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 .
Priority
Claims 1-2, 4-8, 20-23, and 25 are deemed to have an effective priority date of April 4, 2024. Claims 3, 9-19, and 24 are deemed to have an effective priority date of April 4, 2025 as the provisional application does not disclose their limitations/features.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the generator and lead wires of claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1010" and "1036" have both been used to designate a needle (see paragraphs [0044] and [0046] of the originally-filed specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0045], lines 8-9, refers to “endcap 903”. The reference numeral for the endcap in Fig. 9 is --920-- (see paragraph [0044]).
Paragraph [0045] refers to “needle 1036” in lines 6 and 7. The Examiner believes that the reference numeral should be changed to “1010” as “1036” describes an interior portion in paragraph [0046].
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The subject matter of claim 14 should be added to the specification.
Claim Objections
Claims 3 and 15 are objected to because of the following informalities: Bot claims do not end with a period (.). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 15-16, and 20-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 (line 10), 2 (line), and 7 (line), include the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 3-6 and 8-10 are rejected because they depend from an indefinite claim.
Claims 15, line 4, and 16, line 3, include the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 20 (line 5), and 23 (line 3), include the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 21-22, and 24-30 are rejected because they depend from an indefinite claim.
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.
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 1-2, 5, 7-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054188 to Palushi et al. (hereinafter referred to as “Palushi”).
Regarding claim 1, Palushi discloses an apparatus, comprising: an outer shaft defining a first lumen (e.g. paragraph [0203]: shaft assembly 1830 and Figs. 33-34, 1830); an inner shaft disposed within the first lumen and extendable relative to the outer shaft (e.g. paragraph [0203]: inner shaft 1870 within the lumen of the outer shaft, which is extendable to the outer shaft as shown in Figs. 33-34), the inner shaft defining a second lumen (e.g. paragraph [0203]: a needle electrode assembly 1950 extendable from and retractable into the inner shaft 1870, and Figs. 33-34); an expandable electrode disposed on a distal end of the inner shaft, the expandable electrode configured to have a conical shape that increases in diameter from a proximal end to a distal end of the expandable electrode, the expandable electrode is configured to automatically transition from a first unexpanded configuration to a second expanded configuration having the conical shape when the expandable electrode is disposed distal to the outer shaft (e.g. paragraph [0203]: splayed needle electrodes 1981, 1983, 1985, 1087 have a conical shape that increases in diameter from a proximal end at the distal end of the inner shaft 1870 to the distal ends of the expandable electrodes; and Figs. 33-34); and a needle disposed within the second lumen and extendable relative to the inner shaft (e.g. paragraph [0203]: straight needle electrodes 1970, 1972 configured to extend along or parallel to the longitudinal axis of the shaft assembly and extends beyond the distal end of the inner shaft 1870 as shown in Figs. 33-34), the needle including a distal tip that is electrically exposed and a section proximal of the distal tip that is electrically insulated, the distal tip of the needle being insertable into a tissue site (e.g., paragraphs [0074]: needle electrode (140) includes a sharp tip that is configured to pierce tissue as the needle electrode is advanced and [0076]: needle electrode (140) may apply bipolar RF energy to tissue and at least a portion of the needle electrode (140) may include an electrically insulative coating or sheath; and [0397]: further adaption of the methods and system described herein may be accomplished by one of skilled in the art without departing from the scope of the invention), the expandable electrode and the distal tip of the needle, when (1) the expandable electrode is disposed distal to the outer shaft and (2) the needle is extended relative to the inner shaft such that the distal tip of the needle is disposed distally of the distal end of the inner shaft, being capable of applying pulsed field ablation to a zone of tissue at the tissue site (e.g. XIV. Ablation instrument with blunt tip electrodes and splayed needle electrodes and paragraphs [0203] and [0204]: splayed electrodes (1981, 1983, 1985, 1987) and straight electrodes (1970, 1972) apply RF energy to tissue). It would have been obvious to one of ordinary skill in the art to use a needle electrode with a sharp tip and a section proximal of the distal tip that is electrically insulative for the straight electrodes in the embodiment of Figs. 33-34 in view of the teachings discussed above in paragraphs [0074] and [0076] of Palushi that such was a well-known engineering expedient in the ablation instrument art, and because the combination would have yielded a predictable result.
