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 Gregg, (US 20110071516) in view of Panescu et al., (US 20160278856; hereinafter Panescu).
Regarding claim 1, Gregg (Figures 1B-2) discloses a system for preventing energy delivery in response to a fault on an energy delivery pathway, the system comprising: a medical device (3) including an elongate body (body of device 3) having a proximal portion, a distal portion, and a lumen extending between the proximal portion and the distal portion (lumen carrying wires/circuitry in the body), a treatment element (end effector of device 3) at the distal portion having a plurality of electrodes (one or more electrodes) and a plurality of electrode wires (wires connecting the one or more electrodes to the electrosurgical generator 20), each of the plurality of electrodes (one or more electrodes) being connected to one of the plurality of electrode wires, and an energy generator (20) coupled to the medical device (3), the energy generator (20) including a processing unit (24) configured to: apply, via the energy generator, a complex current (output current) to the plurality of electrodes (one or more electrodes) via the energy delivery pathway of the medical device; determine an impedance (complex and real impedance) along the energy delivery pathway based on the complex current (output current); determine whether a fault condition is present on the energy delivery pathway based on the determined impedance; and prevent the medical device from delivering ablation energy in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Gregg fails to disclose that the processing unit is configured to determine whether a fault condition is present on the energy delivery pathway based on the determined impedance by comparing the impedance to a predetermined impedance threshold; determine whether the impedance differs from the predetermined impedance threshold by a predetermined impedance value; determine whether a fault condition is present on the energy delivery pathway based on the comparison; and determine the fault condition is present when the impedance differs from the predetermined impedance threshold by the predetermined impedance value. However, Panescu (Figure 32-32A) teaches a system for determining a fault on an energy delivery pathway ([0430]), wherein a processing unit (processor) is configured to determine whether a fault condition is present on the energy delivery pathway based on a determined impedance (|ZMAG|) by comparing the determined impedance (|ZMAG|) to a predetermined impedance threshold (ZTHR1), ([0430]); determine whether the determined impedance (|ZMAG|) differs from the predetermined impedance threshold (ZTHR1) by a predetermined impedance value ([0432]: subvalues for less or no contact); determine whether a fault condition is present on the energy delivery pathway based on the comparison ([0432]); and determine the fault condition is present when the determined impedance (|ZMAG|) differs from the predetermined impedance threshold (ZTHR1) by the predetermined impedance value ([0432]: subvalues for less or no contact). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gregg to include the processing unit configured to determine whether a fault condition is present on the energy delivery pathway based on the determined impedance by comparing the impedance to a predetermined impedance threshold; determine whether the impedance differs from the predetermined impedance threshold by a predetermined impedance value; determine whether a fault condition is present on the energy delivery pathway based on the comparison; and determine the fault condition is present when the impedance differs from the predetermined impedance threshold by the predetermined impedance value, as taught by Panescu, because the modification would determine the level of the fault condition in addition to simply determining that the fault condition exists (Panescu; [0432]).
