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
The amendment filed February 25th, 2026 has been entered. Applicant’s amendments to the claims have overcome the claim objections and 112(b) rejections previously set forth in the Non-Final Rejection mailed October 28th, 2025.
Response to Arguments
Applicant's arguments filed February 25th, 2026 have been fully considered.
Regarding Applicant’s arguments on pages 12-13 that none of the teaching or images of Pope indicate that any passive electrical element is physically in contact with a target tissue, the Examiner respectfully disagrees on the grounds that “physically in contact with” is broad such that it still does not yet specify whether it is in direct contact or in indirect contact (as in, via an electrode, conductive plate, there is a coating, etc.). See following paragraph.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Applicant argues “physically contacting” but features like direct physical contact) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, this argument is not found persuasive and the Examiner maintains that Pope teaches the amended limitations of claim 5.
Applicant’s arguments, see pages 13-14, with respect to the rejection(s) of claim(s) 11 under 35 U.S.C. 102 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
Applicant’s arguments, see page 14, with respect to the rejection(s) of claim(s) 18 under 35 U.S.C. 102 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
In response to applicant’s argument on pages 14-20 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, voltage dividers are a known electrical circuit component that provide the predictable benefits of controlling power intensity. Both references discuss the benefits of power distribution amongst a plurality of electrodes such that they are a similar field of endeavor such that it would be obvious to of ordinary skill in the art to view them as interchangeable.
In response to applicant's arguments on 18 and 19 that Pope teaches an electrical device to remove fat via lipolysis without deforming tissue and that Sartor teaches an electrosurgical pencil that is used to cauterize, coagulate and cut tissue such that the teachings are vastly different, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Additionally, Applicant has not yet claimed the power signal delivered to the electrodes. Pope’s device is interpreted based on the structure of the device disclosed and the modification is not to incorporate the intended use of Sartor to Pope’s device but instead to teach an alternate way to control power distribution to a plurality of electrodes.
In response to applicant's argument that Pope has no application for different functions other than heating fat to reduce obesity, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding Applicant’s arguments on page 19 that modifying Pope as taught by Sartor would render Pope’s device would render Pope’s device unsatisfactory for its intended purpose of non-tissue deformation, the Examiner respectfully disagrees on the grounds both disclosures discuss controlling power/voltage/current (Pope: Abstract, [0053]; Sartor: Abstract, [0020]) such that the combination is not modifying Pope to deform tissue or to modify Pope to the energy amplitudes for tissue deformation but rather to teach that there are different methods/circuitry for controlling energy such that switching how the energy is delivered is obvious. Absent a recitation for the voltage/amplitude/wattage of energy delivered, the modification is to how the device controls the power such that to one of ordinary skill in the art, modifying the way that Pope’s device controls the electrical parameters would not render the device inoperable or unsatisfactory for its intended purpose. Additionally, none of the claims recite what the intended use is (as in, fat removal, coagulation/cauterization, thermal ablation, etc.) for the claimed invention such that claiming what the signal applied is configured to do or the procedure the device is configured for could help overcome the current prior art of record.
Therefore, these arguments are not persuasive and the Examiner maintains the rejections of claims 1-4. The rejections for the other independent claims have been updated, as detailed in the preceding sections with the following new grounds of rejection set forth:
Claim Objections
Claim 27 objected to because of the following informalities:
Claim 27, line 2: “the ablation source” should read --the ablation energy source--,
Claim 27, line 3: “the ablation source” should read --the ablation energy source--.
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 18-35 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the claim recites “a target tissue” in line 3 and it is unclear if this is the same target tissue or a different target tissue from the target tissue recited in line 1. For examination purposes, these are the same target tissues and the limitation will be interpreted as “the target tissue”.
Claims 19-35 are also rejected by virtue of their dependency on claim 18.
Regarding claim 26, the claim recites “the ablation source” in line 3 and it is unclear if this is the same ablation source as the ablation energy source recited in claim 25, from which claim 26 depends, or a different ablation source. For examination purposes, these are the same ablation energy sources and the limitation will be interpreted as “the ablation energy source”.
Claim 27 is also rejected by virtue of its dependency on claim 26.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 5-9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Pope et al. (U.S. Pub. No. 20080312651), herein referred to as “Pope”.