With respect to claim 2, Palushi teaches the apparatus of claim 1, further comprising: a first lead wire configured to couple the expandable electrode to a generator; and a second lead wire configured to couple the needle to a generator, such that the generator can deliver a pulse waveform to the expandable electrode and the needle to cause the expandable electrode and the needle to function as a bipolar electrode pair (e.g., paragraph [0204]: two of expandable electrode applies RF energy at a first polarity and one of the straight needles apply RF energy at a second polarity and are operable to apply bipolar RF energy to tissue and paragraphs [0068] and [0177]: instrument 100 is coupled with an RF generator 102 and Fig. 2 that shows that a wire connects the generator to the instrument). It would have been obvious to one of ordinary skill in the art to two lead wires and a generator to provide the RF energy to the instrument in the embodiment of Figs. 33-34 in view of the teachings discussed above in paragraphs [0068] and [0177] of Palushi that such was a well-known engineering expedient in the ablation instrument art, and because the combination would have yielded a predictable result.
As to claim 5, Palushi teaches the apparatus of claim 1, wherein the second lumen extends along a portion of the expandable electrode (see Figs. 33-34: the expandable electrode has a portion that extends along the lumen of inner shaft 1870).
With respect to claim 7, Palushi teaches the apparatus of claim 1, wherein the needle is configured to be extended relative to the inner shaft such that the distal tip of the needle is disposed up to about 80 mm from the distal end of the expandable electrode (See Figs. 33-34). With respect to length that the needle is disposed from the expandable electrode, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Palushi so that the length/distance would be up to 80 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for thickness/height of the stimulator housing being at least half as that of the maximum diameter of the coil.
As to claim 8, Palushi teaches the apparatus of claim 1, wherein the expandable electrode, when the distal tip of the needle is inserted into the tissue site, is configured to be spaced from the tissue site (as shown in Figs. 33-34, there is a space between the distal tip of the needle and the splayed/expandable electrode).
With respect to claim 9, Palushi teaches the apparatus of claim 1, wherein the outer shaft and the inner shaft define an annular space therebetween that is configured to deliver a conductive fluid to a region surrounding the expandable electrode to establish at least a portion of a conductive path between the expandable electrode and the distal tip of the needle (e.g., paragraph [0205]: irrigation assembly 1700 is configured and operated as the irrigation assembly described w/r/t Figs. 26-31 and paragraphs [0191]-[0192] w/r/t Figs. 27-29: Conduits 1730, 1750 are in fluid communication with a source of liquid (e.g., saline – a conductive fluid), and when the distal tip electrode is being used to apply RF energy to tissue, liquid may be expelled from one of both of conduits 1730, 1750 to assist in promoting electrical continuity and reduce impedance at the target ablation site, thereby promoting ablation).
As to claim 10, Palushi teaches the apparatus of claim 1, further comprising: a first switch operatively coupled to the inner shaft and configured to be transitioned from a disengaged configuration to an engaged configuration when the expandable electrode is disposed distal to the outer shaft to indicate the expandable electrode has transitioned to the expanded configuration (e.g., paragraphs [0069]: Slider 116 is coupled with electrodes 150 and is thus able to translate electrodes 150 longitudinally as shown in Fig. 6; and [0077]: oblique needle electrodes 150 are coupled to slider 116 so that the needle electrodes are advanced distally when the slider 116 is advanced distally where the electrodes 150 are coupled to the inner shaft 126; and [0203]: needle assembly 1950 is driven by a slider 1122 from a proximal position to a distal position); and a second switch operatively coupled to the needle and configured to be transitioned from a disengaged configuration to an engaged configuration (e.g., paragraphs [0069]: Slider 114 is coupled with electrode 140 and is thus able to translate electrode 140 longitudinally as shown in Fig. 6; and [0203]: needle assembly 1950 is driven by a slider 1122 from a proximal position to a distal position) when the distal tip of the needle is disposed at least a minimum distance from a distal end of the expandable electrode to indicate the pulsed field ablation can be applied (paragraph [0144]: instrument may include one or more position sensors that generate signals to provide a visual indication to show the operator where the expandable arms (624, 634) and/or the needle electrode assembly 640 is located within the patient in real time – thus, Palushi is capable of indicating a distance is achieved to indicate that ablation can begin).
