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 .
Claim Objections
Claims 22-23 & 34 objected to because of the following informalities:
Claim 22, line 6: “to mounted” should read --to be mounted--,
Claim 22, line 8: “the proximal end” should read --wherein the proximal end--,
Claim 22, line 15: “to electrically” should read --to be electrically--,
Claim 23, line 3: “is achieved” should read --is configured to be achieved--,
Claim 34, line 10: “to electrically” should read --to be electrically--,
Claim 34, line 18: “is reduced” should read --is configured to be reduced--,
Claim 34, lines 19-20: “the plurality of the electrodes is” should read --the plurality of electrodes are--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-41 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 22, the claim recites “the element” in line 9 and it is unclear if this is the same as the “shape imparting element” recited in line 8 or is a different element. For examination purposes, these are the same elements and the limitation will be interpreted as “the shape imparting element”.
Regarding claim 22, the claim recites “the steerable loop” in line 10 and it is unclear if this is the first steerable loop recited in line 4, the second steerable loop in lines 4-5 or a different steerable loop. For examination purposes, this is the same loop as the first steerable loop and the limitation will be interpreted as “the first steerable loop”.
Regarding claim 22, the claim recites “the steerable loop” in line 12 and it is unclear if this is the first steerable loop recited in line 4, the second steerable loop in lines 4-5 or a different steerable loop. For examination purposes, this is the same loop as the first steerable loop and the limitation will be interpreted as “the first steerable loop”.
Regarding claim 22, the claim recites “the steerable loop” in line 14 and it is unclear if this is the first steerable loop recited in line 4, the second steerable loop in lines 4-5 or a different steerable loop. For examination purposes, this is the same loop as the first steerable loop and the limitation will be interpreted as “the first steerable loop”.
Claim 22 recites the limitation “the diameter” in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation “the circumference” in line 18. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, the claim recites “the circle” in line 18 and it is unclear which circle this is referring to: the maximum circle in line 16, the minimum circle in line 16 or a different circle. For examination purposes, this circle is the minimum circle and the limitation will be interpreted as “the minimum circle”.
Claims 23-33 are also rejected by their dependency on claim 22.
Regarding claim 23, the claim recites “a proximal end and a distal end” in lines 1-2 and it is unclear if these are the same proximal and distal ends as recited in claim 22, from which claim 23 depends, or are different proximal and distal ends of the shaft. For examination purposes, these are the same proximal and distal ends and the limitations will be interpreted as “the proximal end and the distal end” or the limitation can be omitted.
Claim 23 recites the limitation “the join” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the mating” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 is also rejected by its dependency on claim 23.
Claim 24 recites the limitation “the catheter” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 25, the claim recites “a plurality of electrodes positioned on the second steerable loop, the electrodes being configured to be electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment” and it is unclear if these are the same electrodes as the plurality of electrodes recited in claim 22, from which claim 25 depends, since it is unclear in claim 22 which steerable loop is being recited in line 12 or the same electrical pulsed field ablation energy source or a different energy source as recited in claim 22 from which claim 25 depends. In reference to the Specification, Figs. 1-2, 7-11 & 13-18 all depict the variable loop 2 within the insulative lumen 8, such that the variable loop 2 is the first steerable loop (claim 22) and the diagnostic tool or device 10 as the second steerable loop (claim 22). Paragraph [0085] of the instant application’s Specification recites “The plurality of electrodes 11 are electrically coupled to the energy source 41” such that it is the larger loop/the first steerable loop that has the plurality of electrodes. For examination purposes, these are the same electrodes and the steerable loop is the first steerable loop and the limitation will be interpreted as “the plurality of electrodes positioned on the first steerable loop, the plurality of electrodes being configured to be electrically coupled with the electrical pulsed field ablation energy source to power the plurality of electrodes for treatment” until Applicant amends or clarifies.
Claim 25 recites the limitation “the second half of the circle” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 25, the claim recites “the circle” in line 18 and it is unclear which circle this is referring to: the maximum circle in line 16 of claim 22, the minimum circle in line 16 of claim 22 or a different circle. For examination purposes, this circle is the maximum circle and the limitation will be interpreted as “the maximum circle”.
Claims 26-31 are also rejected by their dependency on claim 25.
