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
Examiner acknowledges applicants’ amendments made to the claims 16, 21, 25, 31 and 40 with new claims 42-44 with claims 32, 39 and 41 canceled in prosecution. Claims 16-17,21-22,24-27,29-31,33-35,37-38,40 and 42-44 are currently pending in the present application.
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 16-17, 24-26, 31, 43 and all pertinent dependent claims 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. Specifically, claims 16-17, 24-26, 31, 43 are rejected as failing to comply with the new matter written description requirement as they contain the negative limitation of “exactly two legs.” This negative limitation found in the claims is not stated or discussed anywhere in the disclosure of the present application. Furthermore, according to the MPEP section 2173.05(i), any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a). Therefore, as the limitation of “expandable member containing exactly two legs” is not explicitly stated or even reasonably inferred in the specification, this raises the issue of new matter being claimed in the present application in such a way that the relevant subject matter was not present in the original disclosure at the time of filing the application. For the purpose of examination, the rejected claims 16-17, 24-26, 31, 43 will be analyzed under the broadest reasonable interpretation as if they read “multiple expandable members,” as stated in the applicant’s present disclosure.
Appropriate correction required.
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) 16-17,22,24-27,29-30 and 42-44 is/are rejected under 35 U.S.C. 103 as being anticipated by Burbank et al (US Patent No 2008/0287828) in view of Bakos et al. (US Patent No 2014/0039491) further in view of Pikus (US Patent No 2015/0105715) further in view of Byrd (US Patent No 20210161582).
Regarding claim 16, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches a method of medical treatment (medical system 10, [0038]), the method comprising: advancing a distal end of a medical tool to within a tissue site (wand 110 used to access target tissue within a patient, [0038]); retracting an outer sheath of the medical tool to expose and end effector having expandable elements (radial wires 20 emerge and extend radially from the shaft 14, [0038], see also fig 1 and fig 2A for extended and retracted form, furthermore, in this case cutting electrode 28 also can be deployed and extended out of the shaft 14 from a retracted state, [0039]); supplying a first waveform to cut tissue of the tissue site (see [0040], wherein an RF power source supplies the cutting electrode 28 with the effective RF power and frequency to effectively cut the tissue when cutting electrode 28 is deployed. This effectively creates the first cutting waveform, [0040]); and supplying a second waveform in the expanded state (wherein the RF power source 34 may comprise more than one source of RF power, [0040], effectively teaching another source for a second waveform), wherein the second waveform ablates the tissue using radiofrequency ablation or irreversible electroporation (see [0040] wherein the radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue. This effectively creates the second waveform).
Burbank does not teach wherein the expandable elements form exactly two legs such that the end effector has an ellipse shape.
However, the analogous electrosurgical instrument delivery system of Bakos does disclose an electrosurgical system in which there are expandable elements that form exactly two legs such that the end effector has an ellipse shape (see fig 12 which depicts the expandable elements 52 disposed at the distal end of the end effector 20, in which two members are depicted in an elliptical shape, [0094]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrosurgical delivery system disclosed by Burbank to have the specific two expandable elements in an elliptical shape on the end effector as disclosed by Bakos as it is another known end effector configuration in the art to effectively deliver and apply the specific surgical energy to the target site as taught by Bakos, [0094].
Neither Burbank nor Bakos teach that a first waveform of energy is supplied both of the expandable elements while they are expanding from a non-expanded state to an expanded state.
However, the analogous ablation catheter basket system taught by Pikus does disclose a first waveform of energy is supplied to both of the expandable elements while they are expanding from a non-expanded state to an expanded state (Pikus, wherein energy supplied in the form of high frequency acoustic energy is supplied to the ablation transducer 210 before, during, or after the basket 212 is shifted to an expandable position, [0054], furthermore Pikus discloses many basket configurations may be used during expansion, including configurations that contain exactly two struts 314, [0068]). Furthermore, Pikus goes on to disclose that although this configuration uses acoustic high frequency energy for ablation, other forms of energy may be used such as RF, Microwave, electrical, or heating, thereby teaching multiple waveforms for energy are used during treatment as well, [0040].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methodology and structure of the expandable medical device treatment of Burbank and Bakos, to have the first waveform energy applied to the expandable elements during expansion taught by Pikus in order to allow for continual cutting and ablation to occur during device expansion as taught by Pikus, [0054].
