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 .
Election/Restrictions
Applicant’s election without traverse of Species IV including claims 1, 13, 83 and 89-107 in the reply filed on 04/28/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/23/2026 is being considered by the examiner.
Claim Objections
Claim 13, 83, 98, 99, 100, 102, 106 and 107 are objected to because of the following informalities:
Claim 13, line 4 recites “a first tether operatively coupled to the first ablation component; and,” should read -- a first tether operatively coupled to the first ablation component; and
Claim 83, line 7 recites “and the tether” should read -- and the first tether --;
Claim 96, line 2 recites “second ablation element comprise selectively engageable cooperating surface features” should read -- second ablation component comprise selectively engageable cooperating surface features --;
Claim 98, line 2 recites “through conduit sized to receive the first ablation component and the tether” should read -- through conduit sized to receive the first ablation component and the first tether --;
Claim 99, line 3 recites “and the tether” should read -- and the first tether –;
Claim 100, line 2 recites “dement or the second magnetic element comprises one or more of a permanent magnet an” should read -- element or the second magnetic element comprises one or more of a permanent magnet, an --;
Claim 100, line 3 recites “electromagnet or a ferromagnetic material”, should read -- electromagnet, or a ferromagnetic material --;
Claim 102, line 2 recites “element or the second magnetic clement comprises an electromagnet; and” should read -- element or the second magnetic element comprises an electromagnet; and --;
Claim 106, line 2 recites “through conduit sized to receive the first ablation component and the tether” should read -- through conduit sized to receive the first ablation component and the first tether --;
Claim 107, line 3 recites “and the tether” should read -- and the first tether --.
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 89, 92, 94, 95, 99, 100, 101, and 107 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 89, which recites “wherein the first ablation element and the first magnetic element are synonymous”, it is unclear at to what the applicant means by synonymous. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “synonymous” in claim 89 is used by the claim to mean “coexist,” while the accepted meaning is “wherein two things share the same meaning.” The term is indefinite because the specification does not clearly redefine the term. For purposes of examination, the examiner interprets this to mean that the first ablation element and the first magnetic element coexist on the same surface of the ablation component.
Claim 92, recites “wherein one or more of the first magnetic element or the second magnetic element comprises one or more of a permanent magnetic, an electromagnet, or a ferromagnetic element”, however it is unclear how the first and second magnetic elements can comprise “one or more of a permanent magnetic, an electromagnet, or a ferromagnetic element” as they are singular objects. It is unclear whether the magnetic elements are singular elements or comprise a plurality of elements.
Claim 94, recites “wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements”, however it is unclear as to how the first magnetic element and the second magnetic element which are singular objects can comprise a plurality of magnetic elements. It is unclear whether the magnetic elements are singular magnets or comprise a plurality of magnets.
Claim 95, recites “wherein one or more of the first ablation element or the second ablation element comprises a plurality of ablation elements”, however it is unclear as to how the first ablation element and the second ablation element which are singular objects can comprise a plurality of ablation elements. It is unclear whether the ablation elements are singular elements or comprise a plurality of elements.
Claim 99 recites “wherein the guide sheath includes a plurality of through conduits, at least one of which is sized to receive the first ablation component and the tether”, however claim 99 depends on claim 98, which mentions only one through conduit. It is unclear whether the guide sheath comprises more than one conduit.
Claim 100, recites “wherein one or more of the first magnetic element or the second magnetic element comprises one or more of a permanent magnetic, an electromagnet, or a ferromagnetic element”, however it is unclear how the first and second magnetic elements can comprise “one or more of a permanent magnetic, an electromagnet, or a ferromagnetic element” as they are singular objects. It is unclear whether the magnetic elements are singular elements or comprise a plurality of elements.
Claim 101, recites “wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements”, however it is unclear as to how the first magnetic element and the second magnetic element which are singular objects can comprise a plurality of magnetic elements. It is unclear whether the magnetic elements are singular magnets or comprise a plurality of magnets.
Claim 107 recites “wherein the guide sheath includes a plurality of through conduits, at least one of which is sized to receive the first ablation component and the tether”, however claim 99 depends on claim 98, which mentions only one through conduit. It is unclear whether the guide sheath comprises more than one conduit.
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.
Claim(s) 1, 13, 83, 89, 90, 91, 92, 93, 96, 100, 102, 103, and 105 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Doty et al. (US 20140142565 A1) herein referred to as “Doty”.
