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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted 10/03/2024, 03/09/2026 and 07/30/2026 have been considered by the Examiner.
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.
Claim 10 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 10, the claim recites “an expanded state” and it is unclear if this is the same expanded state as that recited in claim 1, from which claim 10 depends, or is a different expanded state. For examination purposes, these are the same states and the limitation will be interpreted as “the expanded state”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 7 & 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. (U.S. Pub. No. 20170042615), herein referred to as “Salahieh”.
Regarding claim 1, Salahieh teaches a flexible catheter structure (Abstract: Cardiac tissue ablation catheters) comprising:
a first shaping element (proximal loop of expandable structure 98, Fig. 60D);
a second shaping element (distal loop of expandable support structure 98, Fig. 60D) located distally with respect to the first shaping element (see Fig. 60D), wherein each of the first and the second shaping elements is expandable from a contracted state to an expanded state ([0151]: FIG. 60D illustrates a thin wall membrane 54 with electrodes 6 supported by a coil support structure 98. This embodiment allows for a very small profile in that a coil can be sheathed into an essentially linear structure), and wherein the first and second shaping elements are transversely oriented ([0151]: a coil support structure 98; see Fig. 60D where the coils are transversely oriented relative to the catheter 57), when in the expanded state, with respect to a longitudinal axis that extends through a center of each shaping element (see Fig. 60D where in the expanded state, the coil support structure 98 has a longitudinal axis that extends through a center of each of the loops);
a support structure (thin wall membrane 54) that extends between the first shaping element and the second shaping element ([0150]: The flexible membrane 54 can be disposed around an expandable structure 98; see Fig 60D where the thin wall membrane extends between all of the coils); and
at least one interactive element (electrodes 6).
Regarding claim 2, Salahieh teaches wherein the at least one interactive element is located on the support structure ([0150]: Electrodes 6 may be arranged over the tubular thin walled membrane 54).
Regarding claim 3, Salahieh teaches wherein the at least one interactive element comprises a first interactive element located on the first shaping element and a second interactive element located on the second shaping element ([0151]: FIG. 60D illustrates a thin wall membrane 54 with electrodes 6 supported by a coil support structure 98; see Fig. 60D where each coil comprises an electrode).
Regarding claim 5, Salahieh teaches wherein the support structure comprises a flexible substrate ([0150]: The flexible membrane 54), and wherein the at least one interactive element is located on the flexible substrate ([0150]: Electrodes 6 may be arranged over the tubular thin walled membrane 54).
Regarding claim 7, Salahieh teaches wherein the first shaping element and the second shaping element are formed from a single elongate element ([0151]: FIG. 60D illustrates a thin wall membrane 54 with electrodes 6 supported by a coil support structure 98).
Regarding claim 9, Salahieh teaches wherein the at least one interactive element further comprises one or more of an energy delivery element ([0150]: electrodes 6), a thermocouple, a diagnostic element, a therapy element, a drug element, a chemical element, a biologic element, an acoustic element, an ultrasound element, a light-emitting element, a magnetic element, and a thermoelectric element.
Regarding claim 10, Salahieh teaches wherein the first and the second shaping elements each have a collapsed state and an expanded state, where the collapsed states are configured to fit inside a delivery device ([0151]: FIG. 60D illustrates a thin wall membrane 54 with electrodes 6 supported by a coil support structure 98. This embodiment allows for a very small profile in that a coil can be sheathed into an essentially linear structure).
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 4, 8 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Greifeneder et al. (U.S. Pub. No. 20180161092), herein referred to as “Greifeneder”.
Regarding claim 4, Salahieh fails to disclose a plurality of ring electrodes, wherein the plurality of ring electrodes are located on the first shaping element and the second shaping element.
However, Greifeneder discloses a plurality of ring electrodes, wherein the plurality of ring electrodes are located on the first shaping element and the second shaping element ([0038]: At least one electrode 22, such as a ring electrode; [0040]: At least one electrode 32; see Fig. 1 where both electrodes 22 and 32 are all ring shaped). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the flexible catheter of Salahieh to include a plurality of ring electrodes, as taught by Greifeneder, for the purpose of enabling sensing a target tissue location or electrical signals and the second structure to burn a grid of rings or shapes at a target site (Greifeneder: [0038], [0041]).
Regarding claim 8, Salahieh fails to disclose wherein the first shaping element is formed from a first elongate element and the second shaping element is formed from a second elongate element.
However, Greifeneder discloses wherein the first shaping element is formed from a first elongate element and the second shaping element is formed from a second elongate element. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first and second shaping elements of Salahieh to be formed from first and second elongate elements, as taught by Greifeneder, for the purpose of enabling an operator or clinician to independently adjust or manipulate the relative shape or the relative size of the first structure and/or the second structure (Greifeneder: [0037]).
Regarding claim 11, Salahieh discloses wherein a width of the expanded state of the first shaping element is larger than a diameter of the delivery device (see Fig. 60D) but Salahieh fails to disclose width of the expanded state of the second shaping element is less than the width of the expanded state of the first shaping element.
However, Greifeneder discloses a width of the expanded state of the second shaping element is less than the width of the expanded state of the first shaping element (see Fig. 1 where the first shape structure 20 is smaller than the second shape structure 30). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the width of the expanded state of the second shaping element to be less than the width of the expanded state of the first shaping element, as taught by Greifeneder, for the purpose of allowing the first structure to form an abutting relationship with a tissue of a patient such that the location of the second shape structure may be releasably fixed in a desired location and enabling the first shape structure to be wedged or in an abutting relationship with an artery or other tissue of a patient and the second shape structure may be positioned closer to a target site (Greifeneder: [0039], [0057]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Beetel et al. (U.S. Pub. No. 20120101413), herein referred to as “Beetel”.
Regarding claim 6, while Salahieh discusses the use of a braid for a balloon ([0146]: The structure of the membrane 34 can vary including, but not limited to a membrane sheet, cylinder, tube, inflatable, expandable, or fillable structure, such as a balloon, or braided mesh and the like), Salahieh fails to disclose wherein the support structure is a braided material that extends between the first shaping element and the second shaping element.
However, Beetel discloses wherein the support structure is a braided material that extends between the first shaping element and the second shaping element ([0092]: The mesh structure 22 may be laser cut, braided, knit, or woven to form a conformable structure (e.g., a tubular, barrel-shaped, parachute-shaped, or spherical structure) through which fluids may pass; [0101]: a mesh structure 1222b configured in accordance with another embodiment of the technology may have an opening 1294 at the distal end 44 in addition to the opening 100 at the proximal end 42 to allow maximum blood flow therethrough; where the openings 100 is seen as the first shaping element and the opening 1294 is seen as the second shaping element). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the support structure of Salahieh to be a braided material, as taught by Beetel, for the purpose of enabling the characteristics of the structure to be influenced by the number of fibers or the type of braiding process used to form the mesh structure may influence its compressibility (Beetel: [0092]).
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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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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