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
Acknowledgment is made to the amendment received 9/4/2025.
Response to Arguments
Applicant's arguments filed 9/4/2025 have been fully considered but they are not persuasive. Regarding claim 1, applicant argues that Elliot does not disclose the claim language “another end of the electrode tube carries a plurality of needles”. The word carry is fairly broad and is frequently defined as “to support and move something”. As seen in Figure 8A of Elliot, the proximal-most end of needles 26 are supported by indexer 208, thus indexer 208 is seen as carrying needles 26. Additionally, as seen in Figure 8A, indexer 208 is the only connection between handle 216 and cannula 12, thus indexer 208 must electrically connect needles 26 to handle 216, which comprises an electrical connector 38, as disclosed in paragraph [0043] of Elliot. Also, applicant argues that, based on the claim language, the electrode tube and signal conduit are fixed relative to each other. However, this is not a requirement of the claim language. One end of each of the electrode tube and signal conduit are fixed to the conductive joint, which is disclosed by electrical connector 38 of Elliot. Although the embodiment of Elliot depicted in Figure 8A does not explicitly depict electrical connector 38, paragraphs [0039] and [0044] describe the electrical connector being connected to both the shaft and the needles. As seen in Figure 8A, in order to be connected to the needles and also connect to the generator through the handle, the electrical connected must be connected to indexer 208. Thus, applicant’s arguments on pages 6-7 regarding claim 1 have been fully considered and they are not persuasive.
Applicant’s arguments with respect to the new claim language of lines 23-28 of claim 1 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. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Elliott in view of Embodiment B of Elliott. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin. Although applicant argues that Babkin does not disclose needles, in combination in the rejection below, Babkin is not required to disclose needles, it is merely used to disclose temperature sensors and how they are connected to an ablation system.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities:
Claim 1, line 26: “only the electode tube and the plurality needle” should read –only the electrode tube and the plurality of needles--;
Claim 21, lines 2-3: “from the the another” should read –from the another--;
Claim 21, line 7: “from the the another” should read –from the another--; and
Claim 21, line 7: “as it extends” should read –as each support extends--.
Appropriate correction is required.
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.
Claims 1-6 and 19-22 are 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 1, there is no support for the negative limitations “wherein the current for ablation from the conductive joint is released to a human tissue through only the electode tube and the plurality needle thereon” and “the temperatures detected by the plurality of temperature sensors are transmitted to the radio-frequency ablation system through only the signal conduit and the plurality of supports thereon”. Applicant’s specification mentions current passing though the electrode tube and needles in paragraph [0008] and other paragraphs throughout the specification, but there is no support for the current “only” being released through the electrode tube and the needles. Similarly, in paragraph [0008] of the specification, there is support for the temperatures to be transmitted through the signal conduit, but there is no support for the temperatures to be “only” transmitted through the signal conduit and the supports. Thus, claim 1 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Regarding claim 20, similarly there is no support for the claim language “supplying a current to only the plurality of needles through only the electrode tube and ablating the tissue only by the plurality of needles” and “acquiring temperatures of the tissue adjacent to the plurality of needles by the plurality of temperature sensors on the plurality of supports respectively through only the signal conduit”. Once again, there is support in the specification for the current being supply though the electrode tube, ablation being performed by the plurality of needles, and acquiring temperatures through the signal conduit, but there is no support for the negative limitation of only supplying current, ablating tissue, and acquiring temperatures via these elements. Thus, claim 20 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Regarding dependent claims 2-16, 19, and 21-22, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claims 1-10, 15-16, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Elliott (Figure 8A), US 20110125147, herein referred to as “Elliott”, in view of Embodiment B of Elliott (Figure 4), further in view of Babkin et al., US 20190209229, herein referred to as “Babkin”.