Regarding claim 5, Pope teaches an electrosurgical device (Abstract: Methods and apparatus for selectively heating a target tissue via radiofrequency (RF) electrical energy), comprising:
a first electrode (electrode 32a);
a second electrode (electrode 32b); and
at least one intermediate electrically resistive element ([0091]: Electrode unit 30 may still further include a plurality of passive electrical elements, e.g., first, and second through n.sup.th passive electrical elements 50a, 50b, 50n, substantially as described with reference to FIG. 8A. Each passive electrical element 50a-n may comprise, for example, at least one capacitor, at least one resistor, at least one inductor, or a combination thereof, substantially as described with reference to FIG. 8A. Each of passive electrical elements 50a-n may have a different value of capacitance, inductance, or resistance, such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 may have a different value of an electrical parameter, e.g., current, voltage, or power);
wherein the first electrode, the second electrode, and the at least one intermediate electrically resistive element are spaced from one another along a working surface are configured to physically contact and electrically communicate with a target tissue ([0015]: The electrode unit includes a plurality of concentric electrodes, and a treatment face configured for contacting the patient; [0056]: Electrode unit 30 may be configured for treating and selectively heating a target tissue of a patient (see, for example, FIGS. 3A-4B and 9B); [0057]: Electrode unit 30 may include a plurality of concentric electrodes. In the embodiment of FIG. 3A, each of the concentric electrodes may be at least substantially annular (see, for example, FIGS. 5D and 7A). For example, as shown in FIG. 3A, electrode unit 30 may include a first annular electrode 32a, a second annular electrode 32b, and an nth annular electrode 32n; wherein “physically contact” is seen as including either direct or indirect contact such that the resistive element is in physical/electrical contact with tissue via the electrode, Fig. 5D shows the electrodes being spaced from one another along a working surface, and Fig. 9B shows the interface between a working surface comprising the electrodes and tissue/skin); and
wherein the at least one intermediate electrically resistive element interposes the first electrode and the second electrode (see Fig. 8C where the passive electrical elements 50a … 50n are between each of the electrodes 32a … 32n).
Regarding claim 6, Pope teaches wherein the at least one intermediate electrically resistive element comprises a first electrically resistive element electrically connected to the first electrode (electrode 32a & passive electrical element 50b, Fig. 8C) and a second electrically resistive element electrically connected to the second electrode (electrode 32b & passive electrical element 50c, Fig. 8C); and
wherein the first electrically resistive element is not directly electrically connected to the second electrically resistive element (see Fig. 8C).
Regarding claim 7, Pope teaches wherein the first electrically resistive element and the second electrically resistive element are interposed by a gap ([0081]: FIG. 7A schematically represents a transverse section of an electrode unit 30 having a dielectric material disposed between concentric annular electrodes 32a-n; [0091]: Electrode unit 30 may still further include a plurality of passive electrical elements, e.g., first, and second through n.sup.th passive electrical elements 50a, 50b, 50n, substantially as described with reference to FIG. 8A. Each passive electrical element 50a-n may comprise, for example, at least one capacitor, at least one resistor, at least one inductor, or a combination thereof, substantially as described with reference to FIG. 8A).
Regarding claim 8, Pope teaches wherein the gap comprises at least one of an unoccupied space and a non-conductive element ([0081]: FIG. 7A schematically represents a transverse section of an electrode unit 30 having a dielectric material disposed between concentric annular electrodes 32a-n).
Regarding claim 9, Pope teaches wherein the at least one intermediate electrically resistive element is electrically connected between the first electrode and the second electrode (see Fig. 8C).
Claims 11-16 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Horne et al. (U.S. Pub. No. 20080300590), herein referred to as “Horne”.
