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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Objections
Claim 2 is objected to because of the following informalities: The claimed limitation describes “… has a radially conttracted configuration…”. Appropriate correction is required to correct the typo.
Claims 14 and 16 are objected to for improper claim dependency. Claim 14 relies upon claim 13, which is a cancelled claim. The Examiner is interpreting claim 14 relies upon the most recent prior claim, claim 11. Claim 16 relies upon claim 15, which is a cancelled claim. The Examiner is interpreting claim 16 to rely upon the most recent prior claim, claim 14.
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 1-2, 35, 41, and 44 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipate by Miller (US 2012/0302935), herein after “Miller”.
Regarding claim 1, Miller teaches “A catheter for forming a fistula between two vessels (abstract, p.[0002]), comprising a catheter body having a longitudinal axis (Fig. 10C, catheter body) an electrode (Fig. 10C, electrode 1026, p.[0136]) extending radially from the catheter body for contacting a vessel wall and forming the fistula (p.[0133], where ablation surface 932 is equivalent to electrode 1026); a cutting unit (Fig. 10C, wire 1022, p.[0136]) disposed proximally or distally (Fig. 10C) of the electrode for cutting a venous valve (p.[0136] where wire loop 1022 is considered suitable for destroying a venous valve as 1022 can induce tissue necrosis)”.
Regarding claim 2, the limitations of claim 1 are taught as described above. Miller teaches “wherein the cutting unit is expandable and/or wherein the cutting unit has a radially conttracted configuration and a radially expanded configuration (p.[0136])”.
Regarding claim 35, the limitations of claim 1 are taught as described above. Miller teaches “a second catheter housing (p.[0141]) and a backstop for the electrode (Fig. 26B, nesting material 2614 for electrode 2612)”.
Regarding claim 41, the limitations of claim 35 are taught as described above. Miller teaches “a sheath (sleeve 704) that is disposed over at least a portion of the catheter body and is slidably moveable along the longitudinal axis of the catheter body (Fig. 7A-7B, p.[0062]) and wherein the sheath is slidable to move the cutting unit between a radially contracted configuration and a radially expanded configuration (p.[0063]) and wherein the sheath is slideable to move the electrode between a radially contracted configuration and a radially expanded configuration (p.[0062])”.
Regarding claim 44, the limitations of claim 35 are taught as described above. Miller teaches “further comprising a handle disposed at a proximal end of the first catheter (p.[0154])”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5, 7, 10-11, 14, 16-18, 24, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Deaton (US 2021/0220616), herein after “Deaton”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Miller does not teach "wherein the cutting unit comprises a plurality of cutting tools", but Deaton does in an analogous electrosurgical catheter device. Deaton teaches "wherein the cutting unit comprises a plurality of cutting tools (snare mesh 4702 of Fig. 47A, p.[0524])". It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of multiple cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 5, the limitations of claim 4 are taught as described above. Miller does not teach "wherein the cutting tools are arranged circumferentially around the catheter body and wherein each of the cutting tools extend radially from the catheter body", but Deaton does in an analogous catheter device. Deaton teaches "wherein the cutting tools are arranged circumferentially around the catheter body (Fig. 47A) and wherein each of the cutting tools extend radially from the catheter body (Fig. 47A)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of multiple cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 7, the limitations of claim 4 are taught as described above. Miller does not teach "wherein each of the cutting tools has a substantially convex shape relative to the catheter body" but Deaton does in an analogous catheter device. Deaton teaches "wherein each of the cutting tools has a substantially convex shape relative to the catheter body (Fig. 47A)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. The use of the convex cutting tools is known for cutting materials in the art and produces predictable results of cutting tissue as desired.