Referring to claim 11, Palushi teaches an apparatus, comprising: an outer shaft defining a first lumen (e.g. paragraph [0203]: shaft assembly 1830 and Figs. 33-34, 1830); an inner shaft disposed within the first lumen and extendable relative to the outer shaft, the inner shaft defining a second lumen (e.g. paragraph [0203]: inner shaft 1870 within the lumen of the outer shaft, which is extendable to the outer shaft as shown in Figs. 33-34); an expandable electrode disposed on a distal end of the inner shaft (e.g. paragraph [0203]: a needle electrode assembly 1950 including spayed electrodes 1981, 1983, 1985, 1987 that are extendable from and retractable into the inner shaft 1870, and Figs. 33-34); and a needle disposed within the second lumen and extendable relative to the inner shaft (e.g. paragraph [0203]: straight needle electrodes 1970, 1972 configured to extend along or parallel to the longitudinal axis of the shaft assembly and extends beyond the distal end of the inner shaft 1870 as shown in Figs. 33-34), the needle including a distal tip that is electrically exposed and a section proximal of the distal tip that is electrically insulated, the distal tip of the needle configured to be advanced distal to the expandable electrode and inserted into a tissue site (e.g., paragraphs [0074]: needle electrode (140) includes a sharp tip that is configured to pierce tissue as the needle electrode is advanced and [0076]: needle electrode (140) may apply bipolar RF energy to tissue and at least a portion of the needle electrode (140) may include an electrically insulative coating or sheath; and [0397]: further adaption of the methods and system described herein may be accomplished by one of skilled in the art without departing from the scope of the invention), the outer shaft and the inner shaft defining an annular space therebetween that is configured to deliver a conductive fluid to a region surrounding the expandable electrode, the expandable electrode and the distal tip of the needle, when the needle is inserted into the tissue site and the conductive fluid surrounds the expandable electrode, is capable of applying pulsed field ablation via a conductive path established by the conductive fluid to a zone of tissue at the tissue site needle (e.g., Fig. 34, 1700 and paragraphs [0203]-[0205]: instrument ablates tissue by applying RF energy to tissue, and irrigation assembly 1700 is configured and operated as the irrigation assembly described w/r/t Figs. 26-31 and paragraphs [0191]-[0192] w/r/t Figs. 27-29: Conduits 1730, 1750 are in fluid communication with a source of liquid (e.g., saline – a conductive fluid), and when the distal tip electrode is being used to apply RF energy to tissue, liquid may be expelled from one of both of conduits 1730, 1750 to assist in promoting electrical continuity and reduce impedance at the target ablation site, thereby promoting ablation). It would have been obvious to one of ordinary skill in the art to use a needle electrode with a sharp tip and a section proximal of the distal tip that is electrically insulative for the straight electrodes in the embodiment of Figs. 33-34 in view of the teachings discussed above in paragraphs [0074] and [0076] of Palushi that such was a well-known engineering expedient in the ablation instrument art, and because the combination would have yielded a predictable result.
With respect to claim 12, Palushi teaches the apparatus of claim 11, wherein the expandable electrode in an expanded configuration has a conical shape in which a diameter of the expandable electrode increases distally (e.g. paragraph [0203]: splayed needle electrodes 1981, 1983, 1985, 1087 have a conical shape that increases in diameter from a proximal end at the distal end of the inner shaft 1870 to the distal ends of the expandable electrodes; and Figs. 33-34).
As to claim 13, Palushi teaches the apparatus of claim 11, wherein the expandable electrode, when the distal tip of the needle is inserted into the tissue site, is configured to be spaced from the tissue site (as shown in Figs. 33-34, there is a space between the distal tip of the needle and the splayed/expandable electrode).
