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 .
Information Disclosure Statement
The information disclosure statement filed 01/13/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. There are no copies of the cited foreign patent documents.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-8 and 11- 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-tal et al. (US 20180344202 A1. hereinafter "Bar-tal", of record) in view of Zhu et al. (CN 111388085 A, attached translation cited below, hereinafter "Zhu") and Mariappan et al. (US 20220226046 A1, hereinafter "Mariappan", of record).
Regarding claim 1, Bar-tal teaches a medical system, comprising:
generator coils configured to generate respective magnetic fields having respective different frequencies in a region of a body part of a living subject (each radiator comprising three orthogonal coils which radiate respective magnetic fields at different frequencies [0053]; Alternatively, probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs [0047]);
a catheter being configured to be inserted into the body part of the living subject (catheter [0018]; medical probe 22 having a proximal end 23 and a distal end 26 [0046]; balloon 34 is fixed to distal end 26 [0056]), and comprising:
a distal end assembly collapsible and expandible between a collapsed formation (In a catheter insertion step 82, patient 30 is moved so that their heart is in the magnetic field region, and probe 22 is inserted into the patient so that balloon 34 enters the heart of the patient. The balloon is then inflated [0081]) and a deployed formation along a longitudinal axis of the catheter axis (medical probe 22 having a proximal end 23 and a distal end 26, [0046]; area between distal end and proximal end forms a longitudinal axis);
an insertion tube (a medical professional 32 inserts medical probe 22 into a biocompatible sheath (not shown) that has been pre-positioned in a lumen of the patient so that a balloon 34, described in more detail with reference to FIGS. 2A, 2B, and 2C, affixed to distal end 26 of the medical probe enters a chamber of heart 28 [0048]) connected to the distal end assembly (balloon 34, [0048]);
a first magnetic coil sensor … configured to output electrical signals in response to the respective magnetic fields (balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]), the first magnetic coil sensor having a first axis (each magnetic coil sensor inherently has its own axis, further, each individual spline has its own magnetic coil sensor); and
a second magnetic coil sensor (balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]) … and configured to output electrical signals in response to the respective magnetic fields (The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]),
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Fig. 2A of Bar-Tal reproduced above
processing circuitry (processor [0027]): configured to:
receive the electrical signals from the first and second magnetic coil sensors (A processor receives voltages induced on the splines via the conductors, the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]);
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals (The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]);
Bar-tal discloses computing a dimension of the distal end (the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]), but does not teach:
Bar-tal, however, does not teach:a pusher connected to the distal end assembly;
a first magnetic coil sensor disposed on a distal end of the insertion tube;
a second magnetic coil sensor disposed on the pusher;
the second magnetic coil sensor having a second axis that is substantially parallel with the first axis; and
and processing circuitry configured to:
compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and
compute a dimension of the expandable distal end assembly, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field
Zhu is considered analogous to the instant application as “Heart pulse multipolar ablation catheter is disclosed (title). Zhu teaches:
a pusher (6) connected to the distal end assembly (distal end assembly with pusher 6 shown in fig. 6, reproduced below; As shown in Figures 4, 5 and 1, in order to realize the expansion and contraction of the electrode assembly 1, an expansion member 7 is provided in the center of the electrode assembly 1….in order to realize the expansion and contraction of the electrode assembly 1, an expansion member 7 is provided in the center of the electrode assembly 1. …The end is combined and fixed with the distal end of the electrode assembly 1, and the proximal end is connected with the push button 13 of the handle 9. In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]) ;
a first magnetic coil sensor disposed on a distal end of the insertion tube (17-distal magnetic positioning sensor [47]; wherein, the distal magnetic positioning sensor 17 is arranged in the head end 4 [55]; fig. 6)
a second magnetic coil sensor (and the proximal magnetic positioning sensor 18 is arranged in the end tube 6 [55]) disposed on the pusher (6);
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Fig. 6 of Zhu reproduced above
the second magnetic coil sensor having a second axis that is substantially parallel with the first axis (Fig. 8 is a diagram showing the relationship between the front and rear displacement distance and the expansion diameter of the electrode assembly of the heart pulse multipolar ablation catheter of the present invention [39]; fig. 8 depicts the magnetic sensor coils being substantially parallel); and
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Fig. 4 of Zhu, reproduced above
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Fig. 8 of Zhu, reproduced above
compute a dimension of the expandable distal end assembly (the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]), which is a function of a distance between the first and second magnetic coil sensors(As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. In the contracted state, L is the length of the electrode arm 2. When L decreases, the outer diameter (D) of the electrode assembly 1 will increase. It is confirmed by actual measurement that L and D are in a linear proportional relationship, and the proportional coefficient is fixed. Therefore, when the proportional coefficient is determined, L can be determined indirectly by the magnetic sensor [56]; the combination of magnetic field and electric field calculation is adopted [58]; The potential difference between the electrode 3 and the proximal ring electrode 20 is e2, E=e1-e2, the relationship between the potential difference E and L (calculated using the magnetic field position relationship) can be calculated, so the electrode 3 can be calculated indirectly. The relative position in the middle of the component 1, and finally the theoretical model of the distribution of the electrodes 3 in the electrode component 1 is calculated by combining the magnetic field to accurately determine the shape of the electrode component 1 and the electrode 3 spacing [60]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include a pusher connected to the distal end assembly, a first magnetic coil sensor disposed on a distal end of the insertion tube, a second magnetic coil sensor disposed on the pusher, the second magnetic coil sensor having a second axis that is substantially parallel with the first axis and processing circuitry configured to compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27])
The combined invention still does not teach processing circuitry configured to [compute a dimension of the expandable distal end assembly, which is a function of a distance between the first and second magnetic coil sensors], based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field, and compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals
Mariappan is considered analogous to the instant application as “Systems and methods for performing localization within a body” is disclosed (title).
