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
Information Disclosure Statements (IDS)s submitted on 02/09/2024 and 02/12/2026 have been entered and fully considered by the examiner.
Election/Restrictions
Claims 16-19, 21, 22, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/20/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, claim recites: “positioning system according to claim 1 and the interventional device.” Claim 15 recites the limitation "the interventional device" in line 2. There is insufficient antecedent basis for this limitation in the claim. Further, it is not clear what is the relationship between the interventional device recited in claim 15 and the learning instrument an applied instrument of claim 1 upon which claim 15 depends. As a result, claim 15 is considered to be indefinite as the metes and bounds of the claim are not clear. For the purposes of examination, the broadest reasonable interpretation has been assumed.
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.
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 1-4, 6-8, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (Patent No. 11,399,735) hereinafter “Govari”.
Regarding claim 1, Govari discloses a positioning system [see abstract of Govari] for an interventional device [catheter; see FIG. 1 and column 4, lines 23-35 of Govari], wherein the interventional device comprises a learning instrument [calibration catheter ; see column 4, lines 48-61] and an applied instrument,[mapping catheter 29; see column 4, lines 23-30] which are configured to be placed in a target region of a target object,[see column 5, lines 15-22; the catheter is used in the cardiac region of the patient] wherein the positioning system comprises a magnetic field generation unit, [see column 4, lines 55-60; magnetic field generators generating magnetic field] a stimulus control unit, a data collection unit and a controller, the magnetic field generation unit configured to generate a magnetic field passing through the target object; [see FIG. 1 and column 4, lines 48-65 of Govari] the stimulus control unit configured to create an N-axis electric field by applying stimuli between at least three electrode patches disposed on a surface of the target object [see column 4, lines 35-60 disclosing generating electric field cause by modulated voltages between patches 60P; see FIG. 2; Govari discloses 6 patches which are 3 pairs of electrodes creating 3 axis of electric field] , the controller configured to divide the target region into a plurality of sub-regions; the data collection unit configured to: in a fitting phase,[see FIG. 3; calibration phase 71] in each of the sub-regions,[each data point location is a sub-region; see column 7, lines 1-25] simultaneously [the system disclose measuring both magnetic field and electric field in parallel; see column 7, lines 15-17] collect magnetic field strength information at a first position on the learning instrument,[see column 7, lines 10-20 of Govari] magnetic field strength information at the electrode patches and voltage information at a second position on the learning instrument with respect to a reference position in all stimulus modes; [see column 7, lines 18-25 of Govari] and in a positioning phase, [tracking phase 77; see FIG. 3] simultaneously collect magnetic field strength information at the electrode patches and voltage information at a third position on the applied instrument with respect to the reference position in all the stimulus modes,[see column 7, lines 2540 of Govari] the controller further configured to:
in the fitting phase, in each of the sub-regions, calculate spatial position information of the second position based on magnetic field strength information at the first position and on spatial distance information between the first and second positions [see column 6, lines 40-55; the position of each electrode is calculated based on the other electrode distances] and
derive, for each of the sub-regions, fitted models describing voltage-to-distance mappings, from voltage information at the second position with respect to the reference position in different stimulus modes and distance information between the second position and the electrode patches [see column 6, lines 40-50 discloses a formula which is the equivalent of the model claimed ]; and
in the positioning phase, based on voltage information at the third position with respect to the reference position in the different stimulus modes and information about a sub-region where the applied instrument is situated [see column 5, lines 60- column 6, lines25 discloses a set of equations which are the equivalent of the model to determine position based on voltages], calculate spatial position information of the third position using the fitted models for the sub-region and spatial position information of the electrode patches, [see column 5, lines 60- column 6, lines25] wherein the spatial position information of the electrode patches is calculated from magnetic field strength information at the electrode patches. [see column 6, lines 40-55 of Govari]
Govari discloses 3 pairs of patches (i.e. N=3) and therefore does not expressly disclose wherein the number of N>3.
