprises ring shaped ablation structures on the left and right PV and can be seen as separate rings around opposite ends of the vein by looking at the table 1 which clearly states position of a right and left side pulmonary vein and would indicate two separate ablation circles/rings; fig 4; pages 142-143, column 1); and associating one or more segments of the left PV and right PV for the plurality of ablation points (the ultrasound ablation is anatomically focused (segmented) on the left and right PV vein as seen in figure 4 focusing on that anatomy such that the ultra-sonic ablation is only delivered to the rings marking the left and right PV vein and limits collateral injury/damage; fig 4; pages 142-143, column 1); and providing, by the evaluation engine, the anatomical locations in two separate circular rings around the left PV and the right PV associated with the plurality of ablation points including the one or more segments for the plurality of ablation points to support treatment of cardiac tissue (as stated above in order to assist with treatment ultrasound ablation results are taken and based on table 1 ablate a left and right side pulmonary veins and would indicate the circle depicted in figure 4 are separate circles on opposite sides of the vein and only appear to overlap due to image angle of the tissue example shown; fig 4; pages 142-143, column 1; table 1).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue of MEININGER reference. The Suggestion/motivation for doing so would have been to provide the advantage of accurately depositing the majority of energy directly within the heart muscle, limiting collateral injury as suggested by MEININGER at page 142, top of column 2. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MEININGER with modified HUNDLEY to obtain the invention as specified in claim 1.
As per claim 2, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY fails to disclose wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points.
ZIV-ARI discloses wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points (the system is used to map ablation lines particularly around a heart tissue of a patient wherein that heart tissue is a pulmonary vein of the heart; fig 2; column 4, lines 11-54; column 8, lines 4-64).
It would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the method of HUNDLEY to provide wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points, as taught by ZIV-ARI, in order to provide removing the most amount of lesion tissue with the least invasive ablation cut to determine ablation size mapping to visualize ablation cuts prior to making them as suggested by ZIVARI at column 4, lines 24-54.
As per claim 3, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY further discloses wherein the evaluation engine utilizes manual annotations of training data to determine of the anatomical structural classification (the user input is don via free hand (manual) drawings (annotations) of training image data of the heart tissue classification system; figure 24; page 35, line 18 - page 36, line 6).
As per claim 4, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY fails to disclose wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins.
ZIV-ARI discloses wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins (the system utilizes an ablation line contiguity index ALCI and is computed related to nearby overlapping tissue mappings and is used to insure contiguity between each lesion and that excessive overlapping is avoided wherein the regions could be many locations of the heart tissue of the patient wherein in this case those regions relate to the pulmonary vein; fig 2; column 4 , lines 11-65; column 8, lines 4-64).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins of ZIV-ARI reference. The Suggestion/motivation for doing so would have been to provide a visual indicator to follow during medical ablation procedures as suggested by ZIV-ARI at column 4, lines 11-54. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine ZIV-ARI with modified HUNDLEY to obtain the invention as specified in claim 4.
As per claim 8, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY further discloses wherein the anatomical structural classification comprises an anatomical structure code based on a set of numbers from 1 to 9 (the color-coded graphic display shows the anatomical regions of the heart and includes labeled regions 1-9 as compartments of the model 500; page 6, lines 4-33; page 29, lines 5-34).
As per claim 9, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY further discloses wherein evaluation engine determines anatomical structure classification based on the ablation points and a three-dimensional model of an atria as an input (wherein a 3-D dimensional image model of the heart is generated particularly a generated image of a region of interest of said heart is generated wherein that region of interest would be selected to be an atria of the patients heart; figures 20-21; page 33, lines 23 – 33; page 35, lines 3-30; CLAIM 17).
As per claim 10, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 9. Modified HUNDLEY further discloses wherein evaluation engine determines anatomical structure classification based on at least one of intracardiac electrocardiogram, visualization toolkit (VTK) anatomy file, and body surface electrocardiogram (ECG) (the evaluation engine utilizes electrocardiograms ECG leads to determine anatomical tissue locations and types of cardiac tissue such as the left ventricle; page 26, lines 3 - 30).
As per claim 11, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 10. Modified HUNDLEY further discloses wherein the VTK anatomy file provide a three-dimensional (3D) shell of the atria (wherein the system creates a 3D image model representation of the patient’s heart and regions of interest of said heart to be utilized to determine cardiotoxicity and further methods of treatment to reduce said cardiotoxicity; figs 21-24; page 26, lines 3 – 26; page 35, line 3 – page 36, line 6).