Regarding claim 11, Horne teaches an ablation device (electrosurgical device 1004, Fig. 10C) for creating a lesion in a target tissue (Abstract: Apparatus, systems and methods of welding and coagulating tissue utilize a combination of monopolar and bipolar delivery of RF energy), the ablation device comprising:
an end effector (resilient housing 1014) comprising a tissue engagement portion (portion of resilient housing comprising electrodes 1008n … 1008n=1) configured to engage a target tissue ([0028]: an apparatus for coagulating tissue comprises an elongate flexible member having both proximal and distal ends and a plurality of electrodes disposed near the distal end of the elongate flexible member), the tissue engagement portion configured for electrical contact with the target tissue ([0029]: Adjacent electrodes are generally electrically insulated from one another so that current traveling between electrodes passes through tissue) and comprising a first tissue contact (electrode 1008n), a second tissue contact (electrode 1008n=1), and an intermediate tissue contact (electrode 1008n~1);
wherein the intermediate tissue contact is disposed between the first tissue contact and the second tissue contact (see Fig. 10C);
wherein a surface area of the first tissue contact and the second tissue contact is each greater than and a multiple of a surface area of the intermediate tissue contact (see Fig. 10C where the surface areas of the electrodes 1008n & 1008n-1 are each greater than and a multiple of a surface area of electrode 1008n~1); and
wherein the first tissue contact, the intermediate tissue contact, and the second tissue contact are electrically coupled so that, when the end effector is supplied with electrical ablation energy, a magnitude of at least one electrical parameter differs between the first tissue contact, the intermediate tissue contact, and the second tissue contact so that an intermediate tissue contact magnitude is between a first tissue contact magnitude and a second tissue contact magnitude ([0077]: One or more resistor circuits 1022.sub.n are provided in series with the electrodes 1008.sub.n such that the potential on at least one electrode 1008.sub.n is different from the potential at another electrode 1008.sub.n … If desired, n-1 resistor circuits 1022.sub.n may be used with one resistor provided in series with each of n-1 electrodes such that the potential is different at each of the n-number of electrodes 1008.sub.n).
Regarding claim 12, Horne teaches wherein the tissue engagement portion comprises a discrete first electrode (electrode 1008n) comprising the first tissue contact (see Fig. 10C) and a discrete second electrode (electrode 1008n=1) comprising the second tissue contact (see Fig. 10C).
Regarding claim 13, Horne teaches wherein the tissue engagement portion comprises a discrete intermediate electrode (electrode 1008n~1) comprising the intermediate tissue contact (see Fig. 10C).
Regarding claim 14, Horne teaches wherein the tissue engagement portion comprises a first insulator between the discrete first electrode and the discrete intermediate electrode and a second insulator between the discrete intermediate electrode and the discrete second electrode ([0029]: Adjacent electrodes are generally electrically insulated from one another so that current traveling between electrodes passes through tissue; see also Fig. 10C depicting the electrodes as being independently connected to the voltage source which in addition to the disclosure in [0029] is seen as comprising insulation between each of the electrodes).
Regarding claim 15, Horne teaches wherein the discrete intermediate electrode comprises at least two sequentially disposed, discrete intermediate electrodes (see fig. 10C where after electrode 1008n~1 the ellipses indicate that there may be multiple intermediate electrodes); and
wherein the magnitude of the at least one electrical parameter differs incrementally between the at least two sequentially disposed, discrete intermediate electrodes ([0077]: If desired, n-1 resistor circuits 1022.sub.n may be used with one resistor provided in series with each of n-1 electrodes such that the potential is different at each of the n-number of electrodes 1008.sub.n).
Regarding claim 16, Horne teaches wherein the discrete first electrode, the discrete intermediate electrode, and the discrete second electrode are disposed in a line (see Fig. 10C where electrodes 1008n to 1008n=1 are disposed in a line); and
wherein the discrete first electrode is disposed as a first outermost electrode at a first end (see Fig. 10C where electrode 1008n is a first outermost electrode on a side relative to electrode 1008n=1) and the discrete second electrode is disposed as a second outermost electrode at a second end (see Fig. 10C where electrode 1008n=1 is a first outermost electrode on a side relative to electrode 1008n).
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of Sartor et al. (U.S. Pub. No. 20070093810), herein referred to as “Sartor”.