However, it would have been obvious to a person of ordinary skill in the art at the time of the filing of the invention to modify the number of axis of Govari’s design and make n>3 in order to provide more nodes for calculating voltages and magnetic field and increase the grid point for increased accuracy of detection. Doing so would have been applying a known method of grid point creation to a system of Govari which is ready for improvement resulting in improved and predictable results and would have been obvious to try by an ordinarily skilled in the art. (KSR Rationale B)
Regarding claim 2, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the controller is configured to gather the voltage information at the second position with respect to the reference position in the different stimulus modes [see column 4, lines 5-30 disclosing measuring the voltages by mapping electrode 22 of three data points including second position] and the distance information between the second position and the electrode patches into voltage-distance data pairs of a first type [see column 4, lines 40-50 of Govari] and derive the fitted models describing the voltage-to-distance mappings in the different stimulus modes in each of the sub-regions by fitting the voltage-distance data pairs. [equation 2 is the fitted model connecting the voltages to distance mapping]
Regarding claim 3, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the controller is configured to calculate distance information between the third position and at least three of the electrode patches using the fitted models in the different stimulus modes in the sub-region, [see column 4, lines 40-50 of Govari; the distances for three data points are calculated] and calculate the spatial position information of the third position from the distance information between the third position and the at least three of the electrode patches and spatial position information of the at least three of the electrode patches. [see column 4, lines 40-50 and Equation 2 of Govari]
Regarding claim 4, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the controller is configured to: in the fitting phase, for each of the electrode patches, gather voltage information at the second position with respect to the reference position in different stimulus modes associated with the electrode patch [see column 4, lines 5-30 disclosing measuring the voltages by mapping electrode 22 of three data points including second position] and distance information between the second position and the electrode patch into voltage-distance data pairs of a first type [see column 4, lines 40-50 of Govari; the distances for three data points are calculated] and derive fitted models in the different stimulus modes associated with the electrode patch, in each of the sub-regions; and in the positioning phase, calculate distance information between the third position and the electrode patches using the fitted models for the electrode patches in a sub-region where the applied instrument is situated; [see column 4, lines 40-50 of Govari; the distances for three data points are calculated] wherein the controller is configured to select a fitted model satisfying a first predetermined criterion from the fitted models for the different stimulus modes associated with the electrode patch as a target fitted model, [see column 4, lines 40-50 and Equation 2 of Govari] and calculate distance information between the third position and the electrode patch using the target fitted model[see column 4, lines 40-50 of Govari; the distances for three data points are calculated]
Regarding claim 6, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the controller is configured to select at least three electrode patches satisfying a second predetermined criterion from the electrode patches as target electrode patches [see column 4, lines 34-45; 6 electrode pairs of patches 60P are used], calculate distance information between the third position and the target electrode patches using the fitted models for a sub-region where the applied instrument is situated, [see column 4, lines 40-50 of Govari; the distances for three data points are calculated] and calculate spatial position information of the third position based on spatial position information of the target electrode patches. [see column 4, lines 40-50 and Equation 2 of Govari]
Regarding claim 7, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the applied instrument further comprises a position, wherein: the data collection unit is further configured to collect magnetic field strength information at the position in the positioning phase; [see column 4, lines 5-30 disclosing measuring the voltages by mapping electrode 22 of three data points] and the controller is further configured to, in the positioning phase, calculate spatial position and orientation information of the position based on the magnetic field strength information [ see column 4, lines 40-50 of Govari; the distances for three data points are calculated] at the position and derive information about a sub-region wherein the applied instrument is situated from the spatial position and orientation information of the position. [see column 4, lines 40-50 and Equation 2 of Govari]
Govari discloses using only three positions and therefore does not disclose a fourth position for detection of magnetic and electric field. However, it would have been obvious to a person of ordinary skill in the art at the time of the filing of the invention to modify the design of Govari such that the number of points that the magnetic and electric field are measured are more than three and a fourth position exists since it has been held that mere duplication of the essential working parts of a device or a routine involves only routine skill in the art. St Regis Paper Co. V. Bemis Co. 193 USPQ 8.