None of the previous combinations teach that the first waveform has a duty cycle of greater than 50% and the second waveform has a duty cycle of less than 50%.
However, the analogous IRE system with multiple different waveform signals which is taught by Byrd does disclose a first waveform has a duty cycle of greater than 50% and a second waveform has a duty cycle of less than 50%.
Byrd discloses that the first pulse durations for the first waveform signal may occur in the range of 400 nanoseconds to 20 microseconds, [0067]. Byrd also discloses that the second pulse durations 712 for the second waveform signal are in the range of 500 nanoseconds to 1.5 microseconds, [0067]. Byrd goes on to teach that that the total pulse period is supposed to occur around 20 microseconds, [0006]. Therefore, this results in the duty cycle for the first waveform to fall in the range between 2% to 100% thereby enclosing the claimed range of greater than 50%. The results for the second waveform duty cycle result in a range between 2.5% to 7.5% which falls less than 50% duty cycle as claimed.
Therefore, it would have been obvious for one skilled in the art to combine the previous method of waveform energy treatment taught by the previous combination with that of the specific first and second waveform duty cycle percentages taught by Byrd in order to create the most efficient waveform pulses for cutting and ablating the treatment location as taught by Byrd, [0065]- [0067].
Regarding claim 17, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches the method according to claim 16, wherein the first waveform is independently applied to each of the exactly two legs (in preferred embodiments the source of RF power for electrosurgical electrode 18 is not the same source of RF power for side-cutting electrode 28 or radial wires 20, [0047], which creates an independent application of the waveform for each element).
Regarding claim 22, Burbank teaches the method according to claim 16, wherein expanding the expandable elements includes expanding one of the expandable elements a greater distance from a longitudinal axis of the medical tool than another one of the expandable elements (see fig 1, for cutting electrode extended further out than the radial wires 20. See also [0085] for cutting electrode may be deployed to a variable extent which may include a greater radial distance from the shaft).
Regarding claim 24, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches the method according to claim 16, wherein each of the expandable elements of the exactly two legs includes a shape memory material (cutting electrode 28 and radial wires 20 are comprised of a memory metal, such as nitinol, [0063]), and each of the expandable elements expands when the first waveform is applied, without any applying a force to the expandable elements (effective to aid in the deployment of side-cutting electrode 28 and radial wires 20 upon provision of conditions triggering shape change in the memory metal, [0063], wherein the energy source conditions the shape change similar to the waveform).
Regarding claim 25, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches a method of medical treatment (medical system 10, [0038]), the method comprising: advancing an end effector positioned at a distal end of a medical tool into tissue (wand 110 used to access target tissue within a patient, [0038]); wherein the end effector includes exactly two legs that form an ellipse shape (wherein Bakos teaches the end effector with two legs that form an ellipse shape, see framework members 52 in fig 12); cutting through the tissue by expanding the end effector of the medical tool, wherein a cutting waveform is applied to the end effector (see [0040], wherein an RF power source supplies the cutting electrode 28 with the effective RF power and frequency to effectively cut the tissue when cutting electrode 28 is deployed. This effectively creates the first cutting waveform, [0040]); and then, ablating the tissue by supplying an ablation waveform to the end effector (see [0040] wherein the radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue. This effectively creates the second ablation waveform).
Neither Burbank nor Bakos teach that a first cutting waveform of energy is supplied to the expandable elements while they are expanding from a non-expanded state to an expanded state.
