DETAILED ACTION
NOTICE OF PRE-AIA OR AIA STATUS
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CONTINUED EXAMINATION UNDER 37 CFR § 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/26 (“06/30/26 Amendment") has been entered, and fully considered.
RESPONSE TO AMENDMENT
3. In the 06/30/26 Amendment:
claims 1-7, 11-17, 21, & 22 were amended;
no claims were cancelled (claims 8, 9, 18, & 19 were previously cancelled); &
no claims were newly added.
4. Therefore, claims 1-7, 10-17, & 20-22 remain pending in the application.
5. The 06/30/26 Amendment has overcome the claim objections and the claim rejections under § 112(b) previously set forth in the Final Office Action mailed 04/01/26 (“04/01/26 Action”).
6. New claim objections are set forth herein, necessitated by Applicant’s Amendment.
7. The prior rejections under § 103 have been updated to address the new limitations, and maintained. Applicant's arguments are addressed in detail below in the "RESPONSE TO ARGUMENTS" section.
CLAIM OBJECTIONS
8. Claims 1, 11, 21, & 22 are objected to because of the following informalities:
a. In claim 1, lines 11-12, the recitation of “receiving signals from an assembly of coils coupled to at least one of the distal-end assembly” should be amended as follows: --receiving signals from an assembly of coils coupled to
b. In claim 11, line 3, the recitation of “an distal-end assembly” should be amended
to recite --a distal-end assembly--.
c. In claim 21, lines 1-3, the recitation of “estimating, based on the received signals, a total contact force exerted on the tissue by the distal-end assembly further comprising” should be amended as follows: --wherein estimating, based on the received signals, a total contact force in three dimensions exerted on the tissue by the distal-end assembly further comprises--.
d. In claim 22, lines 1-6, the recitation of “the processor being configured to estimate, based on the received signals, a total contact force exerted on the tissue by the expandable distal-end assembly by using deflection, comprising a change in 3D orientation, together with a known spring constant of the distal-end assembly to calculate the total contact force exerted on the tissue by the distal-end assembly” should be amended as follows: --wherein the processor is configured to estimate, based on the received signals, a total contact force exerted on the tissue by the --.
Appropriate correction is required.
CLAIM REJECTIONS - 35 USC § 103
9. 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.
10. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. Claims 1, 7, 10, 11, 17, & 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0012307 to Harlev et al. ("Harlev") in view of U.S. 2021/0077180 to Govari et al. (“Govari”).
12. Regarding claim 1, Harlev teaches a method to find tissue proximity indications, the method comprising:
inserting a shaft [shaft (122) - ¶[0034]; FIG. 1] of a catheter [catheter (104) - ¶[0034]; FIG. 1] into a body part of a living subject [e.g., ¶[0035] (“The tip section 124 and at least a portion of the shaft 122 can be inserted into an anatomical structure (e.g., a heart) of the patient 102 via a vein or artery in the patient's leg or arm”)], the catheter [(104)] comprising a distal-end assembly [expandable portion (250) of tip section (124) - ¶’s [0034], [0036]; FIG. 2] coupled to a distal end of the shaft [see ¶[0036] (“the tip section 124 can be coupled to a distal end portion 232 of the shaft 122”); FIG. 2], the distal-end assembly [(250)] being expandable and comprising a plurality of splines [expandable portion (250) comprises a plurality of mesh panels (750), each of which includes a plurality of struts (751, 755, 757) - e.g., ¶[0053]; FIGS. 7A, 7B, 8D] arranged in one of a basket assembly and a multi-ray assembly [the plurality of struts (751, 755, 757) are arranged in a basket assembly - e.g., FIG. 8D; note also ¶[0040]] and comprising multiple electrodes [sensors (826) - ¶’s [0093], [0095] (“each sensor 826 can form part of an electrode set useful for detecting contact between each sensor 826 and tissue”)] disposed thereon [e.g., ¶[0071]; note also electrodes (826) on struts (751) - FIG. 8C];
measuring impedances between each electrode [(826)] of the multiple electrodes and a reference electrode [e.g., ¶[0095] (“each sensor 826 can form part of an electrode set useful for detecting contact between each sensor 826 and tissue. For example, electrical energy (e.g., current) can be driven through each sensor 826 and another electrode or a plurality of other electrodes (e.g., any one or more of the various different electrodes described herein) and a change in a measured signal (e.g., voltage or impedance) can be indicative of the presence of tissue”)];
receiving signals from an assembly of coils [one or more location coil sensors (931, 1031, 1032) - ¶’s [0100]-[0102]] coupled to the distal-end assembly [(250)], the assembly of coils comprising three distal coils on three different splines of the plurality of splines [NOTE: (a) expandable portion (250) comprises a plurality of mesh panels (see ¶[0053); Harlev teaches that multiple mesh panels (750), for example three, may be coupled to one another to collectively define the expandable portion – see ¶[0073] (“Referring now to FIG. 8D, as multiple (e.g., two, three, four, five, six, or more (e.g., seven to twelve)) mesh electrode panels 750 are mechanically coupled to one another, the panels 750 collectively form a closed shape to define the expandable portion 250”); (b) Harlev teaches that each mesh panel (750) includes a plurality of struts (751, 755, 757) (see ¶[0053]); (c) as such, in a configuration where there are three mesh panels (750), there are three sets of struts (751, 755, 757); (d) Harlev teaches that location coil sensors (1032) can be mounted on one or more of struts (755) and/or (757) of a mesh panel (see ¶[0100]); (e) as such, it is the Examiner’s position that Harlev teaches at least three location coil sensors (1032) on three different struts (e.g., on respective struts (757) of respective mesh panels (750) of expandable portion (250)] and one proximal coil coupled to the distal end of the shaft [as broadly as currently claimed, location coil sensor (1031) is “coupled to” the distal end of shaft (122) via coupler (367) (e.g., ¶[0100]; FIG. 11A)], receiving the signals from the assembly of coils comprising using the assembly of coils in a local transmitter-receiver configuration [e.g., ¶[0101] (“the location coil sensors 931, 1031, and/or 1032 are magnetic coil sensors configured to emit a magnetic field while other coils (e.g., external to the patient 102, others of the coil sensors 931, 1031, and/or 1032, etc.) can be used to measure the resultant magnetic field. Additionally, or alternatively, coils external to the patient 102 can be configured to emit a magnetic field. In these and other embodiments, the location coil sensors 931, 1031, and/or 1032 can be configured to transmit and/or receive signals indicating information relating to three to six degrees of freedom. For example, the location coil sensors 931, 1031, and/or 1032 can transmit and/or receive signals indicating positional information of the coil sensors 931, 1031, and/or 1032 in three-dimensional space (e.g., signals indicating x, y, and z positional coordinates relative to a defined origin, such as an external reference frame and/or relative to one or more of the location coil sensors 931, 1031, and/or 1032)”)] to sense a three-dimensional position and orientation of the three distal coils [e.g., ¶[0101]]; [and]
