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 with traverse of Group I, claims 1-23 in the reply filed on November 20th, 2025 is acknowledged. The traversal is on the grounds that the shared technical feature of: "one or more longitudinal elements, configured to pass through a sheath within a body of a subject; and one or more expandable multilayered electrode elements coupled to the longitudinal elements and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath, each of the electrode elements comprising: one or more reference electrodes; and one or more active electrodes configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes" does make a contribution over Sepetka, because Sepetka apparently does not disclose an expandable multilayered electrode element. This is not found persuasive because Sepetka discloses an expandable element/retriever wherein each arm of the expandable element/retriever 12 comprises bipolar electrodes ([0087]; Figure 29—element 12), Sepetka further discloses that the retriever 12 “may be made of a material such as nitinol, stainless steel, cobalt chromium, or combinations therein ([0049]), as the expandable element 12 is formed of a material (e.g. nitinol, stainless steel, cobalt chromium, or combinations therein) and also comprises bipolar electrodes (e.g. a second material) (as shown in Figure 29) the examiner is considering the retriever 12 to be an “expandable multilayered electrode element”, as the retriever comprises layered materials (e.g. the material of the retriever itself and the material of the bipolar electrodes).
Claim Objections
Claim 1 is objected to because of the following informalities: “each of the electrode elements” (line 8) should be – each of the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “the electrode elements” (line 11) should be –the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “the active electrodes and the reference electrodes” (line 12) should be – the one or more active electrodes and the one or more reference electrodes —; as introduced in claim 1. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: “the longitudinal elements” (line 1) should be – the one or more longitudinal elements—; as introduced in claim 1. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: “the electrode elements” (lines 2-3) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “the loops” (line 2) should be – the one or more loops—; as introduced in claim 7. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “the loops” (line 1) should be – the one or more loops—; as introduced in claim 7. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “the proximal loops” (line 4) should be – the one or more proximal loops—; as introduced in claim 7. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “the strip” (lines 2-4) should be – the multilayered strip—; as introduced in claim 13. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “the reference electrodes” (line 2) should be – the one or more reference electrodes—; as introduced in claim 1. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “the active electrodes” (line 3) should be – the one or more active electrodes—; as introduced in claim 1. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “the active layers” (line 5) should be – the one or more active layers—; as introduced in claim 14. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “the active layers” (line 1) should be – the one or more active layers—; as introduced in claim 14. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “the insulating layers” (line 2) should be – the one or more insulating layers—; as introduced in claim 14. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “the active layer” (line 3) should be – the single active layers—; as introduced in claim 15. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “the active layers” (line 2) should be – the one or more active layers—; as introduced in claim 14. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “the insulating layers” (line 4) should be – the one or more insulating layers—; as introduced in claim 14. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “the active layers” (line 1) should be – the one or more active layers—; as introduced in claim 14. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “the insulating layers” (line 2) should be – the one or more insulating layers—; as introduced in claim 14. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “the outer gaps” (line 2) should be – the one or more outer gaps—; as introduced in claim 17. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “the insulating layers” (lines 1-2) should be – the one or more insulating layers—; as introduced in claim 14. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “the active layers” (line 2) should be – the one or more active layers—; as introduced in claim 14. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “the strip” (line 1) should be – the multilayered strip—; as introduced in claim 13. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “the reference electrodes and a respective one of the active electrodes” (lines 2-3) should be – the one or more reference electrodes and a respective one of the one or more active electrodes —; as introduced in claim 1. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “the reference electrodes and the respective one of the active electrodes” (lines 1-2) should be – the one or more reference electrodes and the respective one of the one or more active electrodes —; as introduced in claim 1. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: “the electrode elements” (line 2) should be – the one or more expandable multilayered electrode elements—; as introduced in claim 1. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: “the reference electrodes” (line 3) should be – the one or more reference electrodes—; as introduced in claim 1. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: “the active electrodes” (line 5) should be – the one or more active electrodes—; as introduced in claim 1. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: “the outer gaps” (line 3) should be – the one or more outer gaps—; as introduced in claim 22. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “the electrode elements” (lines 7-10) should be – the one or more expandable electrode elements—; as introduced in claim 23. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “the active electrodes” (line 10) should be – the one or more active electrodes—; as introduced in claim 23. Appropriate correction is required.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinke (US 20080262489 A1), hereinafter “Steinke”.