With respect to claim 14, Palushi teaches the apparatus of claim 11, wherein the expandable electrode and the distal tip of the needle are configured to be electrically polarized with opposite polarities to apply the pulsed field ablation to the zone of tissue (e.g., paragraph [0204]: two portions of expandable electrode apply RF energy at a first polarity and one of the straight needles apply RF ablation energy at a second polarity and are operable to apply bipolar RF energy to tissue).
As to claim 15, Palushi teaches the apparatus of claim 11, wherein the expandable electrode is configured to automatically transition from a first unexpanded configuration to a second expanded configuration having a conical shape when the inner shaft is extended relative to the outer shaft such that the expandable electrode is disposed distal to a distal end of the outer shaft (e.g., paragraphs [0146]: Handle assembly 1110 includes a body 1112 and sliders, which are operable to translate longitudinally relative to the body; Figs. 22A-22B show a needle electrode assembly being driven by a slider from a proximal position to a distal position; and [0203] and Figs. 33-34: splayed needles 1981, 1983, 1985, 1987 are resiliently biased to splay outwardly relative to the longitudinal axis of shaft assembly 1830 when distally positioned as in Fig. 33; needle assembly 1950 is shown after it is driven from its proximal position within the second lumen to its distal position via a slider 1122)[.]
With respect to claim 16, Palushi teaches the apparatus of claim 11, further comprising: a first lead wire configured to couple the expandable electrode to a generator; and a second lead wire configured to couple the needle to a generator, such that the generator can deliver a pulse waveform to the expandable electrode and the needle to cause the expandable electrode and the needle to function as a bipolar electrode pair (e.g., paragraph [0204]: two of expandable electrode applies RF energy at a first polarity and one of the straight needles apply RF energy at a second polarity and are operable to apply bipolar RF energy to tissue and paragraphs [0068] and [0177]: instrument 100 is coupled with an RF generator 102 and Fig. 2 that shows that a wire connects the generator to the instrument). It would have been obvious to one of ordinary skill in the art to two lead wires and a generator to provide the RF energy to the instrument in the embodiment of Figs. 33-34 in view of the teachings discussed above in paragraphs [0068] and [0177] of Palushi that such was a well-known engineering expedient in the ablation instrument art, and because the combination would have yielded a predictable result.
As to claim 19, Palushi teaches the apparatus of claim 11, further comprising: a first switch operatively coupled to the inner shaft and configured to be transitioned from a disengaged configuration to an engaged configuration when the expandable electrode is disposed distal to the outer shaft to indicate the expandable electrode has transitioned to the expanded configuration (e.g., paragraphs [0069]: Slider 116 is coupled with electrodes 150 and is thus able to translate electrodes 150 longitudinally as shown in Fig. 6; and [0077]: oblique needle electrodes 150 are coupled to slider 116 so that the needle electrodes are advanced distally when the slider 116 is advanced distally where the electrodes 150 are coupled to the inner shaft 126; and [0203]: needle assembly 1950 is driven by a slider 1122 from a proximal position to a distal position); and a second switch operatively coupled to the needle and configured to be transitioned from a disengaged configuration to an engaged configuration (e.g., paragraphs [0069]: Slider 114 is coupled with electrode 140 and is thus able to translate electrode 140 longitudinally as shown in Fig. 6; and [0203]: needle assembly 1950 is driven by a slider 1122 from a proximal position to a distal position) when the distal tip of the needle is disposed at least a minimum distance from a distal end of the expandable electrode to indicate the pulsed field ablation can be applied (paragraph [0144]: instrument may include one or more position sensors that generate signals to provide a visual indication to show the operator where the expandable arms (624, 634) and/or the needle electrode assembly 640 is located within the patient in real time – thus, Palushi is capable of indicating a distance is achieved to indicate that ablation can begin). It would have been obvious to one of ordinary skill in the art to use position sensors to confirm the position of the expandable electrodes w/r/t the needle electrodes of the instrument of Figs. 33-34 in view of the teachings of Palushi that such was a well-known engineering expedient in the ablation instrument art, and because the combination would have yielded a predictable result.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Palushi as applied to claim 2 above, and further in view of US Patent Application Publication No. 2023/0068059 to Turovskiy et al. (hereinafter referred to as “Turovskiy”) and US Patent No. 3,915,945 to Takahashi et al. (hereinafter referred to as “Takahashi”).