estimating, based on the received signals, a total contact force in three dimensions exerted on the tissue by the distal-end assembly [(250)] [see ¶[0101] (“Therefore, the location coil sensors 931, 1031, and/or 1032 can be used to resolve the location of the tip section 124 (e.g., within the patient 102) relative to a defined origin and/or can be used to computationally determine the shape and/or orientation (e.g., pose) of the expandable portion 250. Additionally, or alternatively, the location coil sensors 931, 1031, and/or 1032 can be used (i) to determine a distance between the coil sensors 931 and the coil sensors 1031, and/or (ii) to determine a distance and/or angle between the coil sensors 931, 1031, and/or 1032. In turn, the determined distances and/or angles can be used to determine and/or estimate a shape (e.g., an extent of expansion and/or deformation) of the expandable portion 250”); and ¶[0108] (“the determined displacement of the expandable portion 250 can be used to determine the amount and direction of force applied to the expandable portion 250. In particular, the processing unit 110 can determine force applied to the expandable portion 250 based on the determined displacement of the expandable portion 250. For example, using a lookup table, a curve fit, or other predetermined relationship, the processing unit 110 can determine the direction and magnitude of force applied to the expandable portion 250 based on the magnitude and direction of the displacement of the expandable portion 250, as determined according to any one or more of the methods of determining displacement described herein”)].
ELECTRODE “SUBSET”
While Harlev teaches that the measured impedances of the sensors [electrodes] (826) can be used to detect contact between each sensor and tissue [e.g., ¶[0095], and that aspects of the contact can be output to, e.g., a display [see ¶[0110] (“the graphical user interface 109 can be used to display the catheter 104 with an icon representing the location, orientation, and/or shape of the tip section 124 and the shaft 122 on a mapping system (e.g., within a model of an anatomical structure of the patient 102)”)], Harlev does not explicitly teach using an identified subset of the multiple electrodes that physically contact tissue to infer one or more qualities of physical contact, and therefore fails to teach the following limitations:
based on the measured impedances, identifying a subset of the multiple electrodes that physically contact tissue of the body part;
based on the identified subset of the multiple electrodes and the estimated total contact force, inferring one or more qualities of physical contact between respective electrodes and the tissue; and
outputting one or more of the one or more qualities of physical contact
Govari, in a similar field of endeavor, teaches a catheter [catheter (300) - ¶[0091]; FIG. 9] comprising an expandable distal-end assembly [inflatable balloon (306) - ¶[0093]; FIG. 9] coupled to a distal end [distal tip (304) - ¶[0093]; FIG. 9] of an insertion shaft [insertion tube (302) - ¶[0092]; FIG. 9] that is configured to be inserted into a body part of a living subject [see ¶[0092] (“The balloon catheter 300 is configured to be inserted into a body-part (such as a heart chamber, or any other suitable body-part) of a living subject”)].
Govari teaches that the distal-end assembly [(306)] comprises multiple electrodes [electrodes (310) - ¶[0093]; FIG. 9] disposed thereon, and further teaches measuring impedances between each of the electrodes and a reference electrode [see, e.g., ¶[0059] (“the catheter may provide signals which provide an indication of impedance between the catheter electrodes and body surface electrodes”)].
Based on the measured impedances, Govari teaches identifying a subset of the electrodes that physically contact tissue of the body part [¶’s [0058], [0059] (“The indication of the impedance provides an indication of a quality of contact… A value of impedance may be selected to define a minimum quality of contact considered to represent sufficient contact between any one of the catheter electrodes and the tissue”); & ¶[0117] (“The processor 22 (FIG. 1) is configured to receive (block 410) contact signals from the electrodes 310 (FIGS. 9 and 10). The processor 22 (FIG. 1) is configured in response to the contact signals, to assess (block 412) a respective quality of contact of each of the electrodes 310 with the tissue”)]. More particularly, Govari teaches that those electrodes determined to have a quality of contact above a given quality of contact are highlighted on a display to allow for easy identification of which electrodes are in contact with the tissue [see ¶[0119]].
In addition to the foregoing, Govari also teaches receiving signals from an assembly of force-sensing coils (118), (170), & (172) [¶[0075]], and estimating, based on the signals, a total contact force exerted on the tissue by the assembly [¶’s [0111], [0114], & [0116] (“The processor 22 is configured to compute (block 408) a position (location and orientation) of the inflatable balloon responsively to the computed position of the distal tip 304 and the force signal(s) (which yields the lateral and angular displacement of the inflatable balloon 306 with respect to the distal tip 304)”)].
Based on the identified subset of the electrodes and the estimated total contact force, Govari teaches inferring one or more qualities of physical contact [e.g., a degree and direction of contact] between respective electrodes and the tissue [as broadly as claimed, the degree of contact of electrodes is determined and displayed using highlighting (¶[0119]; FIG. 14) along with a displayed force vector (which shows the direction in which the force is acting on the balloon, and therefore also on the electrodes which are disposed on the balloon)], as well as outputting one or more of the one or more inferred qualities of physical contact [to a display - see ¶[0119]; FIG. 14].
