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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2nd, 2026 has been entered.
Response to Amendment
The amendment filed January 2nd, 2026 has been entered. Claims 1, 11, & 21 are amended. Claim 20 is cancelled. Claims 1-19, & 21 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-19 & 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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, 4-5, 9, 11-12, 14-15, 19, & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Moisa (previously presented-US 20200022653 A1), hereinafter “Moisa”, in view of Ninni et al. (US 20220202500 A1), hereinafter “Ninni”.
Regarding claim 1, Moisa discloses a system for use with a catheter having a distal structure including (a) a plurality of electrodes ([0078] & [0102]-[0104]; Figure 3C—elements 300 & 306), the system comprising:(b) a display ([0111]; Figure 3C—element 332); and(c) a processor ([0110] & [0111]; Figure 3C—element 324), configured to:(1) ascertain a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0078], & [0134]-[0138]; Figure 6—elements 602 & 604; the processor is configured to receive a degree of contact signal from the plurality of transducers/electrodes 306 indicating whether each transducer is contacting the vessel wall, and identify which transducers/electrodes 306 are not in contact with the vessel wall), and (2) in response to the number equaling or exceeding a predefined lower threshold ([0133], & [0134]-[0137]; the examiner is considering the lower threshold to be a threshold wherein at least one transducer/electrode in the desired group has sufficient contact), carry out an iterative process including, during each iteration of the process:(A) in response to the number being less than a predefined higher threshold ([0133], & [0134]-[0137]; the examiner is considering the predefined higher threshold to be all transducers/electrodes within the desired group comprising sufficient contact/the predetermined tissue contact state), computing an adjustment to a current pose of the distal structure ([0133]), (B) displaying, on the display, a target-pose icon including electrode depictions, which represents the distal structure, offset, per the adjustment, from a current-pose icon representing the distal structure at the current pose (([0068], [0086], [0140], [0146]-[0152], & [0156]-[0158]; Figures 5A-5N & 7A-7D; Figure 6—element 606; the display device is configured to display a graphical representation including a three-dimensional graphical representation of at least a portion of the device (e.g. at least structure 308 in Figs. 3); in response to the number being less than the predefined higher threshold (e.g. transducers/electrodes in the selected group are identified as having insufficient contact), the controller is configured to instruct the user how best to manipulate the catheter in order to improve contact (e.g. a contact improvement procedure); the contact improvement procedure may include a visual presentation provided by the display device and may include text based instruction, graphic symbol-based instruction, and/or graphical animations that represent the catheter device system, the contact improvement procedure may be defined in terms of the resulting movements of the structure 308 (see figures 5A-5N & 7A-7D); the examiner is considering the target-pose icon to be the visual presentation of the contact improvement procedure which may be graphical animations that represent the catheter device system and defined in terms of the resulting movements of the structure 308 and the current pose icon to be the three-dimensional graphical representation of the device 308).
Moisa does not disclose the target-pose icon and the current-pose icon are shown simultaneously on the display, and (C) displaying an adjustment indicator with the target-pose icon and the current-pose icon as a visual indication of the adjustment.
