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 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.
Response to Amendment
Acknowledgement is made to the amendment received 06/26/2026.
Acknowledgement is made to the amendment of claims 1, 3, 5, and 16-17.
Acknowledgement is made to the cancellation of claim 2.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1 and 3-17 are pending. A complete action on the merits appears below.
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.
Claims 1, 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (US-20130324993-A1) in view of Govari (US-20140163546-A1), Schwartz (US-20180125575-A1), and Nelson (US-20100049188-A1).
Regarding claim 1, McCarthy teaches a medical system (Abstract) comprising:
a medical device (Fig. 1A; catheter 120) including a carrier element (Fig. 1A; integrated catheter tip 122) bearing a plurality of electrodes ([0034]- [0035]); and
an energy generator (Fig. 1A; generator 130) in communication with the plurality of electrodes, the energy generator being configured to deliver treatment energy through each of the plurality of electrodes, the energy generator including:
processing circuitry (Fig. 2A; processor 210) to determine when there is a fault condition in the medical system and to prevent a delivery of the treatment energy when the processing circuitry determines there is a fault condition ([0015], [0065], [0081] discuss the processor as receiving information of an unsafe condition and to discontinue the delivery of treatment in response to the unsafe condition),
wherein the processing circuitry is configured to perform a plurality of pre-checks prior to the delivery of the treatment energy ([0015]).
McCarthy further teaches the catheter as being steerable so as to be positioned within a subject during a procedure ([0034]).
However, McCarthy fails to specifically teach the carrier element of the medical device as being transitionable between a linear configuration and expandable configuration in which the carrier element has an arcuate configuration.
Govari teaches a medical device, specifically a catheter for a medical treatment ([0001]) having a distal portion containing a plurality of electrodes (Abstract). Wherein the device is specifically taught as being manipulable so as to be inserted into a patient and brought into contact with tissue at a target location ([0002]).
Govari further teaches the end section of the device as being manipulable between a straightened configuration ([0037]) and an arcuate shape so as to engage the tissue surface ([0008]- [0009]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the incorporate the device as being manipulable between a straightened configuration and an arcuate shaped configuration, as is taught by Govari, into the into the steerable catheter which may be positioned within a patient, as is taught by McCarthy to produce the predictable result of predictable result of contacting the tissue at a target location, as is taught by Govari, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
McCarthy further fails to teach that when the processing circuitry performs the plurality of pre-checks, the processing circuitry is configured to determine an impedance at each electrode of the plurality of electrodes and prevent the delivery of the treatment energy to the medical device when the determined impedance from any electrode to a patient ground is outside a predetermined impedance value range and/or when a bipolar impedance between any adjacent electrodes is outside a predetermined bipolar impedance value range.
McCarthy does however teach the plurality of pre-checks as measuring temperature and detecting tissue contact prior to the ablation and determining that it is safe to proceed with the tissue ablation based on these measurements before allowing ablation energy to be provided ([0015], [0016]).
Schwartz teaches devices and methods for ablation (Abstract, [0060]- [0061], [0091]- [0092]).
Schwartz further teaches taking measurements, such as safety checks, before the ablation where in such a condition the system refuses to begin the ablation ([0198], [0224]- [0225]). This measurement is taught as being by known and/or estimated tissue characteristics, such as temperature ([0011]), or measured dielectric properties, such as impedance ([0010]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the safety check which prevents the delivery of the treatment energy to the medical device in unsafe conditions as being impedance, as is taught by Schwartz, into the system which has a measurement which only allows ablation energy to be provided when it is determined that it is safe to proceed based on said measurement as being temperature as is taught by McCarthy, to produce the predictable result of only providing ablative energy to tissue based on a measurement determining it to be a safe condition to apply energy, as is taught by Schwartz, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Nelson teaches a system and methods for providing energy from a generator to multiple electrodes, ([0217]- [0219]) detecting faults, such as those which impact the effectiveness and safety of the procedure, and controlling, such as not delivering treatment by changing the state of a transistor, in response ([0224], [0235]).
