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 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 3, and 17-19 are 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 3, the claim limitation “the maximum outer diameter of the distal section” lacks antecedent basis.
Regarding claim 17, the claim limitations “wherein the port or ports...” is indefinite because claim 16 which claim 17 depends from limits there are at least 10 ports, so it is unclear what single port the claim is referring to.
Regarding claim 18, the claim limitation “a plurality of irrigation ports” is indefinite because claims 16-17 already recite plurality of ports, and it is unclear if “a plurality of irrigation ports” recited in claim 18 are related to the irrigation ports that is already recited in claims 16-17.
Regarding claim 19, the claim limitation “wherein the proximal or distal radiopaque marker is in a range of 1 mm to 15 mm of the coiled ablation element” is indefinite because it is unclear what is in range of 1 mm to 15 mm of the coiled ablation element the claim is referring to.
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.
Claims 1-11, 13-15 and 20 rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2018/0110561; hereinafter Levin), in view of Hindricks et al. (US 2004/0181138; hereinafter Hindricks).
Regarding claim 1, Levin discloses a device and methods for treatment of heart failure by splanchnic nerve ablation. Levin shows an ablation catheter (see 12 in fig. 6; abstract) for transvascular ablation of thoracic splanchnic nerves (see abstract; par. [0070], [0083], [0088]) comprising: an elongate shaft including an extended section and a distal section at a distal end of the extended section (see catheter 12 in fig. 6 which has an extended section, distal section and a distal end), wherein the extended section is configured to position the distal section in a T9, T10, or T11 intercostal vein (see fig. 6-10); and ablation elements which are conductive, carried by the distal section and extending longitudinally along at least a portion of the distal section (see par. [0063], [0088]; see 32 in fig. 13, or 18), wherein the distal section is configured to take a radius of curvature as small as 5 mm (see par. [0105]) and turn an angle up to 120 degrees to flexibly traverse a bend from an azygos vein to the T9, T10, or T11 intercostal vein (see fig. 7, 9 and 13); wherein the ablation element is connectable to an ablation energy source (see 20 in fig. 6-10), wherein the ablation element has a length in a range of 10 mm to 25 mm (see par. [0097]), and wherein the ablation element is configured to transmit ablation energy from the ablation energy source into the T9, T10, or T11 intercostal vein (see par. [0034], [0035], fig. 6-10).
But, Levin fails to explicitly state that the ablation element is flexible coiled electrode, and wherein the coiled ablation element comprises coils arranged in at least one helix, and wherein the distal section is more flexible than the extended section.
Hindricks discloses a method for treating tissue. Hindricks teaches the ablation element is flexible coiled electrode (see par. [0040]), and wherein the coiled ablation element comprises coils arranged in at least one helix (see 62 in fig. 3; par. [0040]), and wherein the distal section is more flexible than the extended section (see par. [0027]). Hindricks also teaches that the coil ablation element ranged about 5-20 mm (see par. [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to have utilized the teaching of ablation element is flexible coiled electrode, and wherein the coiled ablation element comprises coils arranged in at least one helix, and wherein the distal section is more flexible than the extended section in the invention of Levin, as taught by Hindricks, to be able to provide improved energy distribution and larger ablation zone, and be able to be able to provided precise control at the distal end to maneuver the distal end of the ablation cather in narrow lumen by having the distal section more flexible.
Regarding claim 2, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin shows wherein the ablation element is expandable from a contracted delivery state to an expanded deployed state (see par. [0088]), and Hindricks teaches the coiled ablation element (see par. [0040]), but Levin and Hindricks fail to explicitly state wherein the coiled ablation element has a maximum outer diameter in a range of 1.5 mm to 3 mm in the contracted delivery state and a maximum outer diameter in a range of 2.5 mm to 6 mm in the expanded deployed state. However, it would have been obvious design choice and routine to one of ordinary skill in the art to have wherein the coiled ablation element has a maximum outer diameter in a range of 1.5 mm to 3 mm in the contracted delivery state and a maximum outer diameter in a range of 2.5 mm to 6 mm in the expanded deployed state as it has been held merely change in size or shape is well known and routine to one of ordinary skill in the art.
Regarding claim 3, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin shows wherein each ablation element has a length greater than the maximum outer diameter of the distal section in the delivery state of the ablation catheter (see par. [0097], [0105]).