Ninni teaches a system for computing and displaying an adjustment to a current pose of a distal structure of an ablation device ([0046]) comprising displaying, on a display, a target-pose icon, which represents the distal structure, offset, per the adjustment ([0050], [0060], & [0063]-[0064]; Figures 4A-5A—element 430; a “ghost” (non-real-time) image 430 of the tool is displayed in a virtual image that represents a proposed or desired position based on the treatment plan), from a current-pose icon representing the distal structure at the current pose ([0060], & [0063]-[0064]; Figures 4A-5B—element 432; a real-time image 432 of the tool is displayed in the virtual image) such that the target-pose icon and the current-pose icon are shown simultaneously on the display ([0060], & [0063]-[0064]; Figures 4A-5B—elements 430 & 432), and (C) displaying an adjustment indicator with the target-pose icon and the current-pose icon as a visual indication of the adjustment ([0063] & [0064]; Figure 5A—element 426).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include wherein the target-pose icon and the current-pose icon are shown simultaneously on the display, and displaying an adjustment indicator with the target-pose icon and the current-pose icon as a visual indication of the adjustment, as taught by Ninni, as both references and the claimed invention are directed toward systems configured to correct the position of an ablation device. As disclosed by Moisa, the indication of the target-pose icon may include a visual presentation provided by the display including one or more text based instructions, one or more graphical symbols, or one or more graphical animations which instruct the user to manipulate the catheter to improve contact, the indication may be defined in resulting movement of the distal structure or may be defined in terms of movements applied to a handle of the device, however, the indication may be visually indicated in other ways and the present invention is not limited to any particular one of the above discussed approaches ([0156]-[0158]). As disclosed by Ninni, the target-pose icon and the current-pose can both be displayed on the screen along with an indicator that shows a direction and magnitude which is indicative of the distance between the two poses, this allows a user to interactively move the current-pose icon toward the target-pose icon to align the current-pose icon with the target-pose icon and thus move the device in the desired position, this configuration allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose ([0054], [0060], & [0063]-[0064]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include wherein the target-pose icon and the current-pose icon are shown simultaneously on the display, and displaying an adjustment indicator with the target-pose icon and the current-pose icon as a visual indication of the adjustment, as taught by Ninni, as such a modification would produce the predictable result of providing a suitable and known display for instructing a user to improve contact between the target tissue and the device, and would also allow a user to interactively move the current-pose icon toward the target-pose icon to align the current-pose icon with the target-pose icon and thus move the device in the desired position, which allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose.
Regarding claim 2, Moisa in view of Ninni disclose all of the limitations of claim 1, as described above.
Moisa further discloses the displaying including rendering the target-pose icon and the current-pose icon in three dimensions ([0124], [0140] & [0156]-[0158]; the graphical representations may include three-dimensional graphical representations).
Regarding claim 4, Moisa in view of Ninni disclose all of the limitations of claim 1, as described above.
Moisa further discloses the computing the adjustment including (a) computing a translation of the distal structure in case the number is less than a predefined middle threshold, which is between the lower threshold and the higher threshold ([0011], [0116], [0127], & [0128]; Figures 3E, 3F, & 8A; the examiner is considering the middle threshold to be when a first set of electrodes is in contact with a tissue wall; a first contact improvement procedure may include a translation (advancement or retraction) of the assembly to improve the contact between the first set of electrodes and the tissue wall), or (b) computing a rotation of the distal structure in case the number is equal to or greater than the middle threshold ([0011], [0128], [0164], & [0165]; Figures 3G, 3H, & 10B; the examiner is considering the middle threshold to be when a first set of electrodes is in contact with a tissue wall; once the first set of electrodes have been moved and are in improved contact with the tissue wall, a second contact improvement procedure may be performed and may include a rotation for moving a second set of electrodes into contact with the tissue wall).
Regarding claim 5, Moisa in view of Ninni disclose all of the limitations of claim 4, as described above.
Moisa further discloses the translation being along a proximal-distal axis of the distal structure ([0016] & [0127]; Figures 3E & 3F).
Regarding claim 9, Moisa in view of Ninni disclose all of the limitations of claim 4, as described above.
Moisa further discloses the translation ([0011], [0116], [0127], & [0128]); although, Moisa is silent to the translation being less than 5 mm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the translation being less than 5 mm, 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. In re Aller, 105 USPQ 233.