Regarding claim 10, the limitations of claim 4 are taught as described above. Miller does not teach "wherein the cutting tools extend longitudinally along the catheter body", but Deaton does in an analogous catheter device. Deaton teaches "wherein the cutting tools extend longitudinally along the catheter body (Fig. 47Dii, with snare mesh 4734 which is analogous to snaring mesh 4702 of Fig. 47A, extending along catheter body 4730)".It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of multiple cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 11, the limitations of claim 10 are taught as described above. Miller does not teach “wherein each of the cutting tools has a proximal end and a distal end and wherein the proximal end and distal end of each of the cutting tool is connected to the catheter body and wherein at least one cutting edge is disposed between the proximal end and distal end of each cutting tool”, but Deaton does in an analogous catheter device. Deaton teaches “wherein each of the cutting tools has a proximal end and a distal end (Fig. 47Dii) and wherein the proximal end and distal end of each of the cutting tool is connected to the catheter body (Fig. 47Dii) and wherein at least one cutting edge is disposed between the proximal end and distal end of each cutting tool (Fig. 47Dii, with cutting edge 4736)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of multiple cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 14, the limitations of claim 11 are taught as described above. Miller does not teach “wherein each of the cutting tools further comprises a spike positioned adjacent the cutting edge” but Deaton does in an analogous catheter device. Deaton teaches “wherein the cutting edge is positioned in a recessed portion of the cutting tool (internal cutting edge of cutting blade 4706 of Fig. 47A)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of multiple cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 16, the limitations of claim 14 are taught as described above. Miller does not teach “wherein the cutting edge is positioned in a recessed portion of the cutting tool”, but Deaton does in an analogous catheter device. Deaton teaches “wherein the cutting edge is positioned in a recessed portion of the cutting tool (internal cutting edge of cutting blade 4706 of Fig. 47A)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use the cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 17, the limitations of claim 4 are taught as described above. Miller does not teach “wherein each of the cutting tools has a proximal section and a distal section”, but Deaton does in an analogous catheter device. Deaton teaches “wherein each of the cutting tools has a proximal section and a distal section (Fig. 47A)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. As stated in Deaton, the use of cutting systems provides the advantage of "reducing an overall number of steps in a procedure, reducing a number of device exchanges, reducing procedure time, improving effectiveness of a valvulotome, reducing procedure components, improving procedure cost of goods, and/or other advantages (p.[0522])" and produces predictable results of reducing procedure time.
Regarding claim 18, the limitations of claim 17 are taught as described above. Miller teaches “wherein the cutting unit is disposed proximally of the electrode (Fig. 10C)”, but Miller does not teach "wherein the at least one cutting edge is disposed in the proximal section of each cutting tool" or " wherein the at least one cutting edge is facing proximally" but Deaton does in an analogous catheter device. Deaton teaches "wherein the at least one cutting edge is disposed in the proximal section of each cutting tool and wherein the at least one cutting edge is facing proximally (internal cutting edge of cutting blade 4706 of Fig. 47A)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. The use of the proximal facing cutting edge allows for cutting heart valves and fistulas and produces predictable results of cutting the desired tissue.
Regarding claim 24, the limitations of claim 18 are taught as described above. Miller does not teach "wherein the distal end of each cutting tool is fixed to the catheter body, and the proximal end of each cutting tool is moveable to move the cutting unit between a radially contracted configuration and a radially expanded configuration" however Deaton does in an analogous catheter device. Deaton teaches "wherein the distal end of each cutting tool is fixed to the catheter body, and the proximal end of each cutting tool is movable to move the cutting unit between a radially contracted configuration and a radially expanded configuration (p.[0526])". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Deaton in Miller. The use of the expandable cutting tool allows for the device to be delivered and deployed in the internal structure and produces predictable results of operating in the human body.
Regarding claim 45, the limitations of claim 44 are taught as described. Miller does not teach "wherein the handle comprises a sheath sliding mechanism", but Deaton does in an analogous catheter device. Deaton teaches "wherein the handle comprises a sheath sliding mechanism (Fig 41A-41Ei, p.[0464-470], with handle 1700, slider member 1710 fixed to move the sheath as described)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention before the effective filing date of the claimed invention to use the system of Deaton in Miller. The use of the slider member allows for enhanced grip and useability (p.[0465]) and produces predictable results of better useability for the user.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Deaton and Asirvatham (US 2017/0258521), herein after “Asirvatham”.