However, the analogous ablation catheter basket system taught by Pikus does disclose a first waveform of energy is supplied to the expandable elements while they are expanding from a non-expanded state to an expanded state (Pikus, wherein energy supplied in the form of high frequency acoustic energy is supplied to the ablation transducer 210 before, during, or after the basket 212 is shifted to an expandable position, [0054], whereby ablation and cutting perform the same treatment, furthermore Pikus discloses many basket configurations may be used during expansion, including configurations that contain exactly two struts 314, [0068]). Furthermore, Pikus goes on to disclose that although this configuration uses acoustic high frequency energy for ablation, other forms of energy may be used such as RF, Microwave, electrical, or heating, thereby teaching multiple waveforms for energy are used during treatment as well, [0040].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methodology and structure of the expandable medical device treatment of Burbank and Bakos, to have the first cutting waveform energy applied to the expandable elements during expansion taught by Pikus in order to allow for continual cutting and ablation to occur during device expansion as taught by Pikus, [0054].
The prior art of Pikus does not explicitly state that after applying the cutting waveform, determining whether both of the exactly two legs are in an expanded state: upon determining that both of the exactly two legs are not in the expanded state, again applying the cutting waveform to the end effector; after again applying the cutting waveform, determining whether the both the exactly two legs are in the expanded state; and upon determining that both the exactly two legs are in the expanded state ablating the tissue by applying an ablation waveform.
However, the prior art of record Bakos does disclose how sensing technology and controllers are used during the electrode strut expansion in order to determine if the struts are in a fully expanded state of if they are still in an expanding state. Based on the data received from the sensor, the system determines whether to apply ablation energy to the electrodes if in a fully expanded state, or to not apply energy if not fully expanded. Furthermore, since the prior art of Pikus has already taught that the multiple different waveforms can be applied to the expanding legs both during and once fully expanded.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the expandable strut controlling and sensing capabilities taught by Bakos with that of the multiple different waveforms applied during and after expansion taught by Pikus to arrive at a system which is capable of determining whether the legs are fully expanded or still in expansion and to be able to apply different energy waveforms to the expanding legs based on the expansion state in order to allow for continual cutting and ablation to occur during device expansion as taught by Pikus, [0054].
Regarding claim 26, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches the method according to claim 25, wherein each of the exactly two legs of the end effector includes an expandable element including a shape memory material (cutting electrode 28 and radial wires 20 are comprised of a memory metal, such as nitinol, [0063]), and wherein each of the expandable elements expands when the cutting waveform is applied effective to aid in the deployment of side-cutting electrode 28 and radial wires 20 upon provision of conditions triggering shape change in the memory metal, [0063], wherein the energy source conditions the shape change similar to the waveform).
Regarding claim 27, Burbank teaches the method according to claim 25, wherein the ablation waveform includes a radiofrequency ablation waveform or an irreversible electroporation (IRE) ablation waveform (radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue, [0040]),
Burbank does not teach wherein the radiofrequency ablation waveform is generated by an alternating current, or wherein the IRE ablation waveform is generated by a direct current.
However, the analogous electrosurgical instrument delivery and pulsed power system of Bakos does teach wherein the radiofrequency ablation waveform is generated by an alternating current, or wherein the IRE ablation waveform is generated by a direct current (Electrodes may be energized with DC voltages and conduct currents at various frequencies, amplitudes, pulse widths, and polarities, [0043], and by definition applying energy at various frequencies would result in an alternating current waveform).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the method of medical treatment taught by Burbank, to have the waveform generated by AC current and pulsed direct current waveforms taught by Bakos as this would result in various produced waveforms tailored to the desired application as disclosed by Bakos, [0043]. In this instance the desired application would be ablation.