Regarding claim 1, Pope discloses an electrosurgical system (electrosurgical system 10; Abstract: Methods and apparatus for selectively heating a target tissue via radiofrequency (RF) electrical energy), comprising:
an electrosurgical device (electrode unit 30), including:
a first electrode (electrode 32a);
a second electrode (electrode 32n); and
an intermediate electrical element (electrode 32b);
wherein the first electrode, the second electrode, and the intermediate electrical element are configured to electrically communicate with a target tissue ([0056]: Electrode unit 30 may be configured for treating and selectively heating a target tissue of a patient (see, for example, FIGS. 3A-4B and 9B); [0057]: Electrode unit 30 may include a plurality of concentric electrodes. In the embodiment of FIG. 3A, each of the concentric electrodes may be at least substantially annular (see, for example, FIGS. 5D and 7A). For example, as shown in FIG. 3A, electrode unit 30 may include a first annular electrode 32a, a second annular electrode 32b, and an nth annular electrode 32n); and
wherein the intermediate electrical element interposes the first electrode and the second electrode ([0057]: In an embodiment, the n.sup.th annular electrode 32n may be disposed radially outermost of the plurality of concentric electrodes 32a-n); and
a resistive voltage divider ([0084]: a plurality of passive electrical elements 50a-n) electrically connected to a first input conductor and a second input conductor (see connectivity to electrodes 32a … 32n in Fig. 8C), the resistive voltage divider comprising a first resistor and a second resistor ([0084]: each passive electrical element 50a-n may comprise, for example, at least one capacitor, at least one resistor, at least one inductor, or a combination thereof);
wherein the first electrode is configured to electrically connect to the first input conductor, the second electrode is configured to electrically connect to the second input conductor, and the at least one intermediate electrode is configured to electrically connect to at least one intermediate conductor (see fig. 8C where each electrode 32a … 32n have respective input connectors corresponding to each electrode from the power source 20)
but Pope fails to disclose:
wherein the first resistor and the second resistor are electrically connected in series between the first input conductor and the second input conductor; and
the at least one intermediate electrode is configured to electrically connect to at least one intermediate conductor electrically connected between the first resistor and the second resistor.
However, Sartor discloses a resistive voltage divider (voltage divider network 27, Fig. 16) electrically connected to a first input conductor and a second input conductor (transmission lines 27a & 27b/c), the resistive voltage divider comprising a first resistor and a second resistor (R1 & R2, Fig. 16);
wherein the first resistor (R1) and the second resistor (R2) are electrically connected in series between the first input conductor (transmission line 27a) and the second input conductor (transmission line 27b/c) (see Fig. 16); and
the at least one intermediate electrode (electrocautery blade 6) is configured to electrically connect to at least one intermediate conductor (transmission line 27d) electrically connected between the first resistor and the second resistor (see Fig. 16 where transmission line 27d is between R1 and R2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrosurgical system of Pope to include a resistive voltage divider, as taught by Sartor, for the purpose of controlling the intensity of electrosurgical energy being delivered, enabling a plurality of power intensities (Sartor: [0012], [0020]).
Regarding claim 2, Pope in view of Sartor discloses: wherein the resistive voltage divider is disposed within at least one of a handle, a shaft, an end effector, or a connecting element of the electrosurgical device (Sartor: [0012]: At least one voltage divider network is also supported on the housing);
wherein the first input conductor and the second input conductor are configured to releasably electrically couple to an electrosurgical generator (Pope: [0055]: Power supply 20 may be electrically coupled to electrode unit 30, e.g., via an electrical cord or cable 24 (see, for example, FIG. 9A));
wherein the first input conductor is electrically coupled to the first electrode (see fig. 8C where each electrode 32a … 32n have respective input connectors corresponding to each electrode from the power source 20);
wherein the second input conductor is electrically coupled to the second electrode (see fig. 8C where each electrode 32a … 32n have respective input connectors corresponding to each electrode from the power source 20); and
wherein the at least one intermediate electrode is electrically coupled to the at least one intermediate conductor (see fig. 8C where each electrode 32a … 32n have respective input connectors corresponding to each electrode from the power source 20).
Regarding claim 3, Pope in view of Sartor discloses wherein the resistive voltage divider is disposed within an interface component configured to electrically interpose the electrosurgical device and an electrosurgical generator (Sartor: [0012]: The voltage divider network (hereinafter "VDN") is electrically connected to the source of electrosurgical energy and controls the intensity of electrosurgical energy being delivered to the plurality of activation switches; [0020]: It is envisioned that a single VDN may be supported on the housing; wherein this positioning is seen as interposing the electrosurgical device and the electrosurgical generator);
wherein the first input conductor and the second input conductor are configured to releasably electrically couple to the electrosurgical generator (Pope: [0055]: Power supply 20 may be electrically coupled to electrode unit 30, e.g., via an electrical cord or cable 24 (see, for example, FIG. 9A); wherein a cable connection is seen as a releasable electric coupling);
wherein the first input conductor is configured to releasably electrically couple to the first electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled);
wherein the second input conductor is configured to releasably electrically couple to the second electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled); and
wherein the at least one intermediate conductor is configured to releasably electrically couple to the at least one intermediate electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled).