Regarding claim 8, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the applied instrument further comprises a position, wherein: the data collection unit is further configured to simultaneously collect voltage information at the position with respect to the reference position in all the stimulus modes in the positioning phase; and the controller is further configured to: in the positioning phase, [see column 4, lines 5-30 disclosing measuring the voltages by mapping electrode 22 of three data points] calculate spatial position information of the position based on spatial position and orientation information of the fourth position and spatial distance information between the positions; calculate distance information between the position and the electrode patches based on the spatial position information of the position and spatial position information of the electrode patches; [see column 4, lines 40-50 of Govari; the distances for three data points are calculated] gather the voltage information at the position with respect to the reference position in the different stimulus modes and the distance information between the position and the electrode patches into voltage-distance data pairs of a second type; [ see column 4, lines 40-50 of Govari; the distances for three data points are calculated]and update the fitted models for the sub-region using the voltage-distance data pairs of the second type. [see column 4, lines 40-50 and Equation 2 of Govari]
Govari discloses using only three positions and therefore does not disclose a fifth position for detection of magnetic and electric field. However, it would have been obvious to a person of ordinary skill in the art at the time of the filing of the invention to modify the design of Govari such that the number of points that the magnetic and electric field are measured are more than three and a fifth position exists since it has been held that mere duplication of the essential working parts of a device or a routine involves only routine skill in the art. St Regis Paper Co. V. Bemis Co. 193 USPQ 8.
Regarding claim 12, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that further discloses that a communication control unit, which is configured to connect the controller to the magnetic field generation unit, the stimulus control unit and the data collection unit, thereby controlling communication and data transmission between the controller and the magnetic field generation unit, the stimulus control unit and the data collection unit [above limitations are presented in an alternative language and the second section of the limitation is disclosed by Govari]; or further comprising a display unit, which is communicatively connected to the controller and configured to display a position, orientation, shape and/or travel path of the learning instrument and/or the applied instrument in the target object. [see column 4, lines 45-47 of Govari disclosing a display 26 for displaying electro-anatomical map 31 on the display ]
Regarding claim 14, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that a first magnetic field sensor [magnetic location sensor; see column 4, lines 53-60 of Govari] is disposed at the first position, and second magnetic field sensors is disposed on the electrode patches, wherein the data collection unit collects magnetic field strength information at the first position through the first magnetic field sensor and collects magnetic field strength information at the electrode patches through the second magnetic field sensors [see column 4, lines 47-61 disclosing using a magnetic location sensor on the patches 60p wherein the mapping electrode measures voltages], and a first voltage sensor is disposed at the second position, and a second voltage sensor is disposed at the third position, wherein the data collection unit collects voltage information at the second position with respect to the reference position through the first voltage sensor and collects voltage information at the third position with respect to the reference position through the second voltage sensor [see column 6, lines 5-30 disclosing using three data points to measure their voltages (V(x), V(y), V(z) using the mapping electrodes and at the same locations as magnetically measured 46 (x’, y’,z’)].
Regarding claim 15, Govari further discloses an interventional surgical system, [see abstract of Govari ] comprising the positioning system according to claim 1 [see rejection of claim 1 ] and the interventional device.[catheter ; see FIG. 1 of Govari]
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (Patent No. 11,399,735) hereinafter “Govari” in view of Turgeman et al. (U.S. Publication No. 20200179057) hereinafter “Turgeman”.
Regarding claim 9, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari does not expressly disclose that the learning and applied instruments are provided as a single instrument, wherein the fourth position coincides with the first position, and the fifth position coincides with the second position.