Regarding method claim 11, Moisa discloses a method for use with a catheter having a distal structure including a plurality of electrodes ([0078] & [0102]; Figure 3C—elements 300 & 306), the method comprising:(a) ascertaining a number of the plurality of electrodes contacting an ostium of a pulmonary vein ([0078], & [0134]-[0138]; Figure 6—elements 602 & 604; the processor is configured to receive a degree of contact signal from the plurality of transducers/electrodes 306 indicating whether each transducer is contacting the vessel wall, and identify which transducers/electrodes 306 are not in contact with the vessel wall); and (b) in response to the number of electrodes equaling or exceeding a predefined lower threshold ([0133], & [0134]-[0137]; the examiner is considering the lower threshold to be a threshold wherein at least one transducer/electrode in the desired group has sufficient contact), carrying out an iterative process including, during each iteration of the process:(1) in response to the number being less than a predefined higher threshold ([0133], & [0134]-[0137]; the examiner is considering the predefined higher threshold to be all transducers/electrodes within the desired group comprising sufficient contact/the predetermined tissue contact state), computing an adjustment to a current pose of the distal structure; and (2) displaying a target-pose icon, which represents the distal structure, offset, per the adjustment, from a current-pose icon representing the distal structure at the current pose ([0068], [0146]-[0152], & [0156]-[0158]; Figures 5A-5N & 7A-7D; Figure 6—element 606; In response to the number being less than the predefined higher threshold (e.g. transducers/electrodes in the selected group are identified as having insufficient contact), the controller is configured to instruct the user how best to manipulate the catheter in order to improve contact (e.g. a contact improvement procedure); the contact improvement procedure may include a visual presentation provided by the display device and may include text based instruction, graphic symbol-based instruction, and/or graphical animations that represent the catheter device system(see figures 5A-5N & 7A-7D))
Moisa does not disclose wherein a difference between the current-pose icon and the target-pose icon is displayed, the current-pose icon overlapping and thereby covering at least a portion of the target-pose icon.
Ninni teaches a system for computing and displaying an adjustment to a current pose of a distal structure of an ablation device ([0046]) comprising displaying, on a display, a target-pose icon, which represents the distal structure, offset, per the adjustment ([0050], [0060], & [0063]-[0064]; Figures 4A-5A—element 430; a “ghost” (non-real-time) image 430 of the tool is displayed in a virtual image that represents a proposed or desired position based on the treatment plan), from a current-pose icon representing the distal structure at the current pose ([0060], & [0063]-[0064]; Figures 4A-5B—element 432; a real-time image 432 of the tool is displayed in the virtual image) wherein a difference between the current-pose icon and the target-pose icon is displayed, the current-pose icon overlapping and thereby covering at least a portion of the target-pose icon ([0060], & [0063]-[0064]; Figures 4A-5B—elements 426, 430, 432).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include wherein a difference between the current-pose icon and the target-pose icon is displayed, the current-pose icon overlapping and thereby covering at least a portion of the target-pose icon, as taught by Ninni, as both references and the claimed invention are directed toward systems configured to correct the position of an ablation device. As disclosed by Moisa, the indication of the target-pose icon may include a visual presentation provided by the display including one or more text based instructions, one or more graphical symbols, or one or more graphical animations which instruct the user to manipulate the catheter to improve contact, the indication may be defined in resulting movement of the distal structure or may be defined in terms of movements applied to a handle of the device, however, the indication may be visually indicated in other ways and the present invention is not limited to any particular one of the above discussed approaches ([0156]-[0158]). As disclosed by Ninni, the target-pose icon and the current-pose can both be displayed on the screen along with an indicator that shows a direction and magnitude which is indicative of the distance between the two poses, this allows a user to interactively move the current-pose icon toward the target-pose icon to algin with and overlap the target-pose icon and thus move the device in the desired position, this configuration allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose ([0054], [0060], & [0063]-[0064]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include wherein a difference between the current-pose icon and the target-pose icon is displayed, the current-pose icon overlapping and thereby covering at least a portion of the target-pose icon, as taught by Ninni, as such a modification would produce the predictable result of providing a suitable and known display for instructing a user to improve contact between the target tissue and the device, and would also allow a user to interactively move the current-pose icon toward the target-pose icon to align with and overlap the target-pose icon and thus move the device in the desired position, which allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose.
Regarding method claim 12, Moisa in view of Ninni disclose all of the limitations of claim 11, as described above.
Moisa further discloses the displaying comprising rendering the target-pose icon and the current-pose icon in three dimensions ([0124], [0140] & [0156]-[0158]; the graphical representations may include three-dimensional graphical representations).
Regarding method claim 14, Moisa in view of Ninni disclose all of the limitations of claim 11, as described above.