As per claim 12, HUNDLEY discloses a system comprising: a memory configured to store processor executable program instructions of an evaluation engine (a cardiac imaging and modeling system receives data including points when processed by a heart evaluation model executed by a computer system comprising computing components such as a computer memory and processor; abstract; page 6, lines 4-33; page 7, lines 1-21; figure 2); and a processor configured to execute the program instructions of the evaluation engine to cause an apparatus to (): receive a plurality of ablation points respective to cardiac tissue of a patient (wherein the computing system including the processor after receiving said data points uses them to generate a curve of the anatomical body part in this case the heart is drawn via points and placement of these points respective of the tissue being modeled and drawing a region of interest; page 12, lines 1-29; page 36, lines 10-34); determine an anatomical structural classification (histograms of intensity voxels can allow for of cardiac tissues allow the system to determine a tissue type of the heart based on segmentation and data wherein the cardiac tissue evaluation system provides treatment options to the user and provides effective cardiac tissue treatment; figure 14; page 25, lines 4-32; page 30, lines 4-34; page 16, lines 1-29; page 21, lines 7-30). HUNDLEY fails to disclose comprising anatomical locations in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue, and associating one or more segments of the left PV and right PV for the plurality of ablation points; updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation; and provide the anatomical locations in two separate circular rings around the left PV and the right PV associated with the plurality of ablation points including the one or more segments for the plurality of ablation points to support treatment of the cardiac tissue.
ZIV-ARI discloses updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation (as seen in figure 2 a plurality of circular ablation points are made on the cardiac tissue of the subject and computes an ALCI ablation line contiguity index value in order to determine reconnection risks between a pair of given lesions via the value of the ALCI; abstract; fig 2; column 4, lines 24-60; column 6, lines 35-55; column 8, lines 21-64).
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 HUNDLEY to have updating the plurality of ablation points, based on the anatomical structural classification, to account for reconnection and redo locations using a contiguity estimation of ZIV-ARI reference. The Suggestion/motivation for doing so would have been to provide the advantage of determining the ALCI value to determine risk of reconnection of the arrhythmic pathway between a given pair of lesions increases with decreasing ALCI. As noted earlier, processor 40 in system 20 records the ablation site locations (center points 74 marked in FIG. 2) and ablation parameters applied at each site and automatically computes the ALCI values, either in real time during a procedure or retrospectively, and thus provides an assessment of ablation line quality as suggested by ZIV-ARI at column 8, lines 26-38. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine ZIV-ARI with HUNDLEY to obtain the invention as specified in claim 12.
MEININGER discloses comprising anatomical locations in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue (a system and associated method for providing focused ultra sound ablation to the heart tissue of a patient to specific point the anatomical locations for ablation chosen using an anatomically based approach comprise the delivery of anatomically directed circumferential ablation lesions outside of the pulmonary vein in order to create electrical isolation of the pulmonary vein and as seen in figure 4 comprises ring shaped ablation structures on the left and right PV and can be seen as separate rings around opposite ends of the vein by looking at the table 1 which clearly states position of a right and left side pulmonary vein and would indicate two separate ablation circles/rings; fig 4; pages 142-143, column 1), and associating one or more segments of the left PV and right PV for the plurality of ablation points (the ultrasound ablation is anatomically focused (segmented) on the left and right PV vein as seen in figure 4 focusing on that anatomy such that the ultra-sonic ablation is only delivered to the rings marking the left and right PV vein and limits collateral injury/damage; fig 4; pages 142-143, column 1); and provide the anatomical locations in two separate circular rings around the left PV and the right PV associated with the plurality of ablation points including the one or more segments for the plurality of ablation points to support treatment of the cardiac tissue (as stated above in order to assist with treatment ultrasound ablation results are taken and based on table 1 ablate a left and right side pulmonary veins and would indicate the circle depicted in figure 4 are separate circles on opposite sides of the vein and only appear to overlap due to image angle of the tissue example shown; fig 4; pages 142-143, column 1; table 1).
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 HUNDLEY to have in two separate circular rings around a left pulmonary vein (PV) and a right PV associated with the plurality of ablation points based on a structural segmentation for the cardiac tissue of MEININGER reference. The Suggestion/motivation for doing so would have been to provide the advantage of accurately depositing the majority of energy directly within the heart muscle, limiting collateral injury as suggested by MEININGER at page 142, top of column 2. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MEININGER with HUNDLEY to obtain the invention as specified in claim 12.
As per claim 13, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY fails to disclose wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points.
