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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 11/28/2025. As directed by the amendment: Claims 1-2 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-8 and 10-22 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 8-13, filed 11/28/2025, regarding 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant explains the claimed advantage of the instant claims on pages 9-10. Applicant then acknowledges the Office Action’s assessment that Organ does not teach an adjustable mechanism. Applicant then submits that Makharinsky teaches an electrode spacing that is fixed after fabrication of the device for depth control with multiple proximal electrodes, and Applicant argues on page 12 that “there is no suggestion at all of Makharinsky of moving the position of electrodes relative to one another. Rather, to monitor for different penetration depths, or for performing other purposes, different pairs of existing electrodes may be used.”
Examiner agrees because the claim amendments require the selecting of the distance of the electrodes, that are moveable based on the adjustment mechanism, which alters the intended use capabilities of the adjustable mechanism. Examiner does note that the claim fails to actively recite the movement of the position of electrodes. The claimed language “wherein the catheter further comprises an adjustment mechanism that is mechanically coupled to the first electrode and configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode” is intended use, which means that the prior art structure, of the adjustment mechanism, inherently possesses the functionally defined limitations of the claimed apparatus. Previously, since the device of Bannister provided the adjustable mechanism (structure) by changing the depth of the insertion of a needle (and Makharinsky has a variable depth), the claimed device necessarily had the result of the structure to controllably adjust a variable depth of penetration of a tip of the first electrode. However, due to amendments to the claim, the To reference (US 10667855) which teaches the strain gauge for adjusting the depth of electrodes using a depth gauge (adjustment mechanism), where the relative depth between the inner and outer helical electrodes 103 and 101 (Fig. 1 and Col. 13 lines 1-15), respectively, may be different, the claimed device necessarily has the result of the structure configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode.
Applicant then argues on pages 12-13 that “the Applicant submits that while this reference teaches the use of a deployment mechanism for deploying a needle having a spiral shape and an electrophysiological mapping device there is no teaching at all of placing an electrode on the spiral shaped needle as the spiral shaped needle is only used for delivering therapeutic gel. Furthermore, the electrophysiological mapping device is just used for to guiding the delivery system 1000 (e.g., needle tip) to a site of low electric activity (e.g., see paras. [0047]-[0048] in Bannister)… Therefore, there is no teaching or suggestion in Bannister of moving electrodes with respect to one another to perform different functions as is recited in Applicant's claim 1.”
Examiner disagrees because the Examiner did not rely on Bannister for placing the electrode on the spiral and instead relied on Bannister for the adjustment mechanism. The feature is question was previously taught by Makharinsky and the combination of Makharinsky with Bannister would provide for the adjustable helix having an electrode thereon. Nevertheless, the amendments change the scope of the invention and require a new search and consideration.
Therefore, the rejection of record is withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “adjustment mechanism” in claim 1. The instant specification, in [0016] and [0092], defines the “adjustment mechanism” as a micrometer screw gauge that controllably adjusts a variable depth of penetration. Examiner will interpret adjustment mechanism as any mechanical mechanism as it requires a mechanical adjustment of the depth of penetration.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 1, the claimed language “wherein the catheter further comprises an adjustment mechanism that is mechanically coupled to the first electrode and configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode” is intended use, which means that the prior art structure, of the adjustment mechanism, inherently possesses the functionally defined limitations of the claimed apparatus. Since the device provides the structure of the To reference (US 10667855) which teaches the strain gauge for adjusting the depth of electrodes using a depth gauge (adjustment mechanism), where the relative depth between the inner and outer helical electrodes 103 and 101 (Fig. 1 and Col. 13 lines 1-15), respectively, may be different, the claimed device necessarily has the result of the structure configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode.
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.
Claim(s) 1-2, 4-8, 10, 13, 15-16, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Organ et al. (US 20120089123)(Hereinafter Organ) in view of Makharinsky et al. (US 11045653)(Hereinafter Makharinsky) and To et al. (US 10667855) (Hereinafter To).