Mariappan, however, teaches:
and processing circuitry (array of functional elements is a basket array and the processor determines a shape of the basket array [0060]; the console 5000 includes one or more elements for generating a distribution (e.g. a field) on, within, and/or throughout the body, and elements for measuring one or more characteristics of the distribution… For example, the distribution can be a voltage, current, magnetic, electromagnetic (e.g., RF, microwave) [0329]) configured to:
compute a difference between magnetic field magnitudes of the at least one selected magnetic field (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151 [0445]; each electrode is on separate splines 1157 as seen in fig.2 ) detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals (electrodes 1151 can be located based on the determined location of magnetic sensors 1152 (e.g. the entire position and orientation of all elements of basket array 1150 could be estimated using the magnetic localization system [0308]); and
compute a dimension (expandable/collapsible basket array [0306]) of the expandable distal end assembly (estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]), which is a function of a distance between the first and second magnetic coil sensors (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151), based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field (field created through localization signals generated in between electrodes as disclosed in [0445]) and the magnetic field gradient of the at least one selected magnetic field (local field [0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Bar-tal and Zhu to include processing circuitry configured to compute a dimension of the expandable distal end assembly, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field, and compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals, , as taught by Mariappan, in order to improve localization accuracy during a procedure, as suggested by Mariappan (Also during a procedure, localization accuracy can be improved by better estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]).
Regarding claim 2, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal, however, is silent regarding wherein the distance between the first and second magnetic coil sensors is configured to change as the distal end assembly collapses and expand.
Zhu, however, teaches wherein the distance between the first and second magnetic coil sensors is configured to change as the distal end assembly collapses and expand (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. [56]; In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Bar-tal to include wherein the distance between the first and second magnetic coil sensors is configured to change as the distal end assembly collapses and expands, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
Regarding claim 3, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal, however, does not teach: wherein the computed dimension is the distance between the first and second magnetic coil sensors.
Zhu, however, teaches wherein the computed dimension is the distance between the first and second magnetic coil sensors (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. In the contracted state, L is the length of the electrode arm 2. When L decreases, the outer diameter (D) of the electrode assembly 1 will increase. It is confirmed by actual measurement that L and D are in a linear proportional relationship, and the proportional coefficient is fixed. Therefore, when the proportional coefficient is determined, L can be determined indirectly by the magnetic sensor [56]; the combination of magnetic field and electric field calculation is adopted [58];The potential difference between the electrode 3 and the proximal ring electrode 20 is e2, E=e1-e2, the relationship between the potential difference E and L (calculated using the magnetic field position relationship) can be calculated, so the electrode 3 can be calculated indirectly. The relative position in the middle of the component 1, and finally the theoretical model of the distribution of the electrodes 3 in the electrode component 1 is calculated by combining the magnetic field to accurately determine the shape of the electrode component 1 and the electrode 3 spacing [60]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include wherein the computed dimension is the distance between the first and second magnetic coil sensors, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
Regarding claim 4, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal, further teaches wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial (splines 64 typically comprise other elements… the other elements also comprise location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]; balloon 34 is fixed to distal end 26, and the distal end defines a probe axis of symmetry 60 of the balloon [0056]; as the magnetic coils are attached to the splines, and the splines that are a part of the distal end have an axis of symmetry extending from the end of the catheter as seen in Fig. 2B with dashed line 60, all of the axes are inherently substantially coaxial).
Regarding claim 5, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal further teaches wherein the computed dimension is a dimension of a shape of the distal end of the catheter (using the position, orientation, and magnitude of volume 38 as determined above, the processor may present in step 90, on map 48 of the heart (FIG. 1), a virtual representation of the actual size of balloon 34 [0092]; The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]).
Regarding claim 6, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal, however, does not teach wherein the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field divided by the magnetic field gradient of the at least one selected magnetic field.
Mariappan, however, teaches wherein the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151 [0445]) of the at least one selected magnetic field (local field constant [0446]) divided by the magnetic field gradient of the at least one selected magnetic field (array of functional elements is a basket array and the processor determines a shape of the basket array [0060]; the console 5000, includes one or more elements for generating a distribution (e.g. a field) on, within, and/or throughout the body, and elements for measuring one or more characteristics of the distribution. For example, the distribution can be a voltage, current, magnetic, electromagnetic (e.g., RF, microwave) … distribution is applied across and/or through a volume of the body, it encodes spatial information [0329]; para. [0405]-[0406] and [0408]-[0411] disclose calculation of magnetic field gradients, as well as local field gradients).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention to include compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field divided by the magnetic field gradient of the at least one selected magnetic field, as taught by Mariappan, in order to improve localization accuracy during a procedure, as suggested by Mariappan (Also during a procedure, localization accuracy can be improved by better estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]).
