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 .
Response to Amendment
2. Applicant’s Amendment filed February 23, 2026 (hereinafter “02/23/26 Amendment") has been entered, and fully considered. In the 02/23/26 Amendment, claims 1-7 & 11-17 were amended, claims 8, 9, 18, & 19 were cancelled, and claims 21 & 22 were newly added. Therefore, claims 1-7, 10-17, & 20-22 are now pending in the application.
3. The 02/23/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b), 102, & 103 previously set forth in the Non-Final Office Action mailed 12/03/25 (“12/03/25 Action”), with the exception of the prior rejection of dependent claim 5 under § 112(b), which has been maintained.
4. New claim objections, and new rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Objections
5. Claims 1-4, 6, 7, 11-17, 21, & 22 are objected to because of the following informalities:
a. In claim 1, lines 11-12, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly-- to be consistent with prior recitations in the claim.
b. In claim 1, line 15, the recitation of “the assembly of the coils” should instead recite --the assembly of coils-- to be consistent with the prior recitation in line 14 of the claim.
c. In claim 1, lines 16-17, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly--.
d. In claim 1, line 18, the recitation of “subset of the electrodes” should instead recite --subset of the multiple electrodes--.
e. In claim 2, lines 1-2, the recitation of “wherein inferring the one or more inferred qualities” should instead recite --wherein inferring the one or more qualities--.
f. In claim 2, line 2, the recitation of “the subset of electrodes” should instead recite --the subset of the multiple electrodes--.
g. In claim 2, line 3, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly--.
h. In claim 3, lines 1-3, the recitation of “wherein outputting the one or more inferred qualities of the physical contact comprises providing the one or more inferred qualities of the physical contact” should instead recite -- wherein outputting the one or more of the one or more inferred qualities of the physical contact comprises providing the one or more of the one or more inferred qualities of the physical contact-- to be consistent with the last limitation of amended independent claim 1.
i. In claim 4, lines 1-4, the recitation of “outputting a number when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's impedance is within an estimated range of impedances” should instead recite --outputting a number for one of the respective electrodes when an estimated contact force for the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the expandable distal-end assembly, is above a given threshold, and the respective electrode's measured impedance is within an estimated range of impedances-- since the use of “respective electrode” is consistent with the language of independent claim 1.
j. In claim 6, line 3, the recitation of “the quality” should instead recite --the one or more qualities--.
k. In claim 7, lines 1-3, the recitation of “The method according to claim 1, the electrodes disposed on the plurality of splines” should instead recite --The method according to claim 1, wherein the multiple electrodes are disposed on the plurality of splines--.
l. In claim 7, line 4, the recitation of “the splines” should instead recite --the plurality of splines--.
m. In claim 11, line 4, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly-- to be consistent with the prior recitation in the claim.
n. In claim 11, line 12, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly--.
o. In claim 11, line 16, the recitation of “the assembly of the coils” should instead recite --the assembly of coils-- to be consistent with the prior recitation in lines 14-15 of the claim.
p. In claim 11, lines 17-18, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly--.
q. In claim 11, line 19, the recitation of “subset of the electrodes” should instead recite --subset of the multiple electrodes--.
r. In claim 12, line 2, the recitation of “the subset of electrodes” should instead recite --the subset of the multiple electrodes--.
s. In claim 12, line 3, the recitation of “the distal-end assembly” should instead recite --the expandable distal-end assembly--.
t. In claim 13, lines 1-3, the recitation of “wherein the processor is configured to output the one or more inferred qualities of the physical contact by providing the one or more inferred qualities of the physical contact” should instead recite --wherein the processor is configured to output the one or more of the one or more inferred qualities of the physical contact by providing the one or more of the one or more inferred qualities of the physical contact-- to be consistent with the last limitation of amended independent claim 11.
u. In claim 14, lines 1-3, the recitation of “output a number when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's impedance is within an estimated range of impedances” should instead recite --output a number for one of the respective electrodes when an estimated contact force for the respective electrode, based at least in part on the estimated total contact force exerted on the tissue by the expandable distal-end assembly, is above a given threshold, and the respective electrode's measured impedance is within an estimated range of impedances-- since the use of “respective electrode” is consistent with the language of independent claim 11.
v. In claim 15, lines 1-3, the recitation of “wherein the processor is configured to infer one or more qualities among the qualities of an electrode's physical contact by using Bayesian statistics to deduce a probability of the electrode’s physical contact” should instead recite --wherein the processor is configured to infer one or more qualities of a respective electrode's physical contact by using Bayesian statistics to deduce a probability of the respective electrode’s physical contact-- to be consistent with the language of independent claim 11.
w. In claim 16, lines 1-3, the recitation of “wherein the processor is configured to infer one or more qualities among the qualities of an electrode's physical contact by using a neural network (NN) model to deduce a probability of the quality” should instead recite --wherein the processor is configured to infer one or more 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-- since Applicant’s amendment eliminated antecedent basis for the recitation of “the quality” in line 3, as well as to be consistent with the language of independent claim 11.
x. In claim 17, lines 1-3, the recitation of “The system according to claim 11, the electrodes are disposed on the plurality of splines” should instead recite --The system according to claim 11, wherein the multiple electrodes are disposed on the plurality of splines--.
y. In claim 17, line 4, the recitation of “the splines” should instead recite --the plurality of splines--.
