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 12/10/2025.
Acknowledgement is made to the amendment of claims 1 and 9.
Acknowledgement is made to the cancellation of claims 2-6 and 10-20.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1 and 7-9 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 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2016014368 to Tunay et al. (herein after “Tunay”) in view of U.S. Patent Publication No. 20140257119 to LeMay et al. (herein after “LeMay”), Patent No. 7142908 to Glukhovsky (herein after “Glukhovsky”) and U.S. Patent Publication No. 20150223724 A1 to Hauck et al. (herein after “Hauck”).
Regarding claim 1, Tunay teaches a medical system (¶[0002]), comprising:
a catheter having a catheter distal end and including multiple electrodes situated at the catheter distal end, including a first electrode located at a distal tip of the distal end, a second electrode located proximal to the first electrode, and a proximal electrode located proximal to the second electrode (¶[0033]);
a sheath having a sheath distal end and a lumen configured to receive the catheter such that the catheter distal end protrudes from the sheath distal end, the sheath configured to cover one or more of the multiple electrodes (¶[0034]); and
a controller (¶[0039], [0103]- [0105]) configured to
provide a current between the first electrode and the proximal electrode (¶[0033] teaches the ability for the tip electrode to be used as a source and the ring electrodes located proximal to the tip electrode as being used as sinks);
measure voltages from each of the multiple electrodes (¶[0039], [0103]- [0105]);
calculate impedance values between each of the multiple electrodes (¶[0039], [0103]- [0105] teaches applying current between the electrodes and measuring the voltage drop, and determining the impedance between the pair of electrodes on the electrode catheter) to determine whether one or more of the multiple electrodes is covered by the sheath (¶[0034] discusses the measured impedance between electrode pairs as being used to determine whether the electrode are retracted into the sheath or have exited the sheath);
wherein the controller is configured to source the current from any one of the multiple electrodes and sink the current at any other one of the multiple electrodes (¶[0033]- [0034]).
However, Tunay fails to teach the controller being configured to measure voltages from each of the multiple electrodes to a reference voltage and calculate values between each of the multiple electrodes based on a voltage difference between each pair of electrodes.
LeMay teaches an apparatus which provides current connection between first and second electrodes and detects a voltage difference between the electrodes upon application of the current (¶Abstract). This device measures the impedance between the electrodes to determine information relevant to the environment surrounding and associated with the electrode connection (¶[0001]).
LeMay further teaches a manner of determining impedance by supplying current to an electrode, the current traveling through the patient to the ground electrode, then calculating the difference between the voltage of the electrodes, referred to as a voltage difference, and a reference voltage and dividing this resultant voltage by the current applied to determine the impedance (¶[0013], [0029]- [0030]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of measuring voltage difference between electrodes to a reference voltage and calculating impedance values, as is taught by LeMay into the device of Tunay in order to provide a known manner of calculating impedance values.
Tunay/LeMay further fails to teach calculating the impedance values by: determining a voltage difference between the measured voltages associated with each of the multiple electrodes of each pair of electrodes, determining a multiplier associated with the pair of electrodes based on a physical distance between that pair of electrodes and dividing the voltage difference for each pair of electrodes by the current times the multiplier associated with that pair of electrodes to normalize for electrode spacing.
Glukhovsky teaches an apparatus for measuring electrical characteristics of biological tissue (¶Abstract), such as those characteristic between selected pairs of electrodes (Col. 4, Line 60-Col. 5, Line 5).
Glukhovsky further teaches the known formula for calculating impedance as being the normalized ratio of voltage to current as being the voltage divided by the current times the distance between selected electrodes (Col. 4, Line 60-Col. 5, Line 5)
It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have utilized a known equation which describes the relationship between the impedance, current, voltage, and distance between two electrodes, as is taught by Glukhovsky, into a system for determining a value such as impedance, as is taught by Tunay, to produce the predictable result of determining an impedance value.
Tunay further fails to teach determining a position of the sheath with respect to the multiple electrodes by: determining whether the calculated impedance value associated for one of the multiple electrodes is less than a first threshold value to determine whether the one of the multiple electrodes is uncovered by the sheath;
if the one of the multiple electrodes is determined to be uncovered by the sheath via determining with the first threshold value, determining whether the calculated impedance value for an electrode proximate the one of the multiple electrodes is greater than a second threshold value to determine whether the electrode proximate the one of the multiple electrodes is covered by the sheath; or
determining whether the calculated impedance value associated for one of the multiple electrodes is greater than a third threshold value to determine whether the one of the multiple electrodes is covered by the sheath;
if the one of the multiple electrodes is determined to be covered by the sheath via determining with the third threshold value, determining whether the calculated impedance value for an electrode distal the one of the multiple electrodes is less than a fourth threshold value to determine whether the electrode distal the one of the multiple electrodes is uncovered by the sheath
Hauck teaches a system having a catheter containing a plurality of electrodes located within a sheath which determines the position of the electrodes relative to the sheath based on stored threshold impedance values (¶ [0043], [0048]).
Hauck further teaches that in a situation where a first electrode has been determined to be outside of the sheath, a proximate electrode (as broadly as is currently claimed as all electrodes on a distal end of a catheter are understood to be close to or proximate to one another) position relative to the sheath is determined based on a comparison to a threshold impedance (¶ [0014]- [0016] teaches determining the position of at least a first and second electrode based on the impedance measurements compared to stored values, which therefore teaches determining whether the electrodes are covered or uncovered based on the impedance values in relationship to threshold impedance values), these stored values teaching the known relationship of the impedance being greater when the electrode is covered by the sheath compared to being uncovered by the sheath (¶ [0044]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated determining the electrodes of the catheter as being uncovered by the sheath when the impedance value is below a threshold value, as is taught by Hauck, into the system having a catheter containing electrodes located within a sheath and a controller which is configured to determine whether the electrodes are retracted within or exited from the sheath as is taught by Tunay, to produce the predictable result of determining the positions of catheter electrodes relative to a sheath based on known impedance values relevant to the environment surrounding the electrodes, as is taught by Hauck, 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, Tunay further teaches the medical system of claim 1, wherein the multiple electrodes are longitudinally spaced apart at the catheter distal end (¶[0042]).
Regarding claim 8, Tunay further teaches the medical system of claim 1, wherein the catheter is a linear ablation catheter (¶[0042], [0084]).
Regarding claim 9, the recited methods are considered inherent as being taught by the device currently rejected by Tunay/LeMay/ Glukhovsky /Hauck.
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 Tunay/LeMay/ Kassab /Hauck reference are moot in view of the new rejections under Tunay/LeMay/ Glukhovsky /Hauck.
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794