Regarding claim 7, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal, however, does not teach: the at least one selected magnetic field includes one of the magnetic fields having a highest magnetic field gradient of the magnetic fields; and the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the highest magnetic field gradient.
Mariappan, however, teaches: the at least one selected magnetic field includes one of the magnetic fields having a highest magnetic field gradient of the magnetic fields (When the distribution is applied across and/or through a volume of the body, it encodes spatial information. That is, as the distribution varies as a function of position, various characteristics (e.g. values, rate of change, gradients, linearity, and/or orthogonality) of the distribution possess a relationship (e.g. a correspondence or mapped value) to spatial coordinates of the volume [0329]; the local field gradients [0405]; By measuring the field at a few positions, as described above, an estimate of the field distribution can be obtained [0379] para. [0405]-[0406] and [0408]-[0411] disclose calculation of magnetic field gradients, as multiple field gradients are calculated, the highest value can be selected); and
the processing circuitry is configured to compute the dimension of the expandable distal end assembly (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151 [0445]) as a function of the computed difference between the magnetic field magnitudes (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151 [0445]) of the at least one selected magnetic field and the highest magnetic field gradient (array of functional elements is a basket array and the processor determines a shape of the basket array [0060]; the console 5000, includes one or more elements for generating a distribution (e.g. a field) on, within, and/or throughout the body, and elements for measuring one or more characteristics of the distribution. For example, the distribution can be a voltage, current, magnetic, electromagnetic (e.g., RF, microwave) … distribution is applied across and/or through a volume of the body, it encodes spatial information [0329]; para. [0405]-[0406] and [0408]-[0411] disclose calculation of magnetic field gradients, as well as local field gradients).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention to include the at least one selected magnetic field includes one of the magnetic fields having a highest magnetic field gradient of the magnetic fields; and the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the highest magnetic field gradient, as taught by Mariappan, in order to improve localization accuracy during a procedure, as suggested by Mariappan (Also during a procedure, localization accuracy can be improved by better estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]).
Regarding claim 8, modified Bar-tal teaches modified Bar-tal teaches the medical system according to claim 6, as discussed above. Bar-tal further teaches wherein the expandable distal end assembly is a basket distal end assembly comprising a plurality of flexible strips and electrodes disposed on the flexible strips (balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; one or more of conductors 66 may be configured to perform multiple functions, such as being able to act as the electrodes [0065]; Each spline 64A, 64B, . . . 64H comprises a respective conductor 66A, 66B, . . . 66H [0063]).
Regarding claim 11, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal further teaches:
further comprising a display (screen 56 [0093]), and
wherein the processing circuitry (processor may present on screen 56 [0093]) is configured to:
find a shape of the distal end assembly based on at least the computed dimension (using the position, orientation, and magnitude of volume 38 as determined above, the processor may present in step 90, on map 48 of the heart (FIG. 1), a virtual representation of the actual size of balloon 34 [0092]); and
render to the display a representation of the distal end assembly based on the found shape of the distal end assembly (using the position, orientation, and magnitude of volume 38 as determined above, the processor may present in step 90, on map 48 of the heart (FIG. 1), a virtual representation of the actual size of balloon 34 and the balloon's actual location relative to the structures of the heart [0092]).
Regarding claim 12, modified Bar-tal teaches the medical system according to claim 11, as discussed above. Bar-tal, however, does not teach: wherein the computed dimension is the distance between the first and second magnetic coil sensors.
Zhu, however, teaches wherein the computed dimension is the distance between the first and second magnetic coil sensors (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. In the contracted state, L is the length of the electrode arm 2. When L decreases, the outer diameter (D) of the electrode assembly 1 will increase. It is confirmed by actual measurement that L and D are in a linear proportional relationship, and the proportional coefficient is fixed. Therefore, when the proportional coefficient is determined, L can be determined indirectly by the magnetic sensor [56]; the combination of magnetic field and electric field calculation is adopted [58];The potential difference between the electrode 3 and the proximal ring electrode 20 is e2, E=e1-e2, the relationship between the potential difference E and L (calculated using the magnetic field position relationship) can be calculated, so the electrode 3 can be calculated indirectly. The relative position in the middle of the component 1, and finally the theoretical model of the distribution of the electrodes 3 in the electrode component 1 is calculated by combining the magnetic field to accurately determine the shape of the electrode component 1 and the electrode 3 spacing [60]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include wherein the computed dimension is the distance between the first and second magnetic coil sensors, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
Regarding claim 13, modified Bar-tal teaches the medical system according to claim 11, as discussed above. Bar-tal further teaches wherein the processing circuitry is configured to:
compute a relative orientation between the first axis of the first magnetic coil sensor and the second axis of the second magnetic coil sensor (the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]); and
estimate a shape of the distal end assembly based on the computed relative orientation (The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]; volume, position, and orientation all inherently contribute to the shape of the distal end assembly).