ZIV-ARI discloses wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points (the system is used to map ablation lines particularly around a heart tissue of a patient wherein that heart tissue is a pulmonary vein of the heart; fig 2; column 4, lines 11-64; column 8, lines 4-65).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have wherein the evaluation engine determines right and left wide area circumferential ablation locations, respective to left and right pulmonary veins of the cardiac tissue, for the plurality of effective points of ZIV-ARI reference. The Suggestion/motivation for doing so would have been to remove the most amount of lesion tissue with the least invasive ablation cut to determine ablation size mapping to visualize ablation cuts prior to making them as suggested by ZIVARI at column 4, lines 11-54. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine ZIV-ARI with modified HUNDLEY to obtain the invention as specified in claim 13.
As per claim 14, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY further discloses wherein the evaluation engine utilizes manual annotations of training data to determine of the anatomical structural classification (the user input is don via free hand (manual) drawings (annotations) of training image data of the heart tissue classification system; figure 24; page 35, line 18 - page 36, line 6).
As per claim 15, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY fails to disclose wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins.
ZIV-ARI discloses wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins (the system utilizes an ablation line contiguity index ALCI and is computed related to nearby overlapping tissue mappings and is used to insure contiguity between each lesion and that excessive overlapping is avoided wherein the regions could be many locations of the heart tissue of the patient; fig 2; column 4, lines 11-64; column 8, lines 4-65).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have wherein the structural segmentation of the cardiac tissue comprises at least one of right posterior, right inferior, right roof, right anterior, left posterior, right inferior, right roof, left ridge, and left anterior of left and right pulmonary veins of ZIV-ARI reference. The Suggestion/motivation for doing so would have been to provide a visual indicator to follow during medical ablation procedures as suggested by ZIV-ARI at column 4, lines 11-54. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine ZIV-ARI with modified HUNDLEY to obtain the invention as specified in claim 15.
As per claim 19, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY further discloses wherein the anatomical structural classification comprises an anatomical structure code based on a set of numbers from 1 to 9 (the color-coded graphic display shows the anatomical regions of the heart and includes labeled regions 1-9 as compartments of the model 500; page 6, lines 4-33; page 29, lines 5-34).
As per claim 20, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY further discloses wherein evaluation engine determines anatomical structure classification based on the ablation points and a three-dimensional model of an atria as an input (wherein a 3-D dimensional image model of the heart is generated particularly a generated image of a region of interest of said heart is generated wherein that region of interest would be selected to be an atria of the patients heart; figures 20-21; page 33, lines 23 – 33; page 35, lines 3-30; CLAIM 17).
Claims 5-7, and 16-18 are rejected under 35 § U.S.C. 103 as being obvious over WO 2007/092159 A2 to W, HUNDLEY (hereinafter “HUNDLEY”) in view of US 10,792,097 B2 to ZIV-ARI et al. (hereinafter “ZIV-ARI”)in view of Initial Experience with a Novel Focused Ultrasound Ablation System for Ring Ablation Outside the Pulmonary Vein to MEININGER et al. (hereinafter “MEININGER”) in further view of WO 2019/231844 A1 to M, BUCKLER et al. (hereinafter “BUCKLER”).
As per claim 5, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY fails to disclose wherein the structural segmentation of the cardiac tissue comprises at least one of left WACA, right WACA, ostial PVI, roof line, left carina, right carina, posterior line, inferior line, mitral isthmus line, anterior line, anterior line, and cavo-tricuspid isthmus, superior vena cava isolation.
BUCKLER discloses wherein the structural segmentation of the cardiac tissue comprises at least one of left WACA, right WACA, ostial PVI, roof line, left carina, right carina, posterior line, inferior line, mitral isthmus line, anterior line, anterior line, and cavo-tricuspid isthmus, superior vena cava isolation (the posterior line is estimated (segmented) by accounting a discrete donut shape known as a blob in order to compute the blobs which have been labeled by analyte type; page 51, lines 3-28).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have structural segmentation and estimation features to determine a structure of the heart of BUCKLER reference. The Suggestion/motivation for doing so would have been to provide the ability to accurately and efficiently estimate the wall composition as stated in BUCKLER page 51, lines 19-25. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 5.
As per claim 6, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the method of claim 1. Modified HUNDLEY fails to disclose wherein the evaluation engine extracts morphological features from the plurality of effective points according to the structural segmentation.
BUCKLER discloses wherein the evaluation engine extracts morphological features from the plurality of effective points according to the structural segmentation (the biological feature is observed as biomarkers which indicates the feature has a biological relation to the patient and would be morphological in the feature being observed by the system; page 40 lines 7-28; page 47, lines 14-26).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have the evaluation engine extracts morphological features of BUCKLER reference. The Suggestion/motivation for doing so would have been to observe dynamic tissue behavior such as permeability of cell tissues as suggested by BUCKLER at page 47, lines 14-16. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 6.