Moisa further discloses the computing the adjustment comprising (a) computing a translation provided the number is less than a predefined middle threshold, which is between the lower threshold and the higher threshold ([0011], [0116], [0127], & [0128]; Figures 3E, 3F, & 8A; the examiner is considering the middle threshold to be when a first set of electrodes is in contact with a tissue wall; a first contact improvement procedure may include a translation (advancement or retraction) of the assembly to improve the contact between the first set of electrodes and the tissue wall); or (b) computing a rotation provided the number is equal to or greater than the middle threshold ([0011], [0128], [0164], & [0165]; Figures 3G, 3H, & 10B; the examiner is considering the middle threshold to be when a first set of electrodes is in contact with a tissue wall; once the first set of electrodes have been moved and are in improved contact with the tissue wall, a second contact improvement procedure may be performed and may include a rotation for moving a second set of electrodes into contact with the tissue wall).
Regarding method claim 15, Moisa in view of Ninni disclose all of the limitations of claim 14, as described above.
Moisa further discloses the translation being along a proximal-distal axis of the distal structure ([0016] & [0127]; Figures 3E & 3F).
Regarding method claim 19, Moisa in view of Ninni disclose all of the limitations of claim 14, as described above.
Moisa further discloses the translation ([0011], [0116], [0127], & [0128]); although, Moisa is silent to the translation being less than 5 mm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the translation being less than 5 mm, 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. In re Aller, 105 USPQ 233.
Regarding claim 21, Moisa discloses a system for use with a catheter having a distal structure including (a) a plurality of electrodes ([0078] & [0102]; Figure 3C—elements 300 & 306), the system comprising:(b) a display ([0111]; Figure 3C—element 332); and(c) a processor ([0110] & [0111]; Figure 3C—element 324), configured to:(1) ascertain a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0078], & [0134]-[0138]; Figure 6—elements 602 & 604; the processor is configured to receive a degree of contact signal from the plurality of transducers/electrodes 306 indicating whether each transducer is contacting the vessel wall, and identify which transducers/electrodes 306 are not in contact with the vessel wall), and (2) in response to the number equaling or exceeding a predefined lower threshold ([0133], & [0134]-[0137]; the examiner is considering the lower threshold to be a threshold wherein at least one transducer/electrode in the desired group has sufficient contact), carry out a process including:(A) in response to the number being less than a predefined higher threshold ([0133], & [0134]-[0137]; the examiner is considering the predefined higher threshold to be all transducers/electrodes within the desired group comprising sufficient contact/the predetermined tissue contact state), computing an adjustment to a current pose of the distal structure, and(B) displaying, on the display, a target-pose icon, which represents the distal structure, per the adjustment, from a current-pose icon representing the distal structure at the current pose ([0068], [0146]-[0152], & [0156]-[0158]; Figures 5A-5N & 7A-7D; Figure 6—element 606; In response to the number being less than the predefined higher threshold (e.g. transducers/electrodes in the selected group are identified as having insufficient contact), the controller is configured to instruct the user how best to manipulate the catheter in order to improve contact (e.g. a contact improvement procedure); the contact improvement procedure may include a visual presentation provided by the display device and may include text based instruction, graphic symbol-based instruction, and/or graphical animations that represent the catheter device system(see figures 5A-5N & 7A-7D)).
Moisa does not disclose the current-pose icon overlapping the target-pose icon on the display such that the current-pose icon covers at least a portion of the target-pose icon.