Regarding claim 28, the claim recites “the electrodes” in line 1 and it is unclear if these are the same electrodes or are different electrodes from the plurality of electrodes recited in claim 25, from which claim 28 depends. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the plurality of electrodes”.
Regarding claim 29, the claim recites “adjacent pairs of electrodes” in line 1 and it is unclear if these are the same electrodes or are different electrodes from the plurality of electrodes recited in claim 25, from which claim 29 depends. For examination purposes, these are the same electrodes and the limitation will be interpreted as “adjacent pairs of electrodes of the plurality of electrodes”.
Regarding claim 30, the claim recites “localized first pairs of similar electrodes” in line 1 and “localized second pairs of opposite electrodes” in lines 2-3 and it is unclear if these are the same electrodes or are different electrodes from the plurality of electrodes recited in claim 25, from which claim 30 depends. For examination purposes, these are the same electrodes and the limitation will be interpreted as “localized first pairs of similar electrodes of the plurality of electrodes” and “localized second pairs of opposite electrodes of the plurality of electrodes”.
Regarding claim 31, the claim recites “the steerable loop” in line 1 & lines 2-3 and it is unclear which steerable loop this is referring to, the first steerable loop or the second steerable loop of claim 22, from which claim 31 depends. For examination purposes, this is the first steerable loop and both limitations will be interpreted as “the first steerable loop”.
Claim 31 recites the limitation “the maximum and minimum diameters” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 31, the claim recites “has no electrode overlap other electrodes” and it is unclear which electrodes this limitation is referring to, plurality of electrodes of claim 22, from which claim 31 depends, or another set of electrodes. Additionally, it is unclear what this limitation is claiming as it is grammatically unclear. For examination purposes, these are the same electrodes as recited in claim 22 and the limitation will be interpreted as “has the plurality of electrodes having no electrode overlap with other electrodes of the plurality of electrodes” until Applicant either amends or clarifies.
Claim 32 recites the limitation “the wall” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 is also rejected by its dependency on claim 32.
Regarding claim 33, the claim recites “the braid” and it is unclear what braid this is referring to, the non-metallic braid of claim 32, from which claim 33 depends, or a different braid. For examination purposes, this is the non-metallic braid of claim 32 and the limitation will be interpreted as “the non-metallic braid”.
Regarding claim 34, the claim recites “the element” in line 6 and it is unclear if this is the same as the “shape imparting element” recited in line 5 or is a different element. For examination purposes, these are the same elements and the limitation will be interpreted as “the shape imparting element”.
Regarding claim 34, the claim recites “the steerable loop” in line 7 and it is unclear if this is the same steerable loop as the first steerable loop recited in line 3 or a different steerable loop. For examination purposes, these are the same loop and the limitation will be interpreted as “the first steerable loop”.
Regarding claim 34, the claim recites “the steerable loop” in line 9 and it is unclear if this is the same steerable loop as the first steerable loop recited in line 3 or a different steerable loop. For examination purposes, these are the same loop and the limitation will be interpreted as “the first steerable loop”.
Regarding claim 34, the claim recites “wherein a plurality of electrodes positioned on the first steerable loop, the electrodes are configured to be electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment” in lines 13-15 and it is unclear whether these are the same electrodes or the same electrical pulsed field ablation energy source as recited in lines 9-12. For examination purposes, they are the same features and the limitation will be interpreted as “wherein the plurality of electrodes positioned on the first steerable loop, the electrodes are configured to be electrically coupled with the electrical pulsed field ablation energy source to power the plurality of electrodes for treatment” or the limitation may be omitted.
Claim 34 recites the limitation “the arc” in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation “the second half” in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation “the circle” in lines 16-17. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation “the diameter” in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation “the circumference” in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claims 35-41 are also rejected by virtue of their dependency on claim 34.
Regarding claim 35, the claim recites “a proximal end and a distal end” in lines 1-2 and it is unclear if these are the same proximal and distal ends as recited in claim 34, from which claim 35 depends, or are different proximal and distal ends of the shaft. For examination purposes, these are the same proximal and distal ends and the limitations will be interpreted as “the proximal end and the distal end” or the limitation can be omitted.
Claim 35 recites the limitation “the join” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation “the mating” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 36-41 are also rejected by virtue of their dependency on claim 35.