Palushi teaches the apparatus of claim 2, wherein the first lead wire and the second lead wire are electrically insulated lead wires having an insulating layer, but does not expressly teach that the insulating layer is configured to withstand at least about 300 Volts across a thickness of the insulating layer without dielectric breakdown[.] However, Turovskiy, in a related art: ablation devices, teaches methods and apparatus for providing pulsed electrical energy to the nose of a patient where the treatment includes high voltage, sub-microsecond pulsed electric energy (e.g., abstract and paragraphs [0006] –[0008]) and has peak voltages of 1-5 kV/cm, or even higher (e.g., paragraph [0024]). The instrument of Turovskiy is removably coupled to a pulse generator and is configured to generate the pulse energy to ablate tissue with pulses having an amplitude of 0.1 kV (e.g., paragraph [0026]). While Turovskiy teaches a cable with a high voltage connector to electrically couple the instrument/applicator tool 102 (e.g., paragraph [0141] and Fig. 1), its description does not mention the type of insulation on the cables. However, Takahashi, in a related art: a dielectric polyolefin composition which retains excellent strength over a long period of time and is suitable for use as insulation in high voltage cables (e.g. column 1, lines 4-8), teaches that it was well-known in the electrical cable art that certain insulation used in high voltage cables did not exhibit satisfactory properties and were viewed as having an early stage of dielectric break-down (e.g. column 1, lines 11-25) and teaches a polyolefin composition that has excellent dielectrical properties and which is particularly superior and stable in breakdown voltage strength (e.g. column 1, lines 33-36). Accordingly, one of ordinary skill in the art would have recognized the benefits of having lead wires coupling electrodes of an instrument to a generator having an insulating layer that is configured to withstand at least about 300 Volts across a thickness of the insulating dielectric breakdown in view of the teachings of Turovskiy and Takahashi. Consequently, one of ordinary skill in the art would have modified the apparatus of Palushi so that it has a first lead wire and a second lead wire that both have an insulating layer that is configured to withstand at least about 300 Volts across a thickness of the insulating layer without dielectric breakdown in view of the teachings of Turovskiy that pulsed filed ablation to a patient’s nose may have peak voltages of 1-5 kV/cm or higher, and the teachings of Takahashi that such insulation was known to exist for over 50 years, and because the combination would have yielded a predictable result.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Palushi as applied to claim 1 above, and further in view of US Patent Application Publication No. 2025/0281231 to DeSimone et al. (EFD 04/27/2023 and hereinafter referred to as “DeSimone”).
Palushi teaches the apparatus of claim 1, wherein the expandable electrode is formed of a resiliently biased material (e.g., paragraph [0203]), but does not expressly state that the expandable electrode is formed of a superelastic material. However, DeSimone, in a related art: device for ablation of tissue with expandable electrode, teaches that ablation devices can include a framework that is attached to or disposed on a distal end portion of a catheter where the framework can be self-expandable (e.g., made form a super-elastic material, such as nitinol with shape memory) (e.g., paragraphs [0040] and [0050]). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a super-elastic material for a resiliently biased expandable electrode in view of the teachings of DeSimone. Consequently, one of ordinary skill in the art would have modified the apparatus of Palushi so that the expandable electrode is formed of a superelastic material in view of the teachings of DeSimone that such was a well-known engineering expedient, and because the combination would have yielded a predictable result.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Palushi as applied to claim 1 above, and further in view of US Patent Application Publication No. 2023/0218340 to Werneth et al. (hereinafter referred to as “Werneth”).
Palushi teaches the apparatus of claim 1, wherein the expandable electrode has a first diameter at the proximal end of the expandable electrode and a second diameter at the distal end of the expandable electrode (see splayed electrode of Figs. 33-34), but does not expressly teach a ratio of the second diameter to the first diameter is at least about 1.1. However, Werneth, in the ablation art, teaches that using geometry and a ratio for electrodes with respect to an outer diameter was known to those skilled in the ablation art (e.g., paragraph [0227]). With respect to the ratio of the second diameter to the first diameter being at least about 1.1, , it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Palushi so that the splayed electrodes form a distal diameter and a proximal diameter with a ratio of about 1.1, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the ratio being about 1.1.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi as applied to claims 11 above, and further in view of Turovskiy.