As per claim 7, HUNDLEY in view of ZIV-ARI in view of MEININGER in view of BUCKLER discloses the method of claim 6. Modified HUNDLEY fails to disclose wherein an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright); (x-norm, ynorm, z_norm); and (x norm ring, ynorm_ring, znorm_ring).
BUCKLER discloses wherein an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright) (tissue characteristics are measured as T1, T2, and T3 (xleft, yleft, zleft/right) in order to estimate morphological features via an algorithm such as dynamic tissue behavior and permeability of tissue types; page 47, lines 3-26); (x-norm, ynorm, z_norm) (wherein the blob model used to estimate distances for overlapping mapping of ablation lines has its data provided in 2D, 3D or 4D coordinates has its position normalized; page 49, line 2 - page 50, line 14); and (x norm ring, ynorm_ring, znorm_ring) (wherein the blob models are further normalized based on the overall vessel wall structure; page 49, line 2 - page 50, line 14).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright); (x-norm, ynorm, z_norm); and (x norm ring, ynorm_ring, znorm_ring); of BUCKLER reference. The Suggestion/motivation for doing so would have been to provide the ability to use an iterative interference procedure which allows for current estimate of analyte probability and visualization of blob boundaries as suggested by BUCKLER at page 50, lines 22-24. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 7.
As per claim 16, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY fails to disclose wherein the structural segmentation of the cardiac tissue comprises at least one of left WACA, right WACA, ostial PVI, roof line, left carina, right carina, posterior line, inferior line, mitral isthmus line, anterior line, anterior line, and cavo-tricuspid isthmus, superior vena cava isolation.
BUCKLER wherein the structural segmentation of the cardiac tissue comprises at least one of left WACA, right WACA, ostial PVI, roof line, left carina, right carina, posterior line, inferior line, mitral isthmus line, anterior line, anterior line, and cavo-tricuspid isthmus, superior vena cava isolation (the posterior line is estimated (segmented) by accounting a discrete donut shape known as a blob in order to compute the blobs which have been labeled by analyte type; page 51, lines 3-28).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have structural segmentation and estimation features to determine a structure of the heart of BUCKLER reference. The Suggestion/motivation for doing so would have been to provide the ability to accurately and efficiently estimate the wall composition as stated in BUCKLER page 51, lines 19-25. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 16.
As per claim 17, HUNDLEY in view of ZIV-ARI in view of MEININGER discloses the system of claim 12. Modified HUNDLEY fails to disclose wherein the evaluation engine extracts morphological features from the plurality of effective points according to the structural segmentation.
BUCKLER discloses wherein the evaluation engine extracts morphological features from the plurality of effective points according to the structural segmentation (the biological feature is observed as biomarkers which indicates the feature has a biological relation to the patient and would be morphological in the feature being observed by the system; page 40 lines 7-28; page 47, lines 14-26).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have the evaluation engine extracts morphological features of BUCKLER reference. The Suggestion/motivation for doing so would have been to observe dynamic tissue behavior such as permeability of cell tissues as suggested by BUCKLER at page 47, lines 14-16. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 17.
As per claim 18, HUNDLEY in view of ZIV-ARI in view of MEININGER in view of BUCKLER discloses the system of claim 17. Modified HUNDLEY fails to disclose wherein an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright); (x-norm, ynorm, z_norm); and (x norm ring, ynorm_ring, znorm_ring).
BUCKLER discloses wherein an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright) (tissue characteristics are measured as T1, T2, and T3 (xleft, yleft, zleft/right) in order to estimate morphological features via an algorithm such as dynamic tissue behavior and permeability of tissue types; page 47, lines 3-26); (x-norm, ynorm, z_norm) (wherein the blob model used to estimate distances for overlapping mapping of ablation lines has its data provided in 2D, 3D or 4D coordinates has its position normalized; page 49, line 2 - page 50, line 14); and (x norm ring, ynorm_ring, znorm_ring) (wherein the blob models are further normalized based on the overall vessel wall structure; page 49, line 2 - page 50, line 14).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify HUNDLEY to have an algorithm feature space of the morphological features comprises (x left, yleft, zleft), (x-right, yright, zright); (x-norm, ynorm, z_norm); and (x norm ring, ynorm_ring, znorm_ring); of BUCKLER reference. The Suggestion/motivation for doing so would have been to provide the ability to use an iterative interference procedure which allows for current estimate of analyte probability and visualization of blob boundaries as suggested by BUCKLER at page 50, lines 22-24. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine BUCKLER with modified HUNDLEY to obtain the invention as specified in claim 18.
Conclusion
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/Devin Dhooge/
USPTO Patent Examiner
Art Unit 2677
/ANDREW W BEE/Supervisory Patent Examiner, Art Unit 2677
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