DETAILED ACTION
Response to Arguments
Applicant argues that the objections and 35 U.S.C. 112(b) rejections are overcome by amendment. Examiner agrees and the objections and rejections are withdrawn.
Applicant’s arguments with respect to claim(s) 14-17, 20, 21, 26 and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Govari (Claim 18), Bar-Tal (Claim 19), and Govari ‘550 (Claim 25) do not teach the claimed center of mass or contact vector. Examiner disagrees and submits that these references are not relied upon for those limitations. Rosenburg in view of Hareland teach them, as set forth in claim 14.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 27, the limitation “wherein the centroid is determined geometrically without replying on impedance” is a negative limitation without basis in the original disclosure. The specification never explicitly states that the centroid is determined geometrically without relying on impedance.
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 14-21 and 25-27 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 claim 14, the limitation “the respective impedance values” lacks proper antecedent basis and renders the claim indefinite because it is unclear what these values are and where they come from. The claim only previously sets forth impedance measurements between ground pads and each of the at least three electrodes. For purposes of examination the indefinite limitation has been deemed to claim that the respective impedance values are the impedance values detected from the ground pads and each of the at least three electrodes.
Regarding claim 27, the limitation “wherein the centroid is determined geometrically without relying on impedance” renders the claim in definite, because it contradicts claim 14. Claim 14 sets forth that impedance measurements and determining the center of mass based on impedance values, therefore, it is not understood how the centroid in claim 27 is then determined without replying on impedance. For purposes of examination the indefinite limitation has been deemed to claim where the centroid is determined with or without relying on impedance measurements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14-17 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220192753 A1 to Rosenberg in view of US 20190167360 A1 to Hareland.
Regarding claim 14, Rosenberg 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 ([0062] “a catheter alignment system which assesses levels of contact of catheter electrodes with tissue of a body part (e.g., chamber of a heart of a living subject), finds a direction in which the catheter should be moved to improve the level of contact of one or more of the catheter electrodes, and renders to a display, a representation of the catheter and a direction indicator”) ([0075] “multiple catheter electrodes 55 disposed on the inflatable balloon 45 or on any suitable expandable distal end assembly”), the method comprising the steps of inter alia:
determining a location of at least three electrodes of the plurality of electrodes that are in contact with tissue based at least in part on impedance measurements between ground pads and each of the at least three electrodes of the plurality of electrodes ([0081] “The position coordinates of the sensing-electrodes 52 and the catheter electrodes 55 may be determined by the processing circuitry 41 based on, among other inputs, measured impedances”) ([0079] “body surface electrodes 49 which are attached by wires running through a cable 39 to the chest and to the back of the patient 28.”) ([0102] “The electrodes 55 which have a level of contact above a given limit are highlighted with a thicker border (e.g., electrodes 1-4, and 9-10)”; FIG. 4);
selecting the at least three electrodes of the plurality of electrodes that are in contract with the tissue ([0107] “the catheter electrodes 55 which have an in-contact state (e.g., electrodes 1-4, and 9-10)”; FIG. 4);
determining a centroid based on a geometric definition ([0110] “he position-based center of mass 406 of respective some or all of the catheter electrodes 55) responsively to the position coordinates of the respective catheter electrodes 55”)
determining a center of mass for the at least three electrodes based on the respective impedance values of the at least three electrodes ([0109] “the electrode contact level center of mass 402 of some or all of the catheter electrodes 55 as a weighted electrode contact level center of mass responsively to the respective levels of contact, with more weight being given to the catheter electrodes 55 with a higher quality of contact.”) ([0101] “the levels of contact may be equal to, or proportion to, a measure of contact such as impedance”);
determining a contact vector that extends from the centroid, wherein a length of the contact vector is based at least in part on a magnitude of force of the medical probe against the tissue and a direction of the contact vector is based at least in part on a direction of the force ([0105] “a line 404 connecting the electrode contact level center of mass 402 to a position-based center of mass 406”; FIG. 4) ([0092] “or indirectly, for example in terms of contact force”) ([0093] “a higher value of impedance between one of the catheter electrodes 55 and the body surface electrodes 49 indicates a higher level of contact between that catheter electrode 55 and the tissue”);
displaying a visual indicator of the contact vector ([0110] “The orientation of the direction 400 is generally parallel to the line 404”) ([0112] “a superimposed direction indicator 504 in 2D and 3D. Reference is also made to FIG. 3”; FIG. 5);
(Claim 15) identifying the at least three electrodes in contact with the tissue based at least in part on impedance measurements between each of the at least three electrodes and ground pads ([0093] “he catheter 40 may provide signals which provide an indication of impedance between the catheter electrodes 55 and body surface electrodes 49. The indication of the impedance provides an indication of a level of contact”) ([0079] “body surface electrodes 49 which are attached by wires running through a cable 39 to the chest and to the back of the patient 28”);
(Claim 16) determining the centroid based on locations of the at least three electrodes in contact with the tissue ([0110] “The position-based center of mass 406 is indicative of the center of mass of the catheter electrodes 55 without regard to the level of contact of the individual catheter electrodes 55.”; FIG. 4) ([0107] “the catheter electrodes 55 which have an in-contact state”; FIG. 4);
(Claim 17) where the contact vector is aligned approximately central ([0105] “a line 404 connecting the electrode contact level center of mass 402 to a position-based center of mass 406 of the catheter electrodes 55.”) ([0110] “ the position-based center of mass 406 of respective some or all of the catheter electrodes 55)”)
Roseburg discloses the claimed invention except for expressly disclosing defining a plane contiguous to the at least three electrodes in contact with the tissue, the centroid being a centroid of the plane, defining an orthogonal line orthogonal to the plane, the orthogonal line representing the center of mass, the contact vector intersecting the orthogonal line, and displaying a visual indicator of the plane and the contact vector with respect to a visual representation of the organ.