Regarding claim 1, Embodiment A of Elliott discloses a radio-frequency ablation catheter (Figures 1-3: probe assembly 4 and Figure 8A: probe assembly 200) for a radio-frequency ablation system (Figure 1: tissue ablation system 2), comprising a needle tube portion (Figures 2-3 and 8A: cannula 12) and a handle portion (Figures 2-3: handle assembly 27), wherein the handle portion comprises a sleeve (Figures 2-3: handle sleeve 29) and a booster (Figures 2-3: member 28 and proximal end 24 of shaft 20), wherein the sleeve is mounted around the booster (Figures 2-3: handle sleeve 29 is around proximal end of shaft 20), the booster is slidably arranged at one end of the sleeve (Figures 2-3: member 28 and [0043]: “The handle member 28 is slidably engaged with the handle sleeve 29 (and the cannula 20). ”), the booster is provided with a conductive joint (Figures 2-3: electrical connector 38), and the conductive joint is configured for connection with an external radio-frequency ablation system (Figure 1: RF generator 6 and [0046]: “the RF generator 6 is electrically connected to the electrical connector 38, which as previously described, may be directly or indirectly electrically coupled to the electrode array 27.”); the needle tube portion comprises a puncture tube (Figure 8A: cannula 12), an electrode tube (Figure 8A: indexer 208) and a signal conduit (Figure 8A: shaft 201), wherein the puncture tube is fixed at an another end of the sleeve (Figures 2-3: cannula 12 is fixed at another end of handle sleeve 29), the electrode tube is slidably disposed within the puncture tube ([0055]: “The indexer 208 is configured to be placed within the lumen 206 of the shaft 201, and may be rotated about a longitudinal axis 213 of the shaft 201”), one end of the electrode tube is fixed to the conductive joint (Figure 8A and [0055]: “ A handle 216 that secures to the proximal end 212 of the indexer 208 may be provided to facilitate manipulation of the indexer 208.”) and an another end of the electrode tube carries a plurality of needles (Figure 8A: needle electrodes 26), the plurality of needles are configured to transfer a current for ablation ([0031]) provided by the conductive joint ([0043]: “The handle member 28 also comprises an electrical connector 38 in which the proximal ends of the needle electrodes 26 (or alternatively, intermediate conductors) are coupled. ”), the signal conduit is slidably disposed in the puncture ([0055]: “The electrodes 26 are carried on the distal end 202 of the shaft 201, and may be deployed by distally advancing the shaft 201 relative to the cannula 12.”), the signal conduit is positioned on one side of the electrode tube (Figure 8A: shaft 201 is positioned on the distal side of indexer 208), and one end of the signal conduit is fixed to the conductive joint (Figures 2-3: shaft 20 is fixed to electrical connector 38 and [0044]: “ the electrical connector 38 may be located on the proximal end 24 of the shaft 20 distal to the handle member 28. ”); wherein the current for ablation from the conductive joint are individually transmitted ([0063]) by the electrode tube ([0062] and [0055]); and wherein the current for ablation from the conductive joint is released to a human tissue through only the electrode tube and the plurality of needles thereon (Figure 8A: needle electrodes 26 and [0039] and [0041]-[0042]). Embodiment A of Elliott does not explicitly disclose a radio-frequency ablation catheter wherein the signal conduit comprises a plurality of supports and a plurality of temperature sensors; an another end of the signal conduit is provided with the plurality of supports, and the plurality of supports are positioned on first sides of the plurality of needles; and the plurality of temperature sensors are respectively disposed on the plurality of supports and are electrically connected thereto, the plurality of temperature sensors are configured to detect temperatures adjacent to the plurality of needles and transmit the temperatures to the radio-frequency ablation system by means of the signal conduit; wherein the detected temperatures are individually transmitted by the signal conduit; and the temperatures detected by the plurality of temperature sensors are transmitted to the radio-frequency ablation system through only the signal conduit and the plurality of supports thereon.