z. In claim 21, lines 1-5, the recitation of “estimating, based on the signals a total contact force exerted on the tissue by the expandable distal-end assembly further comprising using deflection, comprising a change in 3D orientation, together with a known spring constant of the expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable distal-end assembly” should instead recite --wherein estimating, based on the received signals, a total contact force exerted on the tissue by the expandable distal-end assembly further comprises using deflection, comprising a change in 3D orientation, together with a known spring constant of the expandable distal-end assembly to calculate the total contact force exerted on the tissue by the expandable distal-end assembly--.
aa. In claim 22, lines 1-5, the recitation of “estimating, based on the signals a total contact force exerted on the tissue by the expandable distal-end assembly further comprising using deflection, comprising a change in 3D orientation, together with a known spring constant of the expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable distal-end assembly” should instead recite --wherein the processor is 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 expandable distal-end assembly to calculate the total contact force exerted on the tissue by the expandable distal-end assembly--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
8. Claim 5 recites the limitation “the physical contact force” in line 3. There is insufficient antecedent basis for this recitation in the claim.
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. Patent Application Publication No. 2023/0012307 to Harlev et al. ("Harlev") in view of U.S. Patent Application Publication No. 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 an expandable 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 expandable distal-end assembly [(250)] comprising a plurality of splines [expandable portion (250) comprises 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 at least one of the distal-end assembly [(250)] [e.g., ¶[0100] (“the tip section 124 can include location coil sensors 1032 (FIGS. 8D, 10A, and 10B) mounted on one or more of the struts 755 and/or 757”)] and the distal end of the shaft [coupler (367) at the distal end of shaft (122) retains location coil sensor (1031) - ¶[0100]; FIGS. 8D, 10A, 10B], receiving the signals from the assembly of coils comprising electromagnetic coils in a local transmitter-receiver layout [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)”)] including a distal coil of the assembly of coils positioned on a distal portion of a spline of the plurality of splines [e.g., location coil sensor (1032) is positioned on a distal portion of strut (755) - ¶[0100]; FIG. 12A] and a proximal coil of the assembly of the coils positioned proximal of the distal coil [e.g., location coil sensor (1031) retained by coupler (367) at the distal end of shaft (122) (e.g., FIG. 11A) is positioned proximal of distal location coil sensor (1032) positioned on a distal portion of strut (755) (FIG. 12A)];
estimating, 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:
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 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 inferred 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 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 inferred 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 electrodes 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 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 expandable 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 comprising a plurality of splines [expandable portion (250) comprises 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]] coupled at at least one of the distal-end assembly [(250)] [e.g., ¶[0100] (“the tip section 124 can include location coil sensors 1032 (FIGS. 8D, 10A, and 10B) mounted on one or more of the struts 755 and/or 757”)] and the distal end of the shaft [coupler (367) at the distal end of shaft (122) retains location coil sensor (1031) - ¶[0100]; FIGS. 8D, 10A, 10B], receiving the signals from the assembly of coils comprising electromagnetic coils in a local transmitter-receiver layout [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)”)] including a distal coil of the assembly of coils positioned on a distal portion of a spline of the plurality of splines [e.g., location coil sensor (1032) is positioned on a distal portion of strut (755) - ¶[0100]; FIG. 12A], and a proximal coil of the assembly of the coils positioned proximal of the distal coil [e.g., location coil sensor (1031) retained by coupler (367) at the distal end of shaft (122) (e.g., FIG. 11A) is positioned proximal of distal location coil sensor (1032) positioned on a distal portion of strut (755) (FIG. 12A)];
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:
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 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 inferred 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 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 inferred 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 electrodes are 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 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 signals a total contact force exerted on the tissue by the expandable distal-end assembly further comprising using deflection, comprising a change in 3D orientation, together with a known spring constant of the expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable 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 expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable 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:
estimating, based on the signals a total contact force exerted on the tissue by the expandable distal-end assembly further comprising using deflection, comprising a change in 3D orientation, together with a known spring constant of the expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable 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 expandable distal-end assembly to calculate the contact force exerted on the tissue by the expandable 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. Patent Application Publication No. 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 inferred qualities of physical contact comprises, using the subset of 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 inferring the one or more inferred qualities of physical contact comprises, using the subset of 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 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 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. Patent Application Publication No. 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 inferred qualities of the physical contact comprises providing the one or more inferred 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 when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's 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 when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's 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 inferred qualities of the physical contact by providing the one or more inferred 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 when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's 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 when a corresponding estimated electrode's contact force, based at least in part on the total contact force exerted on the tissue by the distal-end assembly, is above a given threshold and the electrode's 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. Patent Application Publication No. 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 the 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 the 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 quality 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 quality based on estimated contact forces, since the use of machine learning techniques, including e.g., 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 an electrode's physical contact by using Bayesian statistics to deduce a probability of the 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 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 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 a quality one or more qualities among the qualities of an electrode's physical contact by using a neural network (NN) model to deduce a probability of the quality 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 quality based on estimated contact forces, since the use of machine learning techniques, including e.g., 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 02/23/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b), 102, & 103 previously set forth in the 12/03/25 Action, with the exception of the prior rejection of dependent claim 5 under § 112(b), which has been maintained, as it was not addressed in the 02/23/26 Amendment.
34. New claim objections, and new rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
35. As it concerns the prior art, Applicant's arguments concerning the prior rejections of independent claims 1 & 11 under § 102 based on Govari have been fully considered and are persuasive (in view of the current Amendment). Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection under § 103 based on the combination of Harlev & Govari are set forth in detail above, necessitated by Applicant’s Amendment.
Conclusion
36. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794