Nelson further teaches a variety of known fault conditions, such as high impedance measurements between an electrode and tissue, which may impact the treatment ([0224]- [0227]), such as by changing the state of the transistor ([0235]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known fault conditions which does not provide the delivery of treatment as being a high impedance measurement, as is taught by Nelson, into the system which does not provide the delivery of treatment in response to unsafe conditions, as is taught by McCarthy as currently modified, to produce the predictable result of controlling a device based on known faults which impact the effectiveness and safety of the procedure, as is taught by Nelson, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claims 5 and 17, the method steps provided are the same as described as the steps the system is configured to perform or within the ordinary use of the device and therefore taught by in the same way as seen in claim 1.
Claims 3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (US-20130324993-A1) in view of Govari (US-20140163546-A1), Schwartz (US-20180125575-A1), and Nelson (US-20100049188-A1) further in view of Cartmell (US-5830212-A).
Regarding claim 3, McCarthy as modified teaches the medical system of Claim 1.
However, McCarthy fails to teach the medical system wherein each of the plurality of electrodes is connected to the energy generator by at least one wire, the fault condition is a connection fault condition, and the processing circuitry is configured to determine whether there is a connection fault condition in at least one of the at least one wires.
Cartmell teaches a system having an electrosurgical generator having an active electrode output connector and a return current connector and a fault detection circuit for monitoring the proper operation of the generator (Abstract).
Cartmell further teaches the fault detection circuit for monitoring the proper operation as being a cable continuity monitor circuit which monitors the electrical continuity between the pair of connector conductors so as to determine electrode wire connection (Col. 3, Lines 4-14)
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the fault condition as being the electrical continuity between the pair of connector conductors so as to determine the electrode wire connection, as is taught by Cartmell, into the system which responds to unsafe conditions, also understood to be known as fault conditions, as is taught by McCarthy, to produce the predictable result of monitoring the proper operation of an electrosurgical generator, as is taught by Cartmell, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 7, the method steps provided are the same as described as the steps the system is configured to perform or within the ordinary use of the device and therefore taught by in the same way as seen in claim 3.
Regarding claim 8, in accordance with the above rejection of claim 3, Cartmell teaches the method of Claim 7, further comprising: after the initiation of the delivery of treatment energy, determining whether at least one of the first electrode wire and the second electrode wire are disconnected and determining a delivery fault condition exists when at least one of the first electrode wire and the second electrode wire are disconnected (Col. 3, Lines 4-14).
In accordance with the above provided rejection of claim 1, McCarthy further teaches initiating an electromechanical safeguard when the delivery fault condition is determined to exist ([0048]).
In accordance with the above provided rejection of claim 1, Nelson further teaches initiating an electronic safeguard when the delivery fault condition is determined to exist ([0235]).
Claims 4, 6, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (US-20130324993-A1) in view of Govari (US-20140163546-A1) Schwartz (US-20180125575-A1), and Nelson (US-20100049188-A1) further in view of Giordano (US-5642247-A).
Regarding claim 4, McCarthy as modified teaches the medical system of Claim 1.
However, McCarthy fails to teach the medical system wherein the energy generator further includes an integrating current monitor having a short integration time and a high-energy delivery circuit having a first half bridge and a second half bridge, the fault condition being an excessive charge delivery, the processing circuitry being configured to determine whether there is an excessive charge delivery by: monitoring a current passing through the first half bridge and the second half bridge; integrating the current in real time during the delivery of treatment energy; determining an integral value of the current; and determining the fault condition exists when the integral value is a value other than zero.
Giordano teach a system for determining fault conditions which are detected within a device (Abstract). Specifically, by the use of an over current detector and a timer input integrating circuit, wherein the current detector monitors the current across the device at all times and provides outputs for protection against over-currents (Col. 5, Lines 44-64).