Regarding claim 4, Pope discloses:
wherein the first input conductor is configured to releasably electrically couple to the first electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled);
wherein the second input conductor is configured to releasably electrically couple to the second electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled); and
wherein the at least one intermediate conductor is configured to releasably electrically couple to the at least one intermediate electrode ([0059]: FIG. 4A is a block diagram schematically representing an electrosurgical system 10 for independently controlling the supply of electrical energy to each of a plurality of concentric electrodes, according to an embodiment of the invention … System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; wherein this is seen as being releasably electrically coupled).
But Pope fails to disclose wherein the resistive voltage divider is disposed within the electrosurgical generator.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for wherein the resistive voltage divider is disposed within the electrosurgical generator, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim 10 rejected under 35 U.S.C. 103 as being unpatentable over Pope as applied to claim 5 above, and further in view of Truckai et al. (U.S. Pub. No. 20030220637), herein referred to as “Truckai”.
Regarding claim 10, Pope fails to disclose wherein an electrical resistance of the at least one intermediate electrically resistive element is approximately equal to an electrical resistance of the target tissue.
However, Truckai discloses wherein an electrical resistance of the at least one intermediate electrically resistive element is approximately equal to an electrical resistance of the target tissue ([0099]: the selected resistance across the matrix CM in an exemplary jaw at 37.degree. C. matches or slightly exceeds the resistance of the tissue or body structure that is engaged). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the at least one intermediate electrically resistive element to have an electrical resistance approximately equal to an electrical resistance of a target tissue as taught by Truckai, for the purpose of advantageously provides means for spatial-localization and modulation, of energy application from selected, discrete locations across a single energy-emitting surface coupled to a single energy source (Truckai: [0034]).
Claim 17 rejected under 35 U.S.C. 103 as being unpatentable over Horne as applied to claim 11 above, and further in view of Pope.
Regarding claim 17, Horne fails to disclose wherein the discrete first electrode is nested within the discrete intermediate electrode, and the discrete intermediate electrode is nested within the discrete second electrode.
However, Pope discloses wherein the discrete first electrode (electrode 32a, Fig. 5D) is nested within the discrete intermediate electrode (electrode 32b, Fig. 5D), and the discrete intermediate electrode is nested within the discrete second electrode (electrode 32n, Fig. 5D). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation device of Horne to have a nested electrode configuration, as taught by Pope, for the purpose of minimizing the edge effect from any one ring, and hence from the electrode unit as a whole and creating a gradient of voltage, current, or power, e.g., in which the energy levels are tapered radially from the innermost electrode to the outermost electrode, it is possible to achieve a much more even electric field within a tissue to be treated or contacted by apparatus (Pope: [0054])
Claims 18-21 & 29-35 are rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of Horne.
Regarding claim 18, Pope discloses a method of creating a lesion in a target tissue (Abstract: Methods and apparatus for selectively heating a target tissue via radiofrequency (RF) electrical energy), the method comprising:
positioning a tissue engagement portion of an end effector (electrode unit 30) of an ablation device (handpiece 40) proximate a target tissue ([0017]: a method for treating a patient includes disposing an electrode unit in relation to the patient's body) so that a first tissue contact (electrode 32a) of the tissue engagement portion is in electrical contact with the target tissue ([0056]: Electrode unit 30 may be configured for treating and selectively heating a target tissue of a patient (see, for example, FIGS. 3A-4B and 9B)), a second tissue contact (electrode 32n) of the tissue engagement portion is in electrical contact with the target tissue ([0056]: Electrode unit 30 may be configured for treating and selectively heating a target tissue of a patient (see, for example, FIGS. 3A-4B and 9B)), and an intermediate tissue contact (electrode 32b) of the tissue engagement portion between the first tissue contact and the second tissue contact is in electrical contact with the target tissue ([0056]: Electrode unit 30 may be configured for treating and selectively heating a target tissue of a patient (see, for example, FIGS. 3A-4B and 9B); [0057]: Electrode unit 30 may include a plurality of concentric electrodes. In the embodiment of FIG. 3A, each of the concentric electrodes may be at least substantially annular (see, for example, FIGS. 5D and 7A). For example, as shown in FIG. 3A, electrode unit 30 may include a first annular electrode 32a, a second annular electrode 32b, and an nth annular electrode 32n);
creating a lesion in the target tissue by applying electrical ablation energy to the end effector ([0017]: method further includes selectively heating a target tissue of the patient's body via the concentric electrodes) so that a magnitude of at least one electrical parameter differs between the first tissue contact, the intermediate tissue contact, and the second tissue contact so that the magnitude at the intermediate tissue contact is less than the magnitude at the first tissue contact and greater than the magnitude at the second tissue contact ([0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power; [0109]: In an embodiment, for example, wherein the second electrode is radially outward from the first electrode and the n.sup.th electrode is radially outward from the second electrode, M.sub.1, M.sub.2, and M.sub.n may have the following relationship: M.sub.1<M.sub.2<M.sub.n).
but Pope fails to explicitly disclose creating a lesion in the target tissue to promote scar tissue formation by applying electrical ablation energy to the end effector.