Regarding claim 29, Burbank teaches the method according to claim 27, wherein the medical tool includes a tube extending through a shaft of the medical tool and connected to a distal tip of the end effector, wherein the tube includes a plurality of holes extending along a longitudinal axis of the tube, the method further comprising: supplying a fluid to the tissue at one or more of before, during, and after the ablating (see [0078], a pathway is used for directing fluid to the treatment region of the patient’s body. Used during treatment).
Wherein Bakos also discloses that the end effector tip 28 contains a catheter with holes to facilitate the flow and drainage of fluid to and from the treatment location, [0065], see also fig 1.
Regarding claim 30, Burbank teaches the method according to claim 29, further comprising: upon completion of the ablating, applying a second cutting waveform to the distal end of the medical tool while retracting the only two expandable legs (see specifically [0081]-[0082] which explains the process of ablating the tissue first and once the tissue is ablated the cutting phase starts to cut the desired tissue site with electrode 28 while radial wires 20 are retractable allowing electrode 28 to effectively cut).
Regarding claim 40, the combination teaches the method according to claim 16, wherein the first waveform is sinusoidal waveform (Burbank teaches, wherein an RF power source supplies the cutting electrode 28 effectively creates the first cutting waveform, [0040], and by definition RF energy is represented as perpendicular sinusoids, thereby teaching a sinusoidal waveform), and wherein the second waveform is a radiofrequency ablation waveform (from Byrd, the generator may use multiple forms for ablation therapy including radiofrequency ablation waveforms for ideal applications, [0025]).
Regarding claim 42, the combination teaches the method according to claim 25, wherein the ablation waveform is applied for 200 or less pulses (see from Byrd, in which the pulses applied must not exceed an amount in order to prevent unwanted stimulation, for example less than 50 microseconds, in which the pulse duration may be approximately 2 microseconds, resulting in 25 applied pulses, [0061], which falls less than 200 as claimed), wherein each pulse includes a duration of 40 microseconds to 4000 microseconds (see from Byrd, in which the ablation pulse duration may be in the range of 1 nanosecond to 100 microseconds, [0056], thereby overlapping the claimed range).
Regarding claim 43, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches the method according to claim 25, further comprising: wherein, upon determining that the exactly two legs are in the expanded state (radial wires 20 emerge and extend radially from the shaft 14, [0038], see also fig 1 and fig 2A for extended and retracted form, furthermore, in this case cutting electrode 28 also can be deployed and extended out of the shaft 14 from a retracted state, [0039]), automatically switching from applying the cutting waveform to applying only the ablation waveform (see [0040], wherein an RF power source supplies the cutting electrode 28 with the effective RF power and frequency to effectively cut the tissue when cutting electrode 28 is deployed. This effectively creates the first cutting waveform, [0040], then when in an expanded state the radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue. This effectively creates the second waveform).
Regarding claim 44, the combination teaches the method according to claim 16, wherein the first waveform includes a continuous waveform (Burbank teaches, wherein an RF power source supplies the cutting electrode 28 effectively creates the first cutting waveform, [0040], and by definition RF energy is represented as perpendicular sinusoids, thereby teaching a sinusoidal waveform), wherein the second waveform includes a pulsed, radiofrequency ablation waveform (from Byrd, the generator may use multiple forms for ablation therapy including pulsed radiofrequency ablation waveforms for ideal applications, [0025]).
Claim(s) 31,33-35,37-38,40 is/are rejected under 35 U.S.C. 103 as being anticipated by Burbank et al (US Patent No 2008/0287828) in view of Bakos et al. (US Patent No 2014/0039491) further in view of Pikus (US Patent No 2015/0105715) further in view of Byrd (US Patent No 20210161582) further in view of Coulombe (US Patent No 20200179029).
Regarding claim 21, Burbank, Bakos, Pikus and Byrd teach the method according to claim 16.
The combination does not teach further comprising: supplying a fluid to the tissue site at one or more of before, during, and after expansion of the expandable elements, wherein the fluid is supplied to the tissue site via a tube including a plurality of holes, wherein the plurality of holes are arranged in series along a longitudinal axis of the tube, and wherein the tube is fixedly coupled to a distal tip of the end effector.