Regarding claim 36, the claim recites “the steerable loop” in line 2 and it is unclear if this the first steerable loop of claim 34, from which claim 36 depends, or is a different loop. For examination purposes, this is the first steerable loop and the limitation will be interpreted as “the first steerable loop”.
Claims 37-41 are also rejected by virtue of their dependency on claim 36.
Regarding claim 39, the claim recites “the steerable loop” in line 1 and lines 2-3 and it is unclear if this the first steerable loop of claim 34, from which claim 39 depends, or is a different loop. For examination purposes, these are both the first steerable loop and both limitations will be interpreted as “the first steerable loop”.
Claim 39 recites the limitation “the maximum and minimum diameters” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 39, the claim recites “no electrode overlap other electrodes” and it is unclear which electrodes this is referring to, the plurality of electrodes recited in claim 34, from which claim 39 depends, or another set of electrodes. Additionally, it is unclear what this limitation is claiming as it is grammatically unclear. For examination purposes, these are the same electrodes as those recited in claim 34 and the limitation will be interpreted as “no electrodes of the plurality of electrodes overlapping with other electrodes of the plurality of electrodes”
Claims 40-41 are also rejected by virtue of their dependency on claim 39.
Claim 40 recites the limitation “the wall” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 is also rejected by virtue of its dependency on claim 40.
Regarding claim 41, the claim recites “the braid” in line 1and it is unclear what braid this is referring to, the non-metallic braid of claim 40, from which claim 41 depends, or a different braid. For examination purposes, this is the non-metallic braid of claim 40 and the limitation will be interpreted as “the non-metallic braid”.
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder et al. (U.S. Pub. No. 20180161092), herein referred to as “Greifeneder” in view of Howard et al. (U.S. Pub. No. 20180214202), herein referred to as “Howard”.
Regarding claim 22, Greifeneder discloses a cardiac ablation catheter (Abstract: A double loop catheter for delivering ablation energy; [0065]: Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein) comprising:
i. a shaft (catheter sheath 12) having a proximal end (proximal end 14), a distal end (distal end 16), and at least one insulative lumen (lumen of sheath 12, Fig. 9; [0049]: FIGS. 10 and 11 depict another embodiment of the second shape structure in which the fluid apertures 38 are positioned adjacent to the at least one electrode 32 at sides 33A and 33B, as seen in FIG. 1. This configuration may allow for a more even energization of irrigation fluid; wherein in a device with energization of irrigation fluid, the shaft (catheter shaft 12) must be insulative to have the energy transfer effect to the tissue at/around the end effector and not through the path of the body that the catheter shaft is occupying) and at least one delivery lumen (lumen of aperture 45, Fig. 9);
ii. a first steerable loop (second shape structure 30) capable of being inserted into the insulative lumen ([0059]: the catheter sheath 12 comprises a single lumen (not shown) through which first and second shape structures 20, 30 extend) and a second steerable loop (first shape structure 20) capable of being inserted into the delivery lumen ([0059]: Preferably, the second shape structure 30 comprises a structure lumen (not shown) with an aperture 45 through which the first shape structure 20 may be extended) and wherein the delivery lumen is adapted to mounted within the insulative lumen ([0059]: Referring now to FIG. 9, there is illustrated yet a further embodiment of a double shape catheter 10. In this embodiment, the catheter sheath 12 comprises a single lumen (not shown) through which first and second shape structures 20, 30 extend. Preferably, the second shape structure 30 comprises a structure lumen (not shown) with an aperture 45 through which the first shape structure 20 may be extended);
iii. a handle coupled to the proximal end of the shaft ([0036]: The catheter 10 comprises a catheter handle (not shown)), the handle having a steering mechanism ([0037]: Preferably, any manipulation of the first structure 20 and/or the second structure 30 may be effected by at least one control mechanism (not shown) on or near to the catheter handle (not shown));
iv. a shape imparting element having a proximal end and a distal end; the proximal end is adapted to be coupled to the steering mechanism and the distal end of the element is adapted to be coupled to the steerable loop and wherein the shape imparting element is positioned within the insulative lumen ([0042]: A shape-imparting element (not shown), such as a stylet or wire pull system, may be used to impart a predetermined or desired shape to at least one of the first shape structure 20 and the second shape structure 30. Each shape structure may comprise a separate shape-imparting element such that each shape structure may be individually adjusted or altered. For example, a clinician may alter the shape or the size of a shape of the distal end of at least one of the first shape structure 20 and the second shape structure 30. Alternatively, at least one of the first and second shape structures 20, 30 may be formed with a predetermined shape);
v. a plurality of electrodes (electrodes 32) positioned on the steerable loop electrically coupled to at least one electrical connector ([0040]: At least one electrode 32 is disposed near to the distal end 34 of the second shape structure 30. The at least one electrode 32 is preferably an ablation or energizing electrode sufficient to deliver ablation energy to a target tissue; [0046]: a first and second shape structure 20, 30 with independent conductors or conductive wiring 39 may allow the catheter 10 to sense and ablate simultaneously); and
vi. wherein the first steering loop is reduced in size from a maximum circle to a minimum circle, wherein the minimum circle is half the diameter of the maximum circle ([0042]: For example, a clinician may alter the shape or the size of a shape of the distal end of at least one of the first shape structure 20 and the second shape structure 30; wherein this describes a structure (second shape structure 30) capable of being reduced in size from a maximum circle to a minimum circle, wherein the minimum circle is half the diameter of the maximum circle), wherein the plurality of the electrodes is positioned apart around the circumference of the circle (see distribution of electrodes 32 being evenly distributed in Fig. 1).