Given, as noted above, that Harlev already teaches: (1) measuring impedances using the electrodes to detect contact between each sensor and tissue; (2) determining an estimated total contact force exerted by the distal end assembly; and (3) outputting aspects of the contact to a display, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harlev to include the operations of, based on the measured impedances, identifying a subset of the multiple electrodes that physically contact tissue of the body part, based on the identified subset of the multiple electrodes and the estimated total contact force, inferring one or more qualities of physical contact between respective electrodes and the tissue, and outputting one or more of the one or more qualities of physical contact, since inferring and outputting (displaying) one or more qualities of physical contact [e.g., a degree and direction of contact] between respective electrodes and the tissue by displaying the degree of contact (using highlighting) and a force vector (showing the direction in which the force is acting on the distal end assembly, and therefore also on the electrodes which are disposed thereon), would provide the benefit/advantage of enabling a practitioner to easily identify which electrodes are in contact with tissue [Govari, ¶[0119]], which would facilitate the process of adjusting the positioning of the distal end assembly as needed to ensure that energy is being applied at a desired treatment location in an optimal and effective manner.
13. Regarding claim 7, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches the multiple electrodes being disposed on the plurality of splines [e.g., ¶[0071]; note also electrodes (826) on struts (751) - FIG. 8C], and Harlev as modified by Govari (above in the rejection of claim 1) further teaches wherein estimating the total contact force comprises estimating contact forces exerted by one of one or more of the plurality of splines [in Harlev/Govari, a strut that includes an electrode determined to be in contact with tissue, based on measured impedance, is therefore a strut of the expandable assembly (250) experiencing axial force-displacement and/or lateral force-displacement based on the contact, and the force exerted thereby is therefore a contact force utilized in an estimation of contact force of the expandable assembly (250) - ¶’s [0092], [0095], [0097], [0098], [0106], [0108]].
14. Regarding claim 10, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein measuring impedances comprises receiving at least one of bipolar and unipolar signals acquired by the catheter [both bipolar and unipolar signals - e.g., ¶’s [0096], [0113]].
15. Regarding claim 11, Harlev teaches a system to find tissue proximity indications, the system comprising:
a catheter [catheter (104) - ¶[0034]; FIG. 1] comprising a shaft [shaft (122) - ¶[0034]; FIG. 1] configured for insertion into a body part of a living subject [e.g., ¶[0035] (“The tip section 124 and at least a portion of the shaft 122 can be inserted into an anatomical structure (e.g., a heart) of the patient 102 via a vein or artery in the patient's leg or arm”)], the catheter [(104)] further comprising an distal-end assembly [expandable portion (250) of tip section (124) - ¶’s [0034], [0036]; FIG. 2] coupled to a distal end of the shaft [see ¶[0036] (“the tip section 124 can be coupled to a distal end portion 232 of the shaft 122”); FIG. 2], the distal-end assembly being expandable and comprising a plurality of splines expandable portion (250) comprises a plurality of mesh panels (750), each of which includes a plurality of struts (751, 755, 757) - e.g., ¶[0053]; FIGS. 7A, 7B, 8D] arranged in one of a basket assembly and a multi-ray assembly [the plurality of struts (751, 755, 757) are arranged in a basket assembly - e.g., FIG. 8D; note also ¶[0040]] and comprising multiple electrodes [sensors (826) - ¶’s [0093], [0095] (“each sensor 826 can form part of an electrode set useful for detecting contact between each sensor 826 and tissue”)] disposed thereon [e.g., ¶[0071]; note also electrodes (826) on struts (751) - FIG. 8C]; and
a processor [processing unit (110) - ¶[0032]; FIG. 1], which is configured to:
measure impedances between each electrode [(826)] of the multiple electrodes and a reference electrode [e.g., ¶[0095] (“each sensor 826 can form part of an electrode set useful for detecting contact between each sensor 826 and tissue. For example, electrical energy (e.g., current) can be driven through each sensor 826 and another electrode or a plurality of other electrodes (e.g., any one or more of the various different electrodes described herein) and a change in a measured signal (e.g., voltage or impedance) can be indicative of the presence of tissue”)];
receive signals from an assembly of coils [one or more location coil sensors (931, 1031, 1032) - ¶’s [0100]-[0102]] comprising three distal coils on three different splines of the plurality of splines [NOTE: (a) expandable portion (250) comprises a plurality of mesh panels (see ¶[0053); Harlev teaches that multiple mesh panels (750), for example three, may be coupled to one another to collectively define the expandable portion – see ¶[0073] (“Referring now to FIG. 8D, as multiple (e.g., two, three, four, five, six, or more (e.g., seven to twelve)) mesh electrode panels 750 are mechanically coupled to one another, the panels 750 collectively form a closed shape to define the expandable portion 250”); (b) Harlev teaches that each mesh panel (750) includes a plurality of struts (751, 755, 757) (see ¶[0053]); (c) as such, in a configuration where there are three mesh panels (750), there are three sets of struts (751, 755, 757); (d) Harlev teaches that location coil sensors (1032) can be mounted on one or more of struts (755) and/or (757) of a mesh panel (see ¶[0100]); (e) as such, it is the Examiner’s position that Harlev teaches at least three location coil sensors (1032) on three different struts (e.g., on respective struts (757) of respective mesh panels (750) of expandable portion (250)] and one proximal coil coupled to the distal end of the shaft [as broadly as currently claimed, location coil sensor (1031) is “coupled to” the distal end of shaft (122) via coupler (367) (e.g., ¶[0100]; FIG. 11A)], receiving the signals from the assembly of coils comprising using the assembly of coils in a local transmitter-receiver configuration [e.g., ¶[0101] (“the location coil sensors 931, 1031, and/or 1032 are magnetic coil sensors configured to emit a magnetic field while other coils (e.g., external to the patient 102, others of the coil sensors 931, 1031, and/or 1032, etc.) can be used to measure the resultant magnetic field. Additionally, or alternatively, coils external to the patient 102 can be configured to emit a magnetic field. In these and other embodiments, the location coil sensors 931, 1031, and/or 1032 can be configured to transmit and/or receive signals indicating information relating to three to six degrees of freedom. For example, the location coil sensors 931, 1031, and/or 1032 can transmit and/or receive signals indicating positional information of the coil sensors 931, 1031, and/or 1032 in three-dimensional space (e.g., signals indicating x, y, and z positional coordinates relative to a defined origin, such as an external reference frame and/or relative to one or more of the location coil sensors 931, 1031, and/or 1032)”)] to sense a three-dimensional position and orientation of the three distal coils [e.g., ¶[0101]]; [and]