However, the analogous ablation catheter taught by Coulombe does teach further comprising: supplying a fluid to the tissue site at one or more of before, during, and after expansion of the expandable elements (see in which there is fluid delivered to the treatment site during treatment, [0026]), wherein the fluid is supplied to the tissue site via a tube (fluid injection lumen 43, [0026]) including a plurality of holes, wherein the plurality of holes are arranged in series along a longitudinal axis of the tube (see the fluid delivery elements 44, [0026], in which they are arranged in series along the longitudinal axis, see fig 2), and wherein the tube is fixedly coupled to a distal tip of the end effector (in which the delivery lumen 43 is connected to the distal end 40 of the end effector, [0026]).
Therefore, it would have been obvious for one skilled In the art prior to the effective filing date to combine the medical system and methodology taught by the previous combination with that of the fluid supply and delivery technique taught by Coulombe, in order to effectively deliver cooling and/or treatment fluid to the treatment area to help create a more effective ablation procedure as disclosed by Coulombe, [0026].
Regarding claim 31, as analyzed under the broadest reasonable interpretation in view of the previous 112(a) rejection, Burbank teaches a medical system (medical system 10, [0038]), comprising: a medical tool having (wand 110, fig 1): a handle (motor unit 130 and disposable unit 120 create the handle, fig 1); a shaft extending from the handle and defining one or more lumens (shaft 14 which has an interior opening to define a lumen, [0038]); a wire attached to and extending from the handle through the one or more lumen (see radial wires 20 which extend through the shaft in fig 5A); and an electrical generator (Electrosurgical generator or RF power source 34, [0080]) coupled to a proximal end of the wire (see fig 1 for coupled to the proximal end via cable 37), wherein the electrical generator is configured to supply a first waveform to the wire and the only two expandable elements within a tissue site , and the electrical generator is configured to supply a second waveform to the wire and the only two expandable legs when the only two expandable legs are in the expanded state within the tissue site, wherein the first waveform is configured to cut tissue, and the second waveform is configured to ablate tissue using radiofrequency ablation or irreversible electroporation (see [0040], wherein an RF power source supplies the cutting electrode 28 with the effective RF power and frequency to effectively cut the tissue when cutting electrode 28 is deployed. This effectively creates the first cutting waveform, and wherein the radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue. This effectively creates the second waveform).
Burbank does not teach wherein the expandable elements form exactly two legs such that the end effector has an ellipse shape.
However, the analogous electrosurgical instrument delivery system of Bakos does disclose an electrosurgical system in which there are expandable elements that form exactly two legs such that the end effector has an ellipse shape (see fig 12 which depicts the expandable elements 52 disposed at the distal end of the end effector 20, in which two members are depicted in an elliptical shape, [0094]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrosurgical delivery system disclosed by Burbank to have the specific two expandable elements in an elliptical shape on the end effector as disclosed by Bakos as it is another known end effector configuration in the art to effectively deliver and apply the specific surgical energy to the target site as taught by Bakos, [0094].
Neither Burbank nor Bakos teach that a first waveform of energy is supplied both of the expandable elements while they are expanding from a non-expanded state to an expanded state.
However, the analogous ablation catheter basket system taught by Pikus does disclose a first waveform of energy is supplied to both of the expandable elements while they are expanding from a non-expanded state to an expanded state (Pikus, wherein energy supplied in the form of high frequency acoustic energy is supplied to the ablation transducer 210 before, during, or after the basket 212 is shifted to an expandable position, [0054], furthermore Pikus discloses many basket configurations may be used during expansion, including configurations that contain exactly two struts 314, [0068]). Furthermore, Pikus goes on to disclose that although this configuration uses acoustic high frequency energy for ablation, other forms of energy may be used such as RF, Microwave, electrical, or heating, thereby teaching multiple waveforms for energy are used during treatment as well, [0040].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methodology and structure of the expandable medical device treatment of Burbank and Bakos, to have the first waveform energy applied to the expandable elements during expansion taught by Pikus in order to allow for continual cutting and ablation to occur during device expansion as taught by Pikus, [0054].