Turgeman, directed towards calibration of a tracking device during surgery [see abstract of Turgeman] further discloses that the learning and applied instruments are provided as a single instrument, wherein the fourth position coincides with the first position, and the fifth position coincides with the second position [see [0075] of Turgeman]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Govari such that the learning and applied instruments are provided as a single instrument, wherein the fourth position coincides with the first position, and the fifth position coincides with the second position according to the teachings of Turgeman in order to integrate the two types of probes into one probe to reduce costs and complications in the process.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (Patent No. 11,399,735) hereinafter “Govari” in view of Yang et al. (CN Publication No. 105982644) hereinafter “Yang”.
Regarding claim 10, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the controller is further configured to: gather voltage information at the third position with respect to the reference position in different stimulus modes [see column 4, lines 5-30 disclosing measuring the voltages by mapping electrode 22 of three data points including second position] and distance information between the third position and the electrode patches into voltage-distance data pairs of a third type [see column 4, lines 45-65];
Govari does not expressly disclose screening out valid data pairs from the voltage-distance data pairs of the third type; and update the fitted models for the sub-region using the valid data pairs.
Yang, directed towards a three dimensional mapping of the heart [see abstract of Yang] further disclose screening out valid data pairs from the voltage-distance data pairs of the third type; and update the fitted models for the sub-region using the valid data pairs. ;[see column 6, lines 30-45; only information regarding the three points are considered (i.e. the data is filtered to only data relate to valid points)]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Govari such that it includes screening out valid data pairs from the voltage-distance data pairs of the third type; and update the fitted models for the sub-region using the valid data pairs according to the teaching of Yang in order to determine the value of the voltage at each of the positions in 3D field accurately [see section under technical field of Yang]
Regarding claim 11, Govari discloses all the limitations of claim 1 [see rejection of claim 1 above]
Govari further discloses that the stimulus control unit is configured to apply stimuli between the at least three electrode patches [see column 6, lines 5-15 of Govari; applying voltages to patches] wherein the data collection unit collects voltage information at the second and third positions with respect to the reference position in all the stimulus modes [see column 6, lines 20-45 of Govari] wherein the data collection unit collects and filters voltage information at the second and third positions with respect to the reference position, thereby obtaining voltage information at the second and third positions with respect to the reference position in all the stimulus modes;[see column 6, lines 30-45; only information regarding the three points are considered (i.e. the data is filtered to only these three points)]
Govari does not expressly disclose fast switch between all the stimulus modes in a cyclic and continuous manner, the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches, or the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches, wherein the data collection unit collects voltage information at the second and third positions with respect to the reference position, and the controller is configured to filter the voltage information at the second and third positions with respect to the reference position collected by the data collection unit, thereby obtaining voltage information at the second and third positions with respect to the reference position in all the stimulus modes.
Yang, directed towards a three dimensional mapping of the heart [see abstract of Yang] further disclose a fast switch between all the stimulus modes in a cyclic and continuous manner, [see page 3, third full paragraph disclosing performing loop iteration of adaptive processing of incoming voltage] the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches [see page 3 disclosing a cyclic iteration between the three electrodes], or the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches, wherein the data collection unit collects voltage information at the second and third positions with respect to the reference position, and the controller is configured to filter the voltage information at the second and third positions with respect to the reference position collected by the data collection unit, thereby obtaining voltage information at the second and third positions with respect to the reference position in all the stimulus modes.
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Govari such that it includes fast switch between all the stimulus modes in a cyclic and continuous manner, the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches, or the stimulus control unit is configured to simultaneously apply stimuli, each at a different frequency, between the at least three electrode patches, wherein the data collection unit collects voltage information at the second and third positions with respect to the reference position, and the controller is configured to filter the voltage information at the second and third positions with respect to the reference position collected by the data collection unit, thereby obtaining voltage information at the second and third positions with respect to the reference position in all the stimulus modes according to the teachings of Yang in order to determine the value of the voltage at each of the positions in 3D field accurately [see section under technical field of Yang]
Conclusion
No claim is allowed.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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