estimate, based on the received signals, a total contact force exerted on the tissue by the distal-end assembly [(250)] [see ¶[0101] (“Therefore, the location coil sensors 931, 1031, and/or 1032 can be used to resolve the location of the tip section 124 (e.g., within the patient 102) relative to a defined origin and/or can be used to computationally determine the shape and/or orientation (e.g., pose) of the expandable portion 250. Additionally, or alternatively, the location coil sensors 931, 1031, and/or 1032 can be used (i) to determine a distance between the coil sensors 931 and the coil sensors 1031, and/or (ii) to determine a distance and/or angle between the coil sensors 931, 1031, and/or 1032. In turn, the determined distances and/or angles can be used to determine and/or estimate a shape (e.g., an extent of expansion and/or deformation) of the expandable portion 250”); and ¶[0108] (“the determined displacement of the expandable portion 250 can be used to determine the amount and direction of force applied to the expandable portion 250. In particular, the processing unit 110 can determine force applied to the expandable portion 250 based on the determined displacement of the expandable portion 250. For example, using a lookup table, a curve fit, or other predetermined relationship, the processing unit 110 can determine the direction and magnitude of force applied to the expandable portion 250 based on the magnitude and direction of the displacement of the expandable portion 250, as determined according to any one or more of the methods of determining displacement described herein”)].
ELECTRODE “SUBSET”
While Harlev teaches that the measured impedances of the sensors [electrodes] (826) can be used to detect contact between each sensor and tissue [e.g., ¶[0095], and that aspects of the contact can be output to, e.g., a display [see ¶[0110] (“the graphical user interface 109 can be used to display the catheter 104 with an icon representing the location, orientation, and/or shape of the tip section 124 and the shaft 122 on a mapping system (e.g., within a model of an anatomical structure of the patient 102)”)], Harlev does not explicitly teach using an identified subset of the multiple electrodes that physically contact tissue to infer one or more qualities of physical contact, and therefore fails to teach the following limitations:
[the] processor, which is configured to:
based on the measured impedances, identify a subset of the multiple electrodes that physically contact tissue of the body part;
based on the identified subset of the multiple electrodes and the estimated total contact force, infer one or more qualities of physical contact between respective electrodes and the tissue; and
output one or more of the one or more qualities of physical contact.
Govari, in a similar field of endeavor, teaches a catheter [catheter (300) - ¶[0091]; FIG. 9] comprising an expandable distal-end assembly [inflatable balloon (306) - ¶[0093]; FIG. 9] coupled to a distal end [distal tip (304) - ¶[0093]; FIG. 9] of an insertion shaft [insertion tube (302) - ¶[0092]; FIG. 9] that is configured to be inserted into a body part of a living subject [see ¶[0092] (“The balloon catheter 300 is configured to be inserted into a body-part (such as a heart chamber, or any other suitable body-part) of a living subject”)].
Govari teaches that the distal-end assembly [(306)] comprises multiple electrodes [electrodes (310) - ¶[0093]; FIG. 9] disposed thereon, and further teaches measuring impedances between each of the electrodes and a reference electrode [see, e.g., ¶[0059] (“the catheter may provide signals which provide an indication of impedance between the catheter electrodes and body surface electrodes”)].
Based on the measured impedances, Govari teaches identifying a subset of the electrodes that physically contact tissue of the body part [¶’s [0058], [0059] (“The indication of the impedance provides an indication of a quality of contact… A value of impedance may be selected to define a minimum quality of contact considered to represent sufficient contact between any one of the catheter electrodes and the tissue”); & ¶[0117] (“The processor 22 (FIG. 1) is configured to receive (block 410) contact signals from the electrodes 310 (FIGS. 9 and 10). The processor 22 (FIG. 1) is configured in response to the contact signals, to assess (block 412) a respective quality of contact of each of the electrodes 310 with the tissue”)]. More particularly, Govari teaches that those electrodes determined to have a quality of contact above a given quality of contact are highlighted on a display to allow for easy identification of which electrodes are in contact with the tissue [see ¶[0119]].
In addition to the foregoing, Govari also teaches receiving signals from an assembly of force-sensing coils (118), (170), & (172) [¶[0075]], and estimating, based on the signals, a total contact force exerted on the tissue by the assembly [¶’s [0111], [0114], & [0116] (“The processor 22 is configured to compute (block 408) a position (location and orientation) of the inflatable balloon responsively to the computed position of the distal tip 304 and the force signal(s) (which yields the lateral and angular displacement of the inflatable balloon 306 with respect to the distal tip 304)”)].
Based on the identified subset of the electrodes and the estimated total contact force, Govari teaches inferring one or more qualities of physical contact [e.g., a degree and direction of contact] between respective electrodes and the tissue [as broadly as claimed, the degree of contact of electrodes is determined and displayed using highlighting (¶[0119]; FIG. 14) along with a displayed force vector (which shows the direction in which the force is acting on the balloon, and therefore also on the electrodes which are disposed on the balloon)], as well as outputting one or more of the one or more inferred qualities of physical contact [to a display - see ¶[0119]; FIG. 14].