Regarding claim 2, Gregg (Figures 1B-2) further discloses wherein the energy delivery pathway includes each of the plurality of electrode wires (of the one or more electrodes), and wherein the plurality of electrodes (one or more electrodes) is configured to transition between a linear (closed) configuration and an expanded (open) configuration, via a carrier element (10), to deliver ablation energy ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 3, Gregg (Figures 1B-2) further discloses wherein, in the linear (closed) configuration, the plurality of electrodes (one or more electrodes) is located along the longitudinal axis of the elongate body, and wherein, in the expanded (open) configuration, the carrier element (10) has an arcuate configuration such that the plurality of electrodes (one or more electrodes) is positioned in a plane that is orthogonal to the longitudinal axis ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 4, Gregg (Figures 1B-2) further discloses wherein the processing unit (24) is configured to: verify a signal integrity of the energy delivery pathway based on the comparison ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 5, Gregg (Figures 1B-2) further discloses wherein the processing unit (24) is configured to: supply, via a display (display screen), an indication of the verified signal integrity to a user ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 6, Gregg (Figures 1B-2) further discloses wherein the processing unit (24) is configured to: deliver, via the treatment element (end effector of element 3), ablation energy to a target tissue in response to determining that the fault condition is not present on the energy delivery pathway ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 7, Gregg (Figures 1B-2) further discloses wherein when preventing the medical device (2) from delivering ablation energy in response to determining that the fault condition is present, the processing unit (24) is configured to: prevent delivery of ablation energy, via the treatment element (end effector of element 3), along the energy delivery pathway in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 9, Gregg (Figures 1B-2) discloses a system for preventing energy delivery in response to a fault on an energy delivery pathway, the system comprising: a medical device (3) including an elongate body (body of device 3) having a proximal portion, a distal portion, a longitudinal axis, a lumen extending between the proximal portion and the distal portion (lumen carrying wires/circuitry in the body), and a portion of the energy delivery pathway extending between the proximal portion and the distal portion, a treatment element (end effector of the device 3) at the distal portion having a carrier element (10) and a plurality of electrodes (one or more electrodes) positioned on the carrier element (10), the carrier element (10) configured to transition between a linear (closed) configuration and an expanded (open) configuration to deliver ablation energy via the plurality of electrodes (one or more electrodes), and an energy generator (20) coupled to the medical device (3), the energy generator (20) including a processing unit (24) configured to: determine an impedance (complex and real impedance) of the energy delivery pathway within the medical device (3); determine whether a fault condition is present on the energy delivery pathway based on the determined impedance; and prevent the medical device (3) from delivering ablation energy in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Gregg fails to disclose that the processing unit is configured to determine whether a fault condition is present on the energy delivery pathway based on the determined impedance by comparing the impedance to a predetermined impedance threshold; determine whether the impedance differs from the predetermined impedance threshold by a predetermined impedance value; determine whether a fault condition is present on the energy delivery pathway based on the comparison; and determine the fault condition is present when the impedance differs from the predetermined impedance threshold by the predetermined impedance value. However, Panescu (Figure 32-32A) teaches a system for determining a fault on an energy delivery pathway ([0430]), wherein a processing unit (processor) is configured to determine whether a fault condition is present on the energy delivery pathway based on a determined impedance (|ZMAG|) by comparing the determined impedance (|ZMAG|) to a predetermined impedance threshold (ZTHR1), ([0430]); determine whether the determined impedance (|ZMAG|) differs from the predetermined impedance threshold (ZTHR1) by a predetermined impedance value ([0432]: subvalues for less or no contact); determine whether a fault condition is present on the energy delivery pathway based on the comparison ([0432]); and determine the fault condition is present when the determined impedance (|ZMAG|) differs from the predetermined impedance threshold (ZTHR1) by the predetermined impedance value ([0432]: subvalues for less or no contact). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gregg to include the processing unit configured to determine whether a fault condition is present on the energy delivery pathway based on the determined impedance by comparing the impedance to a predetermined impedance threshold; determine whether the impedance differs from the predetermined impedance threshold by a predetermined impedance value; determine whether a fault condition is present on the energy delivery pathway based on the comparison; and determine the fault condition is present when the impedance differs from the predetermined impedance threshold by the predetermined impedance value, as taught by Panescu, because the modification would determine the level of the fault condition in addition to simply determining that the fault condition exists (Panescu; [0432]).