With respect to claim 17, Palushi teaches the apparatus of claim 11, but does not expressly teach that the outer shaft is coupled to an ultrasound transducer, the ultrasound transducer configured to provide ultrasound imaging to facilitate visualization of one or more portions of at least one of the apparatus or patient anatomy. However, Turovskiy, in a related art: ablation device using an expandable electrode, teaches that the location of the catheter within a body can be verified using fluoroscopy and/or ultrasound (ICE) (e.g., paragraphs [0235] and [0266] of Turovskiy). Accordingly, one of ordinary skill in the art would have recognized the benefits of using an ultrasound transducer (device that converts energy from one form to another) to guide the catheter/instrument/ablation device to the proper position in view of the teachings of Turovskiy. Consequently, one of ordinary skill in the art would have modified the apparatus of Palushi to couple the outer shaft to an ultrasound transducer in order to provide ultrasound imaging to facilitate visualization of at least one of the apparatus or patient anatomy in view of the teachings of Turovskiy that such was a well-known medical protocol in the ablation art, and because the combination would have yielded a predictable result.
As to claim 18, Palushi teaches the apparatus of claim 17, but does not expressly state that the ultrasound transducer is configured to provide ultrasound imaging to facilitate visualization of insertion of the distal tip of the needle into the tissue site. However, Turovskiy teaches that ultrasound guidance can be used to determine where a needle should puncture a body part (e.g., paragraph [0234]). Accordingly, one of ordinary skill in the art would have recognized the benefits of using an ultrasound transducer (device that converts energy from one form to another) to guide needle to the proper location to puncture in view of the teachings of Turovskiy. Consequently, one of ordinary skill in the art would have modified the apparatus of Palushi to provide ultrasound imaging to facilitate insertion of the distal tip of a needle into a tissue site in view of the teachings of Turovskiy that such was a well-known medical protocol in the ablation art, and because the combination would have yielded a predictable result.
Claims 20-21 and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi in view of Turovskiy.
Referring to claim 20, Palushi teaches a method, comprising: positioning a distal portion of a catheter system near a tissue site (e.g., XIX. Method of ablating posterior nasal nerve and paragraph [0209]: performing an ablation on the nasal nerve or other anatomical tissue of a patient using instrument 1900, 2000), the catheter system including an outer shaft defining a first lumen (e.g. paragraph [0203]: shaft assembly 1830 and Figs. 33-34, 1830) and an inner shaft disposed within the first lumen of the outer shaft (e.g. paragraph [0203]: inner shaft 1870 within the lumen of the outer shaft, which is extendable to the outer shaft as shown in Figs. 33-34); disposing a distal end of the inner shaft distal to the outer shaft such that an expandable electrode disposed at the distal end of the inner shaft is transitioned from an unexpanded configuration to an expanded configuration (e.g., paragraph [0210] and Fig. 38B: once the instrument is inserted into the nasal cavity/appropriate area of the body, the operator advances the sliders distally to thereby extent expandable electrode assembly and the needle electrode assembly); extending a distal tip of a needle slidably disposed within a second lumen of the inner shaft distal to a distal end of the expandable electrode to insert the needle into the tissue site (e.g., paragraph [0210] and Fig. 38B: urging needle electrodes 1150 through the surface of the nasal wall), the distal tip of the needle being electrically exposed (implied with the term needle electrode); and applying pulsed field ablation to a zone of tissue at the tissue site while the distal tip of the needle is inserted into the tissue site and the expandable electrode is spaced from the tissue site (e.g., paragraph [0210] and Fig. 38B: loop electrode assembly 1140, spayed electrodes of Fig. 33 and needle electrode assembly 1150, needle electrodes 1970,1972 of Fig. 3 are then energized with bipolar RV energy to thereby ablate the targeted portion of the nasal nerve). Palushi differs from the claimed invention in that it does not expressly teach applying pulsed field ablation. However, Turovskiy, in a related art: ablation devices with expandable electrodes, teaches that it was known in the art to apply pulsed field ablation to a body part (e.g., abstract: providing pulsed electrical treatment to body vessels where the apparatus/instrument include wire loops; [0006]-[0008]: ablation/treatment of walls of an anatomical structure including the nose of a patient using pulsed electrical fields; and [0252]-[0253]: any of the apparatuses may be used to apply other types of energy (e.g., RF or microsecond pulsed energy) where the distances between electrodes can vary and which determines the strength of the pulsed field at every given voltage). Accordingly, one of ordinary skill in the art would have recognized the benefits of applying pulsed field ablation in the method of Palushi in view of the teachings of Turovskiy. Consequently, one of ordinary skill in the art would have modified the method of Palushi to apply pulsed field ablation when its electrodes apply RF energy in view of the teaching of Turovskiy that such was a well-known ablation technique, and because the combination would have yielded a predictable result.