The combination does not teach further comprising: supplying a fluid to the tissue site at one or more of before, during, and after expansion of the expandable elements, wherein the fluid is supplied to the tissue site via a tube including a plurality of holes, wherein the plurality of holes are arranged in series along a longitudinal axis of the tube, and wherein the tube is fixedly coupled to a distal tip of the end effector.
However, the analogous ablation catheter taught by Coulombe does teach further comprising: supplying a fluid to the tissue site at one or more of before, during, and after expansion of the expandable elements (see in which there is fluid delivered to the treatment site during treatment, [0026]), wherein the fluid is supplied to the tissue site via a tube (fluid injection lumen 43, [0026]) including a plurality of holes, wherein the plurality of holes are arranged in series along a longitudinal axis of the tube (see the fluid delivery elements 44, [0026], in which they are arranged in series along the longitudinal axis, see fig 2), and wherein the tube is fixedly coupled to a distal tip of the end effector (in which the delivery lumen 43 is connected to the distal end 40 of the end effector, [0026]).
Therefore, it would have been obvious for one skilled In the art prior to the effective filing date to combine the medical system and methodology taught by the previous combination with that of the fluid supply and delivery technique taught by Coulombe, in order to effectively deliver cooling and/or treatment fluid to the treatment area to help create a more effective ablation procedure as disclosed by Coulombe, [0026].
Regarding claim 33, Burbank teaches the medical system according to claim 31,
Burbank does not teach further comprising: a sheath surrounding the shaft; and an endoscope removably coupled to a distalmost end of the handle, wherein the sheath is provided between an inner wall of the endoscope and a distal tip of the only two expandable legs.
However, the analogous electrosurgical instrument delivery and pulsed power system of Bakos does teach a sheath surrounding the shaft (sheath 40, [0055]); and an endoscope removably coupled to a distalmost end of the handle (endoscope coupled to the handle 12, see also fig 1 showing endoscope within sheath 40 coupled to the handle 12), wherein the sheath is provided between an inner wall of the endoscope and a distal tip of the one or more expandable elements (see fig 1 for sheath configuration on inner wall of endoscope, see also [0055] for the electrode 21 which would equate to the expandable members which resides within the sheath in the withdrawn configuration)
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical system of Burbank with the sheath delivery system of Bakos, in order to effectively deliver an endoscope and electrode configuration to the target tissue as disclosed by Bakos, [0055].
Regarding claim 34, Burbank teaches the medical system according to claim 31, further comprising a non- expanding electrode (see electrosurgical electrode 18, which is stationary, [0040]), wherein the only two expandable legs are arranged about the non-expanding electrode in the unexpanded state (see fig 1, for radial wires 20 expand outwardly where electrosurgical electrode is centralized).
Regarding claim 35, Burbank teaches the medical system according to claim 31, wherein each of the only two expandable legs is independently actuatable (conductors 58A, 58B and 60 would separately provide power to the electrosurgical electrode and radial wires and a conductor 32 would separately provide power to the side-cutting electrode 28, [0064], establishing different waveform sources as well as the cutting electrode 28 using a different deployment mechanism than the radial wires 20 which use a push bar 59, [0063], and therefore it is established that expandable elements are energized and deployed independently).
