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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al., (US 20030199862; hereinafter Simpson) in view of Govari et al., (US 20120116387; hereinafter Govari).
Regarding claim 1, Simpson (Figures 1 and 10-13) discloses a method for ablating tissue, the method comprising: emitting a first radio frequency current (f1) along a first current path between electrodes of a first pair of electrodes (a first pair of electrodes selected from E1-E6) attached to a tissue surface layer (80) at a target tissue site (12); emitting a second radio frequency current (f2) along a second current path between electrodes of a second pair of electrodes (a second pair of electrodes selected from E1-E6) attached to the tissue surface layer (80) at a target tissue site (12); and overlapping the first radio frequency current (f1) with the second radio frequency current (f2) to generate an inferential current (R) within a sub-surface tissue at the target tissue site (within layer 80 of tissue site 12), ([0041]-[0054]).
Simpson fails to disclose overlapping, within a sub-surface tissue, the first current path of the first radio frequency current with the second current path of the second radio frequency current to generate the inferential current. However, Govari (Figure 2) teaches a method for ablating tissue, wherein all of the electrodes (68) of the device (40) may be configured as either a source electrode or a return electrode such that bipolar electrode pairs may be formed between any of the electrodes (68) to emit overlapping current paths between different electrode pairs ([0045], [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson to include the step of overlapping, within a sub-surface tissue, the first current path of the first radio frequency current with the second current path of the second radio frequency current to generate the inferential current using different electrode pairs (rather than adjacent electrode pairs as disclosed by Simpson), as taught by Govari, because the modification would provide monitoring of the impedance presented to individual electrodes since the impedance of tissue varies according to the degree of ablation of the tissue, which would allow the controller to assess, validate, and adjust the ablation performed by the individual electrodes (Govari; [0069]).
Regarding claim 2, Simpson (Figures 1 and 10-13) further discloses wherein the inferential current (R) abates the sub-surface tissue at the target tissue site ([0041]-[0054]).
Regarding claim 3, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency current (f1) has a first magnitude, wherein the second radio frequency current (f2) has a second magnitude, and wherein the inferential current (R) has a third magnitude greater than the first magnitude, the second magnitude or both the first magnitude and the second magnitude ([0041]-[0054]: in the configuration of Figure 10, f1 is 500kHz and f2 is 1500 kHz and the inferential current is 1000 kHz, which is greater than f1).
Regarding claim 4, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency current (f1) and the second radio frequency current (f2) are in the range of 500 kHz to 20000 kHz ([0041]-[0054]).
Regarding claim 5, Simpson (Figures 1 and 10-13) further discloses wherein the frequency of the first radio frequency current (f1) and the frequency of the second radio frequency current (f2) are configured to minimize the heating of the tissue surface layer at the target tissue site ([0041]-[0054]).
Regarding claim 6, Simpson (Figures 1 and 10-13) further discloses wherein the inferential current (R) is in the range of 50 kHz to 1000 kHz ([0041]-[0054]).
Regarding claim 7, Simpson (Figures 1 and 10-13) further discloses wherein the frequency of the first radio frequency current (f1) and the frequency of the second radio frequency current (f2) are configured to generate an inferential current (R) configured to maximize the heating of the sub-surface tissue at the target tissue site ([0041]-[0054]).
Regarding claim 8, Simpson (Figures 1 and 10-13) further discloses wherein overlapping the first radio frequency current (f1) with the second radio frequency current (f2) results in a modulated inferential current (R) sufficient to ablate the sub-surface tissue at the target tissue site ([0041]-[0054]).
Regarding claim 9, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency current (f1) and the second radio frequency current (f2) are applied simultaneously ([0041]-[0054]).
Regarding claim 10, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency current (f1) is configured to directly heat the tissue surface layer at a first rate, wherein the second radio frequency ablation current (f2) is configured to directly heat the tissue surface layer at a second rate, and where the inferential current (R) is configured to heat the sub-surface tissue at a third rate greater than the first rate and the second rate ([0041]-[0054]).
Regarding claim 11, Simpson (Figures 1 and 10-13) discloses a method for ablating tissue, the method comprising: emitting a first radio frequency current (f1) along a first current path between electrodes of a first pair of electrodes (a first pair of electrodes selected from E1-E6) attached to a tissue surface layer (80) at a target tissue site (12); emitting a second radio frequency current (f2) along a second current path between electrodes of a second pair of electrodes (a second pair of electrodes selected from E1-E6) attached to the tissue surface layer (80) at a target tissue site (12); and overlapping the first radio frequency current (f1) with the second radio frequency current (f2) to generate an inferential current (R) within a sub-surface tissue at the target tissue site (within layer 80 of tissue site 12), ([0041]-[0054]).
Simpson fails to disclose overlapping, within a sub-surface tissue, the first current path of the first radio frequency current with the second current path of the second radio frequency current to generate the inferential current. However, Govari (Figure 2) teaches a method for ablating tissue, wherein all of the electrodes (68) of the device (40) may be configured as either a source electrode or a return electrode such that bipolar electrode pairs may be formed between any of the electrodes (68) to emit overlapping current paths between different electrode pairs ([0045], [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson to include the step of overlapping, within a sub-surface tissue, the first current path of the first radio frequency current with the second current path of the second radio frequency current to generate the inferential current using different electrode pairs (rather than adjacent electrode pairs as disclosed by Simpson), as taught by Govari, because the modification would provide monitoring of the impedance presented to individual electrodes since the impedance of tissue varies according to the degree of ablation of the tissue, which would allow the controller to assess, validate, and adjust the ablation performed by the individual electrodes (Govari; [0069]).