Regarding claim 1, Organ teaches A bipolar catheter ([0071] “multi-purpose catheter probe CP2 provides bipolar electrical stimulation and/or bipolar RF ablation to a region of tissue for applications where highly localized stimulation or ablation effects are required”) comprising:
a catheter body having a distal end portion and a proximal end portion ([0006] “a catheter probe comprising a proximal hub comprising a hub housing and at least one wire; a catheter body connected to the proximal hub… a catheter distal end comprising at least one electrode connected to the at least one wire.”);
a first electrode at the distal end portion, the first electrode being provided on a … for rotational insertion into a physiological target region (Fig. 8A(E1));
a second electrode proximal to and spaced apart from the first electrode (Fig. 8C(E3)); and
first and second electrode terminals spaced apart from one another at the proximal end portion and electrically coupled to the first and second electrodes respectively ([0077] “an electrode E1 and a smaller diameter, proximal section 28 (which can be insulated or uninsulated) from which member 27 continues in a straight, insulated wire 29 that makes an electrical connection with a first electrical connector within the hub (not shown) of the multi-purpose catheter probe CP4… the electrode E3 is uninsulated, and the remaining proximal section 36 of member 34 is insulated and continues within the multi-purpose catheter probe to the hub (not shown) where it makes an electrical connection with a third electrical connector.” [0083] “The proximal portion of the catheter probe section 41 contains electrical contacts or metal rings 42, 43, and 44 [see Fig. 9B that show the discs spaces apart., shown in FIG. 9B, which connect to the electrodes E1, E2, and E3 respectively.”),
wherein the first and second electrodes are configured to function as active and dispersive electrodes respectively, or the first and second electrodes are configured to function as dispersive and actives electrodes, respectively ([0071] “The coil 10 has a distal portion that is uninsulated and is used as an electrode E2 in the catheter distal end 4' and has tightly and loosely wound portions, the latter serving as an exit region for ejecting fluids into nearby tissue during use.” [0030] “The use comprises placing the distal catheter end in close proximity to the target tissue region; applying a radiofrequency current to the at least one electrode to ablate a portion of the target tissue region; and measuring an impedance using the at least one electrode to determine effectiveness of the treatment.”).
However, Organ does not teach an adjustable mechanism to controllably adjust a variable depth of penetration of a tip of the first electrode away from or closer to an end face of the catheter body at the distal end portion. Makharinsky, in the same field of endeavor, teaches a multi-electrode lead for implanting into interventricular septum of the right ventricle for depth control (Abstract), and further teaches a spiral structure for electrode placement proximal to the second electrode (Fig. 5 (222) first electrode on spiral and 230 on the multi-electrode lead proximal to electrodes 256, 254, 252, and 250.) and wherein the catheter further comprises an adjustment mechanism … configured to controllably adjust a variable depth of penetration of a tip of the first electrode … away or closer to an end face of the catheter body at the distal end portion (Col. 8 lines 50-67 and Col. 9 lines 1-8 Determining depth of penetration based on impedance values of positioned electrodes. The deeper the penetration, the further the catheter body is to the distal end. See note on intended use under “Claim Interpretation”.) to control the penetration depth to a desired position (Col 9 lines 8-11). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the adjustable mechanism to controllably adjust a variable depth of penetration of a tip of the first electrode away from or closer to an end face of the catheter body at the distal end portion of Makharinsky, because such a modification would allow to control the penetration depth to a desired position.
Although Makharinsky teaches the deployment and adjustment of penetration depth via the use of impedance, Organ and Makharinsky do not teach an adjustment mechanism that is mechanically coupled to the first electrode and configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode. To, in the same field of endeavor, teaches electrodes inserted into tissue for ablation and a needle (Abstract), further teaches an adjustment mechanism that is mechanically coupled to the first electrode and configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode (Fig. 1 shows helical electrodes 101 and 103 and Col. 13 lines 1-15 “the outer coil electrode 101 and configured for adjusting the depth of the outer coil electrode 101 in the tissue (not shown); and, an inner coil electrode handle 103h in an operable connection with the inner coil electrode 103 and configured for adjusting the depth of the inner coil electrode in the tissue (not shown). In some embodiments, a depth gauge [adjustment mechanism] 105 can be provided in the handle assembly with visible markers to help the user determine, for example, a relative depth between the outer coil electrode 101, the inner coil electrode 103, and the guide needles 102, 104, 106 (optionally) in the tissue (not shown).” Examiner notes that the user can select the distance between the electrodes by controlling the depths of electrodes 101 and 103 separately using the depth gauge.) to properly position the distal end ([0048]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the adjustment mechanism that is mechanically coupled to the first electrode and configured to controllably adjust a variable depth of penetration of a tip of the first electrode into tissue as the first electrode is moveable away or closer to an end face of the catheter body at the distal end portion and select a distance between the dispersive electrode and the active electrode of To, because such a modification would allow to properly position the distal end.