However, Hareland teaches defining a plane contiguous to a tissue surface of an organ ([0029] “define or determine a plane P1 that approximates a surface of the target anatomical feature 70”), a centroid of the plane ([0030] “the point lying in the centroid of the surface on plane P.sub.1 bounded by C1”), defining an orthogonal line orthogonal to the plane ([0031] “a vector {right arrow over (n)} that is normal to the plane P1…may have a starting point within plane P1”); and displaying an orthogonal line orthogonal to the plane ([0038] “The display may show a vector line 84…it will be understood that the actual displayed image may be three dimensional…as the image is rotated in space, the pulmonary vein ostia, vector lines, and graphical indicators rotate accordingly”; FIG. 4).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to define the plane of Hareland at the in-contact electrodes of Rosenberg, with Rosenberg’s centroid as the centroid of the plane and Hareland’s orthogonal line at Rosenberg’s center of mass, and to display the plane and contact vector on a representation of the organ to give Rosenberg’s center-of-mass guide a reference to the contacted surface (Rosenberg, [0065] “the direction in which the catheter should be moved may be computer based on an electrode contact level center of mass”), because a plane fitted to tissue, with a line normal to it, aids aligning the device with the tissue (Hareland, [0006] “determine the target location such that the longitudinal axis of the device lies along the vector”) and there would have been reasonable expectation of success, because Rosenberg’s electrodes already lie substantially in a common plane (Rosenberg, [0076] “evenly distributed along an equator of the inflatable balloon 45”).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Hareland, and further in view of US 20090093806 A1 to Govari et al. (hereinafter, Govari).
Rosenberg in view of Hareland teach a contact vector having a length and direction based at least in part on force of the medical probe against the tissue (Rosenberg, [0105] “a line 404 connecting the electrode contact level center of mass 402 to a position-based center of mass 406”; [0097] “a higher value of force or pressure indicates a higher level of contact”). Rosenberg in view of Hareland do not disclose adapting the contact vector based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue organ. However, Govari teaches adapting a measure of contact force based on a change in spatial relationship when the medical probe undergoes deformation during contact with the tissue of the organ ([0054] “Processor 36 processes these signals in order to determine the axial displacement and the magnitude of the angular deflection of the distal tip relative to the insertion tube… he direction of deflection may be determined, as well”) ([0055]) “[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. Generally speaking, this deformation is proportional to the force that is exerted on the resilient member, which is roughly equal to the force that is exerted on the distal tip by the heart tissue with which the distal tip is in contact.”; FIG. 2).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to adapt the contact vector of Rosenberg in view of Hareland based on the probe deformation measured as taught by Govari so that the force-based length and direction of the contact vector reflect the actual force on the tissue, including when the probe engages the tissue at an angle (Govari, [0055] “his pressure sensing system reads the pressure correctly regardless of whether the electrode engages the endocardium head-on or at an angle”) and because the purpose of Rosenberg’s contact vector, guiding the user to proper tissue contact, depends on knowing whether the contact is too light or too heavy (Govari, [0002] “It is important to ensure proper contact between the electrode and the endocardium during ablation in order to achieve the desired therapeutic effect without excessive damage to the tissue.”; [0057] “Excessive pressure of this sort may cause severe cavitation in the tissue, leading to extensive tissue damage and possibly even perforation of the heart wall.)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Hareland, and further in view US 20100079158 A1 to Bar-Tal et al. (hereinafter, Bar-Tal).
