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 .
Response to Arguments
In view of decision in pre-appeal conference, the rejection is withdrawn and new rejection under 35 USC § 103 with new prior art has been made.
Applicant’s arguments, see pre-appeal brief, filed 09 January 2026, with respect to the rejection(s) of claim(s) 1-2, 6-9, 13-16, and 19-20 under 35 USC § 103 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 Therefore, the rejection has been withdrawn.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 combination of different interpretation of previously applied reference and newly found prior art, as Govari discloses “decreasing” the size as the tip approaches the vessel wall, while the size increases when it approaches a wall with a hole. The examiner submits Heeren which teaches one can either increase or decrease the size of graphical indicator as the distance between tip of the instrument and the target (Retina) decreases (implies that the instrument is approaching the target).
The examiner has modified and new rejection can be found under prior art rejection heading as set forth below.
Allowable Subject Matter
Claims 3-5, 10-12, and 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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, 6-9, 13-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over “Syrkin-Nikolau et al.,” US 2024/0325066 (hereinafter Syrkin-Nikolau) and “Govari et al.,” US 2020/0138333 (hereinafter Govari) and “Heeren,” US 2017/0280989 (hereinafter Heeren).
Regarding to claim 1, Syrkin-Nikolau teaches s computer-implemented method of providing real-time visual feedback (real time feedback [0125]) of a contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array placed along a catheter distal assembly (plurality of electrode as an electrode array [0133]), the method comprising:
while the catheter distal assembly is in the luminal organ of a patient ([0009]):
(a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon (Figures 21-22);
(b) for each electrode of the plurality of electrodes:
repeatedly assessing tissue proximity of each of the plurality of electrodes ([0143]); and
dynamically updating visual features indicative of the tissue proximity, said visual features comprising contact lobes ([0144] Figures 21-22),
wherein each contact lobe is centered on a corresponding electrode and overlaid on said graphical representation of the catheter distal assembly (Figures 21-22, spokes of impedance indicator [0144]-[0146]);
Syrkin-Nikolau discloses that local impedance indicator changes color and/or shape as the sensed local impedance values change to provide quick graphical feedback to the user ([0146]), specifically as the sensed impedance increases, the spoke extends or grows away from the center to provide a visual representation of increase in impedance intensity ([0146]).
Syrkin-Nikolau does not further teach a size of said contact lobe increases with the contact level between said tissue wall and said corresponding electrode, based on the tissue proximity.
However, in the analogous field of endeavor in electrode navigating in an organ, Govari teaches that a sphere-model comprising spheres of different sizes, increasing the size of sphere model (Figure 2C) as the electrode tip approaches a target ([0057]-[0059] and [0071]) to estimate and verify the quality of physical contact between electrode and wall surface ([0041]).
Although Govari teaches decreasing the size on the contrary to the claimed limitation of “increasing the radius,” the examiner submits that one of ordinary skill in the art can modify size to be increased as evidenced by Heeren.
In the analogous field of endeavor in graphical representation display of surgical instrument navigation to the target anatomy, Heeren teaches an imaging display that a visual indicator to indicate the change in the distance between the distal tip of the surgical instrument and the retina by increasing or decreasing the size of the visual indicator in proportion to the change in distance between the distal tip of the surgical instrument and the retina ([0010] and [0018]), particular indicator become gradually larger or smaller as the distance between the distal tip and the retina eye decreases ([0083]).
Thus, Govari can incorporate teaching of Heeren to modify its size change to be increasing as the tip approaches the vessel wall in place of decreasing the size of sphere model of Govari, as Heeren teaches that one can either increase or decrease the size of the visual indicator as the distance between the distal tip and the target decreases ([0083]), as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
Therefore, 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 spokes as taught by Syrkin-Nikolau to incorporate teaching of Govari, as both are directed to a visual feedback of electrode proximity to the tissue, and since sphere model with varying radius was well known in the art as taught by Govari. One of ordinary skill in the art could have combined the elements as claimed by Syrkin-Nikolau with no change in their respective functions, replacing spokes model with sphere model of varying radius of Govari, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide simplified and expedite complicated minimally invasive procedures during cardiac catheterizations ([0032]), and there was reasonable expectation of success.
Furthermore, one of ordinary skill in the art could have combined the elements as claimed by Syrkin-Nikolau and Govari with no change in their respective functions, replacing decreasing the size of sphere indicator of Govari, to with increasing the size as the distance between the tip and the target (vessel wall in case of Syrkin-Nikolau and Govari), combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a surgeon with an intuitive, real-time indication of the depth of the distal tip and its distance to the target ([0091]), and there was reasonable expectation of success.