Given, as noted above, that Harlev already teaches: (1) measuring impedances using the electrodes to detect contact between each sensor and tissue; (2) determining an estimated total contact force exerted by the distal end assembly; and (3) outputting aspects of the contact to a display, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harlev such that the processor be further configured to, based on the measured impedances, identify a subset of the multiple electrodes that physically contact tissue of the body part, based on the identified subset of the multiple electrodes and the estimated total contact force, infer one or more qualities of physical contact between respective electrodes and the tissue, and output one or more of the one or more qualities of physical contact, since inferring and outputting (displaying) one or more qualities of physical contact [e.g., a degree and direction of contact] between respective electrodes and the tissue by displaying the degree of contact (using highlighting) and a force vector (showing the direction in which the force is acting on the distal end assembly, and therefore also on the electrodes which are disposed thereon), would provide the benefit/advantage of enabling a practitioner to easily identify which electrodes are in contact with tissue [Govari, ¶[0119]], which would facilitate the process of adjusting the positioning of the distal end assembly as needed to ensure that energy is being applied at a desired treatment location in an optimal and effective manner.
16. Regarding claim 17, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches the multiple electrodes being disposed on the plurality of splines [e.g., ¶[0071]; note also electrodes (826) on struts (751) - FIG. 8C], and Harlev as modified by Govari (above in the rejection of claim 11) further teaches wherein the processor is configured to estimate contact forces by estimating contact forces exerted by one of one or more of the plurality of splines [in Harlev/Govari, a strut that includes an electrode determined to be in contact with tissue, based on measured impedance, is therefore a strut of the expandable assembly (250) experiencing axial force-displacement and/or lateral force-displacement based on the contact, and the force exerted thereby is therefore a contact force utilized in an estimation of contact force of the expandable assembly (250) - ¶’s [0092], [0095], [0097], [0098], [0106], [0108]].
17. Regarding claim 20, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the processor is configured to measure impedances by receiving at least one of bipolar and unipolar signals acquired by the catheter [both bipolar and unipolar signals - e.g., ¶’s [0096], [0113]].
18. Regarding claim 21, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Harlev teaches determining deflection, comprising a change in 3D orientation [e.g., ¶’s [0101], [0102], [0107], [0109], & [0110]], and that the direction and magnitude of force applied to the expandable portion (250) can be determined in a variety of different ways [e.g., using a lookup table, a curve fit, or other predetermined relationship (see ¶[0108])], Harlev does not teach:
estimating, based on the received signals, a total contact force exerted on the tissue by the distal-end assembly further comprising using deflection, comprising a change in 3D orientation, together with a known spring constant of the distal-end assembly to calculate the total contact force exerted on the tissue by the distal-end assembly.
Govari, however, further teaches that it was known to utilize measured deflection together with a spring constant of a flexible member associated with an expandable distal-end assembly [in this instance, a beam coupler (190) having location sensors provided thereon coupled to balloon (306)] to determine contact force [see ¶[0082] (“Beam coupling member 190 has a known or predetermined spring constant providing a relationship between distance and force in accordance with Hooke's law”); and ¶[0109] (“displacement of discrete portions of beam coupling member 190 can be determined (given that spring constant k of beam coupling member 190 is known prior to installation)”)].
Given that Harlev already contemplates determining direction and magnitude of force applied to the expandable portion (250) in a variety of different ways [¶[0108]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to implement a known, art-recognized technique for contact force determination including using deflection, comprising a change in 3D orientation, together with a known spring constant of the distal-end assembly to calculate the total contact force exerted on the tissue by the distal-end assembly, since such a particular known technique was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Govari, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Harlev and Govari, and the results [calculating contact force] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
19. Regarding claim 22, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
While Harlev teaches determining deflection, comprising a change in 3D orientation [e.g., ¶’s [0101], [0102], [0107], [0109], & [0110]], and that the direction and magnitude of force applied to the expandable portion (250) can be determined in a variety of different ways [e.g., using a lookup table, a curve fit, or other predetermined relationship (see ¶[0108])], Harlev does not teach:
the processor being configured to estimate, based on the received signals, a total contact force exerted on the tissue by the expandable distal-end assembly by using deflection, comprising a change in 3D orientation, together with a known spring constant of the distal-end assembly to calculate the total contact force exerted on the tissue by the distal-end assembly.
Govari, however, further teaches that it was known to utilize measured deflection together with a spring constant of a flexible member associated with an expandable distal-end assembly [in this instance, a beam coupler (190) having location sensors provided thereon coupled to balloon (306)] to determine contact force [see ¶[0082] (“Beam coupling member 190 has a known or predetermined spring constant providing a relationship between distance and force in accordance with Hooke's law”); and ¶[0109] (“displacement of discrete portions of beam coupling member 190 can be determined (given that spring constant k of beam coupling member 190 is known prior to installation)”)].
Given that Harlev already contemplates determining direction and magnitude of force applied to the expandable portion (250) in a variety of different ways [¶[0108]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to implement a known, art-recognized technique for contact force determination including using deflection, comprising a change in 3D orientation, together with a known spring constant of the distal-end assembly to calculate the total contact force exerted on the tissue by the distal-end assembly, since such a particular known technique was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Govari, and one of ordinary skill in the art would have been capable of applying this known technique to the known system of Harlev and Govari, and the results [calculating contact force] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
20. Claims 2 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Harlev and Govari, and further in view of U.S. 2021/0361220 to Olson (“Olson”).
21. Regarding claim 2, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Harlev and Govari does not, however, teach:
wherein inferring the one or more qualities of physical contact comprises, using the subset of multiple electrodes, relating the impedances into contact force per any electrode of the distal-end assembly.