Regarding claim 1, Doty discloses an ablation system (system for ablating tissue, Abstract) comprising: a first ablation component configured to be positioned on a first side of a target tissue (first ablation component 50, Figure 6), the first ablation component comprising a first ablation element and a first magnetic element (magnetic electrode assembly 50 comprises transmitting element 21 and magnetic element, Paragraph [0057], Figure 6 and Figure 7) a first tether operatively coupled to the first ablation component (linkage 52 is a flexible linkage connected to epicardial electrode 50, Paragraph [0059], Figure 6); a second ablation component configured to be positioned on a second side of a target tissue (second ablation component 30, Figure 6), the second side being opposite the first side (first ablation component 50 and second ablation component 30 are on opposite sides of atrial wall 40, Figure 6), the second ablation component comprising a second ablation element and a second magnetic element (magnetic electrode assembly 30 comprises transmitting element 21 and magnetic element, Paragraph [0057], Figure 6 and Figure 7); wherein the first magnetic element and the second magnetic element are configured to cooperate to facilitate positioning at least one of the first ablation component and the second component on the target tissue (the electrical and magnetic interaction between electrode assemblies 30 and 50 are described, wherein the mutual magnetic force acts in the same general direction to pull the transmitting elements 21 into close proximity on opposite sides of the operative tissue, Figure 7, Paragraph [0064]); and wherein the first ablation element and the second ablation element are configured to cooperate to create a lesion in the target tissue (during an ablation procedure, wires 35 and 55 are connected to opposite electrical terminals of RF generator 90, with electrode assemblies 30 and 50 in optimal alignment, the RF circuit is completed through the operative tissue, As the electric current is applied, adjacent ions within the tissue begin to oscillate at the same frequency as the RF current. These ions experience opposing frictional forces, and the resulting thermal energy elevates the ambient temperature around the transmitting elements causing coagulation necrosis and cellular damage at temperatures between about 50° C and about 100° C, Paragraph [0064], Figure 6 and 7).
Regarding claim 13, Doty discloses an ablation system (system for ablating tissue, Abstract) comprising: a first ablation component configured to be positioned on a first side of a target tissue (first ablation component 50, Figure 6), the first ablation component comprising a first magnetic element (magnetic electrode assembly 50, Paragraph [0057], Figure 6 and Figure 7); a first tether operatively coupled to the first ablation component (linkage 52 is a flexible linkage connected to epicardial electrode 50, Paragraph [0059], Figure 6); and, a second ablation component configured to be positioned on a second side of a target tissue (second ablation component 30, Figure 6), the second side being opposite the first side (first ablation component 50 and second ablation component 30 are on opposite sides of atrial wall 40, Figure 6), the second ablation component comprising a second magnetic element (magnetic electrode assembly 30 comprises transmitting element 21 and magnetic element, Paragraph [0057], Figure 6 and Figure 7); wherein the first magnetic element and the second magnetic element are configured to cooperate to facilitate positioning at least one of the first ablation component and the second ablation component on the target tissue (the electrical and magnetic interaction between electrode assemblies 30 and 50 are described, wherein the mutual magnetic force acts in the same general direction to pull the transmitting elements 21 into close proximity on opposite sides of the operative tissue, Figure 7, Paragraph [0064]).
Regarding claim 83, Doty discloses an ablation device (system for ablating tissue, Abstract) comprising: a first ablation component configured to be positioned on a first side of a target tissue (first ablation component 50, Figure 6), the first ablation component comprising a first ablation element and a first magnetic element (magnetic electrode assembly 50 comprises transmitting element 21 and magnetic element, Paragraph [0057], Figure 6 and Figure 7); a first tether operatively coupled to the first ablation component (linkage 52 is a flexible linkage connected to epicardial electrode 50, Paragraph [0059], Figure 6); and, a catheter having a through conduit sized to receive the first ablation component and the tether (linkage 52 may be a flexible extension connectable to a subcutaneous probe or an intravenous catheter with sufficient slack, Paragraph [0062], .
Regarding claim 89, Doty discloses the ablation device of claim 83, wherein the first ablation element and the first magnetic element are synonymous (magnetic electrode assembly 50 comprises transmitting element 21 and magnetic element which are synonymous, Paragraph [0057], Figure 6 and Figure 7).
Regarding claim 90, Doty discloses the ablation device of claim 83, wherein the ablation device further includes an atraumatic distal tip (magnetic elements are atraumatic, Figure 6 and 7).
