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 .
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.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8-9, 11, 13-15, 17-18, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins et al., (US 20100312095; hereinafter Jenkins) in view of Kenet et al., (US 5016173; hereinafter Kenet), Reinders et al., (US 20150065899; hereinafter Reinders), Schwartz, (US 20180325597; hereinafter Schwartz), and Brewster et al., (US 20160135690; hereinafter Brewster).
Regarding claim 1, Jenkins discloses (Figures 1-18) a method for map-guided ablation, the method comprising the steps of: acquiring an image of a heart of a subject having a cardiac disorder and displaying the image on a screen display ([0103]), identifying a plurality of target sites (55t as shown in Figures 3, 7, and 15) on the image of the heart, wherein each target site (55t) is a cardiac tissue exhibiting electrical abnormality ([0089], [0104]); identifying one or more critical sites on the image of the heart (marked inside avoid zones 155 such as one for the phrenic nerve as explained in [0017] and shown in Figures 1, 3, and 7) wherein each critical site is an area which may be damaged as a result of ablating one or more of the target sites ([0104]: each avoid zone 155 is typically associated with certain regions of the anatomical structure that should not be treated e.g., ablated during active treatment e.g., ablation); designing treatment comprising interconnecting two of the plurality of target sites (55t) by drawing a target line (55p as shown in Figure 16) on the image of the heart ([0108], [0113]-[0115], [0127]), and a second line (avoid zone 155) that marks the critical sites (the instant specification discloses that the lines may encircle sites on the image, therefore the target path 55p is the target line as shown in Figure 16 and the line encircling the avoid zone 155 is the second line encircling critical sites such as the phrenic nerve as shown in Figures 1, 3, and 7), wherein the target line (55p) or the second line (avoid zone) is drawn automatically or manually by a physician ([0104], [0108], [0117], [0119]); inserting a catheter (80) comprising a plurality of ablation electrodes (80e) in the heart of the subject, wherein the catheter (80) is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality ([0020], [0141]); and ablating the cardiac tissue by using at least one of the plurality of ablation electrodes ([0128]-[0129]).
Jenkins fails to disclose receiving an input from a physician that indicates whether to proceed automatically or manually, and drawing, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually. However, Kenet teaches a method for map-guided imaging in which a physician is required to provide an input with which they may choose whether the system functions will proceed automatically or manually (Col. 8, lines 52-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins to include the steps of receiving an input from input from a physician that indicates whether to proceed automatically or manually, and proceeding according to the input, as taught by Kenet, because the modification would provide control over the set-up of how the method is run for preferred use (Kenet; Col. 8, lines 36-58). Furthermore, since the modified method would include receiving an input from input from a physician that indicates whether to proceed automatically or manually, the method would continue by drawing, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually.
Jenkins/Kenet fails to teach automatically selecting at least one ablation electrode of the plurality of the ablation electrodes, the at least one ablation electrode being closest to the target line; automatically selecting, by a processor, one or more ablation electrodes of the plurality of ablation electrodes, the one or more ablation electrodes being positioned along the target line based on their spatial location; assigning, by the processor, ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line and the one or more critical sites; and automatically ablating the cardiac tissue by using the selected ablation electrodes and the assigned ablation parameters. However, Reinders teaches a method for ablation, including identifying a plurality of target sites on an image ([0087]: an ablation pattern may be formed, which would include a plurality of target sites; [0016]: the device may be configured to concurrently display a map depicting a surface of a tissue wall of the bodily cavity with the graphical representation of the transducer-based device); designing treatment comprising interconnecting two target sites of the plurality of target sites by marking a target line on the image of the heart ([0126]-[0130], [0219]): an ablation path may be selected on the graphical representation between target sites); automatically selecting one or more ablation electrodes of the plurality of the ablation electrodes, the one or more ablation electrodes being positioned along the target line based on their spatial location ([0126]-[0130]; [0130]: the electrode corresponding to a selected path is selected, which is closest to the path); assigning ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line ([0016]-[0017], [0274]); and automatically ablating the cardiac tissue by using the selected ablation electrodes selected and the assigned ablation parameters ([0093], [0126]-[0130], [0219]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet to include the above-mentioned steps, as taught by Reinders, because the modification would exhibit enhanced capabilities for transducer activation (Reinders, [0007]). Furthermore, since the treatment of the primary reference is designed using the target line and the second line corresponding to the one or more critical sites, the processor of the modified method would be configured to assign ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line and the one or more critical sites.