Regarding claim 14, modified Bar-tal teaches the medical system according to claim 1, as discussed above. Bar-tal further teaches: wherein the electrical signals of the first and second magnetic coil sensors comprise components of each respective magnetic field of the generator coils (each radiator comprising three orthogonal coils which radiate respective magnetic fields at different frequencies [0053]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]).
Regarding claim 15, modified Bar-tal teaches a medical system, comprising:
generator coils configured to generate respective magnetic fields having respective different frequencies in a region of a body part of a living subject (each radiator comprising three orthogonal coils which radiate respective magnetic fields at different frequencies [0053]; Alternatively, probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs [0047]);
a catheter configured to be inserted into the body part of the living subject (In a catheter insertion step 82, patient 30 is moved so that their heart is in the magnetic field region, and probe 22 is inserted into the patient so that balloon 34 enters the heart of the patient. The balloon is then inflated [0081]), the catheter comprising:
a distal end (distal end 26 [0046]);
a distal end assembly collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and disposed at the distal end (In a catheter insertion step 82, patient 30 is moved so that their heart is in the magnetic field region, and probe 22 is inserted into the patient so that balloon 34 enters the heart of the patient. The balloon is then inflated [0081]; a balloon 34, described in more detail with reference to FIGS. 2A, 2B, and 2C, affixed to distal end 26 of the medical probe enters a chamber of heart 28 [0048]);
a first magnetic coil sensor disposed on the distal end and configured to output electrical signals in response to the respective magnetic fields (balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]),, the first magnetic coil sensor having a first axis (each magnetic coil sensor inherently has its own axis, further, each individual spline has its own magnetic coil sensor); and
a second magnetic coil sensor disposed on distal end and configured to output electrical signals in response to the respective magnetic fields balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]),
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Fig. 2A of Bar-Tal reproduced above
processing circuitry (processor [0027]): configured to:
receive the electrical signals from the first and second magnetic coil sensors (A processor receives voltages induced on the splines via the conductors, the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]);
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals (The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]) ;
Bar-tal, however, does not teach: the second magnetic coil sensor having a second axis that is substantially parallel with the first axis, the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases; processing circuitry configured to: compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and compute a dimension of the distal end, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
Zhu is considered analogous to the instant application as “Heart pulse multipolar ablation catheter is disclosed (title).
Zhu teaches:
the second magnetic coil sensor (and the proximal magnetic positioning sensor 18 is arranged in the end tube 6 [55]) having a second axis that is substantially parallel with the first axis (Fig. 8 is a diagram showing the relationship between the front and rear displacement distance and the expansion diameter of the electrode assembly of the heart pulse multipolar ablation catheter of the present invention [39]; fig. 8 depicts the magnetic sensor coils being substantially parallel),
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Fig. 6 of Zhu reproduced above
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. [56]; In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]; in the contracted state, the magnetic sensors are further apart as the center wire is not pulled back, as shown in fig. 4 ) , and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]; when the expandable assembly is deployed, the magnetic coil sensors are closer together as the wire is pulled back to expand, as shown in fig.6).
processing circuitry configured to:
compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and (the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]) compute a dimension of the distal end, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. In the contracted state, L is the length of the electrode arm 2. When L decreases, the outer diameter (D) of the electrode assembly 1 will increase. It is confirmed by actual measurement that L and D are in a linear proportional relationship, and the proportional coefficient is fixed. Therefore, when the proportional coefficient is determined, L can be determined indirectly by the magnetic sensor [56]; the combination of magnetic field and electric field calculation is adopted [58]; The potential difference between the electrode 3 and the proximal ring electrode 20 is e2, E=e1-e2, the relationship between the potential difference E and L (calculated using the magnetic field position relationship) can be calculated, so the electrode 3 can be calculated indirectly. The relative position in the middle of the component 1, and finally the theoretical model of the distribution of the electrodes 3 in the electrode component 1 is calculated by combining the magnetic field to accurately determine the shape of the electrode component 1 and the electrode 3 spacing [60])..
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Fig. 8 of Zhu, reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Bar-tal to include the second magnetic coil sensor having a second axis that is substantially parallel with the first axis, the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases, processing circuitry configured to: compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
The combined invention still does not teach compute a dimension of the distal end, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
Mariappan is considered analogous to the instant application as “Systems and methods for performing localization within a body” is disclosed (title).
Mariappan teaches: compute a dimension of the distal end (expandable/collapsible basket array [0306]; estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]), which is a function of a distance between the first and second magnetic coil sensors (generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151), based on the computed difference between the magnetic field magnitudes (local field constant [0446]) of the at least one selected magnetic field (field created through localization signals generated in between electrodes as disclosed in [0445]) and the magnetic field gradient of the at least one selected magnetic field (local field [0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal and Zhu to include compute a dimension of the distal end, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field, as taught by Mariappan, in order to improve localization accuracy during a procedure, as suggested by Mariappan (Also during a procedure, localization accuracy can be improved by better estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]).
