DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS’) submitted on 11/10/2023, 8/20/2024 and 10/09/2025 are compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 20 objected to because of the following informalities: the preamble is missing language such as “further comprising” and leads directly into the claim limitation. Appropriate correction is required.
Claim 21 objected to because of the following informalities: the preamble recites “according of” and should recite “according to”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 14, 15 and 21, the limitation “respective electrodes” renders the claims indefinite. The term “respective electrodes” does not provide clear antecedent basis or a determinable correspondence for which electrodes are being referenced. The claims recite multiple electrode groupings, including “a plurality of electrodes” and “at least three electrodes”, yet do not specify whether the “respective electrodes” refer to (i) each electrode of the plurality, (ii) each of the selected at least three electrodes in contact with tissue, or (iii) some other subset. As a result, it is unclear which electrodes are used for impedance measurements and which electrodes are used to identify electrodes in contact with tissue. For purposes of examination the indefinite limitation has been deemed to claim where the Applicant intends for “respective electrodes” to mean “each electrode of a plurality” or “each of the at least three electrodes in contact with tissue”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14-16, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190183378 A1 to Moseov et al. (hereinafter, Moseov) in view of US 20150080715 A1 to Deno et al. (hereinafter, Deno).
Regarding Claims 14, 16 and 21, Moseov discloses a method for providing visual indicators of electrode contact to tissue of an organ by a catheter end effector of a medical probe comprising a plurality of electrodes (see Abstract), the method comprising the steps of inter alia:
determining a location of at least a portion of the plurality of electrodes based at least in part on impedance measurements between ground pads (“body surface electrodes” / “belly patch”) and a respective electrode (“catheter electrodes”) of the plurality of electrodes (paragraph [0085] states “…the ECU 72 may be configured to control generation of one or more electrical fields and determine the position of one or more electrodes 92 within those fields. …” and paragraph [0086] describes the pads used to generate these fields “…the body surface patch electrodes 82 may be used to generate axes-specific electric fields within the body of the patient 98… a body surface electrode (“belly patch”) 82, may be provided as an electrical reference…”) (paragraph [0089] “The patch data may be used, along with measurements made at one or more…catheter electrode and measurements made at other electrodes and devices, to determine a relative location of the one or more catheter electrodes.”);
selecting at least three electrodes of the plurality of electrodes that are in contact with the tissue (paragraph [0117] “Each time an electrode contacts tissue and a resulting change of the measured impedance differs from a baseline impedance for that electrode by more than the threshold amount, a location of the contacting electrode is recorded and output on the display.”) (paragraph [0121] “…the magnitude of the responses 212, 214, 216 and 218 (shown in Ohms) of the four contacting electrodes vary over time while the responses (collectively 220) of the non-contacting electrodes remain substantially constant over time.”) (Examiner notes Moseov explicitly discloses a method where the system analyzes a plurality of electrodes, identifies a subset of four electrodes (212-218) that are in contact with tissue and distinguishes them form the remaining electrodes that are out of contact with tissue.);
While Moseov discloses defining 3D surface geometry for at least three electrodes in contact with tissue, dividing the 3D space into “sub-regions” or a “grid” and displaying a visual indicator of contact points to generate a visual representation of the organ (see paragraphs [0114] and [0117], Moseov does not expressly disclose defining a plane contiguous to the at least three electrodes in contact with the tissue, configuring a point of each electrode as a vertex for the plane formed between the respective electrodes in contact with the tissue, determining a centroid of the plane based on locations of the at least three electrodes in contact with the tissue, and displaying a visual indicator of the plane with respect to a visual representation of the organ.
However, Deno teaches, like Moseov, a cardiac mapping and visualization system utilizing catheter electrodes to determine position and orientation within a geometric model (see paragraph [0029]). Deno teaches defining a plane contiguous to at least three electrodes in contact with the tissue (paragraph [0042] “The position and orientation of the ICE catheter 30 within the geometric model 14 may be determined in six degrees of freedom by the ECS 22 when the sensor array 38 contains at least three electrodes 42 having electrical positions 50 that are not collinear, thereby defining a plane in space.”), configuring a point of each electrode as a vertex for the plane formed between the respective electrodes in contact with the tissue (paragraph [0042] “The position and orientation of the ICE catheter …when the sensor array 38 contains at least three electrodes 42 having electrical positions 50 that are not collinear, thereby defining a plane in space…identifying the points defining a plane to orient the ultrasound transducer 40 within the geometric model 14.”), determining a centroid of the plane based on locations of the at least three electrodes in contact with the tissue (paragraph [0042] “The centroid location may be determined from the known physical spacing and orientation of the electrodes 42, and thereby the corresponding electrical positions 50.”) and displaying a visual indicator of the plane with respect to a visual representation of the organ (paragraph [0043] “When the echo plane 32 has been oriented in the geometric model 14…the ICE image 12 to be projected (e.g., displayed) within the geometric model 14.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the method of Moseov to include defining a plane contiguous to the at least three electrodes in contact with the tissue, the vertex configuration, the determination of centroid and displaying a visual indicator of the plane with respect to a visual representation of the organ of Deno, as Deno teaches at paragraph [0042] and [0043] that using three electrodes for the generation of an electrode plane allows for quick and robust determination of the catheter because errant position response signals can be properly rejected.