However, Horne discloses creating a lesion in the target tissue to promote scar tissue formation by applying electrical ablation energy to the end effector ([0073]: In FIG. 8C, RF energy is delivered to the multipolar electrode in resilient housing 802 using the multipolar energy delivery modality previously discussed, resulting in heating and welding of tissue layers P and S together; wherein welding tissue is seen as promoting scar tissue formation as the tissue is now fused to heal and form a new tissue structure, the scar). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Pope to include the steps of Horne for the purpose of enabling closure of tissue defects and to provide a reliable tissue connection or weld at the target site (Horne: [0065], [0012]).
Regarding claim 19, Pope discloses wherein applying the electrical ablation energy to the end effector comprises applying the electrical ablation energy to a discrete first electrode comprising the first tissue contact and a discrete second electrode comprising the second tissue contact ([0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power).
Regarding claim 20, Pope discloses wherein applying the electrical ablation energy to the end effector comprises applying the electrical ablation energy to a discrete intermediate electrode comprising the intermediate tissue contact ([0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power; wherein each electrode, including the intermediate electrode 32b each receive energy).
Regarding claim 21, Pope discloses wherein the intermediate electrode comprises at least two sequentially disposed, discrete intermediate electrodes ([0057]: In an embodiment, electrode unit 30 may include from about five (5) to eighteen (18) annular electrodes 32a-n, or from about six (6) to fifteen (15) annular electrodes 32a-n. In an embodiment, the n.sup.th annular electrode 32n may be disposed radially outermost of the plurality of concentric electrodes 32a-n; wherein the electrode numbering is arbitrary); and
wherein applying the electrical ablation energy to the discrete intermediate electrode comprises applying the electrical ablation energy to the at least two sequentially disposed, discrete intermediate electrodes so that the magnitude of the at least one electrical parameter differs incrementally between the at least two sequentially disposed, discrete intermediate electrodes ([0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power).
Regarding claim 29, Pope discloses wherein the at least one electrical parameter comprises electrical potential ([0059]: System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; [0062]: The use of different values for current, or other electrical parameter, of each electrode of a suitably configured electrode unit 30 may eliminate or greatly decrease an electrode edge effect. The use of different values for current, or other electrical parameter, of each electrode of a suitably configured electrode unit 30 may also allow for the controlled selective heating of a target tissue)
Regarding claim 30, Pope discloses wherein the at least one electrical parameter comprises electrical current ([0059]: System 10 may be configured for independently controlling the supply of electrical energy from power supply 20 to each of first annular electrode 32a, second annular electrode 32b, and n.sup.th annular electrode 32n, such that each annular electrode 32a-n may have a different value of an electrical parameter for treating a patient's target tissue; [0062]: The use of different values for current).
Regarding claim 31, Pope discloses wherein the electrical ablation energy comprises radiofrequency electrical energy (Abstract: Methods and apparatus for selectively heating a target tissue via radiofrequency (RF) electrical energy).
Regarding claim 32, Pope discloses wherein the electrical ablation energy comprises pulse field ablation electrical energy ([0054]: By creating a gradient of voltage, current, or power, e.g., in which the energy levels are tapered radially from the innermost electrode to the outermost electrode, it is possible to achieve a much more even electric field within a tissue to be treated; [0087]: As a non-limiting example, in an embodiment wherein passive electrical elements 50a-n comprise capacitors, capacitance values of elements 50a-n may decrease radially outward with respect to electrode unit 30; for example, a first capacitance of element 50a may be greater than a second capacitance of element 50b, which may in turn be greater than an n.sup.th capacitance of element 50n; wherein electrical energy applied to capacitors is seen as pulsed field ablation energy since capacitors are known to discharge energy as pulses).
Regarding claim 33, Pope fails to disclose wherein the ablation device comprises a shaft disposed proximally on the end effector; and
wherein positioning the tissue engagement portion of the end effector of the ablation device proximate the target tissue comprises positioning the tissue engagement portion of the end effector of the ablation device using the shaft.