Regarding claim 37, Burbank teaches The medical system of claim 31, wherein, after the end effector transitions from the unexpanded state to the expanded state (radial wires 20 emerge and extend radially from the shaft 14, [0038], see also fig 1 and fig 2A for extended and retracted form, furthermore, in this case cutting electrode 28 also can be deployed and extended out of the shaft 14 from a retracted state, [0039]), the medical tool is configured to automatically switch from the first waveform to the second waveform (see [0040], wherein an RF power source supplies the cutting electrode 28 with the effective RF power and frequency to effectively cut the tissue when cutting electrode 28 is deployed. This effectively creates the first cutting waveform, [0040], then when in an expanded state the radial wire element 20 is an ablation element and is supplied with the sufficient RF power and frequency to ablate the tissue. This effectively creates the second waveform).
Regarding claim 38, Burbank teaches The medical system of claim 31, wherein one of the only two expandable legs is an actuatable wire (wherein cutting electrode wire 28 is an actuatable wire and can be deployed from an extended configuration, [0039]), wherein actuating the actuatable wire moves the actuatable wire proximally or distally relative to the lumen of the shaft and moves a distal tip of the end effector radially outward relative to a central longitudinal axis of the shaft (see for example figure 4B,4C which show the distal tip radially outward in comparison to the cutting wire 28 in which it can be deployed in an extended or proximal configuration, [0046]).
Response to Arguments
The remarks and arguments filed on 03/02/2026 have been considered but ultimately fall unpersuasive.
The applicant’s arguments with respect to the independent claims 16 and 25 and all relevant dependent claims have been considered but ultimately fall unpersuasive. With regards to the argument presented that the prior art of Burbank does not teach the newly amended limitation of supplying the first and second energy waveforms to both of the exactly two legs as they expand and are at an expanded state, this argument has been considered, and the examiner agrees with the applicant that the prior art of Burbank alone does not teach this feature. However, after further consideration, necessitated by the amended claim language, it has been found that the previous prior art of record of Pikus does teach the newly amended claim limitation of supplying the first and second energy waveforms to both of the exactly two legs as they expand and are at an expanded state. Specifically, Pikus does go on to teach wherein energy supplied in the form of high frequency acoustic energy is supplied to the ablation transducer 210 before, during, or after the basket 212 is shifted to an expandable position, [0054], furthermore Pikus discloses many basket configurations may be used during expansion, including configurations that contain exactly two struts 314, [0068]. Therefore, as the previous prior art of record Pikus teaches the amended limitations found in independent claims 16 and 25, the claims 16 and 25 remain rejected under the previous prior art of record rejection of Burbank in view of Pikus, set forth in the present office action.
Applicants’ arguments with respect to claim(s) 21 and 31 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.
With respect to amended claim 21 and 31, the examiner agrees with the applicant that the previous prior art of record combination did not explicitly teach a fluid delivery tube which is fixedly connected to the distal tip of the end effector and contains a plurality of holes arranged in series along the longitudinal axis of the fluid tube. However, after further search and consideration, necessitated by the amended claim limitations, it has been found that the new analogous prior art of record of Coulombe does teach the new limitations as amended. Specifically, Coulombe does teach further comprising: supplying a fluid to the tissue site at one or more of before, during, and after expansion of the expandable elements (see in which there is fluid delivered to the treatment site during treatment, [0026]), wherein the fluid is supplied to the tissue site via a tube (fluid injection lumen 43, [0026]) including a plurality of holes, wherein the plurality of holes are arranged in series along a longitudinal axis of the tube (see the fluid delivery elements 44, [0026], in which they are arranged in series along the longitudinal axis, see fig 2), and wherein the tube is fixedly coupled to a distal tip of the end effector (in which the delivery lumen 43 is connected to the distal end 40 of the end effector, [0026]). Therefore, as Coulombe does teach the newly amended claim language, the amended claims 21 and 31 remain rejected under the new prior art of record rejection of Burbank in view of Coulombe set forth in the present office action.
As no further arguments or remarks have been made in regard to the dependent claims of claims 16, 25, and 31, all dependent claims including the new claims 42-44 also remain rejected under the prior art of record Burbank in view of Bakos further in view of Pikus further in view of Byrd further in view of Coulombe set forth in the present office action.
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
