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 § 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.
Claims 1-3, 13-14, and 16-18 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated Mizrahi et al. (US 2008/0167643).
Regarding claim 1, Mizrahi discloses a device for treating varicose veins, comprising: a catheter (fig.4; wire coil 72) comprising: an elongated shaft (fig.1; catheter 20) having a proximal end (proximal end catheter 20) and a distal end (distal end catheter 20), the shaft being sized and configured such that the distal end can be inserted into a blood vessel; and a heating element ( heating element 22) disposed near the distal end of the elongated shaft [0062], the heating element comprising a tubular conductor (conductive rod 74) formed from a magnetic material and connected to the elongated shaft [0062], an inductive coil (wire coil 72) helically wound over the tubular conductor (fig.4, see also [0062]), and a dielectric layer (fig.4; non-conductive coating 76) disposed between the tubular conductor and the inductive coil (fig.4).
Regarding claim 2, Mizrahi discloses the device of claim 1, wherein the inductive coil is configured to generate an electromagnetic induction field around the tubular conductor, wherein the tubular conductor is configured to generate thermal energy sufficient for ablation (fig.4).
Regarding claim 3, Mizrahi discloses the device of claim 1, wherein the dielectric layer ( dielectric filler 84) comprises an insulative coating disposed on the inductive coil (fig.4, see also [0062]).
Regarding claim 13, Mizrahi discloses a system for treating varicose veins, comprising: a catheter (catheter 20) comprising: an elongated shaft (elongated shaft of catheter 20) having a proximal end (proximal end of catheter 20) and a distal end (distal end of catheter 20), the shaft being sized and configured such that the distal end can be inserted into a blood vessel (fig.2); and a heating element (fig.1; heating element 22) disposed near the distal end of the elongated shaft (fig.1), the heating element comprising a tubular conductor (fig.4; conductive rod 74) formed from a magnetic material [0062] and connected to the elongated shaft (fig.4), an inductive coil (fig.4; coil 72) helically wound over the tubular conductor (fig.4), and a dielectric layer (fig.4; non-conductive coating 76) disposed between the tubular conductor and the inductive coil (fig.4); an energy generator connected to the elongated catheter and configured to generate an electric signal [0057]; and a controller (fig.1; control unit 26) operatively connected to the energy generator to control the generation of the electric signal ([0056]-[0057]).
Regarding claim 14, Mizrahi discloses the system of claim 13, wherein the inductive coil of the heating element is electrically connected to the energy generator ([0054]-[0057]).
Regarding claim 16, Mizrahi discloses a catheter for ablation within a varicose vein of a patient [0054], the catheter comprising: an elongated shaft (the elongated shaft of catheter 20) having a proximal end and a distal end; a tubular conductor (conductive rod 74) formed from a magnetic material coupled to the distal end of the elongated shaft; an inductive coil (coil 72) helically wound over the tubular conductor; and a dielectric layer (dielectric filler 84) disposed between the tubular conductor and the inductive coil (fig.4, see also [0062]).
Regarding claim 17, Mizrahi discloses the catheter of claim 16, wherein the inductive coil is configured to generate an electromagnetic induction field around the tubular conductor, wherein the tubular conductor is configured to generate thermal energy sufficient for ablation [0056].
Regarding claim 18, Mizrahi discloses the catheter of claim 17, wherein the dielectric layer comprises an insulative coating disposed on the inductive coil (fig.4; see also [0062]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-12 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mizrahi et al. (US 2008/0167643) in view of PRZYGODA (US 2021/0393311).
Regarding claim 4-5 and 19-20, Mizrahi does not disclose wherein the heating element comprises a set of tubular conductors, the set of tubular conductors comprising the tubular conductor and one or more additional tubular conductors, the set of tubular conductors longitudinally spaced from one another along the shaft, wherein the heating element further comprises one or more non-conductive tubular sections, at least one non-conductive tubular section disposed between two adjacent tubular conductors of the set of tubular conductors.
PRZYGODA teaches heating element (fig.4A-B; heating element 106) comprises a set of tubular conductors, the set of tubular conductors comprising the tubular conductor and one or more additional tubular conductors (spiral shape of coils 114) , the set of tubular conductors longitudinally spaced from one another along the shaft (fig.4A-B), wherein the heating element further comprises one or more non-conductive tubular sections, at least one non-conductive tubular section disposed between two adjacent tubular conductors of the set of tubular conductors [0050]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Mizrahi with the tubular conductor and one or more additional tubular conductors as taught by PRZYGODA for the purpose of treating selected target area.
Regarding claim 6, Mizrahi/PRZYGODA teaches the device of claim 5, wherein the one or more non-conductive tubular sections are flexible (fig.2 of Mizrahi or [0042] of PRZYGODA).
Regarding claim 7, Mizrahi/PRZYGODA teaches the device of claim 6, wherein at least one non-conductive tubular section of the one or more non-conductive tubular section is configured to allow bend (fig.2 of Mizrahi or [0042] of PRZYGODA). However, Mizrahi/PRZYGODA does not teach a bending angle of greater than 30 degree between two adjacent tubular conductors. It would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have the desired material that provides the required flexibility including the material that is configured to bend angle of greater than 30 degree between two adjacent tubular conductors, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 8, Mizrahi/PRZYGODA teaches the device of claim 7, wherein the tubular conductor includes stainless steel or carbon steel ([0062] of Mizrahi).
Regarding claim 9, Mizrahi/PRZYGODA teaches the device of claim 8, wherein the inductive coil includes electrically conductive material [0062].
Regarding claim 10, Mizrahi/PRZYGODA does not teach wherein the inductive coil includes varnished copper wire. It would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have the desired material including inductive coil includes varnished copper wire, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 11, Mizrahi/PRZYGODA teaches the device of claim 10, wherein the dielectric layer is configured to withstand high temperature and to insulate the tubular conductor and the inductive coil ([0062] of Mizrahi).
Regarding claim 12, Mizrahi/PRZYGODA teaches the device of claim 11, wherein the dielectric layer includes polyimide ([0052] of Mizrahi).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mizrahi et al. (US 2008/0167643) in view of PRZYGODA (US 2021/0393311) in further view of Olson et al. (US 2001/0014770).
Regarding claim 15, Mizrahi/PRZYGODA teaches wherein the heating element comprises a set of tubular conductors longitudinally spaced from one another along the shaft (fig.4A-B of PRZYGODA). However, Mizrahi/PRZYGODA does not teach wherein the inductive coil comprises a plurality of coil segments individually connected to the energy generator; wherein each coil segment of the plurality of coil segments is individually controllable and addressable. Olson teaches a system comprising a probe that includes an electrode array 94 (fig.13, see also [0066]. The system includes a handle 44 may also include a plurality of individual on-off switches for each electrode [0045]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Mizrahi/PRZYGODA with individually controlled coil electrodes as taught by Olson for the purpose of providing different type of treatments at the same time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thompson (US 2020/0345404) teaches a catheter for ablation within a varicose vein of a patient (fig.1), the catheter (fig.1; catheter 11) comprising: an elongated shaft (the elongated shaft of catheter 11) having a proximal end and a distal end; a tubular conductor (signal wires 49) formed from a magnetic material coupled to the distal end of the elongated shaft; an inductive coil (resistive element 14) helically wound over the tubular conductor; and a dielectric layer (layers 46) disposed between the tubular conductor and the inductive coil (fig.4).
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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