Regarding claim 16, modified Bar-tal teaches the medical system according to claim 15, as discussed above. Bar-tal further teaches wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial (splines 64 typically comprise other elements… the other elements also comprise location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]; balloon 34 is fixed to distal end 26, and the distal end defines a probe axis of symmetry 60 of the balloon [0056]; as the magnetic coils are attached to the splines, and the splines that are a part of the distal end have an axis of symmetry extending from the end of the catheter as seen in Fig. 2B with dashed line 60, all of the axes are inherently substantially coaxial).
Regarding claim 17, Bar-tal teaches a medical method, comprising:
generating magnetic fields having respective different frequencies in a region of a body part of a living subject (each radiator comprising three orthogonal coils which radiate respective magnetic fields at different frequencies [0053]; Alternatively, probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs [0047]);
inserting a catheter into the body part of the living subject (probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs [0047]), the catheter comprising:
a distal end (distal end 26 [0046]),
a distal end assembly collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and disposed at the distal end (In a catheter insertion step 82, patient 30 is moved so that their heart is in the magnetic field region, and probe 22 is inserted into the patient so that balloon 34 enters the heart of the patient. The balloon is then inflated [0081]; a balloon 34, described in more detail with reference to FIGS. 2A, 2B, and 2C, affixed to distal end 26 of the medical probe enters a chamber of heart 28 [0048]);, and
a first magnetic coil sensor and a second magnetic coil sensor, each being configured to output electrical signals as a function of respective magnetic fields (balloon 34 is formed from a biocompatible flexible plastic material 62, and the material is fixed to a plurality of generally similar flexible splines 64A, 64B, . . . 64H. [0057]; Splines 64 typically comprise other elements, such as sensors... location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]), the first magnetic coil sensor having a first axis each magnetic coil sensor inherently has its own axis, further, each individual spline has its own magnetic coil sensor)
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Fig. 2A of Bar-Tal reproduced above
receiving respective electrical signals from the first and second magnetic coil sensors (A processor receives voltages induced on the splines via the conductors, the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]);
selecting at least one of the magnetic fields having a magnetic field gradient as a function of at least one of the received electrical signals (The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]);
Bar-tal, however, does not teach:
the second magnetic coil sensor having a second axis substantially parallel to the first axis,
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases;
detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields;
Zhu is considered analogous to the instant application as “Heart pulse multipolar ablation catheter is disclosed (title).
Zhu teaches:
the second magnetic coil (and the proximal magnetic positioning sensor 18 is arranged in the end tube 6 [55]) sensor having a second axis substantially parallel to the first axis (Fig. 8 is a diagram showing the relationship between the front and rear displacement distance and the expansion diameter of the electrode assembly of the heart pulse multipolar ablation catheter of the present invention [39]; fig. 8 depicts the magnetic sensor coils being substantially parallel),
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Fig. 6 of Zhu reproduced above
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. [56]; In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]; in the contracted state, the magnetic sensors are further apart as the center wire is not pulled back, as shown in fig. 4 ) , and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases In the contracted state, the electrode assembly 1 is linear and has a small outer diameter. When the push and twist 13 is pushed and pulled back, the expansion member 7 is driven to move proximally, and the electrode assembly 1 begins to expand [54]; when the expandable assembly is deployed, the magnetic coil sensors are closer together as the wire is pulled back to expand, as shown in fig.6).
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Fig. 4 of Zhu, reproduced above
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Fig. 8 of Zhu, reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Bar-tal to include the second magnetic coil sensor having a second axis substantially parallel to the first axis, and the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
The combined invention still does not teach detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields.
Mariappan is considered analogous to the instant application as “Systems and methods for performing localization within a body” is disclosed (title).
Mariappan teaches detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields (electrodes 1151 can be located based on the determined location of magnetic sensors 1152 (e.g. the entire position and orientation of all elements of basket array 1150 could be estimated using the magnetic localization system [0308]; generate localization signals between catheter electrodes 1151 to create a field that can be used to estimate the distance between electrodes 1151 [0445]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields, as taught by Mariappan, in order to improve localization accuracy during a procedure, as suggested by Mariappan (Also during a procedure, localization accuracy can be improved by better estimating the size and shape of the diagnostic catheter 1100 (e.g., the shape of basket 1150) during a procedure [0045]).
Regarding claim 18, modified Bar-tal teaches the medical method according to claim 17, as discussed above. Bar-tal further teaches wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial (splines 64 typically comprise other elements… the other elements also comprise location sensors, typically coils, which provide signals in response to magnetic fields from radiators 27 traversing the sensors [0061]; balloon 34 is fixed to distal end 26, and the distal end defines a probe axis of symmetry 60 of the balloon [0056]; as the magnetic coils are attached to the splines, and the splines that are a part of the distal end have an axis of symmetry extending from the end of the catheter as seen in Fig. 2B with dashed line 60, all of the axes are inherently substantially coaxial).
Regarding claim 19, modified Bar-tal teaches the medical system according to claim 17, as discussed above. Bar-tal, however, does not teach: wherein the computed dimension is the distance between the first and second magnetic coil sensors.