But Greifeneder fails to disclose wherein the at least one electrical connector being configured to electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment.
However, Howard discloses wherein the at least one electrical connector being configured to electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment ([0079]: a pulsed electric field or radiofrequency (RF) generator 14; [0087]: The generator 14 may provide electrical pulses to the medical device 12 to perform an electroporation procedure to cardiac tissue or other tissues within the patient's body). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter of Greifeneder to include the electrical pulsed field ablation energy source, as taught by Howard, for the purpose of inducing cell death for purposes of completely blocking an aberrant conductive pathway along or through cardiac tissue, destroying the ability of the so-ablated cardiac tissue to propagate or conduct cardiac depolarization waveforms and associated electrical signals and without causing significant tissue heating and muscle stimulation (Howard: [0087], [0085]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard as applied to claim 22 above, and further in view of Highsmith et al. (U.S. Pub. No. 20150342675, cited in IDS), herein referred to as “Highsmith”.
Regarding claim 23, Greifeneder discloses wherein the shaft has a first diameter (diameter of sheath 12), a proximal end (proximal end 14) and a distal end (distal end 16), wherein the distal end is joined to a distal loop section of the first steerable loop having a second diameter ([0036]: The distal end 16 may have a cap 17 or strain relief 17 (see FIGS. 4 and 10), for example … the catheter 10 comprises two structures, a first shape structure 20 and a second shape structure 30, which are configurable such that they may extend distally of the distal end 16 of the catheter sheath 12; wherein the cap 17 is the second diameter), and but fails to disclose wherein the join is achieved by the mating of a tongue and groove positioned on corresponding mating portions of the distal loop section and the distal end.
However, Highsmith discloses wherein the join is achieved by the mating of a tongue and groove positioned on corresponding mating portions of the distal loop section and the distal end ([0048]: A means for attaching the tubing 50 of the proximal electrode assembly 15 to the catheter is illustrated in FIGS. 4b and 6a. A nonconductive connector tubing 57 constructed of a biocompatible materials, e.g., PEEK, with a single lumen, extends from the distal end of the tubing 13 of the intermediate section 14. An opening 58 is cut or otherwise formed in the wall of the tubing 57 to receive a proximal end of the tubing 50 which can extend proximally into the lumen 24 of the tubing 13 and be affixed by glue 60 which also seals the opening 58; wherein the tongue is the proximal end of tubing 50 and the groove is the opening 58). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the join of Greifeneder in view of Howard to the join of Highsmith for the purpose of enabling the routing of lead wires and a support member (Highsmith: [0048]).
Regarding claim 24, Greifeneder discloses wherein the catheter includes a plurality of lumens ([0053]: It will be appreciated that more than two lumens may be formed in the catheter sheath 12).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard as applied to claim 22 above, and further in view of Corvi et al. (U.S. Pub. No. 20130110104), herein referred to as “Corvi”.