Rosenberg in view of Hareland teach orienting the displayed medical probe based on a magnetic sensor disposed proximate the electrodes ([0074] “The position tracking and ablation system 20 can determine a position and orientation of the shaft 22 of the balloon catheter 40 based on sensing-electrodes 52”) ([0081] “The console 24 drives a display 27, which shows the distal end of the catheter position inside the heart 26.”; FIG. 1). Rosenberg in view of Hareland do not expressly teach a plurality of external reference electromagnetic sensors, the reference EM sensors defining an EM coordinate system and a body coordinate system. However, Bar-Tal teaches a plurality of external EM sensors ([0101] “Each reference patch 80R has an EM sensor”), the reference EM sensors defining an EM coordinate system and a body coordinate system ([0015] “the reference body-electrodes defining an EM coordinate system and a body coordinate system”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to orient the displayed probe of Rosenberg in view of Hareland using the reference EM sensors of Bar Tal to relate Rosenberg’s magnetic and impedance-based positions (Bar-Tal, [0116] “Patches 80R enable measurements made in one of the sub-systems to be converted to the other sub-system”) and to compensate for patient movement (Bar-Tal, [0116] “any motion of the subject with respect to pad 43 is reflected in signal changes in the EM sensors of the reference patches”).
Claim(s) 20 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Hareland, and further in view of US 20190183378 A1 to Mosesov et al. (hereinafter, Mosesov).
Rosenberg in view of Hareland teach where the medical probe further comprises an expandable basket assembly ([0086]) and ablating the tissue via electrodes ([0057]). Rosenberg in view of Hareland do not expressly teach where the expandable basket assembly comprises a plurality of spines extending along a longitudinal axis and converging at a central spine intersection, each spine of the plurality of spines comprising at least two electrodes or delivering, via spray ports, an irrigation fluid to a distal tip of the catheter end effectors. However, Mosesov teaches an expandable basket assembly comprising a plurality of spines extending along a longitudinal axis and converging at a central spine intersection ([0058] “an expandable basket having eight arms”), each spine of the plurality of spines comprising at least two electrodes ([0058] “Each arm includes 16 electrodes”), and delivering, via spray ports, an irrigation fluid to a distal tip of the catheter end effector ([0044] “the distal end portion 26 of the shaft… one or more fluid ports or manifolds for distributing.. fluids”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to use the basket and irrigation ports of Mosesov in the end effector of Rosenberg in view of Hareland because Rosenberg contemplates a basket end effector, and more electrodes that improve mapping and ablation (Mosesov, [0058]) and to irrigate the tissue Rosenberg ablates (Mosesov, [0044] “irrigation fluid during an ablation procedure”).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Hareland, and further in view of US 20150080715 A1 to Deno et al. (hereinafter, Deno).
Rosenberg in view of Hareland teach the claimed invention except for expressly teaching configuring a point of each electrode of the at least three electrodes as a vertex for the plane formed between each of the at least three electrodes in contact with the tissue. However, Deno teaches configuring a point of each electrode of the at least three electrodes as a vertex for the plane formed between each of the at least three electrodes in contact with the tissue ([0042] “at least three electrodes 42 having electrical positions 50 that are not collinear, thereby defining a plane in space… thereby identifying the point defining a plane”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to form the plane of Rosenberg in view of Hareland with the point of each in-contact electrode as a vertex, as taught by Deno, so that the plane is located directly from the measured electrode positions (Deno, [0042] “identifying the point defining a plane to orient the ultrasound transducer 40 within the geometric model 14”).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Hareland, and further in view of US 20210169550 A1 to Govari et al. (hereinafter, Govari ‘550).
Rosenberg in view of Hareland teach delivering via the electrodes in contact with the tissue, ablation energy (Rosenberg, [0075]). Rosenberg in view of Hareland do not expressly teach electrical pulses have a peak voltage of at least 900 V.
However, Govari ‘550 teaches delivering via the electrodes in contact with the tissue, electrical pulses for electroporation ([0028], [0029]), the electrical pulses having a peak voltage of 900 V ([0033] “the peak-to-peak voltage of the biphasic pulse is on the order of up to 4kV, i.e. +/- 2 kV”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to deliver the pulses of Govari ‘550 via the in-contact electrodes of Rosenberg in view of Hareland, to improve clinical outcome of the ablation Rosenberg performs (Govari ‘550, [0024] “enables the application of IRE and RFA treatments to the same location at the same time, and thus may improve the clinical outcome of invasive treatments of cardiac arrhythmia”).
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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
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