Regarding claim 2, Organ teaches wherein the first electrode is part of a coil electrode that has an insulated portion and at least one conductive surface portion ([0020] “the catheter probe comprises first and second insulated members; a first member defining the catheter distal end, the first member comprising an uninsulated first coil electrode at a distal portion thereof and a first insulated wire portion proximal to the first coil electrode to provide an electrical connection between the first coil electrode and a first electrical connector within the hub;” [0072] “the inner wall of the insulated stainless steel tube 11' provides a conductive pathway for the connection of the coil 19, comprising electrode E1, to an electrical stimulus or RF ablation current source”).
Regarding claim 4, Organ teaches wherein the bipolar catheter comprises a conduit that has a first end that is connectable to a source of one or more medical agents and a second end at the distal end of the catheter and during use the one or more medical agents flow through the conduit and are delivered at the distal end portion of the bipolar catheter ([0096] “a special fluid injection port through which medications and other fluids can be directed into tissue or fluid spaces, nor a thermocouple probe for monitoring tissue temperature. However, both of these functions are available to the multi-purpose catheter probe CP8” [0096] “The fluid-filled syringe and IV delivery system are just a few examples of the various devices that can be attached to the hub 54 for fluid injection or extraction.”).
Regarding claim 5, Organ teaches wherein the bipolar catheter comprises a conduit that has a first end that is connectable to a fluid source and a second end at the distal end of the catheter and during use fluid from the fluid source is flowed through the conduit and delivered at the distal end portion of the bipolar catheter for irrigation and/or cooling ([0079] “Portions or substantially all of the electrodes E1, E2, and E3 can be more loosely wound to allow for the infusion of fluid into surrounding tissue or body spaces during use.” [0085] “a pump that is used for fluid infusion can also be implanted. The pump can, for example, be implanted subcutaneously where it connects to an infusion port of the catheter probe section 41.”).
Regarding claim 6, Organ teaches wherein the bipolar catheter comprises first and second conduits with the first conduit having a first end that is connectable to a source of one or more medical agents and a second end that is disposed at the distal end of the bipolar catheter and the second conduit having a first end that is connectable to a fluid source and a second end that is disposed at the distal end of the bipolar catheter and during use the one or more medical agents flow through the first conduit and are delivered at the distal end portion of the bipolar catheter and/or fluid from the fluid source is flowed through the second conduit and delivered at the distal end portion of the bipolar catheter for irrigation (0079] “Portions or substantially all of the electrodes E1, E2, and E3 can be more loosely wound to allow for the infusion of fluid into surrounding tissue or body spaces during use.” [0085] “a pump that is used for fluid infusion can also be implanted. The pump can, for example, be implanted subcutaneously where it connects to an infusion port of the catheter probe section 41.” [0096] “The fluid-filled syringe and IV delivery system are just a few examples of the various devices that can be attached to the hub 54 for fluid injection or extraction.”).
Although Organ teaches an infusion port to send fluid, Organ does not explicitly teach a second infusion port for a second delivery. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple conduits, for the purpose of allowing for multiple deliveries of fluid and medical agents, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 7, Organ teaches wherein the first electrode has pores and the first electrode is connected to the conduit for receiving the one or more medical agents during use ([0096] “a special fluid injection port through which medications and other fluids can be directed into tissue or fluid spaces, nor a thermocouple probe for monitoring tissue temperature. However, both of these functions are available to the multi-purpose catheter probe CP8” [0089] “If the electrodes E1, E2, and E3 are configured as stainless steel cylindrical shells, or other morphologies that similarly have a continuous surface, exit holes, grids, slots, or other openings in these surfaces can be used as an outlet to allow for fluid infusion into the surrounding tissue during use.”).).