Regarding claim 21, the limitations of claim 17 are taught as described above. Deaton nor Miller teach the limitation "wherein the cutting unit is disposed distally of the electrode and wherein the at least one cutting edge is disposed in the distal section of each cutting tool and wherein the at least one cutting edge is facing distally", however Asirvatham does in an analogous catheter device. Asirvatham teaches "wherein the cutting unit is disposed distally of the electrode and wherein the at least one cutting edge is disposed in the distal section of each cutting tool and wherein the at least one cutting edge is facing distally (Fig. 14, p.[0124])". It would have been obvious to one of ordinary art before the effective filing date of the claimed invention to use the system of Asirvatham in Miller/Deaton. The electrode placement of Asirvatham "facilitate penetration through pericardium" (p.[0124]) and produces predictable results of cutting through the desired tissue.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Hancock (US 2019/0099215), herein after “Hancock”.
Regarding claim 48, the limitations of claim 44 are taught as described above. Miller does not teach "wherein the handle further comprises a cutting unit control mechanism for controlling the extend of radial expansion of the cutting unit, and wherein the cutting unit control mechanism comprises a push wire that is connected to the proximal end of the cutting tools"“,but Hancock does in an analogous electrosurgical cutting tool. Hancock teaches "wherein the handle further comprises a cutting unit control mechanism for controlling the extent of radial expansion of the cutting unit, and wherein the cutting unit control mechanism comprises a push wire that is connected to the proximal end of the cutting tools (p.[0023-0024])". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Hancock in Miller. As stated in Hancock, the use of the push wires/control rods to actuate the cutting means allows for the cutting tools to be used by a user when the distal end of the cutting tool is inside a patient and produces predictable results of actuating the cutting tool (p.[0023]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Cao (US 2022/0346868), herein after “Cao”.
Regarding claim 50, the limitations of claim 44 are taught as described above. Miller does not teach the limitations "wherein the handle further comprises an electrode expansion mechanism for controlling the extent of radial expansion of the electrode and wherein the electrode expansion mechanism comprises a push wire that is connected to a proximal end of the electrode" but Cao does in an analogous electrosurgical device. Cao teaches "wherein the handle further comprises an electrode expansion mechanism for controlling the extent of radial expansion of the electrode (Fig. 5, p.[0053] " when the distal end of the movable guide wire 10 is fixed with the distal end of the electrode bracket 1, the electrode bracket 1 can be compacted or expanded by pushing or pulling the movable guide wire 10 forward or backward") and wherein the electrode expansion mechanism comprises a push wire that is connected to a proximal end of the electrode (Fig. 5, p.[0053] " when the distal end of the movable guide wire 10 is fixed with the distal end of the electrode bracket 1, the electrode bracket 1 can be compacted or expanded by pushing or pulling the movable guide wire 10 forward or backward", where the electrode bracket is considered to be the proximal end of the electrode)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Cao in Miller. The use of attaching a pushwire to the electrode "simplifies the operation" and produces predictable results of facilitating the movement of the ablation catheter (p.[0054]).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Miller.
Regarding claim 52, Miller teaches “A method of forming a fistula using a catheter having a catheter body with an electrode and a cutting unit disposed proximally or distally of the electrode (Fig. 10C), the method comprising inserting the catheter into a vein through an access site (p.[0031]) moving the electrode from a radially contracted configuration to a radially expanded configuration (p.[0133]) forming the fistula by supplying RF energy to the electrode (p.[0009,0044]) moving the cutting unit from a radially contracted configuration to a radially expanded configuration (p.[0136])”.
Miller does not explicitly teach that a valve is cut by moving the catheter but does suggest that the catheter can sever tissue based on the need of the procedure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Miller to cut a valve. As stated in Miller, the blade can be rotated, oscillated, or otherwise oriented to cut desired tissue (where a valve is considered a piece of desired tissue under broadest reasonable interpretation) and produces predictable results of severing tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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