However, Horne discloses wherein the ablation device comprises a shaft (electrosurgical catheter 804, Figs. 8A-C) disposed proximally on the end effector (resilient housing 802; see Figs. 8A-C); and
wherein positioning the tissue engagement portion of the end effector of the ablation device proximate the target tissue comprises positioning the tissue engagement portion of the end effector of the ablation device using the shaft ([0073]: The electrosurgical catheter 804 is placed into a patient's vasculature by standard introduction techniques such as the Seldinger technique and then advanced through the vasculature into the right side of the heart, adjacent to the septum primum P and septum secundum S tissues of a PFO; see Figs. 8A-C). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation device and method of Pope to comprise the device features and method of Horne for the purpose of enabling the device to be advanced through a patient’s vasculature and to be positioned against tissue (Horne: [0073]).
Regarding claim 34, Pope in view of Horne discloses wherein the ablation device comprises a handle (Horne: handle 768; [0106]: Although the foregoing description is complete and accurate, it has described only exemplary embodiments of the invention. Various changes, additions, deletions and the like may be made to one or more embodiments of the invention without departing from the scope of the invention. Additionally, different elements of the invention could be combined (e.g. multiple amplitudes or multiple phases) to achieve any of the effects described above) disposed proximally on the shaft (sheath 756); and
wherein positioning the tissue engagement portion of the end effector of the ablation device proximate the target tissue comprises positioning the tissue engagement portion of the end effector of the ablation device using the handle ([0071]: Locking screw 792 disposed in the handle 768 may be tightened to control the amount of catheter shaft 760 movement; [0073]: The electrosurgical catheter 804 is placed into a patient's vasculature by standard introduction techniques such as the Seldinger technique and then advanced through the vasculature into the right side of the heart, adjacent to the septum primum P and septum secundum S tissues of a PFO).
Regarding claim 35, Pope in view of Horne discloses wherein the ablation device comprises at least one connecting element (Horne: lead 122; [0106]: Although the foregoing description is complete and accurate, it has described only exemplary embodiments of the invention. Various changes, additions, deletions and the like may be made to one or more embodiments of the invention without departing from the scope of the invention. Additionally, different elements of the invention could be combined (e.g. multiple amplitudes or multiple phases) to achieve any of the effects described above) configured to electrically couple the end effector to an external ablation energy source ([0051]: A lead 122 couples electrode 108 with the higher potential (positive) terminal 104 of RF power supply 102); and
wherein applying the electrical ablation energy to the end effector comprises applying the electrical ablation energy to the end effector via the at least one connecting element ([0051]: Electrode 108 is manipulated by a physician during an electrosurgical procedure and the distal tip 110 of electrode 108 directs RF energy to target tissue treatment locations in a patient 112. Electrosurgical system 100 is activated, typically with a footswitch or a switch on electrode 108, and on a positive half cycle of RF power from power supply 102, current flows from RF power supply 102 to electrode 108 along lead 122 in the direction indicated by arrow 106).
Claims 22-26 & 28 are rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of Horne, as applied to claim 18, above, and further in view of Longoria (U.S. Pub. No. 20170035492), herein referred to as “Longoria”.
Regarding claim 22, Pope in view of Horne fails to disclose wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy to a semiconductor element comprising the intermediate tissue contact.
However, Longoria discloses wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy to a semiconductor element comprising the intermediate tissue contact ([0030]: the thermal ablation energy component is made of one or more resistors fabricated from a positive temperature co-efficient of resistivity (i.e., PTC) material, e.g., where the PTC material may be present as a coating on the active surface of the resistor, or otherwise incorporated into the resistor. PTC materials of interest include semiconductor materials which exhibit a resistivity increase with increasing temperature; [0053]: the applied ablative energy may be RF and/or thermal ablative energy. Where desired, prior to application of ablative energy, the method may include independently controlling each of the ablative elements of the jaws, e.g., the elongated electrodes and/or one or more PTC resistor). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Pope to include the steps of Longoria for the purpose of enabling temperature control of the resistors (the semiconductors) (Longoria: [0031]).