Regarding claim 12, Simpson (Figures 1 and 10-13) further discloses wherein the inferential current (R) abates the sub-surface tissue at the target tissue site ([0041]-[0054]).
Regarding claim 13, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency current (f1) has a first magnitude, wherein the second radio frequency current (f2) has a second magnitude, and wherein the inferential current (R) has a third magnitude greater than the first magnitude, the second magnitude or both the first magnitude and the second magnitude ([0041]-[0054]).
Regarding claim 14, Simpson (Figures 1 and 10-13) further discloses wherein the first radio frequency ablation current (f1) and the second radio frequency ablation current (f2) are in the range of 500 kHz to 20000 kHz ([0041]-[0054]).
Regarding claim 15, Simpson (Figures 1 and 10-13) further discloses wherein the frequency of the first radio frequency ablation current (f1) and the frequency of the second radio frequency ablation current (f2) are configured to minimize the heating of the tissue surface layer at the target tissue ([0041]-[0054]).
Regarding claim 16, Simpson (Figures 1 and 10-13) further discloses wherein the inferential current (R) is in the range of 50 kHz to 1000 kHz ([0041]-[0054]).
Regarding claim 17, Simpson (Figures 1 and 10-13) further discloses wherein the frequency of the first radio frequency ablation current (f1) and the frequency of the second radio frequency ablation current (f2) are configured to generate an inferential current (R) configured to maximize the heating of the sub-surface tissue at the target tissue ([0041]-[0054]).
Regarding claim 18, Simpson (Figures 1 and 10-13) further discloses wherein overlapping the first radio frequency current (f1) with the second radio frequency current (f2) results in a modulated inferential current (R) sufficient to ablate the sub-surface tissue at the target tissue site ([0041]-[0054]).
Regarding claim 19, Simpson (Figures 1 and 10-13) discloses a system (10) for ablating tissue, the system comprising: a first radio frequency generator ([0017]: frequency divider 1 of main generator 26) configured to generate a first radio frequency current (f1); a second radio frequency generator ([0017]: frequency divider 2 of main generator 26) configured to generate a second radio frequency current (f2); a first pair of electrodes (first pair of electrodes E1-E6) coupled to the first radio frequency generator (frequency divider 1 of main generator 26), wherein the first pair of electrodes (first pair of electrodes E1-E6) are attached to a tissue surface layer (80) at a target tissue site (12) and configured to emit the first radio frequency current along a first current path between electrodes of the first pair of electrodes; a second pair of electrodes (second pair of electrodes E1-E6) coupled to the second radio frequency generator (frequency divider 2 of main generator 26), wherein the second pair of electrodes (second pair of electrodes E1-E6) are attached to a tissue surface layer (80) at a target tissue site (12); the target tissue site and configured to emit the second radio frequency current along a second current path between electrodes of the second pair of electrodes;to generate an inferential current (R) within a sub-surface tissue at the target tissue site (within layer 80 of tissue site 12), ([0041]-[0054]).
Simpson fails to disclose wherein the first pair of electrodes and the second pair of electrodes are configured such that, when the first radio frequency current and the second radio frequency current are emitted, the first current path of the first radio frequency current overlaps, within the sub-surface tissue, the second current path of the second radio frequency current to generate the inferential current. However, Govari (Figure 2) teaches a system for ablating tissue, wherein all of the electrodes (68) of the device (40) may be configured as either a source electrode or a return electrode such that bipolar electrode pairs may be formed between any of the electrodes (68) to emit overlapping current paths between different electrode pairs ([0045], [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson to include the first pair of electrodes and the second pair of electrodes configured such that, when the first radio frequency current and the second radio frequency current are emitted, the first current path of the first radio frequency current overlaps, within the sub-surface tissue, the second current path of the second radio frequency current to generate the inferential current using different electrode pairs (rather than adjacent electrode pairs as disclosed by Simpson), as taught by Govari, because the modification would provide monitoring of the impedance presented to individual electrodes since the impedance of tissue varies according to the degree of ablation of the tissue, which would allow the controller to assess, validate, and adjust the ablation performed by the individual electrodes (Govari; [0069]).
Regarding claim 20, Simpson (Figures 1 and 10-13) further discloses wherein the interference of the first radio frequency current (f1) with the second radio frequency current (f2) generates a modulated inferential current (R) sufficient to ablate the sub-surface tissue at the target tissue site ([0041]-[0054]).
Response to Arguments
Applicant’s arguments filed 05/29/2026, directed to the newly amended limitations of claims 1, 11, and 19, have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is/are made in view of newly found prior art reference Govari, which teaches a method/system for ablating tissue, wherein all of the electrodes of the device may be configured as either a source electrode or a return electrode such that bipolar electrode pairs may be formed between any of the electrodes to emit overlapping current paths between different electrode pairs. In combination with Simpson, the modified method/system teaches the invention as recited at least in amended claims 1, 11, and 19.
Furthermore, Applicant’s argument directed to the newly amended claim amendments overcoming the double patenting rejections is found to be persuasive. Therefore, the double patenting rejections of claims 1, 4, 9, 11, 14, and 19 are withdrawn.
Conclusion
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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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