Regarding to claim 2, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 1 as discussed above.
Syrkin-Nikolau further teaches following limitations:
Of claim 2, wherein assessing tissue proximity comprises measuring impedance of at least one electrode (impedance [0125] and [0146])
Regarding to claims 6-7, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 1 as discussed above.
Govari further teaches following limitations:
Of claim 6, wherein said contact lobes comprise ellipsoidal segments (sphere model Figures 2A-C)
Of claim 7, comprising, for each electrode, computing a variable transverse radius of said ellipsoidal segments, said variable transverse radius being based on the contact level between the tissue wall and said electrode and extending in a direction transverse to a local orientation of the catheter around said electrode (spheres with radii and center variable [0022]-[0023]).
Regarding to claim 8, Syrkin-Nikolau teaches a graphical user interface (GUI) (user interface including a touch screen [0050]-[0051]) for providing real-time visual feedback (real time feedback [0125]) of contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array placed along a catheter distal assembly (plurality of electrode as an electrode array [0133]), the GUI being executable by a computer to:
while the catheter distal assembly is in the luminal organ of a patient ([0009]):
(a) render, on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon (Figures 21-22);
(b) for each electrode of the plurality of electrodes:
repeatedly assessing tissue proximity of each of the plurality of electrodes ([0143]); and
dynamically updating visual features indicative of the tissue proximity, said visual features comprising contact lobes ([0144] Figures 21-22),
wherein each contact lobe is centered on a corresponding electrode and overlaid on said graphical representation of the catheter distal assembly (Figures 21-22, spokes of impedance indicator [0144]-[0146]);
Syrkin-Nikolau discloses that local impedance indicator changes color and/or shape as the sensed local impedance values change to provide quick graphical feedback to the user ([0146]), specifically as the sensed impedance increases, the spoke extends or grows away from the center to provide a visual representation of increase in impedance intensity ([0146]).
Syrkin-Nikolau does not further teach a size of said contact lobe increases with the contact level between said tissue wall and said corresponding electrode, based on the tissue proximity.
However, in the analogous field of endeavor in electrode navigating in an organ, Govari teaches that a sphere-model comprising spheres of different sizes, increasing the size of sphere model (Figure 2C) as the electrode tip approaches a target, blood vessel wall with a hole ([0057]-[0059] and [0071]) to estimate and verify the quality of physical contact between electrode and wall surface ([0041]).
Although Govari teaches decreasing the size on the contrary to the claimed limitation of “increasing the radius,”, the examiner submits that one of ordinary skill in the art can modify size to be increased as evidenced by Heeren.
In the analogous field of endeavor in graphical representation display of surgical instrument navigation to the target anatomy, Heeren teaches an imaging display that a visual indicator to indicate the change in the distance between the distal tip of the surgical instrument and the retina by increasing or decreasing the size of the visual indicator in proportion to the change in distance between the distal tip of the surgical instrument and the retina ([0010] and [0018]), particular indicator become gradually larger or smaller as the distance between the distal tip and the retina eye decreases ([0083]).
Thus, Govari can incorporate teaching of Heeren to modify its size change to be increasing as the tip approaches the vessel wall in place of decreasing the size of sphere model of Govari, as Heeren teaches that one can either increase or decrease the size of the visual indicator as the distance between the distal tip and the target decreases ([0083]), as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
Therefore, 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 spokes as taught by Syrkin-Nikolau to incorporate teaching of Govari, as both are directed to a visual feedback of electrode proximity to the tissue, and since sphere model with varying radius was well known in the art as taught by Govari. One of ordinary skill in the art could have combined the elements as claimed by Syrkin-Nikolau with no change in their respective functions, replacing spokes model with sphere model of varying radius of Govari, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide simplified and expedite complicated minimally invasive procedures during cardiac catheterizations ([0032]), and there was reasonable expectation of success.
Furthermore, one of ordinary skill in the art could have combined the elements as claimed by Syrkin-Nikolau and Govari with no change in their respective functions, replacing decreasing the size of sphere indicator of Govari, to with increasing the size as the distance between the tip and the target (vessel wall in case of Syrkin-Nikolau and Govari), combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a surgeon with an intuitive, real-time indication of the depth of the distal tip and its distance to the target ([0091]), and there was reasonable expectation of success.
Regarding to claim 9, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 8 as discussed above.