Regarding claim 25, Greifeneder discloses a plurality of electrodes (electrodes 32) positioned on the second steerable loop ([0040]: the second shape structure 30 comprises an array of electrodes 32 or a plurality of spaced apart electrodes 32), the electrodes being configured to be electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment ([0041]: The second shape structure 30 may be configured to deliver energy, such as RF energy, to a target tissue); But Greifeneder fails to disclose wherein the plurality of electrodes are spaced at predetermined intervals on an arc of the second half of the circle.
However, Corvi discloses wherein the plurality of electrodes are spaced at predetermined intervals on an arc of the second half of the circle ([0026] The electrode array 28 may be arranged in a resiliently biased manner and have specific geometric configurations which generally allow the electrodes 30 to ablate specific tissue (such as a pulmonary vein, for example) having predetermined or otherwise known geometric or topographical characteristics … Referring now to FIGS. 2-5, the electrodes 30 may be spaced along a fraction of the length of the carrier arm 38 (for example, between approximately 40% to approximately 60% of the overall length) such that, when deployed into an expanded configuration, the electrodes constitute a substantially semi-circular array; see Fig. 3 where the electrodes 30 are spaced at predetermined intervals). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the spacing of the electrodes of Greifeneder in view of Howard to the spacing of Corvi for the purpose of the fractional length and substantially semi-circular configuration of the electrodes allows a user to provide therapy with the electrodes around larger/common ostia or vessel orifices, as well as providing increased ability to create larger, wider-area patterns of treatment on more antral surfaces or tissue regions (Corvi: [0026]).
Regarding claim 26, Greifeneder in view Howard and Corvi disclose wherein the predetermined intervals are equidistant (Corvi: see Figs. 2-5 where the electrodes 30 are shown as being equidistant/have an even spacing between them).
Claims 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard and Corvi as applied to claim 26 above, and further in view of Highsmith.
Regarding claim 27, Greifeneder in view Howard and Corvi fail to disclose wherein the plurality of electrodes is twelve electrodes.
However, Highsmith discloses wherein the plurality of electrodes is twelve electrodes ([0062] The number of the ring electrodes on the assemblies can vary as desired. Preferably, the number of ring electrodes on the lasso assembly 15 ranges from about six to about twenty, preferably from about eight to about twelve, evenly spaced from each other). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the number of electrodes of Greifeneder in view of Howard and Corvi to be twelve electrodes, as taught by Highsmith for the purpose of circumferential tissue contact at the opening of an ostium of a pulmonary vein and enabling the lasso assembly to form a generally circumferential lesion ring around the ostium (Highsmith: [0037], [0081]).
Regarding claim 28, Greifeneder fails to disclose wherein the electrodes comprise alternative positive and negative electrodes.
However, Howard discloses wherein the electrodes comprise alternative positive and negative electrodes ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrodes of Greifeneder to the alternating positive and negative electrode configuration, as taught by Howard for the purpose of energizing every other electrode 38 may allow for a greater separation distance of approximately 5 mm between active electrodes, thereby driving the electric field deeper into the underlying tissue and creating a deeper ablation lesion (Howard: [0097]).
Additionally, absent the claiming of a generator, if the electrodes are configured to deliver energy (Greifeneder [0041]), the electrodes are capable of comprising alternative positive and negative electrodes since that is a function of the signal applied, and a generator configured to “alternate positive and negative electrodes” or similar language to specify the polarity of the signal has not been positively recited.
Regarding claim 29, Greifeneder in view of Howard discloses wherein adjacent pairs of electrodes are configured to fire simultaneously (Howard: [0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity)).
Additionally, absent the claiming of a generator, if the electrodes are configured to deliver energy (Greifeneder [0041]), the electrodes are capable of adjacent pairs of electrodes are configured to fire simultaneously since that is a function of the signal applied, and a generator configured to “adjacent pairs of electrodes are configured to fire simultaneously” or similar language to specify the electrode activation has not been positively recited.
Regarding claim 30, Greifeneder fails to disclose wherein localized first pairs of similar electrodes are configured to fire simultaneously, with corresponding localized second pairs of opposite electrodes configured to fire subsequent to the first pairs.
However, Howard discloses wherein localized first pairs of similar electrodes are configured to fire simultaneously, with corresponding localized second pairs of opposite electrodes configured to fire subsequent to the first pairs ([0098] A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity). After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8. Specifically, electrodes E2, E6, E10, and E14 are connected to the negative polarity of the generator 14 while electrodes E4, E8, E12, and E16 are connected to the positive polarity of the generator 14). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode firing of Greifeneder to the electrode firing of Howard for the purpose of energizing every other electrode 38 may allow for a greater separation distance of approximately 5 mm between active electrodes, thereby driving the electric field deeper into the underlying tissue and creating a deeper ablation lesion (Howard: [0097]).