Regarding claim 8, Organ teaches wherein the second electrode has a porous structure and the second electrode is connected to the conduit for receiving the fluid for irrigation and/or cooling during use ([0089] “If the electrodes E1, E2, and E3 are configured as stainless steel cylindrical shells, or other morphologies that similarly have a continuous surface, exit holes, grids, slots, or other openings in these surfaces can be used as an outlet to allow for fluid infusion into the surrounding tissue during use.”).).
Regarding claim 10, Organ teaches wherein the fluoroscopic markers are attached to the spiral structure to allow for visual confirmation of the depth of the tip of the spiral structure during use via fluoroscopic imaging ([0093] “The orientation and location of the uninsulated longitudinal strip could be determined, for example, fluoroscopically by a radiopaque marker in the proximity of the electrode coil 52, by a radiopaque ring strategically located along the tubular catheter body, and/or by another marker on an external portion of the multi-purpose catheter probe such as its proximal hub.” Ditter teaches the viewing of depth of loop based on placement of SAS sensor underneath electrodes on the loop [0090] “Where the distal assembly carries ten AR electrodes, the SASs are under electrodes AR1, AR5 and AR10 (FIG. 7). The SASs enable the proximal loop 17P to be viewed under mapping systems manufactured and sold by Biosense Webster, Inc”. See [0102] for fluoroscopic means of positioning and placement.).
Regarding claim 13, Organ teaches A method of performing a procedure using a bipolar catheter ([0052] “The various multi-purpose catheter probes described herein generally have a small diameter, and are flexible so that they are steerable to facilitate, and in some cases make uniquely possible, access to various regions such as but not limited to an epidural space, a spinal space, or a paravertebral space for diagnostic and therapeutic procedures to treat chronic neurogenic pain not relieved by more conservative methods.”), wherein the method comprises:
coupling the bipolar catheter to a signal generator, the bipolar catheter being defined according to claim 1 ([0054] “An electrical lead within a flexible, multi-lead cable 8, connected via a connector plug 7 to an instrument with a variable electrical stimulus output, connects to the metallic structure of the tubular catheter body 3 within the proximal hub 2.”);
inserting the bipolar catheter at a physiological target region ([0052] “The various multi-purpose catheter probes described herein generally have a small diameter, and are flexible so that they are steerable to facilitate, and in some cases make uniquely possible, access to various regions such as but not limited to an epidural space, a spinal space, or a paravertebral space for diagnostic and therapeutic procedures to treat chronic neurogenic pain not relieved by more conservative methods.”); and
performing the procedure ([0055]-[0059]).
Regarding claim 15, Organ teaches wherein the physiological target region comprises cardiac tissue and the procedure comprises performing bipolar ablation, transmural mapping, pace mapping, cardiac debulking and/or monitoring lesion formation ([0097] “catheter may be used for other diagnostic and/or therapeutic functions, such as intracardiac electrical mapping or other types of ablation therapy.”).
Regarding claim 16, Organ teaches wherein the bipolar catheter further comprises a temperature sensor at a distal end portion of the catheter body and the procedure comprises performing bipolar ablation or tissue debulking and the method comprises measuring a temperature at the target tissue region and stopping the bipolar ablation when the measured temperature is higher than a temperature threshold ([0059] “A thermocouple member, inside the thermocouple probe, is positioned at a predetermined location within the length of the catheter distal end 4 to measure a change in tissue temperature related to the application of, for example, pulsed RF stimulation or RF ablation energy.” [0063] “For example, temperature rise during pulsed RF treatment can be regulated not to exceed 42.degree. C. to avoid thermal damage to tissue.”).
Regarding claim 21, Organ teaches wherein the procedure comprises delivering one or more medical agents to the physiological target region, the one or more medical agents comprising one or more therapeutic agents, one or more diagnostic agents and/or one or more marker agents ([0085] “The multi-purpose catheter probe CP5 is advantageous for implanting the catheter probe section 41 over periods of time in body spaces or tissues in applications where, for example, it is desired to periodically inject or continuously infuse medications for the relief of pain.{“).
