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.
Status of the Claims
The current office action is made responsive to claims filed 10/10/2025.
Acknowledgement is made to the amendment of claims 1, 11, and 19-22.
Acknowledgement is made to the cancellation of claims 3, 7, 13, 17.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-2, 4-6, 8-12, 14-16 and 18-22 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 1-2, 4-6, 8, 11-12, 14-16, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20170156784 A1) in view Ben-Haim (US 20210128009 A1) and Bencini (US 20090299355 A1).
Regarding claim 1, Aujla teaches a catheter (Fig. 1; catheter 10), comprising:
a shaft for insertion (Fig. 1; elongate catheter body 14) into an organ of a patient;
a distal-end assembly ([0032] teaches the catheter body as having proximal and distal ends), which is coupled to the shaft and comprises a spline ([0032]- [0033]);
at least one ablation electrode (Fig. 1; electrode 22), which is configured: (a) to be coupled to a spline ([0032]), and (b) when placed in contact with tissue of the organ, to apply an ablation signal to the tissue ([0031], [0034]), a first ablation electrode of the at least one ablation electrode including a slot (Fig. 5; electrode 22 is shown as having a slot within the inner layer 31 where temperature sensors 50, 52 are located) and a first electrical contact configured to apply the ablation signal to the tissue of the organ and being configured to conduct the ablation signal to the first ablation electrode ([0040], [0042], [0048]); and
a temperature sensor (Fig. 5; thermocouple 50), which is contained within the slot and is configured, when the first ablation electrode is placed in contact with the tissue ([0032], [0038]), to produce a thermal signal indicative of a temperature of the tissue of the organ, a second electrical contact ([0042], [0048] discusses the thermocouple layers 40, 42 as having lead wire connections) being formed between the temperature sensor and the spline to conduct the thermal signal to a processor ([0042]), the first electrical contact being different from the second electrical contact (([0040], [0042], [0048]).
However, Aujla fails to teach the distal-end assembly which comprises a spline as being an expandable distal-end assembly which comprises multiple splines.
Ben-Haim teaches an intrabody probe having a plurality of electrodes and sensors used to obtain measurements and treat a patient ([0172]).
Ben-Haim further teaches the electrodes being located along the probe at a variety of positions based on the shape of the probe being provided, such as a flexible electrical probe or an expandable deployable probe, such as a basket probe ([0172]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the elongate catheter body as is taught by Aujla with the expandable deployable probe, also referred to as a basket probe as is taught by Ben-Haim as both probe shapes perform the same function of providing electrodes and sensors into a body of a patient and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Aujla further fails to teach the electrical contact as being an electrical contact with the spline, the spline being configured to conduct the signals.
Bencini teaches an elongate catheter device for delivering energy to patient tissue including an expandable distal element having a plurality of electrodes ([0028]- [0029]) with a variety of known electrodes and corresponding wiring schemes for the electrodes being taught ([0069]).
Bencini further teaches a known configuration of electrodes and wiring construction for the electrodes of the elongate catheter’s spline element as comprising two conductor wires which are covered by an insulating portion except for a portion where the insulating material is stripped away so as to provide electrical contact for an electrode to treat patient tissue ([0069]- [0071]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the electrical contact for conducting signals of elements of a catheter, as is taught by Aujla with the configuration which provides an electrical signal to a portion of the catheter, such as to the electrode, as being an electrical contact of the elongate wire comprising the spline to said electrode, as is taught by Bencini, to produce the predictable result of providing wiring for conducting signals along a spline of a catheter, as is taught by Bencini, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 2, Aujla teaches the catheter according to claim 1, wherein the temperature sensor comprises a thermocouple (Fig. 5; thermocouple 50).
Regarding claim 4, Aujla teaches the catheter according to claim 1, wherein the first ablation electrode includes a through hole (Fig. 5; lumen 58) formed along an axis of the first ablation electrode.
Regarding claim 5, Aujla teaches the catheter according to claim 4, wherein the through hole is configured to snuggly fit over the spline of the multiple splines and to thread the spline therethrough for coupling the first ablation electrode to the spline ([0047], [0068] discusses the lumen as accommodating the catheter body and any elements within the catheter body).
Regarding claim 6, Aujla teaches the catheter according to claim 4, wherein the slot is formed in an inner surface of the through hole, and wherein the slot is shaped such that the temperature sensor fits into the slot without protruding into the through hole (Fig. 5; thermocouples 50, 52 are shown as being located within insulator 31 and are shown not to extend into lumen 58).