However, Embodiment B of Elliott teaches a radio-frequency ablation catheter (Figure 4) wherein the signal conduit (Figure 4: shaft 20) comprises a plurality of supports (Figure 4: electrode array 27 has a plurality of supports) and a plurality of temperature sensors (Figure 4: markers 66 and [0040]: “ Each electrode 26 may also include a radio-opaque marker 66 and/or a sensor (not shown) carried at the distal end 60 of the electrode 26. The sensor may be used to sense a characteristic, such as the impedance or the temperature, of tissue being ablated.”); an another end of the signal conduit is provided with the plurality of supports (Figure 3: electrode array 27 is at another end of shaft 20 compared to electrical connector 38), and the plurality of supports are positioned on first sides of the plurality of needles (Figure 4: the supports of electrode array 27 that contain markers 66); and the plurality of temperature sensors are respectively disposed on the plurality of supports and are electrically connected thereto (Figure 4: markers 66), and the plurality of temperature sensors are configured to detect temperatures adjacent to the plurality of needles ([0040]: “Each electrode 26 may also include a radio-opaque marker 66 and/or a sensor (not shown) carried at the distal end 60 of the electrode 26. The sensor may be used to sense a characteristic, such as the impedance or the temperature, of tissue being ablated.”) and transmit the temperatures to the radio-frequency ablation system by means of the signal conduit ([0044]: “the electrical connector 38 may be located on the proximal end 24 of the shaft 20 distal to the handle member 28. ” and [0040]); wherein the detected temperatures are individually transmitted by the signal conduit ([0060]: “After the desired electrode 26 has been verified, the RF generator 6 is then connected to the probe assembly 4 (or 200) via the electrical connector 38.” And [0063]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Embodiment A of Elliott so that the signal conduit comprises a plurality of supports and a plurality of temperature sensors; and the plurality of temperature sensors are respectively disposed on the plurality of supports and are electrically connected thereto, and the plurality of temperature sensors are configured to detect temperatures adjacent to the plurality of needles and transmit the temperatures to the radio-frequency ablation system by means of the signal conduit, wherein the detected temperatures are individually transmitted by the signal conduit as taught by Embodiment B of Elliott so that the temperature of the tissue being ablated can be measured (Elliott [0040] to determine the effective rate of tissue ablation (Elliott [0008]).
Further, Babkin teaches an ablation catheter (Figure 3) wherein the temperatures detected by the plurality of temperature sensors (Figure 3: temperature sensors 20) are transmitted to the radio-frequency ablation system through only the signal conduit (Figure 3: shaft 16 and [0063]) and the plurality of supports thereon (Figure 3: flexible elements 18 and [0063]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Embodiment A of Elliott so that the temperatures detected by the plurality of temperature sensors are transmitted to the radio-frequency ablation system through only the signal conduit and the plurality of supports thereon as taught by Babkin to reduce the number of sensors that are necessary to adequately measure the temperature of the tissue (Babkin [0069]).
Regarding claim 2, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Embodiment B of Elliott further discloses an ablation catheter wherein the plurality of temperature sensors are respectively positioned at distal ends of the plurality of supports (Figure 4: markers 66 are at distal ends of the supports).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Embodiment A of Elliott so that the plurality of temperature sensors are respectively positioned at distal ends of the plurality of supports as taught by Embodiment B of Elliott so that the temperature of the tissue being ablated can be measured (Elliott [0040] to determine the effective rate of tissue ablation (Elliott [0008]).
Regarding claim 3, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Babkin further teaches an ablation catheter (Figure 3) wherein the temperature sensors are capacitance thermometers or thermistors ([0060]: “Examples of temperature sensors 20 that can be used include, and are not limited to, thermocouples, Resistance Temperature Detectors (RTDs) and thermistors.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Elliott so that the temperature sensors are capacitance thermometers or thermistors as taught by Babkin because this is a simple substitution of one known element, a temperature sensor, for another, specifically a thermistor, for the predictable result of accurately measuring temperature (MPEP Section 2143 I. (B)).
Regarding claim 4, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Embodiment A of Elliott further discloses an ablation catheter wherein a number of the plurality of supports is equal to a number of the plurality of needles (Figures 3 and 8A: supports are considered every other needle), and wherein the plurality of supports and the plurality of needles are arranged alternately (Figure 3: supports and needles alternate; there is no claim language that states that supports cannot function as needle electrodes).
Regarding claim 5, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 4, and Embodiment A of Elliott further discloses an ablation catheter wherein the plurality of supports are respectively disposed next to the plurality of needles (Figure 3: supports and needles alternate so they are next to each other), and distances between the plurality of needles and the respective supports are identical (Figure 3 and [0036]: “ In exemplary embodiments, pairs of adjacent needle electrodes 26 can be spaced from each other in similar or identical, repeated patterns and can be symmetrically positioned about an axis of the shaft 20.”).
