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 02/02/2026.
Acknowledgement is made to the amendment of claims 1, 7, 12, and 17.
Acknowledgement is made to the cancellation of claims 2-3, 5-6, 9, 13-15, 19, 22-25, and 27.
Acknowledgement is made to the newly added claims 30-31.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1, 4, 7-8, 10-12, 16-18, 20-21, 26, and 28-31 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, 4, 7-8, 10-12, 16-18, 20-21, 26, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20090177193 A1) in view of Lichtenstein (US 20160100878 A1), Werneth (US 20090149848 A1), Brucker (US 6017338 A1), Subramaniam (US 20090093810 A1) and Beeckler (US 20180104000 A1).
Regarding claim 1, Wang teaches a medical apparatus (Fig. 7A; ablation catheter assembly 12), comprising:
a flexible insertion tube (Fig. 7A; fluid delivery tube 16), which has a first outer diameter and has a distal end configured for insertion into a cavity within a body of a patient ([0011]);
a rigid cylindrical electrode (Fig. 7A; ablation electrode assembly 10), which is fixed to the distal end of the flexible insertion tube and is configured to contact tissue within the cavity, which has a second outer diameter that is greater than the first outer diameter ([0019], [0035]- [0036], [0040]), and which has an exterior wall containing a central volume ([0047] the ablation electrode assembly 10 is taught as being positioning withing an outermost surface), the exterior wall comprising a bore (Fig. 7A; cavity 36) disposed between, relative to a radial direction of the medical apparatus, an outer surface of the cylindrical electrode and the central volume, the exterior wall comprising apertures (Fig. 7A; irrigation passageway 24) therethrough in communication with the central volume, the rigid cylindrical electrode comprising a distal face and a side face with a circular edge between the distal and side faces ([0047]),
a temperature sensor (Fig. 7A; temperature sensor 38) disposed within the bore;
a flow diverter (Fig. 7A; proximal member 18) which is disposed within the central volume of the cylindrical electrode and configured to deflect the fluid in the radial direction toward the exterior wall and through the at least some of the apertures (Fig. 7A; irrigation passageway 24);
an electrical conductor passing through the flexible insertion tube, terminating on the flow diverter within the central volume, and configured to apply radiofrequency (RF) electrical energy to the rigid cylindrical electrode with a power sufficient to ablate the tissue, the electrical conductor being electrically and mechanically secured in a distal space defined in the apparatus ([0045] discusses the electrode assembly as having a cavity for receiving a power, this cavity is positioned so as to terminate on the surface of the proximal member).
However, Wang fails to teach the distal face containing a plurality of elongated grooves, which extend radially outward at different azimuthal angles across a peripheral area of the distal face through the edge; and
multiple sensors, which are disposed within the elongated grooves so as to contact the tissue that is contacted by the rigid cylindrical electrode.
Lichtenstein teaches a flexible catheter having a distal ablation electrode (Abstract). This electrode having a plurality of microelectrodes for receiving signals from tissue, which can be active while the ablation electrode ablates tissue ([0016]).
Lichtenstein further teaches the ablation electrode containing the microelectrodes within cavities which extend along the surface of the electrode between a distal-most surface and a cylindrical surface at a variety of radial points of said electrode (Fig. 2; microelectrodes 47, cavities 43).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the microelectrodes for receiving signals which are located on a distal ablation electrode, as is taught by Lichtenstein, into the ablation electrode of Wang, to produce the predictable result of an ablation electrode which contains electrodes for receiving signals during an ablation of an ablation procedure.
Wang further fails to specifically teach the second outer diameter which is greater than the first outer diameter as being at least 20% greater.
Werneth teaches a device for ablating tissue having a steerable ablation catheter including one or more ablation elements fixedly attached to the ablation catheter’s shaft (Abstract). The ablation elements are discussed as preferably having an outer diameter slightly greater than the shaft diameter to allow for improved contact with tissue during delivery of ablation energy ([0013]).
Werneth further teaches the outer diameter of the tip electrode ([0137]) being at least 20% greater than the outer diameter of the flexible shaft ([0133]).
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 the outer diameter of the flexible shaft ([0133]) and the outer diameter of the tip electrode ([0137]), as is taught by Werneth, into the device of Wang in order to provide improved contact with tissue during delivery of ablation energy ([0013]), as is taught by Werneth.
Wang further fails to teach the power of the RF electrical energy applied to the electrode by the electrical conductor being at least 100 W.
Brucker teaches an RF ablation catheter having a distal cylindrical electrode for ablating cardiac tissue (Abstract, Col. 1, Line 35-55).
Brucker further teaches the power of the RF electrical energy applied to the electrode as being at least 100 W (Col. 12, Line 65- Col. 13, Line, 5; Claim 5).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching of the power applied to the electrode as being at least 100 W (Col. 12, Line 65- Col. 13, Line, 5; Claim 5), as is taught by Brucker, into the device of Wang, as applying a known technique of applying a known electrical power to a known ablation catheter for ablating cardiac tissue to provide the predictable result of ablating cardiac tissue (Col. 1, Line 35-55), as is taught by Brucker.
Wang further fails to teach the portion of the apparatus where the electrical conductor is electrically and mechanically secured as being the flow diverter.
Subramaniam teaches an electrode having a plurality of apertures and a lumen for directing flow of the fluid to the apertures of the electrode (Abstract, [0036]).
Subramaniam further teaches in Fig. 6 the tip electrode 106 having cooling chambers 164 and 166 where the flow of the fluid is diverted from cooling chamber 164 to cooling chamber 166 by thermal mass 168 containing fluid lumen 170, this thermal mass is formed from any suitable electrically and thermally conducting material and is attached by soldering to power wire 142 which provides power to the tip electrode ([0033], [0043]).