Regarding claim 91, Doty discloses the ablation device of claim 90, wherein the atraumatic distal tip comprises at least one of the first ablation element and the first magnetic element (magnetic electrode assembly 50 is atraumatic, Figure 6 and 7).
Regarding claim 92, Doty discloses the ablation system of claim 1, wherein one or more of the first magnetic element or the second magnetic element comprises one or more of a permanent magnet, an electromagnet, or a ferromagnetic material (Fig. 7 is a magnified side view of the device of Fig. 6, showing the direction of magnetic flux lines of the permanent magnets with respect to the direction of magnetic flux lines created by current flow in central conductors, Paragraph [0027], Paragraph [0052], and Paragraph [0057]).
Regarding claim 93, Doty discloses the system of claim 1, wherein one or more of the first ablation element or the second ablation element is configured for one or more of radiofrequency (RF) energy ablation, pulsed field ablation, cryoablation, ultrasound ablation, or laser ablation (during an ablation procedure, wires 35 and 55 are connected to opposite electrical terminals of RF generator 90, with electrode assemblies 30 and 50 in optimal alignment, the RF circuit is completed through the operative tissue, As the electric current is applied, adjacent ions within the tissue begin to oscillate at the same frequency as the RF current. These ions experience opposing frictional forces, and the resulting thermal energy elevates the ambient temperature around the transmitting elements causing coagulation necrosis and cellular damage at temperatures between about 50° C and about 100° C, Paragraph [0064], Figure 6 and 7). .
Regarding claim 96, Doty discloses the system of claim 1, wherein the first ablation component and the second ablation element comprise selectively engageable cooperating surface features configured to engage the target tissue therebetween (The device consists of two complementary magnetic electrode assemblies 30, 50 each having U-shaped magnetic core. Preferably, each electrode assembly 30, 50 has a construction similar to electrode assembly 100. Alternatively, one electrode assembly may include a magnetic core that is a permanent magnet, while the complementary electrode assembly may include a magnetic core that is a demagnetized (or unmagnetized) magnetic material, or stated otherwise, the complementary magnetic core may comprise a magnetically influenced material. In FIG. 6, an endocardial electrode assembly 30 is shown contacting an atrial wall 40 and facing an epicardial electrode assembly 50 that is contacting an opposite side of the atrial wall, Paragraph [0057], Figure 6).
Regarding claim 100, Doty discloses the system of claim 13, wherein one or more of the first magnetic dement or the second magnetic element comprises one or more of a permanent magnet an electromagnet or a ferromagnetic material (Fig. 7 is a magnified side view of the device of Fig. 6, showing the direction of magnetic flux lines of the permanent magnets with respect to the direction of magnetic flux lines created by current flow in central conductors, Paragraph [0027], Paragraph [0052], and Paragraph [0057]).
Regarding claim 102, Doty discloses the system of claim 13, wherein one or more of the first magnetic element or the second magnetic clement comprises an electromagnet (t is also contemplated that embodiments of an electrode assembly may include one or more inductive conductors oriented with respect to the magnetic core to form an electromagnet, such that energization of the inductive conductor with a DC current amplifies the magnetic field. In other or further embodiments, the permanent magnet cores discussed above can be augmented or replaced by such electromagnets. In certain embodiments, an electromagnet-based design could permit for adjustment of the magnetic field strength by the control system 590, Paragraph [0087]); and wherein the first magnetic element and the second magnetic element are configured to cooperate to facilitate positioning at least one of the first ablation component and the second component on the target tissue by energizing the electromagnet (For example, if the electrode assemblies are having difficulty aligning due to gravity, atrial wall topography, or some other obstruction, the control system may temporarily boost the strength of the magnetic field by adding or elevating DC current flow through the inductive conductor, up to a safe limit, until acceptable alignment is achieved. An additional isolated wire may be provided for energizing the inductive conductor. The control system may also allow the temporary boost to be initiated through manual action, Paragraph [0087]).
Regarding claim 103, Doty discloses the system of claim 13, wherein one or more of the first magnetic element or the second magnetic element is generally in the form of a cuboid, a cylinder, a horseshoe, a cone (In some embodiments, the magnetic member of an electrode assembly comprises a permanent magnet, which may be formed as a U-shaped trough from iron or other magnetic material. The U-shaped trough has a cross-member connecting two substantially parallel legs, with a north pole occurring on one end of the U and a south pole occurring on the other end of the U (i.e., horseshoe shaped), Paragraph [0016], Figure 6).