Jenkins/Kenet/Reinders fails to teach automatically assigning one or more ablation parameters based on a proximity of the second line to the target line. However, Schwartz (Figures 1A-2B) teaches a method of map-guided ablation in which operating parameters are automatically assigned during a planning phase based on a proximity of a line/lines (corresponding to the critical sites) to a target line ([0130]-[0134], [0164]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders to include the step of automatically assigning one or more ablation parameters based on a proximity of different planned lines (i.e. the second line and the target line), as taught by Schwartz, because the modification would mitigate the potential for collateral tissue damage (Schwartz; [00164]).
Jenkins/Kenet/Reinders/Schwartz fails to teach that the catheter is a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart; the one or more ablation electrodes being in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line. However, Brewster (Figures 1-5D) a method for map-guided ablation, wherein the catheter is a basket catheter (320) having a catheter body (314) that includes multiple splines (304), each spline containing a plurality of ablation electrodes (315), ([0125]); registering, with a positioning system (324), the basket catheter (320); determining, by a processor (310) using signals from location electrodes of the basket catheter (320) and the positioning system (324), three-dimensional spatial locations of the plurality of ablation electrodes (315) in a coordinate system of the image of the heart ([0144]-[0150]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz to include a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart, as taught by Brewster, because the modification would enable mapping, ablating or stimulating an inside surface of a bodily cavity or lumen without requiring mechanical scanning (Brewster; [0125]). Furthermore, since the modified method would include the three-dimensional spatial locations of the ablation electrodes, the one or more ablation electrodes of the modified method would be in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line.
Regarding claims 8-9, the modified method includes the catheter guiding system taught by Schwartz, which further teaches automatically assigning one or more ablation parameters, wherein the one or more ablation parameters include an ablation energy ([0103]), wherein the ablation energy is decreased based on the proximity of the target line to the one or more critical sites ([0130]-[0134], [0164]), further wherein the one or more ablation parameters include an ablation duration ([0130]-[0134], [0164]), and wherein the ablation duration is decreased based on the proximity of the target line to the one or more critical sites ([0130]-[0134], [0164]).
Regarding claim 11, Jenkins further discloses that the image is an electro-anatomic map of the heart ([0103]).
Regarding claim 13, Jenkins discloses (Figures 1-18) a system for automatically ablating target tissue in a heart of a patient comprising: a screen display (20) and a processor, wherein the processor is configured to acquire an image of a heart of a subject having a cardiac disorder, display the image on a screen display ([0103]), identify a plurality of target sites (55t as shown in Figures 3, 7, and 15) on the image of the heart, wherein each target site (55t) is a cardiac tissue exhibiting electrical abnormality ([0089], [0104]); identify one or more critical sites on the image of the heart (marked inside avoid zones 155 such as one for the phrenic nerve as explained in [0017] and shown in Figures 1, 3, and 7) wherein each critical site is an area which may be damaged as a result of ablating one or more of the target sites ([0104]: each avoid zone 155 is typically associated with certain regions of the anatomical structure that should not be treated e.g., ablated during active treatment e.g., ablation), draw a target line (55p) on the image of the heart and a second line (avoid zone) that marks the critical sites ([0089], [0104], [0108], [0113], [0127]); a catheter (80) comprising a plurality of ablation electrodes (80e), wherein the plurality of ablation electrodes (80e) is configured to be brought into contact with target tissue ([0020], [0141]); a generator adapted to automatically ablate the heart ([0128]-[0129]).
Jenkins fails to disclose that the processor is configured to receive an input from a physician that includes whether to enable automatic or manual selection, and draw, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually. However, Kenet teaches a system for map-guided imaging in which a physician is required to provide an input with which they may choose whether the system functions will proceed automatically or manually (Col. 8, lines 52-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins to include that the processor is configured to receive an input from a physician that includes whether to enable automatic or manual selection, and proceed according to the input, as taught by Kenet, because the modification would provide control over the set-up of how the method is run for preferred use (Kenet; Col. 8, lines 36-58). Furthermore, since the modified system would include receiving an input from input from a physician that indicates whether to proceed automatically or manually, the method would continue by drawing, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually.