Ninni teaches a system for computing and displaying an adjustment to a current pose of a distal structure of an ablation device ([0046]) comprising displaying, on a display, a target-pose icon, which represents the distal structure, offset, per the adjustment ([0050], [0060], & [0063]-[0064]; Figures 4A-5A—element 430; a “ghost” (non-real-time) image 430 of the tool is displayed in a virtual image that represents a proposed or desired position based on the treatment plan), from a current-pose icon representing the distal structure at the current pose ([0060], & [0063]-[0064]; Figures 4A-5B—element 432; a real-time image 432 of the tool is displayed in the virtual image) the current-pose icon overlapping the target-pose icon on the display such that the current-pose icon covers at least a portion of the target-pose icon ([0060], & [0063]-[0064]; Figures 4A-5B—elements 430, 432).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include the current-pose icon overlapping the target-pose icon on the display such that the current-pose icon covers at least a portion of the target-pose icon, as taught by Ninni, as both references and the claimed invention are directed toward systems configured to correct the position of an ablation device. As disclosed by Moisa, the indication of the target-pose icon may include a visual presentation provided by the display including one or more text based instructions, one or more graphical symbols, or one or more graphical animations which instruct the user to manipulate the catheter to improve contact, the indication may be defined in resulting movement of the distal structure or may be defined in terms of movements applied to a handle of the device, however, the indication may be visually indicated in other ways and the present invention is not limited to any particular one of the above discussed approaches ([0156]-[0158]). As disclosed by Ninni, the target-pose icon and the current-pose can both be displayed on the screen along with an indicator that shows a direction and magnitude which is indicative of the distance between the two poses, this allows a user to interactively move the current-pose icon toward the target-pose icon to algin with and cover the target-pose icon and thus move the device in the desired position, this configuration allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose ([0054], [0060], & [0063]-[0064]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the displaying of the target-pose icon and current-pose icon, as disclosed by Moisa, to include the current-pose icon overlapping the target-pose icon on the display such that the current-pose icon covers at least a portion of the target-pose icon, as taught by Ninni, as such a modification would produce the predictable result of providing a suitable and known display for instructing a user to improve contact between the target tissue and the device, and would also allow a user to interactively move the current-pose icon toward the target-pose icon to align with and cover the target-pose icon and thus move the device in the desired position, which allows for accurate device navigation by updating the position and orientation of the device until the current-pose matches the target-pose.
Claims 3, 6, 13, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moisa in view of Ninni and Gross et al. (previously presented-US 20170202614 A1), hereinafter “Gross”.
Regarding claim 3, Moisa in view of Ninni disclose all of the limitations of claim 1, as described above.
Moisa does not disclose the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure.
Gross teaches a system for ascertaining a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0133]; Figures 7A, 7B, & 12), and in response to the number equaling or exceeding a predefined lower threshold improving contact between the electrodes and the vessel; the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure ([0133], [0149], [0156]-[0157], & [0160]; with said lower threshold value being when all electrodes are in moderate contact (e.g. yellow); it is the examiners position that all electrodes in moderate contact would be above 20% of the total number of electrodes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the lower threshold value, as disclosed by Moisa, to include, the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as both references and the claimed invention are directed toward catheter systems for assessing and adjusting contact between electrodes and tissue. As disclosed by Gross, if all of the selected electrodes comprise a yellow/moderate contact with tissue, the system can provide an indication to reposition the catheter in order to achieve better contact, however, if the selected electrodes comprise a red or very poor contact, the system can provide an indication to reconnect or replace the catheter ([0133], [0149], [0156]-[0157], & [0160]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the lower threshold value, as disclosed by Moisa, to include, the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as such a modification would provide for a threshold that indicates whether the catheter needs to be replaced or reconnected due to insufficient contact that is not resolvable by repositioning the catheter. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, 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. In re Aller, 105 USPQ 233.
Regarding claim 6, Moisa in view of Ninni disclose all of the limitations of claim 4, as described above.
Moisa does not disclose the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure.
Gross teaches a system for ascertaining a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0133]; Figures 7A, 7B, & 12), and in response to the number equaling or exceeding a middle threshold improving contact between the electrodes and the vessel; the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure ([0133], [0149], [0156]-[0157], & [0160]; with said middle threshold value being when half of the electrode are in good contact (e.g. green) and half of the electrodes are in moderate contact; it is the examiners position that half of the electrodes in good contact and half of the electrodes are in moderate contact would be at least 50% of the total number of electrodes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the middle threshold value, as disclosed by Moisa, to include, the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as both references and the claimed invention are directed toward catheter systems for assessing and adjusting contact between electrodes and tissue. As disclosed by Gross, the system can provide an indication to reposition the catheter in order to achieve better contact if a portion of the electrodes are in good contact and another portion are in moderate contact ([0133], [0149], [0156]-[0157], & [0160]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the middle threshold value, as disclosed by Moisa, to include, the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as such a modification would provide for a middle threshold that indicates whether the catheter needs further repositioning to achieve desired tissue contact. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, 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. In re Aller, 105 USPQ 233.