Regarding claims 4-6, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin shows wherein the ablation element includes a first group of the ablation elements (see fig. 13 and 18) and a second group of the ablation elements (see fig. 13 and 18), and the first group is spaced axially from the second group by a gap having an axial length (see fig. 13 and 18), and Hindricks teaches the coiled ablation element (see par. [0040]), but Levin and Hindricks fail to explicitly state that the length in a range of 1 mm to 15 mm, wherein the gap is greater than a separation between adjacent ones the coils in the first group. However, it would have been obvious design choice and routine to one of ordinary skill in the art to have the length in a range of 1 mm to 15 mm, wherein the gap is greater than a separation between adjacent ones the coils in the first group, wherein the axial length of the gap is no greater than 8 mm, and wherein the first group and the second group each have an axial length in a range of 4 mm to 12 mm as it has been held merely change in size or shape is well known and routine to one of ordinary skill in the art.
Regarding claim 7, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Hindricks teaches an irrigation port on the distal section and in gap (see par. [0043]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of an irrigation port in the invention of Levin, as taught by Hindricks, to be able to permit fluid such as saline to ablated region of interest.
Regarding claims 8-9, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin further shows a deployable element on the distal section and in the gap (see par. [0088]; fig. 18), wherein the deployable element has a contracted state (see par. [0088]) and deployed state (see par. [0088]), but fails to explicitly state that the deployable element has a maximum outer diameter in a range of 1.5 mm to 3 mm and the deployed state in which the deployable element as a maximum outer diameter in a range of 3 mm to 7 mm. However, it would have been obvious design choice and routine to one of ordinary skill in the art to have the deployable element has a maximum outer diameter in a range of 1.5 mm to 3 mm and the deployed state in which the deployable element as a maximum outer diameter in a range of 3 mm to 7 mm, wherein the maximum outer diameter of the deployable element in the deployed state is greater than a maximum outer diameter of the coiled ablation element in the deployed state as it has been held merely change in size or shape is well known and routine to one of ordinary skill in the art.
Regarding claim 10, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin further shows wherein the ablation elements are uniformly spaced from the other coils in the coiled ablation element while the ablation catheter is in a deployed state (see fig. 13 and 18), and Hindricks teaches the coiled ablation element (see par. [0040]).
Regarding claim 11, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin further shows wherein the ablation elements in the first group are uniformly spaced from the other ablation elements in the first group while the ablation catheter is in a deployed state (see fig. 13 and 18), and Hindricks teaches the coiled ablation element (see par. [0040]).
Regarding claim 13, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin further shows wherein a first portion of the distal section where the first group is positioned differs from a second portion of the distal section where the second group is positioned (see fig. 13 and 18).
Regarding claim 14, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Levin further shows wherein the first portion of the distal section differs from the second portion by at least one of: an outer diameter of the first portion is greater than an outer diameter of the second portion (see fig. 18 shows that the balloon has different outer diameter from the proximal section to middle section of the balloon).
Regarding claim 15, the claim limitation “wherein, when the coiled ablation element is configured to ablate tissue in the T9, T10 or TI1 intercostal vein to a depth in the tissue in a range of 2 mm to 10 mm" is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Levin and Hindricks is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 20, Levin discloses a device and methods for treatment of heart failure by splanchnic nerve ablation. Levin shows a method to ablate an intercostal vein (see abstract) comprising: advancing through a vascular system of a patient an elongate shaft of an ablation catheter (see fig. 6; abstract), wherein, the elongate shaft includes an extended section and a distal section at a distal end of the extended section see catheter 12 in fig. 6 which has an extended section, distal section and a distal end) and wherein the advancement positions the distal section in a T9, T10, or T11 intercostal vein (see fig. 6-10); delivering energy to an ablation element carried by the distal section (see par. [0063], [0088]; see 32 in fig. 13, or 18), wherein the ablation element is conductive, carried by the distal section and extends longitudinally along at least a portion of the distal section (see par. [0063], [0088]; see 32 in fig. 13, or 18), transmitting the energy from the ablation element into the T9, T10, or T11 intercostal vein (see par. [0063], [0088]; fig. 6-10); wherein the distal section is configured to take a radius of curvature as small as 5 mm (see par. [0105]) and turn an angle up to 120 degrees to flexibly traverse a bend from an azygos vein to the T9, T10, or T11 intercostal vein (see fig. 7, 9 and 13); wherein the coiled ablation element is configured to transmit ablation energy from the ablation energy source into the T9, T10, or T11 intercostal vein (see par. [0034], [0035], fig. 6-10).
But, Levin fails to explicitly state that the ablation element is flexible coiled electrode, and wherein the coiled ablation element comprises coils arranged in at least one helix, and wherein the distal section is more flexible than the extended section.