Zhu, however, teaches wherein the computed dimension is the distance between the first and second magnetic coil sensors (As shown in FIG. 8, the electrode 3 is arranged in the middle part of the distal magnetic positioning sensor 17 and the proximal magnetic positioning sensor 18. A plurality of electrode arms 2 Joint displacement realizes expansion or contraction of electrode assembly 1. The length (L) of the electrode assembly 1 is the distance between the two magnetic positioning sensors. In the contracted state, L is the length of the electrode arm 2. When L decreases, the outer diameter (D) of the electrode assembly 1 will increase. It is confirmed by actual measurement that L and D are in a linear proportional relationship, and the proportional coefficient is fixed. Therefore, when the proportional coefficient is determined, L can be determined indirectly by the magnetic sensor [56]; the combination of magnetic field and electric field calculation is adopted [58];The potential difference between the electrode 3 and the proximal ring electrode 20 is e2, E=e1-e2, the relationship between the potential difference E and L (calculated using the magnetic field position relationship) can be calculated, so the electrode 3 can be calculated indirectly. The relative position in the middle of the component 1, and finally the theoretical model of the distribution of the electrodes 3 in the electrode component 1 is calculated by combining the magnetic field to accurately determine the shape of the electrode component 1 and the electrode 3 spacing [60]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include wherein the computed dimension is the distance between the first and second magnetic coil sensors, as taught by Zhu, in order to greatly improve the ablation efficiency, as suggested by Zhu ([27]).
Regarding claim 20, modified Bar-tal teaches the medical system according to claim 17, as discussed above. Bar-tal further teaches wherein the computed dimension is a dimension of a shape of the distal end of the catheter (using the position, orientation, and magnitude of volume 38 as determined above, the processor may present in step 90, on map 48 of the heart (FIG. 1), a virtual representation of the actual size of balloon 34 [0092]; The signals from the splines may be used on their own, or together with other location sensors incorporated in the catheter, to provide the location of a volume encompassed by the splines of the catheter [0043]).
Claims 9-10 is rejected under 35 U.S.C. 103 as being unpatentable over Bar-tal et al. (US 20180344202 A1. hereinafter "Bar-tal", of record) in view of Zhu et al. (CN 111388085 A, attached translation cited below, hereinafter "Zhu") and Mariappan et al. (US 20220226046 A1, hereinafter "Mariappan", of record), and Fuimaono et al. (US 20060009689 A1, hereinafter “Fuimaono”).
Regarding claim 9, modified Bar-tal teaches modified Bar-tal teaches the medical system according to claim 6, as discussed above. Bar-tal further teaches:
compute a relative orientation between the first axis of the first magnetic coil sensor and the second axis of the second magnetic coil sensor (the voltages being induced on the splines by an alternating magnetic field traversing the volume encompassed by the splines. The processor calculates a position and an orientation of the volume in response to the received voltages [0045]).
Bar-tal, however, does not teach estimate a bow of a first flexible strip based on the computed dimension and the computed relative orientation.
Fuimaono is considered analogous to the instant application as “Basket catheter with multiple location sensors” is disclosed (title).
Fuimaono teaches estimate a bow of a first flexible strip based on the computed dimension and the computed relative orientation (The plurality of coils enables six-dimensional position and orientation coordinates to be determined [0028]; The coordinates of the distal sensor 32, relative to those of the proximal sensor 34, are determined and taken together with other known information pertaining to the curvature of the spines 20 of the basket-shaped mapping assembly 18. This information is used to find the positions of the ring electrodes 28 mounted on the spines 20 [0030])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include estimate a bow of a first flexible strip based on the computed dimension and the computed relative orientation, as taught by Fuimaono. Doing so would provide improved mapping capabilities, as suggested by Fuimaono ([0002]).
Regarding claim 10, modified Bar-tal teaches modified Bar-tal teaches the medical system according to claim 6, as discussed above. Bar-tal further teaches:
wherein the electrodes comprise a first plurality of electrodes disposed on the first flexible strip (Splines 64 typically comprise other elements, such as sensors, typically thermocouples or thermistors, to measure the temperature of heart tissue contacted by the splines, and electrodes. The electrodes may be used, inter alia, for radiofrequency (RF) ablation of the heart tissue [0061]).
Bar-tal, however, does not teach the processing circuitry is configured to: estimate a position of each electrode of the first plurality of electrodes based on the computed dimension and the computed relative orientation.
Fuimaono is considered analogous to the instant application as “Basket catheter with multiple location sensors” is disclosed (title).
Fuimaono teaches the processing circuitry is configured to: estimate a position of each electrode (28) of the first plurality of electrodes based on the computed dimension and the computed relative orientation (The plurality of coils enables six-dimensional position and orientation coordinates to be determined [0028]; The coordinates of the distal sensor 32, relative to those of the proximal sensor 34, are determined and taken together with other known information pertaining to the curvature of the spines 20 of the basket-shaped mapping assembly 18. This information is used to find the positions of the ring electrodes 28 mounted on the spines 20 [0030])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bar-tal to include the processing circuitry is configured to: estimate a position of each electrode of the first plurality of electrodes based on the computed dimension and the computed relative orientation, as taught by Fuimaono. Doing so would provide improved mapping capabilities, as suggested by Fuimaono ([0002]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 11-19 (instant application) rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 18, and 20 of U.S. Patent No. US 12201786 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other . See comparison chart below.