Additionally, absent the claiming of a generator, if the electrodes are configured to deliver energy (Greifeneder [0041]), the electrodes are capable of localized first pairs of similar electrodes are configured to fire simultaneously, with corresponding localized second pairs of opposite electrodes configured to fire subsequent to the first pairs since that is a function of the signal applied, and a generator configured to “localized first pairs of similar electrodes are configured to fire simultaneously, with corresponding localized second pairs of opposite electrodes configured to fire subsequent to the first pairs” or similar language to specify the electrode activation has not been positively recited.
Regarding claim 31, Greifeneder discloses herein the steerable loop in a configuration between the maximum and minimum diameters has no electrode overlap other electrodes on the steerable loop (see Greifeneder Figs. 1-9 where the second shape structure is shown as has no electrode overlap and is capable of having a configuration between maximum and minimum diameters).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard as applied to claim 22 above, and further in view of Ditter et al. (U.S. Pub. No. 20160143689), herein referred to as “Ditter”.
Regarding claim 32, Greifeneder in view of Howard fails to disclose a non-metallic braid encapsulated within the wall of the shaft proximal to the distal end of the shaft.
However, Ditter discloses a non-metallic braid encapsulated within the wall of the shaft proximal to the distal end of the shaft ([0049]: The multi-lumened tubing 15 of the intermediate section 14 is made of a suitable non-toxic material that is preferably more flexible than the catheter body 12. A suitable material is braided polyurethane; see Fig. 4A where intermediate section 14 is proximal to the distal end of the shaft). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the shaft of Greifeneder in view of Howard to comprise a non-metallic braid, as taught by Ditter, for the purpose of enabling the intermediate section to be more flexible than the rest of the catheter body (Ditter: [0049]).
Regarding claim 33, Greifeneder in view of Howard and Ditter disclose wherein the braid is constructed of a non- electrically conductive material (Ditter: [0049]: The multi-lumened tubing 15 of the intermediate section 14 is made of a suitable non-toxic material that is preferably more flexible than the catheter body 12. A suitable material is braided polyurethane; see Fig. 4A where intermediate section 14 is proximal to the distal end of the shaft).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard and Corvi.
Regarding claim 34, Greifeneder discloses a cardiac ablation catheter (Abstract: A double loop catheter for delivering ablation energy; [0065]: Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein) comprising:
i. a shaft (catheter sheath 12) having a proximal end (proximal end 14), a distal end (distal end 16), and at least one insulative lumen (lumen of sheath 12, Fig. 9; [0049]: FIGS. 10 and 11 depict another embodiment of the second shape structure in which the fluid apertures 38 are positioned adjacent to the at least one electrode 32 at sides 33A and 33B, as seen in FIG. 1. This configuration may allow for a more even energization of irrigation fluid; wherein in a device with energization of irrigation fluid, the shaft (catheter shaft 12) must be insulative to have the energy transfer effect to the tissue at/around the end effector and not through the path of the body that the catheter shaft is occupying);
ii. a first steerable loop (second shape structure 30) capable of being inserted into the insulative lumen ([0059]: the catheter sheath 12 comprises a single lumen (not shown) through which first and second shape structures 20, 30 extend);
iii. a handle coupled to the proximal end of the shaft ([0036]: The catheter 10 comprises a catheter handle (not shown)), the handle having a steering mechanism ([0037]: Preferably, any manipulation of the first structure 20 and/or the second structure 30 may be effected by at least one control mechanism (not shown) on or near to the catheter handle (not shown));
iv. a shape imparting element having a proximal end and a distal end; the proximal end is adapted to be coupled to the steering mechanism and the distal end of the element is adapted to be coupled to the steerable loop and wherein the shape imparting element is positioned within the insulative lumen ([0042]: A shape-imparting element (not shown), such as a stylet or wire pull system, may be used to impart a predetermined or desired shape to at least one of the first shape structure 20 and the second shape structure 30. Each shape structure may comprise a separate shape-imparting element such that each shape structure may be individually adjusted or altered. For example, a clinician may alter the shape or the size of a shape of the distal end of at least one of the first shape structure 20 and the second shape structure 30. Alternatively, at least one of the first and second shape structures 20, 30 may be formed with a predetermined shape);