Olson, in a similar field of endeavor, is directed to a mapping catheter [¶[0002]] that utilizes a balloon [an expandable member] comprising a plurality of electrodes utilized for diagnosing or treating cardiac arrhythmias, for example, mapping electrophysiological signals of tissue within the body [e.g., ¶[0026]]. Olson teaches that it was known to determine electrodes in contact with tissue based on an electrical characteristic such as impedance, as well as to determine contact force for respective electrodes based on the electrical characteristic [see, e.g., ¶’s [0064], [0080]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari such that wherein inferring the one or more qualities of physical contact comprises, using the subset of multiple electrodes, relating the impedances into contact force per any electrode of the distal-end assembly, as taught by Olson, since such a modification would provide the benefit/advantage of enabling a practitioner to identify, on an even more granular level, which electrodes are experiencing the greatest (and/or the least) contact force, which again would facilitate the process of adjusting the positioning of the distal end assembly as needed to ensure that energy is being applied at a desired treatment location in an optimal and effective manner.
22. Regarding claim 12, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
The combination of Harlev and Govari does not, however, teach:
wherein the processor is configured to infer the one or more qualities of physical contact by, using the subset of the multiple electrodes, relating the impedances into contact force per any electrode of the distal-end assembly.
Olson, in a similar field of endeavor, is directed to a mapping catheter [¶[0002]] that utilizes a balloon [an expandable member] comprising a plurality of electrodes utilized for diagnosing or treating cardiac arrhythmias, for example, mapping electrophysiological signals of tissue within the body [e.g., ¶[0026]]. Olson teaches that it was known to determine electrodes in contact with tissue based on an electrical characteristic such as impedance, as well as to determine contact force for respective electrodes based on the electrical characteristic [see, e.g., ¶’s [0064], [0080]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari such that the processor be configured to infer the one or more qualities of physical contact by, using the subset of the multiple electrodes, relating the impedances into contact force per any electrode of the distal-end assembly, as taught by Olson, since such a modification would provide the benefit/advantage of enabling a practitioner to identify, on an even more granular level, which electrodes are experiencing the greatest (and/or the least) contact force, which again would facilitate the process of adjusting the positioning of the distal end assembly as needed to ensure that energy is being applied at a desired treatment location in an optimal and effective manner.
23. Claims 3, 4, 13, & 14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Harlev and Govari, and further in view of U.S. 2020/0367829 to Govari et al. (“Govari ‘829”).
24. Regarding claim 3, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Govari teaches that outputting the one or more inferred qualities of the physical contact comprises displaying the degree/quality of contact of electrodes using highlighting [see ¶[0119] (“The electrodes 310 having a quality of contact above a given quality of contact are highlighted as compared to other electrodes 310. The electrode representations in FIG. 14 are labeled with reference numeral 510. The highlighted electrodes may be displayed in a different color and/or using a greater brightness and/or using a border or any suitable way to distinguish the electrodes 310 having the quality of contact above the given quality of contact as compared to other electrodes 310”); the combination of Harlev and Govari does not teach:
wherein outputting the one or more of the one or more qualities of the physical contact comprises providing the one or more of the one or more qualities of the physical contact as numbers on a scale.
Govari ‘829, in a similar field of endeavor, teaches a catheter including catheter electrodes configured to contact tissue at respective locations within the chamber of the heart, a display, and processing circuitry to receive signals from the catheter, and in response to the signals assess a respective quality of contact of each of the catheter electrodes with the tissue in the heart [Abstract]. Govari ‘829 further teaches that it was known to present a measure of contact for an electrode numerically or graphically [e.g., ¶[0044] (“monitoring the contact may be performed by presenting a measure of the contact, such as the impedance seen by an electrode or the force on the electrode, numerically or even graphically”)].
In view of the teachings of Govari ‘829, and while Govari ‘829 may not explicitly teach that the numerical presentation comprises presenting numbers on a scale, it is the Examiner’s position that it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to provide the graphical representation of physical contact in whatever manner/format was desired or expedient, including, e.g., via different colors, patterns/hatching, letters, symbols, shapes, or as numbers on a scale, since Applicant has not disclosed that the particular use of numbers on a scale presents a novel or unexpected result over the graphical representations of physical contact used in the prior art (of Govari).
25. Regarding claim 4, the combination of Harlev, Govari, & Govari ‘829 teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Claim 4 further recites the limitation of “outputting a number for one of the respective electrodes when an estimated electrode’s contact force for the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the distal-end assembly, is above a given threshold ,and the respective electrode's measured impedance is within an estimated range of impedances.”
The combination of Harlev and Govari was modified above (in the rejection of claim 3) to utilize numbers on a scale to graphically represent the degree/quality of contact of electrodes (as taught by Govari ‘829), which is based on the total contact force of the expandable member (250) of Harlev/Govari (as established in the rejection of claim 1 above).
Govari further teaches outputting a graphical representation when contact exceeds a given contact quality threshold [e.g., ¶[0119]. Govari also teaches that impedance values are selected based on impedance ranges [e.g., a comparison to pre-measured impedance values from when an electrode is known to be in contact with tissue - see ¶’s [0059]-[0060]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev, Govari, and Govari ‘829 to include outputting a number for one of the respective electrodes when an estimated electrode’s contact force for the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the distal-end assembly, is above a given threshold ,and the respective electrode's measured impedance is within an estimated range of impedances, since the comparison of measured values to known thresholds and ranges to ensure reliability/validity, prior to output, provides the benefit/advantage of ensuring that a practitioner is receiving accurate electrode quality contact information in real-time for purposes of ensuring that energy is being applied at a desired treatment location in an optimal and effective manner, thereby improving surgical outcomes.