Regarding claim 105, Doty discloses the system of claim 13, wherein one or more of the first magnetic element or the second magnetic element is configured to control a magnetic clamping force between the first ablation component and the second ablation component (the electrical and magnetic interactions between the illustrated electrode assemblies 30 and 50 are described. In optimal alignment, the magnetic flux lines 45 of the magnetic cores pass from the north poles N to the south poles S in the directions shown, and the mutual magnetic force acts in the same general directions to pull the transmitting elements 21 into close proximity on opposite sides of the operative tissue, Paragraph [0064], Figure 7).
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.
Claim(s) 94, 95, 98, 101 and 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doty in view of Verin et al. (US 20110288544 A1) herein referred to as “Verin”.
Regarding claim 94, Doty discloses the system of claim 1.
However Doty does not explicitly disclose wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements.
Verin discloses a medical device for ablating tissues comprising magnets (Abstract) wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements (plurality of successive magnetic means 122, 123, the system places in a stable manner the two members which undergo magnetic coupling between them, the geometry allows such coupling over a certain distance which in turn allows an ablation over said distance as well when using several ablation elements, Paragraph [0074], Figure 23).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Verin by including wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements. The motivation to do so being to secure the system in a stable manner (Verin, Paragraph [0074]).
Regarding claim 95, Doty discloses the system of claim 1.
However Doty does not explicitly disclose wherein one or more of the first ablation element or the second ablation element comprises a plurality of ablation elements.
Verin discloses wherein one or more of the first ablation element or the second ablation element comprises a plurality of ablation elements (plurality of successive magnetic means 122, 123, the system places in a stable manner the two members which undergo magnetic coupling between them, the geometry allows such coupling over a certain distance which in turn allows an ablation over said distance as well when using several ablation elements, Paragraph [0074], Figure 23).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Verin by including wherein one or more of the first ablation element or the second ablation element comprises a plurality of ablation elements. The motivation to do so being to allow for an ablation over a larger distance (Verin, Paragraph [0074]).
Regarding claim 98, Doty discloses the system of claim 1.
However Doty does not explicitly disclose wherein the system further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether.
Verin discloses wherein the system further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether (To help the guiding and placement of catheter 121 before ablation, one preferably uses an external guiding relatively rigid sheath 126 that can be removed once the catheters are properly positioned to then carry out the ablation step. Of course other equivalent means may be used to help bringing the catheter(s) in position (guidewires etc.), Paragraph [0075]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Verin by including wherein the system further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether. The motivation to do so being to guide placement of the catheter before ablation (Verin, Paragraph [0075]).
Regarding claim 101, Doty discloses the system of claim 13.
However Doty does not explicitly disclose is wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements.
Verin discloses a medical device for ablating tissues comprising magnets (Abstract) wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements (plurality of successive magnetic means 122, 123, the system places in a stable manner the two members which undergo magnetic coupling between them, the geometry allows such coupling over a certain distance which in turn allows an ablation over said distance as well when using several ablation elements, Paragraph [0074], Figure 23).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Verin by including wherein one or more of the first magnetic element or the second magnetic element comprises a plurality of magnetic elements. The motivation to do so being to secure the system in a stable manner (Verin, Paragraph [0074]).
Regarding claim 106, Doty discloses the system of claim 1.
However Doty does not explicitly disclose wherein the device further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether.
Verin discloses wherein the system further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether (To help the guiding and placement of catheter 121 before ablation, one preferably uses an external guiding relatively rigid sheath 126 that can be removed once the catheters are properly positioned to then carry out the ablation step. Of course other equivalent means may be used to help bringing the catheter(s) in position (guidewires etc.), Paragraph [0075]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Verin by including wherein the system further comprises a guide sheath having a through conduit sized to receive the first ablation component and the tether. The motivation to do so being to guide placement of the catheter before ablation (Verin, Paragraph [0075]).
Claim(s) 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doty in view of Holmes et al. (US 20180360531 A1) herein referred to as “Holmes”.
Regarding claim 97, Doty discloses the system of claim 1.
However Doty does not explicitly disclose wherein one of the first ablation component or the second ablation component comprises a tissue anchor, the tissue anchor being configured to secure the one of the first ablation component or the second ablation component to the target tissue.