v. a plurality of electrodes (electrodes 32) positioned on the steerable loop electrically coupled to at least one electrical connector ([0040]: At least one electrode 32 is disposed near to the distal end 34 of the second shape structure 30. The at least one electrode 32 is preferably an ablation or energizing electrode sufficient to deliver ablation energy to a target tissue; [0046]: a first and second shape structure 20, 30 with independent conductors or conductive wiring 39 may allow the catheter 10 to sense and ablate simultaneously);
vi. wherein a plurality of electrodes (electrodes 32) positioned on the first steerable loop, the electrodes are configured to be electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment ([0040]: At least one electrode 32 is disposed near to the distal end 34 of the second shape structure 30. The at least one electrode 32 is preferably an ablation or energizing electrode sufficient to deliver ablation energy to a target tissue; [0046]: a first and second shape structure 20, 30 with independent conductors or conductive wiring 39 may allow the catheter 10 to sense and ablate simultaneously); and
vii. wherein the first steering loop is reduced in size from a maximum circle to a minimum circle, wherein the minimum circle is half the diameter of the maximum circle ([0042]: For example, a clinician may alter the shape or the size of a shape of the distal end of at least one of the first shape structure 20 and the second shape structure 30; wherein this describes a structure (second shape structure 30) capable of being reduced in size from a maximum circle to a minimum circle, wherein the minimum circle is half the diameter of the maximum circle), wherein the plurality of the electrodes is positioned apart around the circumference of the circle (see distribution of electrodes 32 being evenly distributed in Fig. 1).
But Greifeneder fails to disclose the at least one electrical connector being configured to electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment; and
and wherein the plurality of electrodes are spaced at predetermined intervals on the arc of the second half of the circle.
However, Howard discloses the at least one electrical connector being configured to electrically coupled with an electrical pulsed field ablation energy source to power the plurality of electrodes for treatment ([0079]: a pulsed electric field or radiofrequency (RF) generator 14; [0087]: The generator 14 may provide electrical pulses to the medical device 12 to perform an electroporation procedure to cardiac tissue or other tissues within the patient's body). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter of Greifeneder to include the electrical pulsed field ablation energy source, as taught by Howard, for the purpose of inducing cell death for purposes of completely blocking an aberrant conductive pathway along or through cardiac tissue, destroying the ability of the so-ablated cardiac tissue to propagate or conduct cardiac depolarization waveforms and associated electrical signals and without causing significant tissue heating and muscle stimulation (Howard: [0087], [0085]).
But Howard fails to disclose wherein the plurality of electrodes are spaced at predetermined intervals on the arc of the second half of the circle.
However, Corvi discloses wherein the plurality of electrodes are spaced at predetermined intervals on the arc of the second half of the circle ([0026] The electrode array 28 may be arranged in a resiliently biased manner and have specific geometric configurations which generally allow the electrodes 30 to ablate specific tissue (such as a pulmonary vein, for example) having predetermined or otherwise known geometric or topographical characteristics … Referring now to FIGS. 2-5, the electrodes 30 may be spaced along a fraction of the length of the carrier arm 38 (for example, between approximately 40% to approximately 60% of the overall length) such that, when deployed into an expanded configuration, the electrodes constitute a substantially semi-circular array; see Fig. 3 where the electrodes 30 are spaced at predetermined intervals). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the spacing of the electrodes of Greifeneder in view of Howard to the spacing of Corvi for the purpose of the fractional length and substantially semi-circular configuration of the electrodes allows a user to provide therapy with the electrodes around larger/common ostia or vessel orifices, as well as providing increased ability to create larger, wider-area patterns of treatment on more antral surfaces or tissue regions (Corvi: [0026]).
Claims 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard and Corvi as applied to claim 34 above, and further in view of Highsmith
Regarding claim 35, Greifeneder discloses wherein the shaft has a first diameter (diameter of sheath 12), a proximal end (proximal end 14) and a distal end (distal end 16), and wherein the distal end is joined to a distal loop section having a second diameter ([0036]: The distal end 16 may have a cap 17 or strain relief 17 (see FIGS. 4 and 10), for example … the catheter 10 comprises two structures, a first shape structure 20 and a second shape structure 30, which are configurable such that they may extend distally of the distal end 16 of the catheter sheath 12; wherein the cap 17 is the second diameter), But Greifeneder fails to disclose wherein the join is achieved by the mating of a tongue and groove positioned on corresponding mating portions of the distal loop section and the distal end.