Regarding claim 22, Organ teaches wherein the one or more medical agents comprise pharmaceuticals, antiarrhythmics, MRNA and DNA to reprogram cells in the physiological target region, stem cells, viral vectors to reprogram existing cells in the physiological target region, biological pacemakers, radiology markers for later targeting therapy with radiation or a gamma knife and/or biological reporters ([0085] “The multi-purpose catheter probe CP5 is advantageous for implanting the catheter probe section 41 over periods of time in body spaces or tissues in applications where, for example, it is desired to periodically inject or continuously infuse medications for the relief of pain.” Or Ditter recites [0095] “During ablation, an irrigation pump is used to deliver normal heparinized saline to the ring electrodes to cool the ring electrodes to prevent blood from coagulating.”).
Claim(s) 11-12, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Organ et al. (US 20120089123)(Hereinafter Organ) in view of Makharinsky et al. (US 11045653)(Hereinafter Makharinsky), To et al. (US 10667855) (Hereinafter To), and Ditter (US 20160143689)(Hereinafter Ditter).
Regarding claim 11, claim 1 is obvious over Organ, To, and Makharinsky. However, Organ does not teach a bipolar mapping with multiple electrodes on the spiral. Ditter, in the same field of endeavor, teaches a catheter containing electrodes used for RF ablation ([0009]), similar to the device of Organ, and further teaches wherein the bipolar catheter comprises a second pair of electrodes configured for measuring voltages thereat and/or the first electrode is on a portion of the spiral structure and the spiral structure comprises a plurality of additional electrodes for providing at least two bipoles for performing high density intramural bipolar mapping or unipolar mapping ([0080] “Closely-spaced bipoles permit the physician to more accurately determine whether he is looking at a close signal or a far signal. Accordingly, by having closely-spaced electrodes, one is able to better target the locations of myocardial tissue that have PV potentials and therefore allows the clinician to deliver therapy to the specific tissue” [0090] “Where the distal assembly carries ten AR electrodes, the SASs are under electrodes AR1, AR5 and AR10 (FIG. 7). The SASs enable the proximal loop 17P to be viewed under mapping systems manufactured and sold by Biosense Webster, Inc., including the CARTO, CARTO XP and NOGA mapping systems.”) to ensure accurate placement into tissue ([0044]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the bipolar mapping with multiple electrodes on the spiral of Ditter, because such a modification would allow to ensure accurate placement into tissue.
Regarding claim 12, claim 1 is obvious over Organ, To, and Makharinsky. However, Organ does not teach a bipolar ablation. Ditter, in the same field of endeavor, teaches a catheter containing electrodes used for RF ablation ([0009]), similar to the device of Organ, and further teaches wherein the physiological target region comprises cardiac tissue and the bipolar catheter is configured for use in bipolar ablation, transmural mapping, pace mapping, cardiac debulking and/or monitoring lesion formation ([0097] “catheter may be used for other diagnostic and/or therapeutic functions, such as intracardiac electrical mapping or other types of ablation therapy.”) to ensure accurate placement into tissue ([0044]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the bipolar ablation of Ditter, because such a modification would allow to ensure accurate placement into tissue.
Regarding claim 20, claim 1 is obvious over Organ, To, and Makharinsky. However, Organ does not teach a delivering fluid to target region for cooling. Ditter, in the same field of endeavor, teaches a catheter containing electrodes used for RF ablation ([0009]), similar to the device of Organ, and further teaches wherein the procedure comprises delivering fluid to the physiological target region to provide cooling and/or reduce formation of char during RF ablation ([0095] “During ablation, an irrigation pump is used to deliver normal heparinized saline to the ring electrodes to cool the ring electrodes to prevent blood from coagulating. The apertures in the ring electrodes facilitate irrigation of the ablation areas of the catheter. Where deeper lesions are desired, the greater flow distribution (without greater flow rate) of each ring electrode via the apertures reduces the increased risk of charring and coagulum on the ablation surfaces that would normally be encountered when the amount of power delivered to the electrode/tissue interface is increased.”) to ensure accurate placement into tissue ([0044]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the delivering fluid to target region for cooling of Ditter, because such a modification would allow to ensure accurate placement into tissue.