Regarding claim 10, Gregg (Figures 1B-2) further discloses wherein, in the linear (closed) configuration, the plurality of electrodes (one or more electrodes) is located along the longitudinal axis of the elongate body, and wherein, in the expanded configuration, the carrier element (10) has an arcuate configuration such that the plurality of electrodes (one or more electrodes) is positioned in a plane that is orthogonal to the longitudinal axis ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 11, Gregg (Figures 1B-2) further discloses wherein the processing unit (24) is configured to: verify a signal integrity of the energy delivery pathway based on the comparison ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 12, Gregg (Figures 1B-2) further discloses wherein when preventing the medical device (3) from delivering ablation energy in response to determining that the fault condition is present, the processing unit (24) is configured to: prevent delivery of ablation energy, via the treatment element (end effector), along the energy delivery pathway in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 14, Gregg (Figures 1A-2) discloses a method of preventing energy delivery from a medical system, the method comprising: providing a medical device (3) configured to deliver ablation energy; determining, via a processing unit (24), an impedance of an energy delivery pathway within the medical device (3); determining, via the processing unit (24), whether a fault condition is present on the energy delivery pathway based on the determined impedance; and preventing the medical device (3) from delivering ablation energy in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Gregg fails to disclose comparing, via the processing unit, the determined impedance to a predetermined impedance threshold; determining, via the processing unit, whether a fault condition is present on the energy delivery pathway based on the comparison; and determining, via the processing unit, the fault condition is present when the determined impedance differs from the predetermined impedance threshold by a predetermined impedance value. However, Panescu (Figure 32-32A) teaches a method for determining a fault on an energy delivery pathway ([0430]), wherein a processing unit (processor) is configured to determine whether a fault condition is present on the energy delivery pathway based on a determined impedance (|ZMAG|) by comparing, via the processing unit (processor), the determined impedance (|ZMAG|) to a predetermined impedance threshold (ZTHR1); determining, via the processing unit (processor), whether a fault condition is present on the energy delivery pathway based on the comparison; and determining, via the processing unit (processor), the fault condition is present when the determined impedance (|ZMAG|) differs from the predetermined impedance threshold (ZTHR1) by a predetermined impedance value ([0432]: subvalues for less or no contact). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gregg to include comparing, via the processing unit, the determined impedance to a predetermined impedance threshold; determining, via the processing unit, whether a fault condition is present on the energy delivery pathway based on the comparison; determining, via the processing unit, the fault condition is present when the determined impedance differs from the predetermined impedance threshold by a predetermined impedance value, as taught by Panescu, because the modification would determine the level of the fault condition in addition to simply determining that the fault condition exists (Panescu; [0432]).
Regarding claim 15, Gregg (Figures 1A-2) further discloses verifying, via the processing unit (24), a signal integrity of the energy delivery pathway based on the comparison ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 16, Gregg (Figures 1A-2) further discloses supplying, via a display (display screen), an indication of the verified signal integrity to a user ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 17, Gregg (Figures 1A-2) further discloses delivering, via the medical device (3), ablation energy to a target tissue in response to determining that the fault condition is not present on the energy delivery pathway ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 18, Gregg (Figures 1A-2) further discloses wherein preventing the medical device (3) from delivering ablation energy in response to determining that the fault condition is present includes: preventing, via the processing unit (24), delivery of ablation energy along the energy delivery pathway in response to determining that the fault condition is present ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Regarding claim 19, Gregg (Figures 1A-2) further discloses wherein the fault condition is one selected from the group consisting of a partial short circuit, a complete short circuit, an open circuit, an overheating condition, and a compromised component ([0021], [0026]-[0028], [0041], [0044]-[0045]).
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered.
As an initial matter, Examiner notes that the amendments and arguments are sufficient to overcome the provisional double patenting rejections of claims 1-2, 9, and 14.
Applicant’s arguments, directed to the newly amended limitations of independent claim 1, 9, and 14, 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 Panescu, which teaches determining whether the impedance differs from the predetermined impedance threshold by a predetermined impedance value, determining whether a fault condition is present on the energy delivery pathway based on the comparison, and determining the fault condition is present when the impedance differs from the predetermined impedance threshold by the predetermined impedance value. In combination with Gregg, the modified system/method teaches the invention as recited at least in amended independent claims 1, 9, and 14.
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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