With respect to claim 21, Palushi in view of Turovskiy teaches the method of claim 20, wherein the expandable electrode in the expanded configuration has a conical shape in which a diameter of the expandable electrode increases distally (e.g. paragraph [0203] of Palushi: splayed needle electrodes 1981, 1983, 1985, 1087 have a conical shape that increases in diameter from a proximal end at the distal end of the inner shaft 1870 to the distal ends of the expandable electrodes; and Figs. 33-34).
As to claim 23, Palushi in view of Turovskiy teaches the method of claim 20, wherein extending the needle distal to the distal end of the expandable electrode includes: extending the needle relative to the inner shaft such that the distal tip of the needle is disposed up to about 80 mm from the distal end of the expandable electrode (See Figs. 33-34 of Palushi). With respect to length that the needle is disposed from the expandable electrode, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Palushi so that the length/distance would be up to 80 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for thickness/height of the stimulator housing being at least half as that of the maximum diameter of the coil.
With respect to claim 24, Palushi in view of Turovskiy teaches the method of claim 20, wherein the expandable electrode and the distal tip of the needle are configured to be electrically polarized with opposite polarities to apply the pulsed field ablation to the zone of tissue (e.g., paragraph [0204] of Palushi: two portions of expandable electrode apply RF energy at a first polarity and one of the straight needles apply RF ablation energy at a second polarity and are operable to apply bipolar RF energy to tissue).
As to claim 25, Palushi in view of Turovskiy teaches the method of claim 20, but does not expressly teach capturing, using an ultrasound transducer coupled to the catheter system, a view of a portion of the catheter system and patient anatomy near the tissue site to confirm placement of the catheter system. However, Turovskiy, in a related art: ablation device using an expandable electrode, teaches that the location of the catheter within a body can be verified/confirmed using fluoroscopy and/or ultrasound (ICE) (e.g., paragraphs [0235] and [0266] of Turovskiy). Accordingly, one of ordinary skill in the art would have recognized the benefits of using an ultrasound transducer (device that converts energy from one form to another) to guide the catheter/instrument/ablation device to the proper position in view of the teachings of Turovskiy. Consequently, one of ordinary skill in the art would have modified the method of Palushi in view of Turovskiy to capture, using an ultrasound transducer coupled to the catheter systema view of a portion of the apparatus and patient anatomy to confirm proper placement in view of the teachings of Turovskiy that such was a well-known medical protocol in the ablation art, and because the combination would have yielded a predictable result.
With respect to claim 26, Palushi in view of Turovskiy teaches the method of claim 20, but does not expressly teach capturing, using an ultrasound transducer coupled to the catheter system, a view of a portion of the catheter system and patient anatomy near the tissue site to confirm insertion of the needle into the tissue site. However, Turovskiy teaches that ultrasound guidance can be used to determine where a needle should puncture a body part (e.g., paragraph [0234]). Accordingly, one of ordinary skill in the art would have recognized the benefits of using an ultrasound transducer (device that converts energy from one form to another) to guide needle to the proper location to puncture in view of the teachings of Turovskiy. Consequently, one of ordinary skill in the art would have modified the method of Palushi to capture, using an ultrasound transducer coupled to the catheter system, a view of a portion of the catheter system and patient anatomy near the tissue site to confirm insertion a needle into a tissue site in view of the teachings of Turovskiy that such was a well-known medical protocol in the ablation art, and because the combination would have yielded a predictable result.