Regarding claim 8, Aujla teaches the catheter according to claim 1, wherein the temperature sensor is configured to produce the thermal signal: (i) while the first ablation electrode applies the ablation signal to the tissue, and (ii) when the first ablation electrode is placed in contact with the tissue and does not apply the ablation signal to the tissue ([0032]).
Regarding claim 21, Aujla teaches the catheter according to claim 1, wherein the slot is formed in an inner surface of a through hole such that the slot extends along an axis of the first ablation electrode from a terminal end of the ablation electrode (Fig. 5; thermocouples 50, 52 are shown as being located within the inner side of the electrode 22, this opening where they are positioned is shown as being on edges 47, 49 as broadly as is currently claimed.
Regarding claims 11-12, 14-16, 18, and 22, the recited methods are considered inherent in the ordinary production of the device as described in claims 1-6, 8, and 21.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20170156784 A1) in view Ben-Haim (US 20210128009 A1) and Bencini (US 20090299355 A1) further in view of Sallee (US 20170049349 A1) and Townley (US 20200405383 A1).
Regarding claim 9, Aujla teaches the catheter according to claim 1, and comprising at least one sensing electrode, which is configured: (a) to be coupled to the spline, and (b) when placed in contact with the tissue, to produce a sensing signal indicative of an electrocardiogram (ECG) signal sensed in the tissue ([0076]).
However, Aujla fails to teach the at least one sensing electrode comprising: (i) a gold substrate, which is formed on the spline of the multiple splines and is configured to conduct the sensing signal, (ii) a first polymer layer, which is formed over a first section of the gold substrate and is configured to electrically isolate between the tissue and the gold substrate, and (iii) a second polymer layer, which is formed over a second section of the gold substrate, different from the first section, and is configured to conduct the ECG signal between the tissue and the gold substrate.
Sallee teaches a catheter having a plurality of splines including a plurality of electrodes for cardiac signal sensing (Abstract, [0052]). The electrodes comprising: a gold substrate (Fig. 3; intermediate metal layer 42; [0057] teaches the intermediate metal layer as being made of gold) formed on the spline ([0052], [0055]), a first polymer layer (Fig. 3; insulting polymer layer 48) formed over a first section of the gold substrate as is configured to electrically isolate between the tissue and the gold substrate ([0055]), and a second layer (Fig. 3; iridium oxide layer 46) which is formed over a second section of the gold substrate, different from the first section and is configured to conduct the ECG signal between the tissue and the gold substrate ([0052], [0055]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of the layers which form an electrode for sensing cardiac signals into the electrodes which sense cardiac signals of Aujla to producing the predictable result of an electrode which senses cardiac signals.
Sallee however fails to disclose the second layer as being a polymer layer.
Townley teaches a handheld device for treating patient tissue by an expandable end effector located at the distal portion of a shaft, the end effector having a plurality of struts containing electrodes ([0065]- [0066]). These electrodes are taught as being able to be made from a plurality of materials, such as iridium oxide, which is the material utilized for the layer of Sallee, or polymers, such as polyethylenedioxythiophene (“PEDOT”) ([0071]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the iridium oxide material of Salle with the polymer layer taught by Townley, since both materials have been taught to perform the same function of conducting electrical signals and is has been held that substituting part of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 19, the recited methods are considered inherent in the ordinary production of the device as described in claim 9.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20170156784 A1and Ben-Haim (US 20210128009 A1) and Bencini (US 20090299355 A1) in view of Sallee (US 20170049349 A1) and Townley (US 20200405383 A1) further in view of Viswanathan (US 20190231421 A1).
Regarding claim 10, Aujla further teaches the catheter according to claim 9.
However, Aujla fails to teach the catheter wherein the first ablation electrode is positioned on the spline of the multiple splines at a first position, and the at least one sensing electrode is positioned on the spline at a second position, different from the first position.
Viswanathan an ablation system having a catheter containing a plurality of electrodes formed on a plurality of splines located at the distal end of said catheter (Abstract). The electrodes being comprised of multiple sets, such as a set to ablate tissue and a separate set to record electrophysiology data, such as intracardiac electrocardiogram signal data which are located separate from the set to ablate tissue ([0018], [0268]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of having sets both ablation electrodes and sensing electrodes for sensing a signal indicative of an ECG signal, as is taught by Viswanathan, to produce the predictable result of performing both ablation and ECG measurements during an ablation procedure.
Regarding claim 20, the recited methods are considered inherent in the ordinary production of the device as described in claim 10.
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 Aujla and Ben-Haim references are moot in view of the new rejections under Aujla, Ben-Haim, and Bencini.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794