Regarding claim 6, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Babkin further teaches an ablation catheter (Figure 3) wherein the electrode tube further comprises a plurality of metal balls respectively disposed at distal ends of the plurality of needles (Figure 3: temperature sensors 20 and [0059]: “In some embodiments, the flexible elements 18 can be nitinol wires. ” wherein nitinol is a metal and [0060]: “the temperature sensors 20 are included on ball-like or spherical elements.”), and the plurality of metal balls are electrically connected to the plurality of needles respectively ([0060]: “Included on the free ends of the flexible elements 18 (the ends not connected to the shaft/hollow tube-like structure 16) are temperature sensors 20, which are used to measure/monitor either (1) the temperature of the fluid (as discussed below) within the expandable component 14 or (2) the temperature of the tissue that the exterior of the expandable component 14 contacts adjacent to the temperature sensor 20.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Elliott so that the electrode tube further comprises a plurality of metal balls respectively disposed at distal ends of the plurality of needles, and the plurality of metal balls are electrically connected to the plurality of needles as taught by Babkin so that the temperature sensors do not puncture or otherwise damage the device or the tissue (Babkin [0060]).
Additionally, it would have been an obvious matter of design choice to make the ratio of an outer diameter of each metal ball to a diameter of a corresponding needle is 1.05:1.01, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Regarding claim 7, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Embodiment B of Elliott further discloses an ablation catheter comprising a fixed ring (Figure 5: tubes 70 and [0034]), wherein the fixed ring is positioned within the puncture tube (Figures 4-5: tubes 70 are within cannula 12), and the fixed ring is configured to fix the plurality of supports and the plurality of needles ([0034]: “Each of the electrodes 26 comprises a lumen 64 that is in communication with a respective lumen 72 of the shaft 20”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Embodiment A of Elliott so that there is a fixed ring positioned within the puncture tube that is configured to fix the plurality of supports and the plurality of needles as taught by Embodiment B of Elliott so that one or more occlusive elements may be delivered from the needles ([0034]).
Regarding claim 8, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 7, and Embodiment B of Elliott further discloses an ablation catheter wherein the fixed ring is provided with a plurality of through holes (Figure 5: lumens 72), a number of the plurality of through holes is equal to a sum of a number of the plurality of supports and a number of the plurality of needles ([0035]: “Each of the electrodes 26 comprises a lumen 64 that is in communication with a respective lumen 72 of the shaft 20”), and wherein the plurality of supports and the plurality of needles extend through the plurality of through holes respectively ([0035]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Embodiment A of Elliott so that there is a fixed ring provided with a plurality of through holes, a number of the plurality of through holes is equal to a sum of a number of the plurality of supports and a number of the plurality of needles, and the plurality of supports and the plurality of needles extend through the plurality of through holes as taught by Embodiment B of Elliott so that one or more occlusive elements may be delivered from the needles ([0034]).
Regarding claim 9, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Embodiment A of Elliott further discloses an ablation catheter wherein surfaces of the electrode tube and the signal conduit are provided with insulating layers ([0032]: “the cannula 12 is preferably covered with an insulative material. ” and [0033]: “the shaft 20 is composed of a suitable material, such as plastic” and [0038]), and the insulating layers are configured to shield a signal ([0032]: “the cannula 12 is preferably covered with an insulative material. ” and [0033]: “the shaft 20 is composed of a suitable material, such as plastic” and [0038]).
Regarding claim 10, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 1, and Embodiment A of Elliott further discloses an ablation catheter wherein the plurality of needles are arranged in a flower-radiation shape, and the plurality of supports are arranged in a flower-radiation shape (Figures 3 and 8A: needle electrodes 26, which correspond to supports and needles are arranged in a flower-radiation shape).
Regarding claim 15, Embodiment A of Elliott in view of Embodiment B of Elliott in view of Babkin discloses the radio-frequency ablation catheter according to claim 6, and Embodiment A of Elliott further discloses an ablation catheter wherein the plurality of needles are annularly distributed in a spherical shape in space, and the plurality of supports are annularly distributed in a spherical shape in space ([0036]: “When deployed from the cannula 12, the array 27 of needle electrodes 26 is placed in a three-dimensional configuration that usually defines a generally ellipsoidal or spherical volume having a periphery with a maximum radius in the range from 0.5 to 3 cm.”).