26. Regarding claim 13, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
While Govari teaches that outputting the one or more inferred qualities of the physical contact comprises displaying the degree/quality of contact of electrodes using highlighting [see ¶[0119] (“The electrodes 310 having a quality of contact above a given quality of contact are highlighted as compared to other electrodes 310. The electrode representations in FIG. 14 are labeled with reference numeral 510. The highlighted electrodes may be displayed in a different color and/or using a greater brightness and/or using a border or any suitable way to distinguish the electrodes 310 having the quality of contact above the given quality of contact as compared to other electrodes 310”); the combination of Harlev and Govari does not teach:
wherein the processor is configured to output the one or more of the one or more qualities of the physical contact by providing the one or more of the one or more qualities of the physical contact as numbers on a scale.
Govari ‘829, in a similar field of endeavor, teaches a catheter including catheter electrodes configured to contact tissue at respective locations within the chamber of the heart, a display, and processing circuitry to receive signals from the catheter, and in response to the signals assess a respective quality of contact of each of the catheter electrodes with the tissue in the heart [Abstract]. Govari ‘829 further teaches that it was known to present a measure of contact for an electrode numerically or graphically [e.g., ¶[0044] (“monitoring the contact may be performed by presenting a measure of the contact, such as the impedance seen by an electrode or the force on the electrode, numerically or even graphically”)].
In view of the teachings of Govari ‘829, and while Govari ‘829 may not explicitly teach that the numerical presentation comprises presenting numbers on a scale, it is the Examiner’s position that it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to provide the graphical representation of physical contact in whatever manner/format was desired or expedient, including, e.g., via different colors, patterns/hatching, letters, symbols, shapes, or as numbers on a scale, since Applicant has not disclosed that the particular use of numbers on a scale presents a novel or unexpected result over the graphical representation of physical contact used in the prior art (of Govari).
27. Regarding claim 14, the combination of Harlev, Govari, & Govari ‘829 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Claim 14 further recites the limitation of “wherein the processor is further configured to output a number for one of the respective electrodes when an estimated contact force of the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the distal-end assembly, is above a given threshold, and the respective electrode's measured impedance is within an estimated range of impedances.”
The combination of Harlev and Govari was modified above (in the rejection of claim 13) to utilize numbers on a scale to graphically represent the degree/quality of contact of electrodes (as taught by Govari ‘829), which is based on the total contact force of the expandable member (250) of Harlev/Govari (as established in the rejection of claim 11 above).
Govari further teaches outputting a graphical representation when contact exceeds a given contact quality threshold [e.g., ¶[0119]. Govari also teaches that impedance values are selected based on impedance ranges [e.g., a comparison to pre-measured impedance values from when an electrode is known to be in contact with tissue - see ¶’s [0059]-[0060]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev, Govari, and Govari ‘829 to include outputting a number for one of the respective electrodes when an estimated contact force of the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the distal-end assembly, is above a given threshold, and the respective electrode's measured impedance is within an estimated range of impedances, since the comparison of measured values to known thresholds and ranges to ensure reliability/validity, prior to output, provides the benefit/advantage of ensuring that a practitioner is receiving accurate electrode quality contact information in real-time for purposes of ensuring that energy is being applied at a desired treatment location in an optimal and effective manner, thereby improving surgical outcomes.
28. Claims 5, 6, 15, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Harlev and Govari, and further in view of U.S. 2018/0116751 to Schwartz et al. (“Schwartz”).
29. Regarding claim 5, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Govari further teaches utilizing a threshold impedance value to define a minimum quality of contact to represent sufficient contact between any one catheter electrode and tissue [e.g., ¶’s [0059], [0060]], the combination of Harlev and Govari does not teach:
wherein inferring one or more qualities comprises using Bayesian statistics to deduce a probability of a physical contact force being above a given threshold contact force.
Schwartz, in a similar field of endeavor, is directed to systems and methods for probe positioning within a body cavity, and more particularly to assessment of contact between an intra-body electrode and a tissue surface [¶’s [0003], [0091]]. More particularly, Shwartz teaches converting measured dielectric properties of tissue (including, e.g., impedance) [¶’s [0010], [0115], [0116]] into one or more measures of contact quality, such as contact force [e.g., ¶’s [0091], [0093], [0146]].
Schwartz further teaches that it was known to implement machine learning techniques to enhance contact quality and contact force determinations, including, e.g., Bayesian networks [see ¶[0163] (“In some embodiments, multivariate nonlinear regression and/or classification analysis is used to establish correlations and/or mappings between measurements (and/or intervals of measurements obtained as a time series) and one or more of contact quality and contact force. Optionally, correlation and/or mapping is derived from use of a machine learning technique; for example: one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to utilize known, art-recognized machine learning techniques, including, e.g., Bayesian networks when inferring one or more qualities to deduce a probability of a physical contact force being above a given threshold contact force, since the use of machine learning techniques, e.g., Bayesian networks, to improve/enhance contact quality and contact force determinations was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Schwartz, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Harlev/Govari, and the results [improving/enhancing contact quality and contact force determinations] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
30. Regarding claim 6, the combination of Harlev and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Harlev and Govari does not, however, teach:
wherein inferring one or more qualities comprises using a neural network (NN) model to deduce a probability of the one or more qualities based on estimated contact forces.
Schwartz, in a similar field of endeavor, is directed to systems and methods for probe positioning within a body cavity, and more particularly to assessment of contact between an intra-body electrode and a tissue surface [¶’s [0003], [0091]]. More particularly, Shwartz teaches converting measured dielectric properties of tissue (including, e.g., impedance) [¶’s [0010], [0115], [0116]] into one or more measures of contact quality, such as contact force [e.g., ¶’s [0091], [0093], [0146]].