Jenkins/Kenet fails to teach a navigator configured to automatically select at least one ablation electrode of the plurality of ablation electrodes, the at least one ablation electrode being positioned along the target line; the processor configured to automatically select, based on spatial alignment to the target line, one or more ablation electrodes of a catheter comprising a plurality of ablation electrodes; and assign ablation parameters to each of the selected ablation electrodes based on their position relative to the target line and the one or more critical sites; and a generator adapted to automatically ablate the heart using the selected ablation electrodes and the assigned ablation parameters. However, Reinders teaches (Figures 1-6) a catheter guiding system which includes a navigator (data processing device system), wherein the navigator is configured to select at least one ablation electrode of the plurality of the ablation electrodes, the at least one ablation electrode being positioned along the target line ([0126]-[0130]; [0130]: the electrode corresponding to a selected path is selected, which is positioned along the target line path); a processor adapted to store programs in a memory ([0076], [0081]), the programs configured to automatically select, based on spatial alignment to the target line, one or more ablation electrodes of a catheter comprising a plurality of ablation electrodes; and assign ablation parameters to each of the selected ablation electrodes based on their position relative to the target line ([0016]-[0017], [0274]); and a generator adapted to automatically ablate the heart using the selected ablation electrodes and the assigned ablation parameters ([0093], [0126]-[0130]), [0219]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet to include the navigator, generator, and programs taught by Reinders because the modification would exhibit enhanced capabilities for transducer activation (Reinders, [0007]). Furthermore, since the treatment of the primary reference is designed using the target line and the second line corresponding to the one or more critical sites, the processor of the modified method would be configured to assign ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line and the one or more critical sites.
Jenkins/Kenet/Reinders fails to teach that the processor is configured to assign one or more ablation parameters based on a proximity of the second line to the target line. However, Schwartz (Figures 1A-2B) teaches a method of map-guided ablation in which operating parameters are automatically assigned during a planning phase based on a proximity of a line/lines (corresponding to the critical sites) to a target line ([0130]-[0134], [0164]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders to include the step of automatically assigning one or more ablation parameters based on a proximity of different planned lines (i.e. the second line and the target line), as taught by Schwartz, because the modification would mitigate the potential for collateral tissue damage (Schwartz; [00164]).
Jenkins/Kenet/Reinders/Schwartz fails to teach that the catheter is a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart; the one or more ablation electrodes being in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line. However, Brewster (Figures 1-5D) a method for map-guided ablation, wherein the catheter is a basket catheter (320) having a catheter body (314) that includes multiple splines (304), each spline containing a plurality of ablation electrodes (315), ([0125]); registering, with a positioning system (324), the basket catheter (320); determining, by a processor (310) using signals from location electrodes of the basket catheter (320) and the positioning system (324), three-dimensional spatial locations of the plurality of ablation electrodes (315) in a coordinate system of the image of the heart ([0144]-[0150]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz to include a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart, as taught by Brewster, because the modification would enable mapping, ablating or stimulating an inside surface of a bodily cavity or lumen without requiring mechanical scanning (Brewster; [0125]). Furthermore, since the modified method would include the three-dimensional spatial locations of the ablation electrodes, the one or more ablation electrodes of the modified method would be in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line.
Regarding claim 14, Jenkins further discloses that the image is an electro-anatomic map of the heart ([0103]).
Regarding claim 15, the modified system includes the catheter guiding system taught by Reinders, which further teaches that the catheter is one of a lasso catheter or a basket catheter ([0101]).
Regarding claim 17, Jenkins/Reinders teaches the system of claim 13, and Jenkins further discloses that the catheter comprises a plurality of ablation electrodes ([0020], [0141]), but fails to disclose that the catheter comprises specifically at least thirty ablation electrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Reinders to include at least thirty ablation electrodes since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 18, the modified system includes the catheter guiding system taught by Schwartz, which further teaches automatically assigning one or more ablation parameters, wherein the one or more ablation parameters include an ablation energy ([0103]), wherein the ablation energy is decreased based on the proximity of the target line to the one or more critical sites ([0130]-[0134], [0164]).