Therefore, is would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the position of the power wire within an electrode having an irrigation member as is taught by Wang with the position of the power wire within an electrode having a thermal mass which allows fluid to flow between areas within the electrode, as is taught by Subramaniam to produce the predictable result of providing power to an irrigated electrode, as is taught by Subramaniam, 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).
Wang further fails to teach a distal end of the flow diverter being spaced apart from the exterior wall.
Beeckler teaches a medical probe for insertion that has at least one hollow distal electrode coupled to an energy source, a plurality of apertures formed in the electrode and a fluid-directing assembly (Abstract).
Beeckler further teaches the fluid-directing assembly as being located within and spaced separate from the walls of the hollow electrode, this space between the fluid-directing assembly and the electrode being referred to as a lumen ([0048]).
Therefore, while Wang does not teach the proximal portion as being spaced apart from the electrode’s outermost surface, there is no evidence that positioning these parts separate from one another makes a meaningful difference to the function of the device and/or would produce an unexpected result and it has been held that making parts separable is an obvious modification (MPEP 2144.04(V)(C)). For this reason, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have made separate any functional elements of the device which produce the function of the device delivering fluid by a flow diverting element through a plurality of apertures of an electrode, as is taught by Beeckler, into the electrode for providing fluid, as is taught by Wang as long as each functional element retains its ability to function in a desired and/or predictable manner.
Regarding claim 4, Wang teaches the apparatus according to claim 1, wherein the rigid cylindrical electrode has a rounded distal edge ([0047]).
Regarding claim 7, Wang teaches the apparatus according to claim 1, wherein the rigid cylindrical electrode has apertures formed through the exterior wall in communication with the central volume, and wherein the apparatus comprises a lumen passing through the flexible insertion tube and coupled to supply a fluid to the central volume, whereby the fluid exits through the apertures to irrigate the tissue ([0035]).
Regarding claim 8, Wang teaches the apparatus according to claim 7, wherein the lumen is configured to input the fluid to the central volume along an axial direction, and the flow diverter is configured to deflect the fluid in the radial direction toward the apertures ([0048]).
Regarding claim 10, Lichtenstein teaches the apparatus according to claim 1, wherein the multiple sensors comprise sensing electrodes, which are configured to sense electrophysiological signals generated by the tissue with which the sensing electrodes are in contact ([0016]).
Regarding claim 11, Lichtenstein teaches the apparatus according to claim 1, wherein the circular edge has a rounded profile extending between the distal and side faces, and wherein the sensors are sized and shaped to fit within the elongated grooves such that an outer surface of each of the sensors is flush with the distal face and with the rounded profile of the circular edge ([0036]).
Regarding claim 20, Brucker teaches the apparatus according to claim 1, wherein the power of the RF electrical energy applied to the electrode by the electrical conductor is in excess of 100 W (Col. 12, Line 65- Col. 13, Line, 5; Claim 5).
Regarding claim 26, Lichtenstein teaches the apparatus according to claim 1, each sensor of the multiple sensors being connected to a sensing circuit via a wire that passes (i) through the insertion tube and (ii) through the outer wall of the cylindrical electrode between an outer surface of the cylindrical electrode and the central volume ([0036]- [0037]).
Regarding claim 30, in accordance with the above rejection of claim 1, Beeckler further teaches the apparatus according to claim 1, wherein the flow diverter is disposed within the central volume of the cylindrical electrode such that the flow diverter overlaps with at least some of the apertures in an axial direction of the medical apparatus ([0048]- [0049]).
Regarding claims 12, 16-18, 21 and 31, the method steps are the same as described as the steps the apparatus is configured to perform and therefore taught in the same way as seen in claims 1, 4, 7-8, 10-11, 20, 22, 26 and 30.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20090177193 A1) in view of Lichtenstein (US 20160100878 A1), Werneth (US 20090149848 A1) Brucker (US 6017338 A1), Subramaniam (US 20090093810 A1) and Beeckler (US 20180104000 A1), further in view of Govari (US 20140171821 A1).
Regarding claim 28, Wang/ Lichtenstein/Werneth/Brucker/ Subramaniam teaches the apparatus according to claim 1.
However, Wang/ Lichtenstein/Werneth/Brucker/ Subramaniam fails to teach the apparatus further comprising a resilient rod, which is disposed in the bore and supports the temperature sensor such that the temperature sensor faces towards the outer surface of the cylindrical electrode.
Govari teaches a medical system comprising an irrigated ablation electrode with embedded temperature sensors to provide accurate tissue temperature assessment ([0028]) this medical system having a medical probe including a conductive cap attached to the distal end of an insertion tube (Abstract).
Govari further teaches the electrode comprising a bore within the wall of the electrode which holds in place using any suitable material, a temperature sensor ([0037], [0043]- [0044]).
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 a temperature sensor being embedded and held in place within the irrigated ablation electrode, as is taught by Govari, into the device of Wang/ Lichtenstein/Werneth/Brucker/ Subramaniam, to provide the predictable result of holding a sensor within a tube using a known suitable material, as is taught by Govari.
Regarding claim 29, the method steps are the same as described as the steps the apparatus is configured to perform and therefore taught in the same way as seen in claim 28.
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 Wang as modified reference are moot in view of the new rejections under Wang as previously modified and Beeckler.
Additionally, in response to applicant's argument that Subramaniam may not be incorporated into the reference of Wang as the analogous element of Subramaniam uses a different material than that of the element of Wang, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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