Schwartz further teaches that it was known to implement machine learning techniques to enhance contact quality and contact force determinations, including, e.g., neural networks [see ¶[0163] (“In some embodiments, multivariate nonlinear regression and/or classification analysis is used to establish correlations and/or mappings between measurements (and/or intervals of measurements obtained as a time series) and one or more of contact quality and contact force. Optionally, correlation and/or mapping is derived from use of a machine learning technique; for example: one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to utilize known, art-recognized machine learning techniques, including, e.g., neural networks when inferring one or more qualities to deduce a probability of the one or more qualities based on estimated contact forces, since the use of neural networks to improve/enhance contact quality and contact force determinations was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Schwartz, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Harlev/Govari, and the results [improving/enhancing contact quality and contact force determinations] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
31. Regarding claim 15, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
While Govari further teaches utilizing a threshold impedance value to define a minimum quality of contact to represent sufficient contact between any one catheter electrode and tissue [e.g., ¶’s [0059], [0060]], the combination of Harlev and Govari does not teach:
wherein the processor is configured to infer one or more qualities among the qualities of a respective electrode's physical contact by using Bayesian statistics to deduce a probability of the respective electrode's physical contact being above a given threshold contact force.
Schwartz, in a similar field of endeavor, is directed to systems and methods for probe positioning within a body cavity, and more particularly to assessment of contact between an intra-body electrode and a tissue surface [¶’s [0003], [0091]]. More particularly, Shwartz teaches converting measured dielectric properties of tissue (including, e.g., impedance) [¶’s [0010], [0115], [0116]] into one or more measures of contact quality, such as contact force [e.g., ¶’s [0091], [0093], [0146]].
Schwartz further teaches that it was known to implement machine learning techniques to enhance contact quality and contact force determinations, including, e.g., Bayesian networks [see ¶[0163] (“In some embodiments, multivariate nonlinear regression and/or classification analysis is used to establish correlations and/or mappings between measurements (and/or intervals of measurements obtained as a time series) and one or more of contact quality and contact force. Optionally, correlation and/or mapping is derived from use of a machine learning technique; for example: one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to utilize known, art-recognized machine learning techniques, including, e.g., Bayesian networks when inferring one or more qualities to deduce a probability of the respective electrode's physical contact being above a given threshold contact force, since the use of machine learning techniques, e.g., Bayesian networks, to improve/enhance contact quality and contact force determinations was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Schwartz, and one of ordinary skill in the art would have been capable of applying this known technique to the known system of Harlev/Govari, and the results [improving/enhancing contact quality and contact force determinations] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
32. Regarding claim 16, the combination of Harlev and Govari teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
The combination of Harlev and Govari does not, however, teach:
wherein the processor is configured to infer one or more qualities among the qualities of a respective electrode's physical contact by using a neural network (NN) model to deduce a probability of the one or more qualities based on estimated contact forces.
Schwartz, in a similar field of endeavor, is directed to systems and methods for probe positioning within a body cavity, and more particularly to assessment of contact between an intra-body electrode and a tissue surface [¶’s [0003], [0091]]. More particularly, Shwartz teaches converting measured dielectric properties of tissue (including, e.g., impedance) [¶’s [0010], [0115], [0116]] into one or more measures of contact quality, such as contact force [e.g., ¶’s [0091], [0093], [0146]].
Schwartz further teaches that it was known to implement machine learning techniques to enhance contact quality and contact force determinations, including, e.g., neural networks [see ¶[0163] (“In some embodiments, multivariate nonlinear regression and/or classification analysis is used to establish correlations and/or mappings between measurements (and/or intervals of measurements obtained as a time series) and one or more of contact quality and contact force. Optionally, correlation and/or mapping is derived from use of a machine learning technique; for example: one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Govari to utilize known, art-recognized machine learning techniques, including, e.g., neural networks when inferring one or more qualities to deduce a probability of the one or more qualities based on estimated contact forces, since the use of neural networks to improve/enhance contact quality and contact force determinations was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Schwartz, and one of ordinary skill in the art would have been capable of applying this known technique to the known system of Harlev/Govari, and the results [improving/enhancing contact quality and contact force determinations] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
RESPONSE TO ARGUMENTS
33. As noted above, the 06/30/26 Amendment has overcome the claim objections and the claim rejections under § 112(b) previously set forth in the 04/01/26 Action.
34. New claim objections are set forth herein, necessitated by Applicant’s Amendment.
35. The prior rejections under § 103 have been updated to address the new limitations, and maintained.
36. As it concerns the rejection of independent claims 1 & 11 under § 103, Applicant argues that neither Harlev nor Govari teach an assembly of coils “comprising three distal coils on three different splines of the plurality of splines and one proximal coil coupled to the distal end of the shaft” [see 06/30/26 Amendment, pgs. 8-9].
This argument is not persuasive. As the updated rejections make clear:
(a) In Harlev, expandable portion (250) comprises a plurality of mesh panels (750) (see ¶[0053). Harlev teaches that multiple mesh panels (750), for example three, may be coupled to one another to collectively define the expandable portion – see ¶[0073] (“Referring now to FIG. 8D, as multiple (e.g., two, three, four, five, six, or more (e.g., seven to twelve)) mesh electrode panels 750 are mechanically coupled to one another, the panels 750 collectively form a closed shape to define the expandable portion 250”).
(b) Harlev teaches that each mesh panel (750) includes a plurality of struts (751, 755, 757) (see ¶[0053]).
(c) As such, in a configuration where there are three mesh panels (750), there are three sets of struts (751, 755, 757).
(d) Harlev teaches that location coil sensors (1032) can be mounted on one or more of struts (755) and/or (757) of a mesh panel (see ¶[0100]).
(e) Accordingly, it is the Examiner’s position that Harlev teaches at least three location coil sensors (1032) on three different struts (e.g., on three respective struts (757) of three respective mesh panels (750) of expandable portion (250).
Additionally, Harlev teaches one proximal coil coupled to the distal end of the shaft [as broadly as currently claimed, location coil sensor (1031) is “coupled to” the distal end of shaft (122) via coupler (367) (e.g., ¶[0100]; FIG. 11A)].
For the foregoing reasons, Harlev clearly teaches an assembly of coils “comprising three distal coils on three different splines of the plurality of splines and one proximal coil coupled to the distal end of the shaft.” As such, the rejections under § 103 have been maintained.
CONCLUSION
37. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617.
The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights