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 18th, 2026 has been entered. Claims 1, 5, 8, 10-11, & 13 are amended. Claims 1-15 remain pending.
Response to Arguments
Applicant's arguments filed February 18th, 2026 have been fully considered but they are not persuasive.
Regarding independent claims 1 & 13 applicant argues that Shin fails to disclose the third switching circuit and the fourth switching circuit configured to connect any one of the plurality of electrode to the main grounding line and the sub-grounding line, respectively, as Shin only discloses a system that can implement a monopolarity mode and Cosman fails to disclose a circuit topology where there are dual grounding lines for return paths for the main amplifier and sub-amplifier respectfully. The examiner respectfully disagrees, as 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). The Shin reference discloses the main amplifier ([0014] & [0016]; Figure 1—elements 111 & 121), the sub-amplifier ([0014] & [0016]; Figure 1—elements 112 & 122), the main grounding line ([0014]; Figure 1—elements 121 & 151), the sub-grounding line ([0014]; Figure 1—elements 122 & 152), the first switching circuit configured to transfer the main RF electric power provided by the main amplifier to any one of a plurality of electrodes including at least three electrodes ([0014] & [0020]; Figure 1—element 141), the second switching circuit configured to transfer the sub-RF electric power provided by the sub-amplifier to any one of the plurality of electrodes ([0014] & [0020]; Figure 1—element 142), the third switching circuit configured to connect a main ground pad to the main grounding line ([0014] & [0024]; Figure 1—element 151); and the fourth switching circuit configured to connect a sub-ground pad to the sub-grounding line ([0014] & [0024]; Figure 1—element 152); the Shin reference does not disclose the third switching circuit being configured to connect or any one of the plurality of electrodes to the main grounding line and the fourth switching circuit being configured to connect or any one of the plurality of electrodes to the sub-grounding line. The Cosman reference is being relied on to teach that it is known for an amplifier comprising switching circuit for connecting the grounding line to a grounding pad to further include a switching circuit configuration that is configured to connect any one of the plurality of electrodes to the grounding line ([0076]; Figure 1—element S12, S22, & S23) in order to allow the system to operate in a bipolar mode, a monopolar mode, or a multipolar mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). The examiner is not relying on the Cosman reference to teach the main amplifier, the sub-amplifier, and the a circuit topology where there are dual grounding lines for return paths for the main amplifier and sub-amplifier respectfully, as the Shin reference already discloses the circuit comprising these components, the examiner is only modifying the third switching unit and fourth switching unit, as disclosed by Shin, to each include the additional switches that are configured to connect to the plurality of electrodes, as known in the art and taught by Cosman, so as to allow the instrument to operate in a monopolar mode, bipolar mode, and multipolar mode when delivering the main RF electric power and sub RF electric power, which would allow for treatment at a plurality of positions in tissue, save time if there are multiple sites to be treated, and provide for different heating profiles which allows the system to achieve desired temperatures.
Regarding dependent claim 10, applicant argues that Shin is silent to the hybrid mode and therefore cannot possibly disclose claim 10. The examiner respectfully disagrees, the examiner is not relying on only the Shin reference to disclose the limitations of dependent claim 10, rather the examiner is relying on Shin in view of Cosman, as dependent claim 10 depends from claim 9; claim 9 introduces the “hybrid mode”. Shin does not disclose the radiofrequency ablation system configured to selectively execute the bipolarity mode, and a hybrid mode (of claim 9), Cosman provides the teaching for a radiofrequency ablation system configured to selectively execute the bipolarity mode, and a hybrid mode ([0076], [0077], & [0161]; Figure 29—element “ta4”), which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], [0077], & [0161]). Therefore Shin in view of Cosman disclose the “hybrid mode” of claim 9 and claim 10, Shin further discloses the wherein the one predetermined pair of electrodes is configured to be switched to another pair of electrodes when the predetermined time elapses or according to the impedance value of the lesion ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes); therefore Shin in view of Cosman disclose all of the limitations of claim 10.
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 13-15 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.
Claim 13 recites the limitation “wherein the radiofrequency ablation system includes: a main grounding line; a sub-grounding line” (in lines 23-25), claim 13 introduces “either a main groundling line or a sub-ground line” (in lines 10-11), it is unclear if the “a main grounding line” and “a sub-grounding line” (of lines 23-25) are the same as or different than the “a main grounding line” and “a sub-grounding line” (as introduced in lines 10-11), which renders the claim indefinite. For examination purposes the examiner is considering them to be the same; dependent claims 14-15 are rejected by virtue of their dependency on independent claim 13.
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, 3-13, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (previously presented-US 20150265333 A1), hereinafter “Shin”, in view of Cosman et al. (previously presented-US 20170049513 A1), hereinafter “Cosman”.
Regarding claim 1, Shin discloses a radiofrequency ablation system comprising: a main amplifier configured to amplify electric power supplied to the main amplifier, the main amplifier being configured to provide main radiofrequency (RF) electric power resulting from amplification by the main amplifier ([0014] & [0016]; Figure 1—elements 111 & 121); a sub-amplifier configured to amplify electric power supplied to the sub-amplifier, the sub-amplifier being configured to provide sub-RF electric power resulting from amplification by the sub-amplifier ([0014] & [0016]; Figure 1—elements 112 & 122); a main grounding line connected to the main amplifier ([0014]; Figure 1—elements 121 & 151); a sub-grounding line connected to the sub-amplifier ([0014]; Figure 1—elements 122 & 152); a first switching circuit configured to transfer the main RF electric power provided by the main amplifier to any one of a plurality of electrodes including at least three electrodes ([0014] & [0020]; Figure 1—element 141); a second switching circuit configured to transfer the sub-RF electric power provided by the sub-amplifier to any one of the plurality of electrodes ([0014] & [0020]; Figure 1—element 142); a third switching circuit configured to connect a main ground pad to the main grounding line ([0014] & [0024]; Figure 1—element 151); and a fourth switching circuit configured to connect a sub-ground pad to the sub-grounding line ([0014] & [0024]; Figure 1—element 152), wherein the radiofrequency ablation system is configured to selectively execute a monopolarity mode according to operations of the first switching circuit, second switching circuit, third switching circuit, and fourth switching circuit, wherein, in the monopolarity mode, the radiofrequency ablation system is configured to supply the main RF electric power to one of one predetermined pair of electrodes, among the plurality of electrodes, and the sub-RF electric power to the other of the one predetermined pair of electrodes ([0024], [0025], & [0034]; Figure 1—elements 141, 142, 151, & 152; Figure 2—elements “S210” & “S220”).
Shin does not disclose the third switching circuit configured to connect any one of the plurality of electrodes to the main grounding line; the fourth switching circuit configured to connect any one of the plurality of electrodes to the sub-grounding line; wherein the radiofrequency ablation system is configured to selectively execute a bipolarity mode, and wherein, in the bipolarity mode, the radiofrequency ablation system is configured to supply either the main RF electric power or the sub-RF electric power to one of the one predetermined pair of electrodes, the radiofrequency ablation system being configured to connect either the main grounding line or the sub-grounding line to the other of the one predetermined pair of electrodes.
Cosman teaches a radiofrequency ablation system configured to selectively execute a monopolarity mode or a bipolarity mode comprising a plurality of switching circuits configured to connect a plurality of electrodes to the power source and a ground pad to the grounding line([0076] & [0077]; Figure 1—element 2027); the switching circuit configured to connect any one of the plurality of electrodes to the grounding line ([0076]; Figure 1—element S12, S22, & S23); wherein the radiofrequency ablation system is configured to selectively execute a bipolarity mode, and wherein, in the bipolarity mode, the radiofrequency ablation system is configured to supply the power to one of the one predetermined pair of electrodes, the radiofrequency ablation system being configured to connect the grounding line to the other of the one predetermined pair of electrodes ([0076]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as taught by Cosman, as both references and the claimed invention are directed toward radio frequency ablation systems configured to selectively activate electrodes. As disclosed by Shin, the third switching circuit and fourth switching circuit make and break connections between the main and sub amplification unit and the ground pads ([0024] & [0025]). As disclosed by Cosman, each generator can include a switching circuit for selectively coupling the positive pole of the power source to any one of the plurality of electrodes, a switching circuit for selectively connecting the negative/grounding pole of the power source to a ground pad, and a switching circuit for selectively connecting the negative/grounding pole of the power source to any one of the plurality of electrodes, the switching circuits allow the system to operate in a bipolar mode, a monopolar mode, or a multipolar mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Regarding claim 3, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin further discloses wherein, in the monopolarity mode, the main ground pad is configured to be connected to the main grounding line, and the sub-ground pad is configured to be connected to the sub-grounding line ([0014], [0024], & [0025]).
Regarding claim 4, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin does not disclose wherein, in the bipolarity mode, when the main RF electric power is supplied to one of the one predetermined pair of electrodes, the main grounding line is configured to be connected to the other of the one predetermined pair of electrodes, and, when the sub-RF electric power is supplied to one of the one predetermined pair of electrodes, the sub-grounding line is configured to be connected to the other of the one predetermined pair of electrodes.
Cosman further teaches wherein, in the bipolarity mode, when the electric power is supplied to one of the one predetermined pair of electrodes, the grounding line is configured to be connected to the other of the one predetermined pair of electrodes ([0076]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute the bipolarity mode, as further taught by Cosman, as both references and the claimed invention are directed toward radio frequency ablation systems configured to selectively activate electrodes. As disclosed by Shin, the third switching circuit and fourth switching circuit make and break connections between the main and sub amplification unit and the ground pads ([0024] & [0025]). As disclosed by Cosman, each generator can include a switching circuit for selectively coupling the positive pole of the power source to any one of the plurality of electrodes, a switching circuit for selectively connecting the negative/grounding pole of the power source to a ground pad, and a switching circuit for selectively connecting the negative/grounding pole of the power source to any one of the plurality of electrodes, the switching circuits allow the system to operate in a bipolar mode, a monopolar mode, or a multipolar mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute the bipolarity mode, as further taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Regarding claim 5, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin further discloses wherein the one predetermined pair of electrodes that operate in the monopolarity mode or the bipolarity mode is configured to be switched to another pair of electrodes, among the plurality of electrodes, when a predetermined time elapses or according to an impedance value of a lesion ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes).
Regarding claim 6, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin further discloses a main board sensor configured to monitor voltage and current on a main amplifier side while the main amplifier outputs the main RF electric power; and a sub-sensor board configured to monitor voltage and current on a sub-amplifier side while the sub-amplifier outputs the sub-RF electric power ([0014], [0017]-[0019]; Figure 1—elements 131 & 132).
Regarding claim 7, Shin in view of Cosman disclose all of the limitations of claim 6, as described above.
Shin further discloses a controller configured to continuously compute impedance of a lesion using the voltage and the current that are monitored by the main board sensor and the voltage and the current that are monitored by the sub-sensor board, during radiofrequency ablation, the controller being configured to compare the impedance with a preset reference value ([0014], [0018], & [0031]; Figure 1—element 170).
Regarding claim 8, Shin in view of Cosman disclose all of the limitations of claim 7, as described above.
Shin further discloses wherein, in a case where a predetermined time elapses or in a case where the impedance exceeds the preset reference value, the controller is configured to control the first switching circuit, second switching circuit, third switching circuit, and fourth switching circuit to switch the one predetermined pair of electrodes that operate in the monopolarity mode or the bipolarity mode to another pair of electrodes, among the plurality of electrodes ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes).
Regarding claim 9, Shin in view of Cosman disclose all of the limitations of claim 5, as described above.
Shin further discloses wherein the radiofrequency ablation system is configured to selectively execute one of the monopolarity mode (as described in the above rejection of claim 1).
Shin does not disclose wherein the radiofrequency ablation system is configured to selectively execute the bipolarity mode, and a hybrid mode, and wherein, in the hybrid mode, the radiofrequency ablation system is configured to supply either the main RF electric power or the sub-RF electric power to one of the one predetermined pair of electrodes, and the other of the one predetermined pair of electrodes and the main ground pad are configured to be simultaneously connected to the main grounding line, or the other of the one predetermined pair of electrodes and the sub-ground pad are configured to be simultaneously connected to the sub-grounding line.
Cosman further teaches wherein the radiofrequency ablation system is configured to selectively execute the bipolarity mode, and a hybrid mode, and wherein, in the hybrid mode, the radiofrequency ablation system is configured to supply either the electric power to one of the one predetermined pair of electrodes, and the other of the one predetermined pair of electrodes and the main ground pad are configured to be simultaneously connected to the grounding line ([0076], [0077], & [0161]; Figure 29—element “ta4”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute the bipolarity mode and a hybrid mode, as further taught by Cosman, as both references and the claimed invention are directed toward radio frequency ablation systems configured to selectively activate electrodes. As disclosed by Shin, the third switching circuit and fourth switching circuit make and break connections between the main and sub amplification unit and the ground pads ([0024] & [0025]). As disclosed by Cosman, each generator can include a switching circuit for selectively coupling the positive pole of the power source to any one of the plurality of electrodes, a switching circuit for selectively connecting the negative/grounding pole of the power source to a ground pad, and a switching circuit for selectively connecting the negative/grounding pole of the power source to any one of the plurality of electrodes, the switching circuits allow the system to operate in a bipolar mode, a monopolar mode, or a multipolar/hybrid mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify to modify each of the third switching circuit and the fourth switching circuit, as disclosed by Shin, to further include switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute the bipolarity mode and a hybrid mode, as further taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar/hybrid configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Regarding claim 10, Shin in view of Cosman disclose all of the limitations of claim 9, as described above.
Shin in view of Cosman disclose the hybrid mode (as described in the above rejection of claim 9).
Shin further discloses wherein the one predetermined pair of electrodes is configured to be switched to another pair of electrodes, among the plurality of electrodes, when the predetermined time elapses or according to the impedance value of the lesion ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes).
Regarding claim 11, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin further discloses wherein, in a case where the plurality of electrodes includes a first electrode, a second electrode, and a third electrode, the first switching circuit comprises: a first switch configured to transfer the main RF electric power to the first electrode; a second switch configured to transfer the main RF electric power to the second electrode; and a third switch configured to transfer the main RF electric power to the third electrode ([0022]; Figure 1—elements SW1, SW2, & SW3), and wherein the second switching circuit comprises: an eighth switch configured to transfer the sub-RF electric power to the first electrode; a ninth switch configured to transfer the sub-RF electric power to the second electrode; and a tenth switch configured to transfer the sub-RF electric power to the third electrode ([0023]; Figure 1—elements SW4, SW5, SW6).
Regarding claim 12, Shin in view of Cosman disclose all of the limitations of claim 11, as described above.
Shin further discloses wherein, the third switching circuit comprises: a fourth switch configured to connect the main ground pad to the main grounding line ([0025]; Figure 1—element SW7); and wherein the fourth switching circuit comprises: an eleventh switch configured to connect the sub-ground pad to the sub-grounding line ([0025]; Figure 1—element SW10).
Shin does not disclose wherein, the third switching circuit comprises: a fifth switch configured to connect the first electrode to the main grounding line; a sixth switch configured to connect the second electrode to the main grounding line; and a seventh switch configured to connect the third electrode to the main grounding line, and wherein the fourth switching circuit comprises: a twelfth switch configured to connect the first electrode to the sub-grounding line; a thirteenth switch configured to connect the second electrode to the sub-grounding line; and a fourteenth switch configured to connect the third electrode to the sub-grounding line.
Cosman further teaches the radio frequency ablation system comprising a first electrode, a second electrode, and a third electrode ([0076]; Figure 1—element E1, E2, & E3), wherein the switching circuits each comprise switches configured to connect the first electrode, the second electrode, and the third electrode to the grounding line ([0076]; Figure 1—elements S12, S22, S32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the third switching circuit and fourth switching circuit, as disclosed by Shin, to each include three additional switches (e.g. a fifth switch, a sixth switch, a seven switch and a twelfth switch, a thirteenth switch, and a fourteenth switch) that are configured to connect the first, second, and electrodes to the respective grounding line of the main RF electric power and sub-RF electric power so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as further taught by Cosman, as both references and the claimed invention are directed toward radio frequency ablation systems configured to selectively activate electrodes. As disclosed by Shin, the third switching circuit and fourth switching circuit make and break connections between the main and sub amplification unit and the ground pads ([0024] & [0025]). As disclosed by Cosman, each generator can include a switching unit for selectively coupling the positive pole of the power source to any one of the three plurality of electrodes, a switching unit for selectively connecting the negative/grounding pole of the power source to a ground pad, and a switching unit for selectively connecting the negative/grounding pole of the power source to any one of the three plurality of electrodes, the switching circuits allow the system to operate in a bipolar mode, a monopolar mode, or a multipolar mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the third switching circuits and fourth switching circuits, as disclosed by Shin, to each include three additional switches (e.g. a fifth switch, a sixth switch, a seven switch and a twelfth switch, a thirteenth switch, and a fourteenth switch) that are configured to connect the first, second, and electrodes to the respective grounding line of the main RF electric power and sub-RF electric power so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Regarding method claim 13, as best understood in view of the 112(b) rejection above, Shin discloses a method of controlling a radiofrequency ablation system that uses a plurality of electrodes having at least three electrodes ([0006] & [0014]), the method comprising: selecting monopolarity mode; performing switching in a manner that main radiofrequency (RF) electric power is supplied to one of one predetermined pair of electrodes, among the plurality of electrodes ([0014], [0016], [0020], [0021], [0024], [0025], & [0034]; Figure 1—elements 111, 121, & 141; Figure 2—element “S210”), and sub-RF electric power is supplied to the other of the one predetermined pair of electrodes, when selecting the monopolarity mode ([0014], [0016], [0020], [0021], [0024], [0025], & [0034]; Figure 1—elements 112, 122, & 142; Figure 2—element “S220”); monitoring voltage and current on a main amplifier side while a main amplifier outputs the main RF electric power ([0014], [0017], [0018], [0031], & [0035]; Figure 1—element 131; Figure 2—element “S230”), and monitoring voltage and current on a sub-amplifier side while a sub-amplifier outputs the sub-RF electric power ([0014], [0017], [0018], [0031], & [0035]; Figure 1—element 132; Figure 2—element “S230”); computing continuously impedance of a lesion using the voltage and the current on the main amplifier side and the voltage and the current on the sub-amplifier side during radiofrequency ablation and comparing the impedance with a preset reference value ([0006], [0018], & [0031]); and performing another switching, wherein the one predetermined pair of electrodes that operate in the monopolarity mode or the bipolarity mode is switched to another pair of electrodes, in a case where a predetermined time elapses or where the impedance exceeds the preset reference value ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes); wherein the radiofrequency ablation system includes: a main grounding line ([0014]; Figure 1—elements 121 & 151); a sub-grounding line ([0014]; Figure 1—elements 122 & 152); a first switching circuit configured to connect a main ground pad to the main grounding line ([0014] & [0024]; Figure 1—element 151); and a second switching circuit configured to connect a sub-ground pad to the sub-grounding line ([0014] & [0024]; Figure 1—element 152).
Shin does not disclose the method comprising: selecting bipolarity mode; and in a manner that either the main RF electric power or the sub-RF electric power is supplied to one of the one predetermined pair of electrodes, and either a main grounding line or a sub-grounding line is connected to the other of the one predetermined pair of electrodes, when selecting the bipolarity mode; the first switching circuit being configured to connect any one of the plurality of electrodes to the main grounding line; the second switching circuit being configured to connect any one of the plurality of electrodes to the sub-grounding line.
Cosman teaches a method of controlling radiofrequency ablation system in a monopolarity mode and bipolarity mode that uses a plurality of electrodes having at least three electrodes ([0076] & [0077]; Figure 1—element 2027); the method comprising selecting bipolarity mode; and in a manner that the electric power is supplied to one of the one predetermined pair of electrodes, and a grounding line is connected to the other of the predetermined pair of electrodes, when selecting the bipolarity mode ([0076]; Figure 1—element S12, S22, & S23); the switching circuits configured to connect any one of the plurality of electrodes to the grounding line ([0076]; Figure 1—element S12, S22, & S23)
Cosman teaches a radiofrequency ablation system configured to selectively execute a monopolarity mode or a bipolarity mode comprising a plurality of switching circuits configured to connect a plurality of electrodes to the power source and a ground pad to the grounding line([0076] & [0077]; Figure 1—element 2027); the switching circuit configured to connect any one of the plurality of electrodes to the grounding line ([0076]; Figure 1—element S12, S22, & S23); wherein the radiofrequency ablation system is configured to selectively execute a bipolarity mode, and wherein, in the bipolarity mode, the radiofrequency ablation system is configured to supply the power to one of the one predetermined pair of electrodes, the radiofrequency ablation system being configured to connect the grounding line to the other of the one predetermined pair of electrodes ([0076]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a monopolarity mode and the first switching circuit and second switching circuit, as disclosed by Shin, to further include the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a bipolarity mode and the switching circuit including switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as taught by Cosman, as taught by Cosman, as both references and the claimed invention are directed toward methods of controlling radio frequency ablation systems to selectively activate electrodes. As disclosed by Shin, the method of controlling the radio frequency ablation system in monopolarity mode comprises making and breaking connections between the main and sub amplification unit and the ground pads via the first switching circuit and second switching circuit ([0024] & [0025]). ([0024] & [0025]). As disclosed by Cosman, the method of controlling the radio frequency ablation system in monopolarity mode and bipolarity mode comprising selectively coupling the positive pole of the power source to any one of the plurality of electrodes, selectively connecting the negative/grounding pole of the power source to a ground pad, selectively connecting the negative/grounding pole of the power source to any one of the plurality of electrodes, the switching circuits to selectively couple the plurality of electrodes to the negative/grounding pole allows the system to operate in a bipolar mode, a monopolar mode, or a multipolar mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], & [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a monopolarity mode and the first switching circuit and second switching circuit, as disclosed by Shin, to further include the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a bipolarity mode and the switching circuit including switches that are configured to connect any one of the plurality of electrodes to the grounding lines so that the radiofrequency ablation system is configured to selectively execute a bipolarity mode, as taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Regarding method claim 15, Shin in view of Cosman disclose all of the limitations of claim 13, as described above.
Shin further discloses wherein the selecting is performed by selecting one of the monopolarity mode (see above rejection of claim 13), and wherein another switching is performed, wherein the one predetermined pair of electrodes is switched to another pair of electrodes, in the case where the predetermined time elapses or where the impedance exceeds the preset reference value ([0006], [0028], [0029],& [0034]-[0040]; Figure 2—elements S210-S290; the control unit turns on the first switch SW1 and fifth SW5 and monitors voltage and current values for a predetermined period of time S210-S230, then switches to another pair of electrodes S240-260; further additional cycles may be performed according to impedance values measured using voltage and currents of the electrodes).
Shin does not disclose the bipolarity mode, and a hybrid mode, wherein, when the hybrid mode is selected, switching in the hybrid mode is performed in a manner that either the main RF electric power or the sub-RF electric power is supplied to one of the one predetermined pair of electrodes and in a manner that the other of the one predetermined pair of electrodes and a main ground pad are simultaneously connected to the main grounding line by the switching in the hybrid mode, or that the other of the one predetermined pair of electrodes and a sub-ground pad are simultaneously connected to the sub-grounding line by the switching in the hybrid mode, and wherein another switching in the hybrid mode is performed, wherein the one predetermined pair of electrodes that operate in the hybrid mode is switched to another pair of electrodes, in the case where the predetermined time elapses or where the impedance exceeds the preset reference value.
Cosman further teaches the bipolarity mode, and a hybrid mode, wherein, when the hybrid mode is selected, switching in the hybrid mode is performed in a manner that electric power is supplied to one of the one predetermined pair of electrodes and in a manner that the other of the one predetermined pair of electrodes and a ground pad are simultaneously connected to the grounding line by the switching in the hybrid mode ([0076], [0077], & [0161]; Figure 29—element “ta4”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been to modify the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a monopolarity mode, as disclosed by Shin, to further include the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a bipolarity mode and hybrid mode, as taught by Cosman, as both references and the claimed invention are directed toward radio frequency ablation systems configured to selectively activate electrodes. As disclosed by Shin, the method of controlling the radio frequency ablation system in monopolarity mode comprises making and breaking connections between the main and sub amplification unit and the ground pads ([0024] & [0025]). As disclosed by Cosman, the method of controlling the radio frequency ablation system in monopolarity mode and bipolarity mode comprising selectively coupling the positive pole of the power source to any one of the plurality of electrodes, selectively connecting the negative/grounding pole of the power source to a ground pad, selectively connecting the negative/grounding pole of the power source to any one of the plurality of electrodes, the switching circuits to selectively couple the plurality of electrodes to the negative/grounding pole allows the system to operate in a bipolar mode, a monopolar mode, or a multipolar/hybrid mode, which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures ([0008], [0035], [0076], [0077], & [0161]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a monopolarity mode, as disclosed by Shin, to further include the method of controlling radiofrequency ablation system so that the main RF electric power and sub-RF electric power are supplied in a bipolarity mode and a hybrid mode, as taught by Cosman, as such a modification would allow for each of the sub-RF electric power and the main RF electric power to be delivered to the plurality of electrodes in both a monopolar, bipolar, and multipolar/hybrid configuration which allows for treatment at a plurality of positions in tissue, saves time if there are multiple sites to be treated, and provides for different heating profiles which allows the system to achieve desired temperatures.
Claims 2 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Cosman and Edwards et al. (US 5536267 A), hereinafter “Edwards”.
Regarding claim 2, Shin in view of Cosman disclose all of the limitations of claim 1, as described above.
Shin further discloses wherein the plurality of electrodes is configured to be inserted into a surrounding tissue ([0003]).
Shin does not explicitly disclose the plurality of electrodes configured to surround a lesion, without direct insertion into the lesion.
Edwards teaches a radio frequency ablation system comprising a plurality of electrodes configured to be inserted into a surrounding tissue ([Col. 6, lines 16-45]; Figure 1—element 10), the plurality of electrodes configured to surround a lesion, without direct insertion into the lesion ([Col. 6, lines 44-48]; Figures 13-16—elements 20).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of electrodes, as disclosed by Shin, to include the plurality of electrodes configured to surround a lesion, without direct insertion into the lesion, as taught by Edwards, as both references and the claimed invention are directed toward radio frequency ablation systems comprising a plurality of electrodes configured to ablate a tumor. As disclosed by Shin, the plurality of electrodes are configured to treat a tumor/cancer by forming an ablation volume in tissue ([0003]). As disclosed by Edwards, the plurality of electrodes are configured to be placed in a surrounding relationship to a tumor in order to define a controlled ablation volume ([Col. 2, line 60 – Col. 3, line 6]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the plurality of electrodes, as disclosed by Shin, to include the plurality of electrodes configured to surround a lesion, without direct insertion into the lesion, as taught by Edwards, as such a modification would produce the predictable result of ablating a tumor, and would also provide for a controlled ablation volume in tissue.
Regarding method claim 14, Shin in view of Cosman disclose all of the limitations of claim 13, as described above.
Shin further discloses inserting the plurality of electrodes in a surrounding tissue ([0003]).
Shin does not disclose the plurality of electrodes to surround a lesion, without direct insertion into the lesion on which cauterization is to be performed.
Edwards teaches a method of controlling radio frequency ablation comprising inserting the plurality of electrodes in a surrounding tissue ([Col. 6, lines 16-45]; Figure 1—element 10), the plurality of electrodes to surround a lesion, without direct insertion into the lesion on which cauterization is to be performed ([Col. 6, lines 44-48]; Figures 13-16—elements 20).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of inserting the plurality of electrodes, as disclosed by Shin, to include the plurality of electrodes to surround a lesion, without direct insertion into the lesion on which cauterization is to be performed, as taught by Edwards, as both references and the claimed invention are directed toward radio frequency ablation systems comprising a plurality of electrodes configured to ablate a tumor. As disclosed by Shin, the plurality of electrodes are configured to treat a tumor/cancer by forming an ablation volume in tissue ([0003]). As disclosed by Edwards, the plurality of electrodes are configured to be placed in a surrounding relationship to a tumor in order to define a controlled ablation volume ([Col. 2, line 60 – Col. 3, line 6]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of inserting the plurality of electrodes, as disclosed by Shin, to include the plurality of electrodes to surround a lesion, without direct insertion into the lesion on which cauterization is to be performed, as taught by Edwards, as such a modification would produce the predictable result of ablating a tumor, and would also provide for a controlled ablation volume in tissue.
Conclusion
Accordingly, claims 1-15 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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