However, Highsmith discloses wherein the join is achieved by the mating of a tongue and groove positioned on corresponding mating portions of the distal loop section and the distal end ([0048]: A means for attaching the tubing 50 of the proximal electrode assembly 15 to the catheter is illustrated in FIGS. 4b and 6a. A nonconductive connector tubing 57 constructed of a biocompatible materials, e.g., PEEK, with a single lumen, extends from the distal end of the tubing 13 of the intermediate section 14. An opening 58 is cut or otherwise formed in the wall of the tubing 57 to receive a proximal end of the tubing 50 which can extend proximally into the lumen 24 of the tubing 13 and be affixed by glue 60 which also seals the opening 58; wherein the tongue is the proximal end of tubing 50 and the groove is the opening 58). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the join of Greifeneder in view of Howard to the join of Highsmith for the purpose of enabling the routing of lead wires and a support member (Highsmith: [0048]).
Regarding claim 36, Greifeneder in view of Howard and Corvi discloses wherein the plurality of electrodes is positioned around the circumference of the circle when the steerable loop is reduced to the minimum circle (see Corvi Figs. 2-5 where this depicts a flexible lasso such that the steerable loop is capable of comprising the plurality of electrodes is positioned around the circumference of the circle when the steerable loop is reduced to the minimum circle).
Regarding claim 37, Greifeneder in view of Howard and Corvi discloses wherein the predetermined intervals are equidistant (Corvi: see Figs. 2-5 where the electrodes 30 are shown as being equidistant/have an even spacing between them).
Regarding claim 38, Greifeneder in view of Howard and Corvi fails to disclose wherein the plurality of electrodes is twelve electrodes.
However, Highsmith discloses wherein the plurality of electrodes is twelve electrodes ([0062] The number of the ring electrodes on the assemblies can vary as desired. Preferably, the number of ring electrodes on the lasso assembly 15 ranges from about six to about twenty, preferably from about eight to about twelve, evenly spaced from each other). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the number of electrodes of Greifeneder in view of Howard and Corvi to be twelve electrodes, as taught by Highsmith for the purpose of circumferential tissue contact at the opening of an ostium of a pulmonary vein and enabling the lasso assembly to form a generally circumferential lesion ring around the ostium (Highsmith: [0037], [0081]).
Regarding claim 39, Greifeneder discloses wherein the steerable loop in a configuration between the maximum and minimum diameters has no electrode overlap other electrodes on the steerable loop (see Greifeneder Figs. 1-9 where the second shape structure is shown as has no electrode overlap and is capable of having a configuration between maximum and minimum diameters).
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Greifeneder in view of Howard, Corvi and Highsmith as applied to claim 39 above, and further in view of Ditter.
Regarding claim 40, Greifeneder in view of Howard, Corvi and Highsmith fail to disclose a non-metallic braid encapsulated within the wall of the shaft proximal to the distal end of the shaft.
However, Ditter discloses a non-metallic braid encapsulated within the wall of the shaft proximal to the distal end of the shaft ([0049]: The multi-lumened tubing 15 of the intermediate section 14 is made of a suitable non-toxic material that is preferably more flexible than the catheter body 12. A suitable material is braided polyurethane; see Fig. 4A where intermediate section 14 is proximal to the distal end of the shaft). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the shaft of Greifeneder in view of Howard, Corvi and Highsmith to comprise a non-metallic braid, as taught by Ditter, for the purpose of enabling the intermediate section to be more flexible than the rest of the catheter body (Ditter: [0049]).
Regarding claim 41, Greifeneder in view of Howard, Corvi, Highsmith and Ditter wherein the braid is constructed of a non- electrically conductive material (Ditter: [0049]: The multi-lumened tubing 15 of the intermediate section 14 is made of a suitable non-toxic material that is preferably more flexible than the catheter body 12. A suitable material is braided polyurethane; see Fig. 4A where intermediate section 14 is proximal to the distal end of the shaft).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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