Regarding method claim 13, Moisa in view of Ninni disclose all of the limitations of claim 11, as described above.
Moisa does not disclose the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure.
Gross teaches a method for ascertaining a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0133]; Figures 7A, 7B, & 12), and in response to the number equaling or exceeding a predefined lower threshold improving contact between the electrodes and the vessel; the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure ([0133], [0149], [0156]-[0157], & [0160]; with said lower threshold value being when all electrodes are in moderate contact (e.g. yellow); it is the examiners position that all electrodes in moderate contact would be above 20% of the total number of electrodes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the lower threshold value, as disclosed by Moisa, to include, the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as both references and the claimed invention are directed toward methods for assessing and adjusting contact between electrodes and tissue. As disclosed by Gross, if all of the selected electrodes comprise a yellow/moderate contact with tissue, the system can provide an indication to reposition the catheter in order to achieve better contact, however, if the selected electrodes comprise a red or very poor contact, the system can provide an indication to reconnect or replace the catheter ([0133], [0149], [0156]-[0157], & [0160]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the lower threshold value, as disclosed by Moisa, to include, the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as such a modification would provide for a threshold that indicates whether the catheter needs to be replaced or reconnected due to insufficient contact that is not resolvable by repositioning the catheter. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the lower threshold being at least 20% of a total number of the electrodes around a circumference of the distal structure, 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. In re Aller, 105 USPQ 233.
Regarding method claim 16, Moisa in view of Ninni disclose all of the limitations of claim 14, as described above.
Moisa does not disclose the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure.
Gross teaches a system for ascertaining a number of the plurality of electrodes of the distal structure contacting an ostium of a pulmonary vein ([0133]; Figures 7A, 7B, & 12), and in response to the number equaling or exceeding a middle threshold improving contact between the electrodes and the vessel; the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure ([0133], [0149], [0156]-[0157], & [0160]; with said middle threshold value being when half of the electrode are in good contact (e.g. green) and half of the electrodes are in moderate contact; it is the examiners position that half of the electrodes in good contact and half of the electrodes are in moderate contact would be at least 50% of the total number of electrodes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the middle threshold value, as disclosed by Moisa, to include, the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as both references and the claimed invention are directed toward methods for assessing and adjusting contact between electrodes and tissue. As disclosed by Gross, the system can provide an indication to reposition the catheter in order to achieve better contact if a portion of the electrodes are in good contact and another portion are in moderate contact ([0133], [0149], [0156]-[0157], & [0160]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the middle threshold value, as disclosed by Moisa, to include, the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, as taught by Gross, as such a modification would provide for a middle threshold that indicates whether the catheter needs further repositioning to achieve desired tissue contact. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the middle threshold being at least 50% of a total number of the electrodes around a circumference of the distal structure, 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. In re Aller, 105 USPQ 233.
Claims 7-8, 10, & 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Moisa in view of Ninni and Viswanathan et al. (previously presented-US 20050020911 A1), hereinafter “Viswanathan”.
Regarding claim 7, Moisa in view of Ninni disclose all of the limitations of claim 4, as described above.
Moisa does not disclose the computing the rotation including: (a) computing a first centroid M of those of the plurality of electrodes contacting the ostium and a second centroid C of the distal structure, (b) computing a normal vector
N
→
, which is normal to a hypothetical plane tangent to the distal structure at the first centroid, (c) computing an axis-of-rotation vector
R
→
as
N
→
x
(
C
-
M
)
→
, and (d) computing rotation about
R
→
.