Regarding claim 21, Jenkins discloses (Figures 1-18) a computer software product, including a non-transitory computer readable storage medium in which computer program instructions are stored ([0034]-[0039], [0255]-[0260]), which instructions, when executed by a computer, cause the computer to perform a method comprising: acquiring an image of a heart of a subject having a cardiac disorder and displaying the image on a screen display (20), ([0103]); identifying a plurality of target sites (55t) on the image of the heart, wherein each target site (55t) is a cardiac tissue exhibiting electrical abnormality; identifying one or more critical sites on the image of the heart (marked inside avoid zones 155 such as one for the phrenic nerve as explained in [0017] and shown in Figures 1, 3, and 7), wherein each critical site is an area which may be damaged as a result of ablating one or more of the target sites ([0104]: each avoid zone 155 is typically associated with certain regions of the anatomical structure that should not be treated e.g., ablated during active treatment e.g., ablation); designing treatment comprising interconnecting two of the plurality of target sites (55t) by drawing a target line (55p) on the image of the heart ([0089], [0104]), drawing a target line (55p) on the image of the heart and a second line (avoid zone) that marks the critical sites ([0089], [0104], [0108], [0113], [0127]), wherein the target line (55p) or the second line (avoid zone) is drawn automatically or manually by a physician ([0104], [0108]); inserting a catheter (80) comprising a plurality of ablation electrodes (80e) in the heart of the subject, wherein the catheter (80) is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality ([0020], [0141]); and automatically ablating the cardiac tissue by using the at least one selected ablation electrode ([0128]-[0129]).
Jenkins fails to disclose receiving an input from input from a physician that indicates whether to proceed automatically or manually, and drawing, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually. However, Kenet teaches a method for map-guided imaging in which a physician is required to provide an input with which they may choose whether the system functions will proceed automatically or manually (Col. 8, lines 52-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins to include the steps of receiving an input from input from a physician that indicates whether to proceed automatically or manually, and proceeding according to the input, as taught by Kenet, because the modification would provide control over the set-up of how the method is run for preferred use (Kenet; Col. 8, lines 36-58). Furthermore, since the modified product would include receiving an input from input from a physician that indicates whether to proceed automatically or manually, the method would continue by drawing, in accordance with the input, the target line and the second line automatically when the input indicates automatically and manually by the physician when the input indicates manually.
Jenkins/Kenet fails to teach automatically selecting at least one ablation electrode of the plurality of the ablation electrodes, the at least one ablation electrode being closest to the target line; automatically selecting, by a processor, one or more ablation electrodes of the plurality of ablation electrodes, the one or more ablation electrodes being positioned along the target line based on their spatial location; assigning, by the processor, ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line and the one or more critical sites; and automatically ablating the cardiac tissue by using the selected ablation electrodes and the assigned ablation parameters. However, Reinders teaches a method for ablation, including identifying a plurality of target sites on an image ([0087]: an ablation pattern may be formed, which would include a plurality of target sites; [0016]: the device may be configured to concurrently display a map depicting a surface of a tissue wall of the bodily cavity with the graphical representation of the transducer-based device); designing treatment comprising interconnecting two target sites of the plurality of target sites by marking a target line on the image of the heart ([0126]-[0130], [0219]): an ablation path may be selected on the graphical representation between target sites); automatically selecting one or more ablation electrodes of the plurality of the ablation electrodes, the one or more ablation electrodes being positioned along the target line based on their spatial location ([0126]-[0130]; [0130]: the electrode corresponding to a selected path is selected, which is closest to the path); assigning ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line ([0016]-[0017], [0274]); and automatically ablating the cardiac tissue by using the selected ablation electrodes selected and the assigned ablation parameters ([0093], [0126]-[0130], [0219]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet to include the above-mentioned steps, as taught by Reinders, because the modification would exhibit enhanced capabilities for transducer activation (Reinders, [0007]). Furthermore, since the treatment of the primary reference is designed using the target line and the second line corresponding to the one or more critical sites, the processor of the modified method would be configured to assign ablation parameters to each of the selected ablation electrodes based on their location with respect to the target line and the one or more critical sites.