Regarding claim 23, Pope in view of Horne and Longoria discloses wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy to the semiconductor element, the semiconductor element further comprising the first tissue contact and the second tissue contact (Pope: [0017]: method further includes selectively heating a target tissue of the patient's body via the concentric electrodes; Longoria: [0053]: the applied ablative energy may be RF and/or thermal ablative energy. Where desired, prior to application of ablative energy, the method may include independently controlling each of the ablative elements of the jaws, e.g., the elongated electrodes and/or one or more PTC resistor … the device may be configured to independently control the temperature of one or more of the resistors, including all of the resistors. For example, the device may be configured to independently control the temperature of each of the resistors, such that during use the operator may assign the desired temperature to each of the resistors).
Regarding claim 24, Pope in view of Horne and Longoria discloses wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy from an ablation energy source to a first electrical conductor and a second electrical conductor (Pope: [0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power);
wherein the first electrical conductor is electrically coupled to the semiconductor element proximate the first tissue contact (Longoria: [0035]: an surface proximal RF ablation energy component 40 made up of first and second elongated electrodes 42 and 44, and a surface distal thermal energy component 50 made up of two linear arrangements of multiple PTC resistors, 52 and 54); and
wherein the second electrical conductor is electrically coupled to the semiconductor element proximate the second tissue contact (Longoria: [0035]: an surface proximal RF ablation energy component 40 made up of first and second elongated electrodes 42 and 44, and a surface distal thermal energy component 50 made up of two linear arrangements of multiple PTC resistors, 52 and 54).
Regarding claim 25, Pope in view of Horne and Longoria discloses wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy from the ablation energy source to an intermediate electrical conductor (Pope: [0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power);
wherein the intermediate electrical conductor is electrically coupled to the semiconductor element proximate the intermediate tissue contact (Longoria: [0035]: an surface proximal RF ablation energy component 40 made up of first and second elongated electrodes 42 and 44, and a surface distal thermal energy component 50 made up of two linear arrangements of multiple PTC resistors, 52 and 54).
Regarding claim 26, Pope in view of Horne and Longoria discloses wherein applying the electrical ablation energy from the ablation energy source to the intermediate electrical conductor comprises applying the electrical ablation energy from the ablation source to the intermediate electrical conductor so that the magnitude of the at least one electrical parameter differs between the first electrical conductor, the intermediate electrical conductor, and the second electrical conductor so that the intermediate tissue contact magnitude is between the first tissue contact magnitude and the second tissue contact magnitude (Pope: [0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power).
Regarding claim 28, Pope discloses wherein applying electrical ablation energy to the end effector comprises applying the electrical ablation energy to a discrete first electrode comprising the first tissue contact and a discrete second electrode comprising the second tissue contact ([0016]: The method further includes applying electrical energy to the target tissue via each of the concentric electrodes according to the predetermined treatment values; [0087]: electrical energy supplied by power supply 20 may be distributed from direct-coupled center electrode 34 to indirect-coupled first through n.sup.th annular electrodes 32a-n according to a respective value of passive electrical elements 50a-n. Each of passive electrical elements 50a-n may be selected to have a different value (capacitance, inductance, or resistance), such that each of first through n.sup.th annular electrodes 32a-n and center electrode 34 has a different value of an electrical parameter, e.g., current, voltage, or power).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of Horne, as applied to claim 26, above, and further in view of Sartor.
Regarding claim 27, while Pope discloses applying the electrical ablation energy from the ablation source to the intermediate electrical conductor from the first electrical conductor via a first resistor ([0084]: Each passive electrical element 50a-n may comprise, for example, a capacitor, a resistor, or an inductor. In an embodiment, each passive electrical element 50a-n may comprise, for example, at least one capacitor, at least one resistor, at least one inductor, or a combination thereof), Pope fails to disclose wherein applying the electrical ablation energy from the ablation source to the intermediate electrical conductor comprises applying the electrical ablation energy from the ablation source to the intermediate electrical conductor from the first electrical conductor via a first resistor and from the second electrical conductor via a second resistor.
However, Sartor discloses wherein applying the electrical ablation energy from the ablation source to the intermediate electrical conductor comprises applying the electrical ablation energy from the ablation source to the intermediate electrical conductor (transmission line 27d) from the first electrical conductor (transmission line 27a) via a first resistor (R1) and from the second electrical conductor (transmission line 27b/c) via a second resistor (R2) ([0071]: generator "G" transmits an appropriate waveform output to electrocautery blade 6 via transmission wire 14; see Fig. 16 where transmission line 27d is between R1 and R2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Pope in view of Horne to include the steps taught by Sartor, for the purpose of controlling the intensity of electrosurgical energy being delivered, enabling a plurality of power intensities (Sartor: [0012], [0020]).
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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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