Regarding claim 1, Steinke discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0083], [0090], & [0095]; Figure 3—element 14; a sheath can be withdrawn from around the expandable structure 26 and catheter 14 to allow the expandable body 26 to flex radially outward); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0090], [0091], & [0128]; Figure 4—elements 50 & 54; Figure 17C—elements 306; the examiner is considering the one or more expandable multilayered electrode elements to be the struts 54 that comprise electrodes 50 mounted thereon, as there would be at least two layers (e.g. the strut material 54 and the electrode material 50) the examiner is considering the elements to be multi-layered)); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus, each of the electrode elements comprising: one or more reference electrodes; and one or more active electrodes configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], [0091], [0128], & [0245]; Figure 4—elements 50; Figure 17C—elements 306; bipolar energy may be directed between electrodes 50; Figure 17C portrays each multilayered electrode elements comprising multiple electrodes 306 that can be activated in a bipolar manner).
Regarding claim 2, Steinke discloses all of the limitations of claim 1, as described above.
Steinke further discloses the sheath ([0090] & [0095]; the examiner is considering the sheath to be the restraining sheath which may be withdrawn to expand the expandable body).
Claims 1-4, 7, 10-11, 13-15, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meadowcroft et al. (US 20190110837 A1), hereinafter “Meadowcroft”, in light of Steinke.
Regarding claim 1, in a first interpretation, Meadowcroft discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0065] & [0102]; Figures 13A-13D—element 206; in the first interpretation, the examiner is considering the one or more longitudinal elements to be the coaxial cable 206); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—elements 410; the applicator structure may comprise multilayered elements 410, composed of dielectric, comprising a first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206 and a second electrically conductive material 412 on a front surface of the dielectric 410, which is configured to act as radiating elements, the radiating elements are electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206); Figures 13B-13D show that the one or more multilayered electrode elements can be expandable; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator)); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus ([0065] & [0104]-[0108]; Figures 13B-13D—element 202), each of the electrode elements comprising: one or more reference electrodes ([0010], [0012], [0018], [0061], [0102]-[0108]; Figure 13A—element 412; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the one or more reference electrodes to be the second electrically conductive material 412 on a front surface of the dielectric 410, which is configured to be electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206)); and one or more active electrodes ([0010], [0012], [0018], [0061], [0102]-[0108]; Figure 13A—element 410; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the one or more active electrodes to be the first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206) configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0007], [0010], [0012], [0018], [0061]; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator to ablate tissue; although Meadowcroft is silent to the one or more active electrodes “configured to attract the thrombus”; however, the Steinke reference teaches that it is known in the art for one or more active electrodes, in an RF ablation device, to be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], & [0245]-[0247]), therefore it is the examiners position that the one or more active electrodes, of Meadowcroft, would be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes, in light of the teachings of Steinke, as both references are directed toward bipolar ablation devices configured to deliver RF energy).
Regarding claim 1, in a second interpretation, Meadowcroft discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0107]; Figure 13C—element 432; in the second interpretation, the examiner is considering the one or more longitudinal elements to be the control rod 432 that is attached to the distal end of the multilayered element 410); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—elements 410; the applicator structure may comprise multilayered elements 410, composed of dielectric, comprising a first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206 and a second electrically conductive material 412 on a front surface of the dielectric 410, which is configured to act as radiating elements, the radiating elements are electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206); Figures 13B-13D show that the one or more multilayered electrode elements can be expandable; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator)); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus ([0065] & [0104]-[0108]; Figures 13B-13D—element 202), each of the electrode elements comprising: one or more reference electrodes ([0010], [0012], [0018], [0061], [0102]-[0108]; Figure 13A—element 412; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the one or more reference electrodes to be the second electrically conductive material 412 on a front surface of the dielectric 410, which is configured to be electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206); and one or more active electrodes ([0010], [0012], [0018], [0061], [0102]-[0108]; Figure 13A—element 410; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the one or more active electrodes to be the first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206) configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0007], [0010], [0012], [0018], [0061]; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator to ablate tissue; although Meadowcroft is silent to the one or more active electrodes “configured to attract the thrombus”; the Steinke reference teaches that it is known in the art for one or more active electrodes, in an RF ablation device, to be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], & [0245]-[0247]), therefore it is the examiners position that the one or more active electrodes, of Meadowcroft, would be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes, in light of the teachings of Steinke, as both references are directed toward bipolar ablation devices configured to deliver RF energy).
Regarding claim 2, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses the sheath ([0065] & [0104]-[0108]; Figure 13B-13D—element 202).
Regarding claim 3, in the first interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein the longitudinal elements comprise a proximally-coupled longitudinal element coupled to respective proximal ends of the electrode elements ([0065] & [0102]; Figures 13A-13D—element 206 & 410).
Regarding claim 4, in the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein the longitudinal elements comprise a distally-coupled longitudinal element coupled to respective distal ends of the electrode elements ([0107]; Figure 13C—elements 410 & 432).
Regarding claim 7, in the first interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein the electrode elements are configured to expand so as to define one or more loops ([0108]; Figure 13D—element 410).