Regarding claim 16, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 15, and Babkin further discloses an ablation catheter (Figure 3) with metal balls ([0060]: “the temperature sensors 20 are included on ball-like or spherical elements.”). In combination with Embodiment B of Elliott, the markers 66 of Elliot would be part of metal balls and thus, the metal balls are located at a same latitude on the spherical shape ([0036]: “When deployed from the cannula 12, the array 27 of needle electrodes 26 is placed in a three-dimensional configuration that usually defines a generally ellipsoidal or spherical volume having a periphery with a maximum radius in the range from 0.5 to 3 cm.”), the temperature sensors are located at a same latitude on the spherical space ([0036]: “When deployed from the cannula 12, the array 27 of needle electrodes 26 is placed in a three-dimensional configuration that usually defines a generally ellipsoidal or spherical volume having a periphery with a maximum radius in the range from 0.5 to 3 cm.”); and the temperature sensors and the metal balls are located at a same latitude (In combination, the markers 66 of Elliot are attached to the metal balls of Babkin, just as the temperature sensors 20 of Babkin are included on the metal balls.).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Elliott so that the electrode tube further comprises a plurality of metal balls respectively disposed at distal ends of the plurality of needles as taught by Babkin so that the temperature sensors do not puncture or otherwise damage the device or the tissue (Babkin [0060]).
Regarding claim 19, Embodiment A of Elliott discloses a radio-frequency ablation system (Figure 1), comprising a radio-frequency ablation catheter according to claim 1 (Figure 1: probe assembly 4).
Regarding claim 20, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin teaches an ablation method using the radio-frequency ablation catheter according to claim 1 (Figure 1), with Elliot teaching a method comprising: delivering the radio-frequency ablation catheter in a human body to a tissue to be ablated ([0031]); supplying a current to only the plurality of needles through only the electrode tube and ablating the tissue by the plurality of needles (Figure 3: needle electrodes 26 and [0062] and [0055]); acquiring temperatures of the tissue adjacent to the plurality of needles by the plurality of temperature sensors on the plurality of supports respectively ([0040]). Babkin teaches a method comprising acquiring temperatures though only the signal conduit (Figure 3: temperature sensors 20 and [0063]) and controlling the current according to the temperatures measured by the plurality of temperature sensors ([0088]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Elliott so that it includes controlling the current according to the temperatures measured by the plurality of temperature sensors as taught by Babkin to avoid unwanted tissue damage due to ablation (Babkin [0088]).
Regarding claim 21, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 10, with Embodiment A of Elliot further disclosing an ablation catheter wherein the electrode tube has a central axis (Figure 8A: longitudinal axis 213), each needle extends curvedly and distally away from the another end of the electrode tube (Figure 8A: needles 26 extend curvedly and distally away from indexer 208); and as it extends distally, each needle initially extends outwardly in a direction away from the central axis of the electrode tube and then extends inwardly in a direction towards the central axis of the electrode tube (Figure 1: needles 26 first extend outwardly away from the central axis and then extend inwardly towards the central axis and [0036]); and wherein the signal conduit has a central axis (Figure 8A: longitudinal axis 213). Babkin teaches an ablation catheter (Figure 4) wherein each support extends curvedly and distally away from the another end of the signal conduit (Figure 4: flexible elements 18 extend curvedly and distally away from shaft 16); and as it extends distally, each support initially extends outwardly in a direction away from the central axis of the signal conduit and then extends inwardly in a direction towards the central axis of the signal conduit (Figure 4: flexible elements 18 and [0060]: “In some embodiments, as depicted in FIG. 4, the free ends 21 of the flexible elements 18 are curved back towards the flexible elements 18 such that the free ends 21 are smooth and therefore, will not puncture or damage the expandable component 14. ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Elliot so that each support initially extends outwardly in a direction away from the central axis of the signal conduit and then extends inwardly in a direction towards the central axis of the signal conduit as taught by Babkin so that the device can measure the temperature of itself in addition to the temperature of the surrounding tissue (Babkin [0060]).
Regarding claim 22, Embodiment A of Elliott in view of Embodiment B of Elliott and Babkin discloses the radio-frequency ablation catheter according to claim 6, and Babkin further discloses an ablation catheter wherein the plurality of metal balls ([0060]: “the temperature sensors 20 are included on ball-like or spherical elements.”) and the plurality of temperature sensors (Figure 3: temperature sensors 20) are staggered in an axial direction of the needle tube portion ([0060]) when the electrode tube and the signal conduit are pushed out from the puncture tube ([0090]: “After or simultaneously with the expansion/inflation of the expandable member 14, the flexible elements 18 also expand/spring open up such that the temperature sensors 20 on the free ends of the flexible elements 18 contact the interior surface of the expandable member 14. ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter disclosed by Elliot so that the plurality of metal balls and the plurality of temperature sensors are staggered in an axial direction of the needle tube portion when the electrode tube and the signal conduit are pushed out from the puncture tube as taught by Babkin so that the temperature sensors can measure and/or monitor a larger tissue area (Babkin [0069]).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Elliott in view of Babkin, further in view of Willard, US 20120116392, herein referred to as “Willard”.