As to claim 27, Palushi in view of Turovskiy teaches the method of claim 20, further comprising: delivering, while distal tip of the needle is inserted into the tissue site and the expandable electrode is spaced from the tissue site, a conductive fluid to a region surrounding the expandable electrode to establish at least a portion of a conductive path between the expandable electrode and the distal tip of the needle (e.g., Palushi paragraph [0205]: irrigation assembly 1700 is configured and operated as the irrigation assembly described w/r/t Figs. 26-31 and Palushi paragraphs [0191]-[0192] w/r/t Figs. 27-29: When the distal tip electrode is being used to apply RF energy to tissue, delivery of a conductive fluid (e.g., saline) – a conductive fluid), and when the distal tip electrode is expelling fluid one of both of conduits 1730, 1750 assists in promoting electrical continuity and reduce impedance at the target ablation site, thereby promoting ablation).
With respect to claim 28, Palushi in view of Turovskiy teaches the method of claim 27, wherein the outer shaft and the inner shaft define an annular space therebetween, the conductive fluid being delivered through the annular space (see Fig. 34 of Palushi).
As to claim 29, Palushi in view of Turovskiy teaches the method of claim 20, wherein the expandable electrode is configured to automatically transition from the unexpanded configuration to the expanded configuration when the distal end of the inner shaft is disposed distal to the outer shaft (e.g., paragraphs [0146]: Handle assembly 1110 includes a body 1112 and sliders, which are operable to translate longitudinally relative to the body; Figs. 22A-22B show a needle electrode assembly being driven by a slider from a proximal position to a distal position; and [0203] and Figs. 33-34: splayed needles 1981, 1983, 1985, 1987 are resiliently biased to splay outwardly relative to the longitudinal axis of shaft assembly 1830 when distally positioned as in Fig. 33; needle assembly 1950 is shown after it is driven from its proximal position within the second lumen to its distal position via a slider 1122).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Palushi in view of Turovskiy as applied to claim 21 above, and further in view of Werneth.
Palushi in view of Turovskiy teaches the method of claim 21, wherein the expandable electrode has a first diameter at a proximal end of the expandable electrode and a second diameter at the distal end of the expandable electrode, but does not expressly teach a ratio of the second diameter to the first diameter is at least about 1.1. However, Werneth, in the ablation art, teaches that using geometry and a ratio for electrodes with respect to an outer diameter was known to those skilled in the ablation art (e.g., paragraph [0227]). With respect to the ratio of the second diameter to the first diameter being at least about 1.1, , it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Palushi so that the splayed electrodes form a distal diameter and a proximal diameter with a ratio of about 1.1, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the ratio being about 1.1.
Allowable Subject Matter
Claim 30 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The primary reference to Palushi teaches generating signals indicative of the position of the end effector/arcuate arms and/or needle electrodes and providing a visual indication to the operator to show the operator where the end effector/electrodes is/are within the patient (e.g., paragraphs [0087] and [0144]). Palushi also teaches sliders to move electrodes out of the shaft; but, there is no teaching of detecting whether a switch operably coupled to the needle has transitioned from disengaged configuration to an engaged configuration to indicate that the distal tip of the needle is disposed within at least a minimum distance from a distal end of the expandable electrode and applying, in response to detecting the first switch and second switch are in the engaged configuration, the pulsed field ablation to the zone of tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2021/0212760 to Perfler is directed to an ablation catheter and ablation apparatus having an outer shaft 4a, inner shaft 4b with a second lumen, an expandable electrode disposed on a distal end of the inner shaft 3, 3a, a needle 5, 5a disposed within the second lumen and extendable relative to the inner shaft, which is used in pulsed ablation (e.g., abstract and Figs. 1-2) .
US Patent No. 10/842,572 to Viswanathan is directed to methods and systems for tracking ablation device where the shape/configuration of the distal portion (splines) of an ablation device is an important consideration in determining spatial information associated with the ablation device; and in particular that the splines have a proximal diameter and a distal diameter and that the ablation device may be characterized by these parameters (see Figs. 3 and column 11, lines 8-54).
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792