Viswanathan teaches a navigation system comprising computing the rotation, the computing the rotation including: (a) computing a first centroid M of those of the plurality of electrodes contacting the ostium and a second centroid C of the distal structure, (b) computing a normal vector
N
→
, which is normal to a hypothetical plane tangent to the distal structure at the first centroid, (c) computing an axis-of-rotation vector
R
→
as
N
→
x
(
C
-
M
)
→
, and (d) computing rotation about
R
→
([0019]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the computing rotation, as disclosed by Moisa, to include the steps of computing rotating, as taught by Viswanathan, as both references and the claimed invention are directed toward systems for repositioning medical devices to be in contact with target tissue. As disclosed by Viswanathan, the system can receive a vector of the tip location, a vector of the tip orientation, and the normal vector to determine if the determine the rotation axis and if the tip location is closely aligned with the target tissue or rotation is needed ([0019]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the computing rotation, as disclosed by Moisa, to include the steps of computing rotating, as taught by Viswanathan, as such a modification would aid in determining the axis of rotation upon which rotational adjustments can be made to position the device in contact with target tissue.
Regarding claim 8, Moisa in view of Ninni and Viswanathan disclose all of the limitations of claim 7, as described above.
Moisa in view of Viswanathan disclose the computing the first centroid (as described in the above rejection of claim 7).
Moisa further discloses assigning a respective weight to each of the electrodes contacting the ostium as an increasing function of a degree to which the electrode contacts the ostium ([0134] & [0136]; the processor is configured to receive via the input output device the degree of contact respectively from the plurality of electrodes).
Regarding claim 10, Moisa in view of Ninni disclose all of the limitations of claim 4, as described above.
Moisa does not disclose the rotation being less than 10 degrees.
Viswanathan teaches a system for rotating a medical device to achieve desired contact, the rotation being less than 10 degrees ([0021]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the rotation, as disclosed by Moisa, to include the rotation being less than 10 degrees, as taught by Viswanathan, as both references and the claimed invention are directed toward systems for repositioning medical devices to be in contact with target tissue. As disclosed by Viswanathan, the system can apply a sequence of small rotations, e.g. 2 degrees, until the desired tip alignment with target tissue is complete ([0021]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the rotation, as disclosed by Moisa, to include the rotation being less than 10 degrees, as taught by Viswanathan, as such a modification would provide for a suitable and known rotation for a medical device in order to achieve alignment with target tissue. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the rotation being less than 10 degrees, 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. In re Aller, 105 USPQ 233.
Regarding method claim 17, Moisa in view of Ninni disclose all of the limitations of claim 14, as described above.
Moisa does not disclose the computing the rotation including: (a) computing a first centroid M of those of the electrodes contacting the ostium and a second centroid C of the distal structure, (b) computing a normal vector
N
→
, which is normal to a hypothetical plane tangent to the distal structure at the first centroid, (c) computing an axis-of-rotation vector
R
→
as
N
→
x
(
C
-
M
)
→
, and (d) computing rotation about
R
→
.
Viswanathan teaches a navigation method comprising computing the rotation, the computing the rotation including: (a) computing a first centroid M of those of the electrodes contacting the ostium and a second centroid C of the distal structure, (b) computing a normal vector
N
→
, which is normal to a hypothetical plane tangent to the distal structure at the first centroid, (c) computing an axis-of-rotation vector
R
→
as
N
→
x
(
C
-
M
)
→
, and (d) computing rotation about
R
→
([0019]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the computing rotation, as disclosed by Moisa, to include the steps of computing rotating, as taught by Viswanathan, as both references and the claimed invention are directed toward methods for repositioning medical devices to be in contact with target tissue. As disclosed by Viswanathan, the system can receive a vector of the tip location, a vector of the tip orientation, and the normal vector to determine if the determine the rotation axis and if the tip location is closely aligned with the target tissue or rotation is needed ([0019]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the computing rotation, as disclosed by Moisa, to include the steps of computing rotating, as taught by Viswanathan, as such a modification would aid in determining the axis of rotation upon which rotational adjustments can be made to position the device in contact with target tissue.
Regarding method claim 18, Moisa in view of Ninni and Viswanathan disclose all of the limitations of claim 17, as described above.
Moisa in view of Viswanathan disclose the computing the first centroid (as described in the above rejection of claim 17).
Moisa further discloses assigning a respective weight to each of the electrodes contacting the ostium as an increasing function of a degree to which the electrode contacts the ostium ([0134] & [0136]; the processor is configured to receive via the input output device the degree of contact respectively from the plurality of electrodes).
Conclusion
Accordingly, claims 1-19 & 21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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