Syrkin-Nikolau further teaches following limitations:
Of claim 9, wherein the tissue proximity values correspond measured impedance values of the plurality of electrodes (impedance [0146])
Regarding to claims 13-14, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 8 as discussed above.
Govari further teaches following limitations:
Of claim 13, wherein said contact lobes comprise ellipsoidal segments (sphere model Figures 2A-C)
Of claim 14, comprising, for each electrode, computing a variable transverse radius of said ellipsoidal segments, said variable transverse radius being based on the contact level between the tissue wall and said electrode and extending in a direction transverse to a local orientation of the catheter around said electrode (spheres with radii and center variable [0022]-[0023]).
Regarding to claim 15, Syrkin-Nikolau teaches a computer system comprising at least one processing circuitry ([0009]), configured to execute a method of providing real-time visual feedback (real-time feedback [0125]) of a contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array placed along a catheter distal assembly (plurality of electrode as an electrode array [0133]), the method comprising:
while the catheter distal assembly is in the luminal organ of a patient ([0009]):
(a) render, on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon (Figures 21-22);
(b) for each electrode of the plurality of electrodes:
repeatedly assessing tissue proximity of each of the plurality of electrodes ([0143]); and
dynamically updating visual features indicative of the tissue proximity, said visual features comprising contact lobes ([0144] Figures 21-22),
wherein each contact lobe is centered on a corresponding electrode and overlaid on said graphical representation of the catheter distal assembly (Figures 21-22, spokes of impedance indicator [0144]-[0146]);
Syrkin-Nikolau discloses that local impedance indicator changes color and/or shape as the sensed local impedance values change to provide quick graphical feedback to the user ([0146]), specifically as the sensed impedance increases, the spoke extends or grows away from the center to provide a visual representation of increase in impedance intensity ([0146]).
Syrkin-Nikolau does not further teach a size of said contact lobe increases with the contact level between said tissue wall and said corresponding electrode, based on the tissue proximity.
However, in the analogous field of endeavor in electrode navigating in an organ, Govari teaches that a sphere-model comprising spheres of different sizes, increasing the size of sphere model (Figure 2C) as the electrode tip approaches a target, blood vessel wall with a hole ([0057]-[0059] and [0071]) to estimate and verify the quality of physical contact between electrode and wall surface ([0041]).
Although Govari teaches decreasing the size on the contrary to the claimed limitation of “increasing the radius,”, the examiner submits that one of ordinary skill in the art can modify size to be increased as evidenced by Heeren.
In the analogous field of endeavor in graphical representation display of surgical instrument navigation to the target anatomy, Heeren teaches an imaging display that a visual indicator to indicate the change in the distance between the distal tip of the surgical instrument and the retina by increasing or decreasing the size of the visual indicator in proportion to the change in distance between the distal tip of the surgical instrument and the retina ([0010] and [0018]), particular indicator become gradually larger or smaller as the distance between the distal tip and the retina eye decreases ([0083]).
Thus, Govari can incorporate teaching of Heeren to modify its size change to be increasing as the tip approaches the vessel wall in place of decreasing the size of sphere model of Govari, as Heeren teaches that one can either increase or decrease the size of the visual indicator as the distance between the distal tip and the target decreases ([0083]), as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
Therefore, 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 spokes as taught by Syrkin-Nikolau to incorporate teaching of Govari, as both are directed to a visual feedback of electrode proximity to the tissue, and since sphere model with varying radius was well known in the art as taught by Govari. One of ordinary skill in the art could have combined the elements as claimed by Syrkin-Nikolau with no change in their respective functions, replacing spokes model with sphere model of varying radius of Govari, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide simplified and expedite complicated minimally invasive procedures during cardiac catheterizations ([0032]), and there was reasonable expectation of success.
Regarding to claim 16, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 15 as discussed above.
Syrkin-Nikolau further teaches following limitations:
Of claim 16, wherein assessing tissue proximity comprises measuring impedance of at least one electrode (impedance [0146])
Regarding to claims 19-20, Syrkin-Nikolau, Govari, and Heeren together teach all limitations of claim 15 as discussed above.
Govari further teaches following limitations:
Of claim 19, wherein said contact lobes comprise ellipsoidal segments (sphere model Figures 2A-C)
Of claim 20, wherein the method comprises, for each electrode, computing a variable transverse radius of said ellipsoidal segments, said variable transverse radius being based on the contact level between the tissue wall and said electrode and extending in a direction transverse to a local orientation of the catheter around said electrode (spheres with radii and center variable [0022]-[0023]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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