Regarding claim 10, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein at least one of the electrode elements has a sinusoidal shape when expanded ([0107]; Figure 13C—element 410; the examiner is considering the helical coil shape to be a sinusoidal shape).
Regarding claim 11, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein at least one of the electrode elements has a helical shape when expanded ([0107]; Figure 13C—element 410).
Regarding claim 13, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft further discloses wherein each of the electrode elements comprises a multilayered strip ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—element 410).
Regarding claim 14, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 13, as described above.
Meadowcroft further discloses wherein a reference layer of the strip comprises the reference electrodes, wherein one or more active layers of the strip comprise the active electrodes, and wherein the strip further comprises one or more insulating layers that electrically insulate the reference layer from the active layers ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—elements 410 & 412; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the reference layer that comprises the one or more reference electrodes to be the second electrically conductive material 412 on a front surface of the dielectric 410, which is configured to be electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206), the one or more active layers that comprise the one or more active electrodes to be the first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206, and the one or more insulating layers to be the dielectric 410).
Regarding claim 15, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 14, as described above.
Meadowcroft further discloses wherein the active layers consist of a single active layer, and wherein the insulating layers consist of a single insulating layer disposed between the reference layer and the active layer ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—elements 410 & 412; the examiner is considering the single active layers to be the first electrically conductive material (not shown) on a back surface of the dielectric 410 which is connected to the inner conductor of the coaxial cable 206, and the single insulating layers to be the dielectric 410 that is disposed between the reference layer 412 and the active layer (not shown)).
Regarding claim 19, in the first interpretation and the second interpretation, Meadowcroft in light of Steinke disclose all of the limitations of claim 13, as described above.
Meadowcroft further discloses wherein the strip comprises: a substrate layer; and one or more electrode layers mounted to the substrate layer, each of the electrode layers comprising a respective one of the reference electrodes and a respective one of the active electrodes ([0010], [0012], [0018], [0061], & [0102]-[0108]; Figures 13A-13D—elements 410 & 412; the coaxial cable is capable of conveying radiofrequency and microwave energy from the generator, and the applicator may act as a bipolar radiator; the examiner is considering the substrate layer to be the dielectric 410; and the one or more electrode layers to be the one or more reference electrodes 412 that are disposed on a front surface of the dielectric 410 and are configured to be electrically grounded (e.g. by being electrically connected to the outer conductor of the coaxial cable 206) and the one or more active electrodes (not shown) that are disposed on a back surface of the dielectric 410 and are connected to the inner conductor of the coaxial cable 206).
Claims 1-3, 7, 13, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lagodzki (US 20120101499 A1), hereinafter “Lagodzki”, in light of Steinke.
Regarding claim 1, Lagodzki discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0048]; Figure 10—element 44); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0040], [0041], [0048]; Figures 1 & 10—elements 14, 16, 18, & 46); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus ([0047] & [0048]; Figure 10—element 38) each of the electrode elements comprising: one or more reference electrodes ([0003], [0040], & [0041]; Figures 1-3 & 10—elements 14/24 & 16/22; the inner bipolar electrode 14 comprises first and second poles 22 and the outer bipolar electrode 16 comprises first and second poles 24; the examiner is considering the one or more reference electrodes to be the second poles 22 & 24 of the inner and outer electrodes 14 & 16); and one or more active electrodes ([0003], [0040], & [0041]; Figures 1-3 & 10—elements 14/24 & 16/22; the inner bipolar electrode 14 comprises first and second poles 22 and the outer bipolar electrode 16 comprises first and second poles 24; the examiner is considering the one or more active electrodes to be the first poles 22 & 24 of the inner and outer electrodes 14 & 16) configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0040]; the proximal end of the active electrodes and reference electrodes are coupled to a bipolar energy generator to ablate tissue; although Lagodzki is silent to the one or more active electrodes “configured to attract the thrombus”, the Steinke reference teaches that it is known in the art for one or more active electrodes, in a bipolar ablation device, to be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], & [0245]-[0247]), therefore it is the examiners position that the one or more active electrodes, of Lagodzki, would be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes, in light of the teachings of Steinke, as both references are directed toward bipolar ablation devices).
Regarding 2, Lagodzki in light of Steinke disclose all of the limitations of claim 1, as described above.
Lagodzki further discloses the sheath ([0047] & [0048]; Figure 10—element 38).
Regarding 3, Lagodzki in light of Steinke disclose all of the limitations of claim 1, as described above.
Lagodzki further discloses wherein the longitudinal elements comprise a proximally-coupled longitudinal element coupled to respective proximal ends of the electrode elements ([0048]; Figure 10—element 44).
Regarding 7, Lagodzki in light of Steinke disclose all of the limitations of claim 1, as described above.