Holmes discloses an ablation catheter device (Paragraph [0008]) wherein the device comprises a tissue anchor configured to secure the ablation component to the target tissue (the expandable end portion 132 includes one or more vacuum applying elements that serve to suction expandable end portion 132 into sealed contact with the wall of left atrium 102, mechanical elements (e.g., helical anchors and the like) can be included in some embodiments, Paragraph [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty to incorporate
the teachings of Holmes by including wherein the device comprises a tissue anchor configured to secure the ablation component to the target tissue. The motivation to do so being to anchor the ablation device into sealed contact with the tissue (Holmes, Paragraph [0069]).
Claim(s) 99 and 107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doty in view of Verin further in view of Narayan et al. (US 20200238058 A1) herein referred to as “Narayan”.
Regarding claim 99, Doty in view of Verin discloses the system of claim 98.
However Doty does not explicitly disclose wherein the guide sheath includes a plurality of through conduits, at least one of which is sized to receive the first ablation component and the tether.
Verin discloses the guide sheath is sized to receive the first ablation component and the tether (see claim 98), however Verin does not explicitly disclose wherein the guide sheath includes a plurality of through conduits.
Narayan discloses a magnetic catheter system (Paragraph [0003]) wherein the guide sheath includes a plurality of through conduits (catheter illustrating a first lumen 1030 configured to house the elongate member 1015 including axially spaced apart magnets, and a second lumen 1032 configured to house a guidewire for an over-the-wire purpose or to house a puncture wire mechanism, Paragraph [0110], Figure 10E).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty in view of Verin to incorporate the teachings of Narayan by including wherein the guide sheath includes a plurality of through conduits. The motivation to do so being to include a second lumen configured to house a guidewire or to house a puncture wire mechanism (Narayan, Paragraph [0110]).
Regarding claim 107, Doty in view of Verin discloses the system of claim 106.
However Doty does not explicitly disclose wherein the guide sheath includes a plurality of through conduits, at least one of which is sized to receive the first ablation component and the tether.
Verin discloses the guide sheath is sized to receive the first ablation component and the tether (see claim 98), however Verin does not explicitly disclose wherein the guide sheath includes a plurality of through conduits.
Narayan discloses a magnetic catheter system (Paragraph [0003]) wherein the guide sheath includes a plurality of through conduits (catheter illustrating a first lumen 1030 configured to house the elongate member 1015 including axially spaced apart magnets, and a second lumen 1032 configured to house a guidewire for an over-the-wire purpose or to house a puncture wire mechanism, Paragraph [0110], Figure 10E).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty in view of Verin to incorporate the teachings of Narayan by including wherein the guide sheath includes a plurality of through conduits. The motivation to do so being to include a second lumen configured to house a guidewire or to house a puncture wire mechanism (Narayan, Paragraph [0110]).
Claim(s) 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doty in view of Wan et al. (US 20040260273 A1) herein referred to as “Wan”.
Regarding claim 104, Doty discloses the system of claim 13.
Doty discloses wherein one or more of the first magnetic element or the second magnetic element comprises an electromagnet, however Doty does not explicitly disclose wherein the electromagnet comprising two or more selectively energizable coils.
Wan discloses a magnetic surgical instrument (Abstract) wherein one or more of the first magnetic element or the second magnetic element comprises an electromagnet comprising two or more selectively energizable coils (magnetic probes 202, 208, the magnetic force produced by the electromagnets 212, 214, the magnetic clamping force can be varied by varying the number of energized coils associated with the electromagnet, Paragraph [0028], (i.e., the electromagnet can include two or more selectively energizable coils)).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Doty to incorporate the teachings of Wan by including wherein one or more of the first magnetic element or the second magnetic element comprises an electromagnet comprising two or more selectively energizable coils. The motivation to do so being to produce sufficient magnetic clamping pressure to clamp or tightly sandwich the walls of the anatomic structure to perform the surgical operation by varying the amount of energized coils (Wan, Paragraph [0028]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hooven et al. (US 2005/0187545 A1) discloses a method and apparatus for ablation wherein the first and second bodies are applied on opposed sides of tissue and magnetically attractive elements, Opolski (US 7618435 B2) discloses a magnetic attachment device for use in a transcatheter delivery system, Krishnan (US 2016/0184011 A1) discloses a dual catheter ablation system comprising magnetic elements, and Rupley et al. (US 2024/0050151 A1) discloses a magnetic ablation system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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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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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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