Hindricks discloses a method for treating tissue. Hindricks teaches the ablation element is flexible coiled electrode (see par. [0040]), and wherein the coiled ablation element comprises coils arranged in at least one helix (see 62 in fig. 3; par. [0040]), and wherein the distal section is more flexible than the extended section (see par. [0027]). Hindricks also teaches that the coil ablation element ranged about 5-20 mm (see par. [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to have utilized the teaching of ablation element is flexible coiled electrode, and wherein the coiled ablation element comprises coils arranged in at least one helix, and wherein the distal section is more flexible than the extended section in the invention of Levin, as taught by Hindricks, to be able to provide improved energy distribution and larger ablation zone, and be able to be able to provided precise control at the distal end to maneuver the distal end of the ablation cather in narrow lumen by having the distal section more flexible.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2018/0110561; hereinafter Levin), in view of Hindricks et al. (US 2004/0181138; hereinafter Hindricks) as applied to claims 1 and 4 above, and further in view of Long et al. (US 2018/0064488; hereinafter Long).
Regarding claim 12, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, wherein the first group has a coiled configuration which is different from a coiled configuration of the second group, wherein the difference between the coiled configurations of the first group and the second group is at least one of: a thickness of the coils in the first group is different than a thickness of the coils in the second group.
Long discloses an ablation catheter and teaches first group has a coiled configuration which is different from a coiled configuration of the second group (see fig. 10B), wherein the difference between the coiled configurations of the first group and the second group is at least one of: a thickness of the coils in the first group is different than a thickness of the coils in the second group (see fig. 10B). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of first group has a coiled configuration which is different from a coiled configuration of the second group, wherein the difference between the coiled configurations of the first group and the second group is at least one of: a thickness of the coils in the first group is different than a thickness of the coils in the second group in the invention of Levin and Hindricks, to be able to perform different size ablation without needing to moving the ablation catheter.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2018/0110561; hereinafter Levin), in view of Hindricks et al. (US 2004/0181138; hereinafter Hindricks) as applied to claim 1 above, and further in view of de la Rama et al. (US 20180193090; hereinafter Rama).
Regarding claim 16, Levin and Hindricks disclose the invention substantially as described in the 103 rejection above, furthermore, Hindricks teaches irrigation ports uniformly distributed in distal section (see par. [0043]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching irrigation ports uniformly distributed in distal section the invention of Levin, as taught by Hindricks, to be able to permit fluid such as saline to ablated region of interest.
But, Levin and Hindricks fails to explicitly state at least 10 irrigation ports uniformly distributed along the distal section.
Rama discloses an ablation catheter and teaches at least 10 irrigation ports uniformly distributed along the distal section (see fig. 7). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of at least 10 irrigation ports uniformly distributed along the distal section in the invention of Levin and Hindricks, as taught by Rama, to provide additional irrigation ports which would help mitigating blood coagulation and charring on and around electrode coils during ablation.
Regarding claim 17, Levin, Hindricks and Rama disclose the invention substantially as described in the 103 rejection above, furthermore as best understood of indefinite limitation, Hindricks teaches wherein the irrigation port or ports are located on the distal section on surfaces of the distal section not covered by the coils of the coiled ablation element (see fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the irrigation port or ports are located on the distal section on surfaces of the distal section not covered by the coils of the coiled ablation element in the invention of Levin, as taught by Hindricks, to be able to permit fluid such as saline to ablated region of interest.
Regarding claim 18, Levin, Hindricks and Rama disclose the invention substantially as described in the 103 rejection above, furthermore as best understood of indefinite limitation, Hindricks teaches wherein a plurality of the irrigation ports are located in gaps between the coils of the coiled ablation element (see fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein a plurality of the irrigation ports are located in gaps between the coils of the coiled ablation element in the invention of Levin, as taught by Hindricks, to be able to permit fluid such as saline to ablated region of interest.
Regarding claim 19, Levin, Hindricks and Rama disclose the invention substantially as described in the 103 rejection above, furthermore, Levin teaches radiopaque marker (see par. [0088]), but fails to explicitly state radiopaque marker carried by the distal section and proximal to the coiled ablation element, wherein the proximal or distal radiopaque marker is in a range of 1 mm to 15 mm of the coiled ablation element.
Rama discloses an ablation catheter and teaches radiopaque marker carried by the distal section and proximal to the coiled ablation element (see 772 in fig. 7). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of radiopaque marker carried by the distal section and proximal to the coiled ablation element in the invention of Levin and Hindricks, as taught by Rama, to be able to facilitate precise localization of the balloon. But, as best understood of indefinite claim limitation, combined invention of Levin, Hindricks and Rama fails to explicitly state wherein the proximal or distal radiopaque marker is in a range of 1 mm to 15 mm of the coiled ablation element, However, it would have been obvious design choice and routine to one of ordinary skill in the art to have wherein the proximal or distal radiopaque marker is in a range of 1 mm to 15 mm of the coiled ablation element as it has been held merely change in size or shape is well known and routine to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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