Giordano further teaches fault detection means being provided by measuring current through a monitoring system at all times across a pair of inputs for a timer input integrating circuit (Col. 5, Lines 44-64) and determining by the integrated value if a fault condition occurs based on a comparison to internally generated condition outputs (Col. 5, Line 65- Col. 6, Line 40).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known energy delivery circuit and a known monitoring circuit, specifically measuring current through a known monitoring device, for a known integration time when determining faults in circuitry, as is taught by Giordano, into the system for determining faults, also referred to as unsafe conditions, as is taught by McCarthy, to produce the predictable result of providing circuitry for fault detection within an electrical system, as is taught by Giordano, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claims 6 and 14-16, the method steps provided are the same as described as the steps the system is configured to perform or within the ordinary use of the device and therefore taught by in the same way as seen in claim 4.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (US-20130324993-A1) in view of Govari (US-20140163546-A1), Nelson (US-20100049188-A1) and Cartmell (US-5830212-A), further in view Santana (US-20150116884-A1).
Regarding claim 9, McCarthy teaches the method of Claim 8, wherein the electronic safeguard includes at least one of a primary electronic safeguard ([0048]) and a redundant electronic safeguard .
In accordance with the above provided rejection of claim 2, Nelson teaches the electromechanical safeguard including at least one of a primary electromechanical safeguard ([0235]) and a redundant electromechanical safeguard.
However, McCarthy as currently modified to by the incorporation of Nelson fails to specifically teach the safeguards as each including primary and redundant safeguards.
Santana teaches an electronic safety shutoff being provided within an electronic device to prevent fire, electrocution, or shock (Abstract).
Santana further teaches this electronic safety shutoff having dual redundancy to make the energized equipment safer ([0006]- [0007], [0012]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of safeguards which utilize dual redundancy, as is taught by Santana, into McCarthy as currently modified, to produce the predictable result of safer equipment, as is taught by Santana, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 10, in accordance with the above provided rejection of claim 9, Nelson as modified by Santana, teaches the method of Claim 9, wherein the electronic safeguard includes terminating the delivery of treatment energy from the energy generator by turning off a delivery transistor in the energy generator ([0235]).
In accordance with the above provided rejection of claim 9, Santana teaches the safeguards as having dual redundancy, producing at least one of a primary and a redundant safeguard ([0006]- [0007], [0012]).
Nelson currently fails to teach the transistor as being a plurality of transistors.
However, while Nelson does not explicitly teach the transistor as being a plurality of transistors, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught wire and opening and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 11, in accordance with the above provided rejection of claim 9, Nelson as modified by Santana, teaches the method of Claim 10, wherein the electronic safeguard includes terminating the delivery of treatment energy from the energy generator by turning off a supplemental transistor in the energy generator ([0235]).
In accordance with the above provided rejection of claim 9, Santana teaches the safeguards as having dual redundancy, producing at least one of a primary and a redundant safeguard ([0006]- [0007], [0012]).
Nelson currently fails to teach the transistor as being a plurality of transistors.
However, while Nelson does not explicitly teach the transistor as being a plurality of transistors, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught wire and opening and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 12, McCarthy teaches the method of Claim 11, wherein the electromechanical safeguard includes interrupting the delivery of treatment energy from the energy generator by activating at least one relay in the energy generator ([0018]).
In accordance with the above provided rejection of claim 9, Santana teaches the safeguards as having dual redundancy, producing at least one of a primary and a redundant safeguard ([0006]- [0007], [0012]).
Regarding claim 13, McCarthy further teaches the method of Claim 12, wherein the electromechanical safeguard includes interrupting the delivery of treatment energy from the energy generator by activating at least one relay ([0018]).
In accordance with the above provided rejection of claim 9, Santana teaches the safeguards as having dual redundancy, producing at least one of a primary and a redundant safeguard ([0006]- [0007], [0012]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Nelson in view of Govari reference are moot in view of the new rejections under Nelson in views of Govari, Schwartz and Nelson.
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 extension fee 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 date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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