Regarding claim 11, Elliott in view of Babkin discloses the radio-frequency ablation catheter according to claim 10, with Elliot disclosing a catheter wherein each needle has a length (Figure 3: needle electrodes), but does not explicitly disclose an ablation catheter wherein the lengths of the needles located at a middle position are the longest, the lengths of the needles located at outermost ends are the shortest, and the lengths of the plurality of needles are gradually decreased from the middle position towards two ends.
However, Willard teaches an ablation catheter (Figure 4) wherein the lengths of the needles located at a middle position are the longest (Figure 4: electrodes 120 labeled 1 and 2), the lengths of the needles located at outermost ends are the shortest (Figure 4: electrodes 120 labeled 3 and 4), and the lengths of the plurality of needles are gradually decreased from the middle position towards two ends (Figure 4).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Elliott so that the lengths of the needles located at a middle position are the longest, the lengths of the needles located at outermost ends are the shortest, and the lengths of the plurality of needles are gradually decreased from the middle position towards two ends as taught by Willard so that each needle is configured so that there is good contact with an artery wall (Willard [0020]).
Regarding claim 12, Elliott in view of Babkin and Willard discloses the radio-frequency ablation catheter according to claim 11, and Elliott further discloses an ablation catheter wherein the plurality of needles are distributed symmetrically with respect to a central axis of the electrode tube ([0036]: “the needle electrodes 26 diverge radially outwardly from the cannula 12 in a uniform pattern, i.e., with the spacing between adjacent needle electrodes 26 diverging in a substantially uniform and/or symmetric pattern. In the illustrated embodiment, the needle electrodes 26 also evert proximally, so that they face partially or fully in the proximal direction when fully deployed. In exemplary embodiments, pairs of adjacent needle electrodes 26 can be spaced from each other in similar or identical, repeated patterns and can be symmetrically positioned about an axis of the shaft 20.”), and the lengths of the corresponding needles symmetrical with respect to the central axis of the electrode tube are identical (Figure 3: all needle electrodes 26 have the same length).
Regarding claim 13, Elliott in view of Babkin discloses the radio-frequency ablation catheter according to claim 10, and Elliot further discloses an ablation catheter wherein each support has a length (Figure 3: needle electrodes), but does not explicitly disclose an ablation catheter wherein the lengths of the supports located in a middle position are the longest, the lengths of the supports located at outmost ends are the shortest, and the lengths of the plurality of supports are gradually decreased from the middle position towards two ends.
However, Willard teaches an ablation catheter (Figure 4) wherein the lengths of the supports located at a middle position are the longest (Figure 4: electrodes 120 labeled 1 and 2), the lengths of the supports located at outermost ends are the shortest (Figure 4: electrodes 120 labeled 3 and 4), and the lengths of the plurality of supports are gradually decreased from the middle position towards two ends (Figure 4).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Elliott so that the lengths of the supports located in a middle position are the longest, the lengths of the supports located at outmost ends are the shortest, and the lengths of the plurality of supports are gradually decreased from the middle position towards two ends as taught by Willard so that each support is configured so that there is good contact with an artery wall (Willard [0020]).
Regarding claim 14, Elliott in view of Babkin and Willard discloses the radio-frequency ablation catheter according to claim 13, and Elliott further discloses an ablation catheter wherein the plurality of supports are distributed symmetrically with respect to a central axis of the electrode tube ([0036]: “the needle electrodes 26 diverge radially outwardly from the cannula 12 in a uniform pattern, i.e., with the spacing between adjacent needle electrodes 26 diverging in a substantially uniform and/or symmetric pattern. In the illustrated embodiment, the needle electrodes 26 also evert proximally, so that they face partially or fully in the proximal direction when fully deployed. In exemplary embodiments, pairs of adjacent needle electrodes 26 can be spaced from each other in similar or identical, repeated patterns and can be symmetrically positioned about an axis of the shaft 20.”), and the lengths of the corresponding supports symmetrical with respect to the central axis of the electrode tube are identical (Figure 3: all needle electrodes 26 have the same length).
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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794