Claim(s) 3, 14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Organ et al. (US 20120089123)(Hereinafter Organ) in view of Makharinsky et al. (US 11045653)(Hereinafter Makharinsky), To et al. (US 10667855) (Hereinafter To), and Koblish et al. (US 20190038349)(Hereinafter Koblish).
Regarding claim 3, claim 1 is obvious over Organ, Makharinsky and To. Organ teaches wherein the dispersive electrode is … electrode that is disposed about a circumference of the distal end portion ([0089] “If the electrodes E1, E2, and E3 are configured as stainless steel cylindrical shells, or other morphologies that similarly have a continuous surface, exit holes, grids, slots, or other openings in these surfaces can be used as an outlet to allow for fluid infusion into the surrounding tissue during use.”).
However, Organ does not teach a proximal second electrode ring. Koblish, in the same field of endeavor, teaches ablation catheters that contain electrodes (Abstract), similar to the device of Organ, and further teaches a ring electrode ([0726] and Fig. 9) to provide to a user additional electrical measurement data during the execution of an ablation procedure ([0726]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the proximal second electrode ring of Koblish, because such a modification would allow to provide to a user additional electrical measurement data during the execution of an ablation procedure.
Regarding claim 14, claim 1 is obvious over Organ, Makharinsky and To. However, Organ does not teach a second electrode inserted and touching the physiological target region. Koblish, in the same field of endeavor, teaches ablation catheters that contain electrodes (Abstract), similar to the device of Organ, and further teaches wherein the bipolar catheter is inserted at an initial tissue region until the second electrode contacts a surface of the physiological target region ([0004] “making a second comparison between the second detected voltage and a second threshold voltage, wherein the second threshold voltage is indicative of contact between viable body tissue and a second portion of the ablation catheter, the second portion of the ablation catheter positioned at a location between the second and third electrodes…wherein contact between viable body tissue and the second portion of the ablation catheter is confirmed if the second voltage is at or above the second threshold voltage.”) to determine contact of electrodes with the body tissue ([0004]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the second electrode inserted and touching the physiological target region of Koblish, because such a modification would allow to determine contact of electrodes with the body tissue.
Regarding claim 19, claim 1 is obvious over Organ, Makharinsky and Bannister. However, Organ does not teach an ablation comprising measuring voltage and determining a loss in signal capture. Koblish, in the same field of endeavor, teaches ablation catheters that contain electrodes (Abstract), similar to the device of Organ, and further teaches wherein the procedure comprises performing bipolar ablation or tissue debulking and the method comprises measuring voltage during the procedure and determining that the procedure is complete when there is a loss in signal capture ([0610] “The Contact Criterion (CC) overall value may be calculated by bracketing the impedance magnitude (|Z.sub.MAG|), the slope (S) and the phase (P) into intervals corresponding to good, medium, low and no contact levels. Subvalues corresponding to either good, medium, low or not contact are determined for each of the impedance magnitude, slope and phase components depending on comparisons to various predetermined threshold values.” [0611] “using impedance magnitude, slope and phase, other characteristics of the complex impedance may be used in other embodiments. For example, analyses of the real and imaginary components of impedance may be used. Analyses of admittance parameters or scattering parameters may also be used. In some embodiments, direct analyses of the voltages and currents described in FIGS. 25A-27 (e.g., processing of voltage or current magnitudes, frequency changes or relative phase) may be used.” [0577] “contact state and/or tissue type determinations are performed during energy delivery or other treatment procedures using filters and/or other signal processing techniques and mechanisms to separate out the different frequency signals.”) to determine the contact state ([0610]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the ablation comprising measuring voltage and determining a loss in signal capture of Koblish, because such a modification would allow to determine the contact state.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Organ et al. (US 20120089123)(Hereinafter Organ) in view of Makharinsky et al. (US 11045653)(Hereinafter Makharinsky), To et al. (US 10667855) (Hereinafter To), and Iranitalab et al. (US 20210220043)(Hereinafter Iranitalab).