Regarding Claim 15, Moseov in view of Deno teach the method of claim 14, further comprising: identifying the at least three electrodes in contact with the tissue based at least in part on the impedance measurements between the respective electrode and ground pads (Moseov: paragraph [0082] “… the assessed value for each electrode may be displayed on the graphical user interface 68 along with a graphical depiction of the catheter to provide a user with feedback on the contact status of each electrode…”).
Regarding Claim 20, Moseov discloses the method of claim 14, the medical probe (Moseov: catheter 16) comprising an expandable basket assembly comprising a plurality of spines (Moseov: paragraph [0058] “…catheter 16 is formed as an expandable basket have eight arms 18A-G…”) extending along a longitudinal axis (Moseov: FIG. 4, central arm 18C) and converging at a central spine intersection (Moseov: FIG. 4, 18G), each spine of the plurality of spines comprising at least two electrodes (Moseov: paragraph [0111] “…multiple electrodes or pairs of electrodes on each arm 18…”).
Claim(s) 17, 18, 22, 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moseov in view of Deno, and further in view of US 20090093806 A1 to Govari et al. (hereinafter, Govari).
Moseov in view of Deno teach the method of claim 16, further comprising: determining a center of mass for the at least three electrodes in contact with tissue (Deno: paragraph [0042] “The centroid location may be determined from the known physical spacing and orientation of the electrodes 42, and thereby the corresponding electrical positions 50.”), the center of mass being based on the impedance measurements of the at least three electrodes (Moseov: paragraph [0085] states “…the ECU 72 may be configured to control generation of one or more electrical fields and determine the position of one or more electrodes 92 within those fields. …” and paragraph [0086] describes the pads used to generate these fields “…the body surface patch electrodes 82 may be used to generate axes-specific electric fields within the body of the patient 98… a body surface electrode (“belly patch”) 82, may be provided as an electrical reference…”). For purposes of examination the claim limitation “determining a center of mass” is interpreted as determining the geometric centroid of the electrode arrangement, as discussed in the rejections of Claims 14, 16 and 21 above, because the center of mass of the electrode coordinates is equivalent to the centroid.
Moseov in view of Deno do not expressly teach an orthogonal line that is orthogonal to the plane, the orthogonal line representing the center of mass; and displaying a contact vector intersecting the orthogonal line and aligned approximately central within the plane, adapting the contact vector based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue of the organ, wherein the contact vector is indicative of a magnitude of force and a direction of force of the medical probe against the tissue of the organ, displaying the contact vector in relation to the tissue of the organ, and adapting the contact vector based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue of the organ.
However, Govari teaches a method of navigating and positioning a catheter to a target location (see paragraph [0003]). Govari teaches that a plane can be represented by a vector perpendicular to the plane (paragraph [0029] “The plane described by equation (1) is described by a normalized vector perpendicular to the surface of the plane…”), defines a vector normal to the plane anchored to the centroid (paragraph [00031] “…the vector…may have a starting point within plane…that is the centroid 72 location…”), displays a line corresponding to the vector (paragraph [0008] “…displaying a line on the display of the navigation system, the display corresponding to the vector.”), and teaches that the line represents the centroid/center of mass (see paragraph [0032]).
Govari also teaches adapting the contact vector based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue of the organ (paragraph [0009] “…signals are processed both to determine coordinates of the distal tip within the body and to detect changes in the position of the distal tip relative to the distal end of the insertion tube, which are indicative of deformation of the resilient member and hence of the pressure exerted on the distal tip.”) (paragraph [0049] “…signals are indicative of both the position of the distal end of the catheter and of force exerted on the distal end…”) (paragraph 0054 “The magnitudes of the displacement and deflection may be combined by vector addition to give a total magnitude of the movement of distal tip 52 relative to the distal end of insertion tube 54.”) (Examiner notes that “spatial relationship” is the relative displacement between the tip sensor and the shaft sensor caused by the bending (deformation) of the spring. The system adapts the vector calculation based on this changing relationship. See paragraphs [0009], [0017], [0054]).