Jenkins/Kenet/Reinders fails to teach automatically assigning one or more ablation parameters based on a proximity of the second line to the target line. However, Schwartz (Figures 1A-2B) teaches a method of map-guided ablation in which operating parameters are automatically assigned during a planning phase based on a proximity of a line/lines (corresponding to the critical sites) to a target line ([0130]-[0134], [0164]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders to include the step of automatically assigning one or more ablation parameters based on a proximity of different planned lines (i.e. the second line and the target line), as taught by Schwartz, because the modification would mitigate the potential for collateral tissue damage (Schwartz; [00164]).
Jenkins/Kenet/Reinders/Schwartz fails to teach that the catheter is a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart; the one or more ablation electrodes being in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line. However, Brewster (Figures 1-5D) a method for map-guided ablation, wherein the catheter is a basket catheter (320) having a catheter body (314) that includes multiple splines (304), each spline containing a plurality of ablation electrodes (315), ([0125]); registering, with a positioning system (324), the basket catheter (320); determining, by a processor (310) using signals from location electrodes of the basket catheter (320) and the positioning system (324), three-dimensional spatial locations of the plurality of ablation electrodes (315) in a coordinate system of the image of the heart ([0144]-[0150]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz to include a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart, as taught by Brewster, because the modification would enable mapping, ablating or stimulating an inside surface of a bodily cavity or lumen without requiring mechanical scanning (Brewster; [0125]). Furthermore, since the modified method would include the three-dimensional spatial locations of the ablation electrodes, the one or more ablation electrodes of the modified method would be in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line.
Regarding claim 22, the modified system includes the catheter guiding system taught by Schwartz, which further teaches automatically assigning one or more ablation parameters, wherein the one or more ablation parameters include an ablation duration ([0130]-[0134], [0164]), and wherein the ablation duration is decreased based on the proximity of the target line to the one or more critical sites ([0130]-[0134], [0164]).
Regarding claim 23, the modified product includes the catheter guiding system taught by Schwartz, which further teaches automatically assigning one or more ablation parameters, wherein the one or more ablation parameters include an ablation duration ([0130]-[0134], [0164]), and wherein the ablation duration is decreased based on the proximity of the target line to the one or more critical sites ([0130]-[0134], [0164]).
Regarding claim 24, Jenkins further discloses (Figures 1-18) wherein the target line (55p) comprises a line encircling at least two pulmonary veins of the subject selected from a left superior pulmonary vein, a left inferior pulmonary vein, a right superior pulmonary vein, and aright inferior pulmonary vein, and optionally further comprises a line encircling a superior vena cava ([0103], [0167], [0170]).
Regarding claim 25, Jenkins further discloses (Figures 1-18) wherein identifying the plurality of target sites (55t) comprises determining, at locations along the target line (55p), at least one of tissue thickness and presence of scar tissue, and wherein assigning the ablation parameters comprises modifying at least one of an ablation time, an ablation temperature, and an ablation energy for the selected ablation electrodes based on the determined tissue thickness and/or presence of scar tissue at corresponding locations on the image of the heart ([0186], [0192], ([0274]-[0278]).
Regarding claim 26, Jenkins/Kenet/Reinders/Schwartz/Brewster further teaches wherein assigning the ablation parameters includes, for at least one of the selected ablation electrodes that overlies the second line or is located in proximity to the one or more critical sites, assigning ablation parameters that avoid delivery of ablation energy at that ablation electrode so as to skip ablation at that location, as explained in the rejection of claim 1.
Regarding claim 27, Jenkins/Kenet/Reinders/Schwartz/Brewster further teaches wherein the basket catheter (Brewster; 320) further comprises an array of temperature sensors (Brewster; 408) located adjacent the plurality of ablation electrodes (Brewster; 315), the array of temperature sensors (Brewster; 408) being configured to monitor local tissue heating during ablation to prevent collateral damage to at least one of an epicardium, lungs, and an esophagus (Brewster; [0129]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jenkins/Kenet/Reinders/Schwartz/Brewster as applied to claim 1 above, and further in view of Groth et al., (US 20080300588; hereinafter Groth).