Instant Application (19/018,963)
Reference application (US 12201786 B2)
1. A medical system, comprising:
generator coils configured to generate respective magnetic fields having
respective different frequencies in a region of a body part of a living subject;
a catheter being configured to be inserted into the body part of the living subject, and comprising:
a distal end assembly collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter;
an insertion tube connected to the distal end assembly;
a pusher connected to the distal end assembly;
a first magnetic coil sensor disposed on a distal end of the insertion tube and configured to output electrical signals in response to the respective magnetic fields, the first magnetic coil sensor having a first axis; and
a second magnetic coil sensor disposed on the pusher and configured to output electrical signals in response to the respective magnetic fields, the second magnetic coil sensor having a second axis that is substantially parallel with the first axis; and
processing circuitry configured to:
receive the electrical signals from the first and second magnetic coil sensors;
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals;
compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and
compute a dimension of the expandable distal end assembly, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one
selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
1. A medical system, comprising:
generator coils configured to generate respective magnetic fields having respective different frequencies in a region of a body part of a living subject;
a catheter collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and being configured to be inserted into the body part of the living subject, and comprising:
an insertion tube connected to an expandable distal end assembly, and
magnetic coil sensors configured to output electrical signals in response to the respective magnetic fields, the magnetic coil sensors comprising:
a first magnetic coil sensor having a first axis, the first magnetic coil sensor being disposed on a distal end of the insertion tube, and
a second magnetic coil sensor having a second axis, the second magnetic coil sensor being disposed on a pusher tube inside the expandable distal end assembly, the respective axes of the first and second magnetic coil sensors being substantially parallel with each other,
….
processing circuitry configured to:
receive the electrical signals from the magnetic coil sensors;
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals;
compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and
compute a dimension of the expandable distal end assembly, which is a function of a distance between the magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
6. The medical system according to claim 1, wherein:
the first axis and the second axis are substantially parallel in the collapsed formation.
2. The medical system according to claim 1, wherein the distance between the first and second magnetic coil sensors is configured to change as the distal end assembly collapses and expands.
1. A medical system, comprising:
…
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases;
…
3. The medical system according to claim 2, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
2. The medical system according to claim 1, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
4. The medical system according to claim 1, wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial.
7. The medical system according to claim 6, wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial.
5. The medical system according to claim 1, wherein the computed dimension is a dimension of a shape of the expandable distal end assembly of the catheter.
3. The medical system according to claim 1, wherein the computed dimension is a dimension of a shape of the expandable distal end assembly of the catheter.
6. The medical system according to claim 1, wherein the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field divided by the magnetic field gradient of the at least one selected magnetic field.
4. The medical system according to claim 1, wherein the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field divided by the magnetic field gradient of the at least one selected magnetic field.
7. The medical system according to claim 1, wherein: the at least one selected magnetic field includes one of the magnetic fields having a highest magnetic field gradient of the magnetic fields; andthe processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the highest magnetic field gradient.
5. The medical system according to claim 1, wherein:
the at least one selected magnetic field includes one of the magnetic fields having a highest magnetic field gradient of the magnetic fields; and
the processing circuitry is configured to compute the dimension of the expandable distal end assembly as a function of the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the highest magnetic field gradient
8. The medical system according to claim 1, wherein the distal end assembly comprises a basket distal end assembly comprising a plurality of flexible strips and electrodes disposed on the flexible strips.
8. The medical system according to claim 6, wherein the expandable distal end assembly is a basket distal end assembly comprising a plurality of flexible strips and electrodes disposed on the flexible strips.
11. The medical system according to claim 1, further comprising a display, and wherein the processing circuitry is configured to:
find a shape of the distal end assembly based on at least the computed dimension; and render to the display a representation of the distal end assembly based on the found shape of the distal end assembly.
9. The medical system according to claim 6, further comprising a display, and wherein the processing circuitry is configured to:
find a shape of the distal end assembly based on at least the computed dimension; and
render to the display a representation of the distal end assembly based on the found shape of the distal end assembly.
12. The medical system according to claim 11, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
10. The medical system according to claim 9, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
13. The medical system according to claim 1, wherein the processing circuitry is configured to: compute a relative orientation between the first axis of the first magnetic coil sensor and the second axis of the second magnetic coil sensor; and estimate a shape of the distal end assembly based on the computed relative orientation.
11. The medical system according to claim 1, wherein the processing circuitry is configured to:
compute a relative orientation between the first axis of the first magnetic coil sensor and the second axis of the second magnetic coil sensor; and
estimate a shape of the distal end assembly based on the computed relative orientation.