Govari as teaches wherein the contact vector is indicative of a magnitude of force and a direction of force of the medical probe against the tissue of the organ (paragraph [0055] “The relative movement of the distal tip relative to the distal end of the insertion tube gives a measure of the deformation of resilient member 58…is proportional to the force that is exerted on the resilient member…the combination of field generator 64 with sensor 62 serves as a pressure sensing system).
Govari also teaches calculating the contact force through “vector addition” of the tip’s displacement and deflection (paragraph [0054]) and further teaches “output[ing] an indication of the pressure” (paragraph [0058]) and providing visual feedback of the catheter’s position within the patient’s body (paragraph [0048]). It would have been notoriously obvious to display the calculated vector addition (the contact vector) on the display with the patient’s body/organs, as body are already taught as displayed, and to display them together would have allowed the operator to visualize not just the magnitude of force, but also the direction of the deflection with respect to patient anatomy.
Govari also teaches adapting the contact vector based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue of the organ (paragraph [0054] “The magnitudes of the displacement and deflection may be combined by vector addition to give a total magnitude of the movement of distal tip 52 relative to the distal end of insertion tube 54”) (paragraph [0055] “The relative movement of the distal tip relative to the distal end of the insertion tube gives a measure of the deformation…this deformation is proportional to the force that is exerted on the resilient member…”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Moseov in view of Deno with the orthogonal line representing the center of mass and displaying a contact vector intersecting the orthogonal line and aligned approximately central within the plane, the adaptation of the contact vector and the contact vector being indicator of force and direction of Govari, as Govari teaches in the Abstract that the vector line would assist the user in placing the device for treatment.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moseov in view of Deno, and further in view of EP 2322089 to Bar-Tal et al. (hereinafter, Bar Tal).
Moseov in view of Deno teach the method of claim 14 except for expressly disclosing orienting the medical probe based on a magnetic sensor disposed proximate the electrodes and a plurality of external reference electromagnetic (EM) sensors, the reference EM sensors defining an EM coordinate system and a body coordinate system.
However, Bar-Tal teaches reference sensors attached to a patient that are used to define a specific “body coordinate system” separate from a magnetic field generators system (see paragraphs [0009] and [0068]). Bar-Tal teaches transforming (orienting) a probe’s position from the fixed EM system into a body coordinate system (paragraph [0078]).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Moseov in view of Deno to include the reference sensors and body coordinate system as taught by Bar-Tal, as Bar-Tal teaches at paragraph [0009] that the reference sensors defining a body coordinate system would have allowed the system to compensate for patient movement.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moseov in view of Deno, and further in view of US 20210169550 A1 to Govari et al. (cited in IDS and hereinafter, Govari).
Moseov in view of Deno teach the method of claim 14 except for expressly disclosing delivering, via the electrodes in contact with the tissue, electrical pulses for irreversible electroporation, the electrical pulses having a peak voltage of at least 900 volts (V).
However, Govari teaches the manipulation of a catheter shaft with electrodes on the distal end (paragraphs [0027]-[0029]), where the electrodes are able to generate pulses with peak voltages of up to kV (paragraph [0021]).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electrodes of Moseov in view of Deno to give tissue electrical pulses having a peak voltage of at least 900 volts (V), as Govari teaches at paragraph [0021] this would have provided effective treatment, in which tissue is not destroyed in one modality, to be fully destroyed in another.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moseov in view of Deno, and further in view of US 20140276562 A1 to Govari et al. (hereinafter, Govari).
Moseov in view of Deno teach the method of claim 14 except for expressly disclosing delivering, via spray ports, an irrigation fluid to a distal tip of the catheter end effector. However, Govari teaches a catheter system that supplies irrigation to a distal end of the catheter via a channel (paragraphs [0024] and [0026]), where spray ports are connected to the channel and direct fluid toward tissue (paragraph [0026]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the catheter of Moseov in view of Deno to be able to delivering, via spray ports, an irrigation fluid to a distal tip of the catheter end effector, as Govari teaches at paragraph [0032] this would have cooled tissue to reduce charring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791