Regarding claim 12, Jenkins/Kenet/Reinders/Schwartz/Brewster teaches the method of claim 1, but fails to disclose comparing the plurality of target sites before the ablation with the plurality of target sites after ablation and indicating differences. However, Groth teaches a method for map-guided automatic ablation, wherein the plurality of target sites before the ablation are compared with the plurality of target sites after and ablation differences are indicated to identify new points in need of ablation ([0032]-[0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz/Brewster to include the step of comparing the target sites before the ablation with the target sites after ablation and indicating differences, as taught by Groth, because the modification would provide a post-ablation outcome control procedure (Groth, [0032]) to ensure successful treatment.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins/Kenet/Reinders/Schwartz/Brewster as applied to claim 13 above, and further in view of Groth.
Regarding claim 19, Jenkins/Kenet/Reinders/Schwartz/Brewster teaches the system of claim 13, but fails to disclose that the navigator is a magnetic-based navigator or an impedance-based navigator. However, Groth teaches a system for automatically ablating target tissue, wherein the system uses a magnetic-based navigator ([0022], [0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz/Brewster to include a magnetic-based navigator, as taught by Groth, because the modification would automatically guide the catheter, without user intervention (Groth, [0031]) making the system easy to use.
Regarding claim 20, Jenkins/Kenet/Reinders/Schwartz/Brewster teaches the system of claim 13, but fails to disclose that the processor is adapted to compare the target sites after ablation with the target sites before ablation and indicate differences. However, Groth teaches a system for automatically ablating target tissue, wherein a processing device is adapted to compare the target sites before the ablation with the target sites after ablation and indicate differences to identify new points in need of ablation ([0032]-[0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz/Brewster such that the processing device is adapted to compare the target sites after ablation with the target sites before ablation and indicate differences, as taught by Groth, because the modification would provide a post-ablation outcome control procedure (Groth, [0032]) to ensure successful treatment.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Jenkins/Kenet/Reinders/Schwartz/Brewster, as applied to claim 1 above.
Regarding claim 28, Jenkins/Kenet/Reinders/Schwartz/Brewster teaches the method of claim 1, but fails to teach wherein the basket catheter comprises from 50 to 54 ablation electrodes each having a size of 4 mm and spaced from 3 mm to 4 mm from an adjacent ablation electrode. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz/Brewster to include the basket catheter comprising from 50 to 54 ablation electrodes each having a size of 4 mm and spaced from 3 mm to 4 mm from an adjacent ablation electrode since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Jenkins/Kenet/Reinders/Schwartz/Brewster, as applied to claim 13 above.
Regarding claim 29, Jenkins/Kenet/Reinders/Schwartz/Brewster teaches the system of claim 13, but fails to teach wherein the basket catheter comprises from 50 to 54 ablation electrodes each having a size of 4 mm and spaced from 3 mm to 4 mm from an adjacent ablation electrode. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jenkins/Kenet/Reinders/Schwartz/Brewster to include the basket catheter comprising from 50 to 54 ablation electrodes each having a size of 4 mm and spaced from 3 mm to 4 mm from an adjacent ablation electrode since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Response to Arguments
Applicant’s arguments, filed 12/03/2025, with regard to the newly filed claim amendments, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Brewster, which teaches a basket catheter having a catheter body that includes multiple splines, each spline containing a plurality of ablation electrodes; registering, with a positioning system, the basket catheter, wherein the basket catheter is inserted into a portion of the heart having the cardiac tissue exhibiting the electrical abnormality; determining, by a processor using signals from location electrodes of the basket catheter and the positioning system, three-dimensional spatial locations of the plurality of ablation electrodes in a coordinate system of the image of the heart. The combination of references teaches the one or more ablation electrodes being in proximity to and positioned along the target line based on the determined three- dimensional spatial locations of the ablation electrodes relative to the target line. Therefore, the new combination of references teaches the invention as recited in the newly amended set of claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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