15. A medical system, comprising:
generator coils configured to generate respective magnetic fields having respective different frequencies in a region of a body part of a living subject;
a catheter configured to be inserted into the body part of the living subject, the
catheter comprising:
a distal end;
a distal end assembly collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and disposed at the distal end;
a first magnetic coil sensor disposed on the distal end and configured to output electrical signals in response to the respective magnetic fields, the first magnetic coil sensor having a first axis; and
a second magnetic coil sensor disposed on distal end and configured to output electrical signals in response to the respective magnetic fields, the second
magnetic coil sensor having a second axis that is substantially parallel with the first axis,
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable
distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases;
processing circuitry configured to:
receive the electrical signals from the first and second magnetic coil sensors;
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals;
compute a difference between magnetic field magnitudes of the at least
one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and
compute a dimension of the distal end, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected
magnetic field and the magnetic field gradient of the at least one selected magnetic field.
1. A medical system, comprising:
generator coils configured to generate respective magnetic fields having respective different frequencies in a region of a body part of a living subject;
a catheter collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and being configured to be inserted into the body part of the living subject, and comprising:
an insertion tube connected to an expandable distal end assembly, and
magnetic coil sensors configured to output electrical signals in response to the respective magnetic fields, the magnetic coil sensors comprising:
a first magnetic coil sensor having a first axis, the first magnetic coil sensor being disposed on a distal end of the insertion tube, and
a second magnetic coil sensor having a second axis, the second magnetic coil sensor being disposed on a pusher tube inside the expandable distal end assembly, the respective axes of the first and second magnetic coil sensors being substantially parallel with each other,
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases; and
processing circuitry configured to:
receive the electrical signals from the magnetic coil sensors;
select at least one of the magnetic fields having a magnetic field gradient defined by at least one of the received electrical signals;
compute a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor based on the received electrical signals; and
compute a dimension of the expandable distal end assembly, which is a function of a distance between the magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
6. The medical system according to claim 1, wherein:
the first axis and the second axis are substantially parallel in the collapsed formation.
16. The medical systema according to claim 15,wherein the first axis, the second
axis, and the longitudinal axis are substantially coaxial.
7. The medical system according to claim 6, wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial.
17. A medical method, comprising:
generating magnetic fields having respective different frequencies in a region of a body part of a living subject;
inserting a catheter into the body part of the living subject, the catheter comprising:
a distal end,
a distal end assembly collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter and
disposed at the distal end, and
a first magnetic coil sensor and a second magnetic coil sensor, each being configured to output electrical signals as a function of respective magnetic fields, the first magnetic coil sensor having a first axis and the second magnetic coil sensor having a second axis substantially parallel to the first axis, the first and second
magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases;
detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields;
receiving respective electrical signals from the first and second magnetic coil sensors;
selecting at least one of the magnetic fields having a magnetic field gradient as a function of at least one of the received electrical signals;
computing a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor as a function of the received electrical signals; and
computing a dimension of the expandable distal end assembly, which is a
function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
12. A medical method, comprising:
generating magnetic fields having respective different frequencies in a region of a body part of a living subject;
inserting a catheter into the body part of the living subject, the catheter being collapsible and expandible between a collapsed formation and a deployed formation along a longitudinal axis of the catheter, the catheter comprising:
an insertion tube connected to an expandable distal end assembly; and
a first magnetic coil sensor and a second magnetic coil sensor, each being configured to output electrical signals as a function of respective magnetic fields, the first and second magnetic coil sensors having respective first and second axes substantially parallel with each other, the first magnetic coil sensor being disposed on a distal end of the insertion tube, and the second magnetic coil sensor being disposed on a pusher tube inside the expandable distal end assembly,
the first and second magnetic coil sensors being configured to move with respect to each other along the longitudinal axis of the catheter as the expandable distal end assembly is expanded and collapsed such that (i) when the expandable distal end assembly collapses towards the collapsed formation, a distance between the first and second magnetic coil sensors increases, and (ii) when the expandable distal end assembly expands towards the deployed formation, the distance between the first and second magnetic coil sensors decreases;
detecting respective ones of the magnetic fields with the first and second magnetic coil sensors outputting the electrical signals as the function of the respective magnetic fields;
receiving respective electrical signals from the first and second magnetic coil sensors;
selecting at least one of the magnetic fields having a magnetic field gradient as a function of at least one of the received electrical signals;
computing a difference between magnetic field magnitudes of the at least one selected magnetic field detected by the first magnetic coil sensor and the second magnetic coil sensor as a function of the received electrical signals; and
computing a dimension of the expandable distal end assembly, which is a function of a distance between the first and second magnetic coil sensors, based on the computed difference between the magnetic field magnitudes of the at least one selected magnetic field and the magnetic field gradient of the at least one selected magnetic field.
18. The medical method according to claim 17, wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial.
18. The medical method according to claim 17, wherein the first axis, the second axis, and the longitudinal axis are substantially coaxial.
19. The method according to claim 17, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
20. The medical method according to claim 19, wherein the computed dimension is the distance between the first and second magnetic coil sensors.
Instant claim 1 merely combines features included within reference claims 1 and 6. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the reference invention to combine the claimed features of reference claim 1 with the claimed features of reference claim 6, in order to achieve more complex functionality that includes the claimed features of both of references claims 1 and 6.
Instant claim 15 merely combines features included within reference claims 1 and 6. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the reference invention to combine the claimed features of reference claim 1 with the claimed features of reference claim 6, in order to achieve more complex functionality that includes the claimed features of both of references claims 1 and 6.
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798