Regarding claim 17, claim 1 is obvious over Organ, Makharinsky and To. Organ teaches wherein the procedure comprises performing bipolar ablation or tissue debulking and the method comprises measuring an impedance at a distal end portion of the bipolar catheter and performing the bipolar ablation or tissue debulking while the measured impedance is within an effective … or comparing the measured impedance to an impedance threshold to determine when the ablation or debulking has been done for a sufficient amount of time ([0058] “A fourth function of the multi-purpose catheter probe CP1 is as a means for measuring electrical impedance of tissue or fluids at the catheter distal end 4 when the multi-purpose catheter probe CP1 is connected to an instrument with an impedance measurement module. Impedance values can be used, for example, as a confirmation of the location of the catheter distal end 4 (e.g. very low values indicate fluid rather than tissue) or for assessing the effectiveness of an RF ablation procedure (e.g. high values indicate thermocoagulation). Once again, the catheter distal end 4 acts as an electrode” [0062] “It also serves as a means for assessing, together with temperature rise, the effectiveness of an RF ablation procedure. No impedance change is indicative of an ineffective lesion, whereas lower or higher impedance values indicate tissue liquefaction or coagulation respectively.”).
However, Organ does not teach an effective operating range for impedance. Iranitalab, in the same field of endeavor, teaches the use of a catheter for electrode ablation ([0064]), similar to the devic of Organ, and further teaches an effective operating range for impedance (claim 30 and 36) for bipolar mode to calculate the accumulated volume of liquid (claim 30). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the effective operating range for impedance of Iranitalab, because such a modification would allow to calculate the accumulated volume of liquid.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Organ et al. (US 20120089123)(Hereinafter Organ) in view of Makharinsky et al. (US 11045653)(Hereinafter Makharinsky), To et al. (US 10667855) (Hereinafter To) and Koblish et al. (US 20200107877)(Hereinafter Koblish2).
Regarding claim 18, claim 1 is obvious over Organ, Makharinsky and To. However, Organ does not teach a first and second voltage that determines a magnitude reduction between the voltage comparisons that indicates a successful procedure. Koblish2, in the same field of endeavor, teaches ablation catheters that contain electrodes (Abstract), similar to the device of Organ, and further teaches wherein the procedure comprises performing bipolar ablation or tissue debulking and the method comprises measuring a first voltage before the procedure and a second voltage after the procedure, determining a magnitude reduction for the second voltage compared to the first voltage and determining that the medical procedure was successful when the magnitude reduction is greater than a magnitude reduction threshold ([0026]-[0027] “a visual indication is determined using, at least in part, (i) a temperature of the electrode assembly, and (ii) at least one of (a) the first comparison between the first detected voltage and the first threshold voltage, and (b) the second comparison between the second detected voltage and the second threshold voltage. In one embodiment, providing a visual indication comprises displaying a graphical representation indicative of the status of the ablation on an output.” [0584], [0594] “if the ratio of the impedance magnitude value at the higher frequency f2 to the impedance magnitude value at the lower frequency f1 is greater than a threshold, then the processing device 4624 determines that the contacted tissue is ablated tissue. [successful procedure]” [0629] “more than two frequencies are used (e.g., three or four frequencies) for tissue contact or tissue type detection…In some embodiments, direct analyses of the voltages and currents described in FIGS. 25A-27 (e.g., processing of voltage or current magnitudes, frequency changes or relative phase) may be used.”) to indicate the status of ablation ([0026]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the first and second voltage that determines a magnitude reduction between the voltage comparisons that indicates a successful procedure of Koblish2, because such a modification would allow to indicate the status of ablation.
Although Koblish2 uses the collected frequency to determine the status of ablated tissue, Koblish2 suggests the use of voltage to perform the tissue type detection as frequency and voltage analysis can be interchanged. It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Organ, with the first and second voltage that determines a magnitude reduction between the voltage comparisons that indicates a successful procedure of Koblish2, because such a modification would allow to perform the tissue type detection as frequency and voltage analysis can be interchanged.
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.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796