Lagodzki further discloses wherein the electrode elements are configured to expand so as to define one or more loops ([0048]; Figure 10—element 46).
Regarding 13, Lagodzki in light of Steinke disclose all of the limitations of claim 1, as described above.
Lagodzki further discloses wherein each of the electrode elements comprises a multilayered strip ([0040]-[0042]; Figures 2-8—elements 18, 14/24, & 16/22).
Regarding 19, Lagodzki in light of Steinke disclose all of the limitations of claim 1, as described above.
Lagodzki further discloses wherein the strip comprises: a substrate layer; and one or more electrode layers mounted to the substrate layer, each of the electrode layers comprising a respective one of the reference electrodes and a respective one of the active electrodes ([0040]-[0042]; Figures 2-8—elements 18, 14/24, & 16/22; with the substrate layer being the insulation layer, and the one or more electrode layers being the bipolar electrodes 14 & 16 including respective poles 24 & 22).
Claims 1 & 4-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dale et al. (US 20220226041 A1), hereinafter “Dale”, in light of Steinke.
Regarding claim 1, in a first interpretation, Dale discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0032]-[0034]; Figures 1-3—element 120; in the first interpretation, the examiner is considering the longitudinal element to be the distal end 120 of the electrode assembly 114; the apparatus may comprise a guide catheter or sheath); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0033], [0034], [0037], & [0071]; Figures 1-4 & 10-11—elements 114, 204, & 304; the examiner is considering the multilayered electrode element to be the electrode assembly 114 which is formed of an inner basket 204 comprising struts 224 and outer basket 304 comprising struts 324; the basket struts may be coated with insulating material 128 over the inner and outer surfaces to define conductive portions 130; as the expandable multilayered electrode elements comprise the strut material and insulating material the examiner is considering them to be multi-layered); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus ([0032] & [0034]) each of the electrode elements comprising: one or more reference electrodes ([0065]; Figures 2-4—element 204; the inner basket 204 of the electrode element 114 functions as a negative electrode); and one or more active electrodes ([0065]; Figures 2-4—element 204; the outer basket 204 of the electrode element 114 functions as a positive electrode) configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0029]-[0031], [0065]; the negative electrode and the positive electrode are coupled to a generator to ablate tissue; although Dale is silent to the one or more active electrodes “configured to attract the thrombus”, the Steinke reference teaches that it is known in the art for one or more active electrodes, in a bipolar ablation device, to be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], & [0245]-[0247]), therefore it is the examiners position that the one or more active electrodes, of Dale, would be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes, in light of the teachings of Steinke, as both references are directed toward bipolar ablation devices).
Regarding claim 1, in a second interpretation, Dale discloses an apparatus, comprising: one or more longitudinal elements, configured to pass through a sheath within a body of a subject ([0032]-[0034]; Figures 1-3—element 118; in the second interpretation, the examiner is considering the longitudinal element to be the proximal end 118 of the electrode assembly 114; the apparatus may comprise a guide catheter or sheath); and one or more expandable multilayered electrode elements coupled to the longitudinal elements ([0033], [0034], [0037], & [0071]; Figures 1-4 & 10-11—elements 114, 204, & 304; the examiner is considering the multilayered electrode element to be the electrode assembly 114 which is formed of an inner basket 204 comprising struts 224 and outer basket 304 comprising struts 324; the basket struts may be coated with insulating material 128 over the inner and outer surfaces to define conductive portions 130; as the expandable multilayered electrode elements comprise the strut material and insulating material the examiner is considering them to be multi-layered); and configured to: advance to a thrombus in the body while collapsed inside the sheath, and expand distally to the sheath following the advance to the thrombus ([0032] & [0034]) each of the electrode elements comprising: one or more reference electrodes ([0065]; Figures 2-4—element 204; the inner basket 204 of the electrode element 114 functions as a negative electrode); and one or more active electrodes ([0065]; Figures 2-4—element 204; the outer basket 204 of the electrode element 114 functions as a positive electrode) configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the reference electrodes ([0029]-[0031], [0065]; the negative electrode and the positive electrode are coupled to a generator to ablate tissue; although Dale is silent to the one or more active electrodes “configured to attract the thrombus”, the Steinke reference teaches that it is known in the art for one or more active electrodes, in a bipolar ablation device, to be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes ([0013], [0088], & [0245]-[0247]), therefore it is the examiners position that the one or more active electrodes, of Dale, would be capable of attracting a thrombus upon application of a voltage between the active electrodes and the reference electrodes, in light of the teachings of Steinke, as both references are directed toward bipolar ablation devices).
Regarding claims 4-6, in the first interpretation, Dale in light of Steinke disclose all of the limitations of claim 1, as described above.
Dale further discloses wherein the longitudinal elements comprise a distally-coupled longitudinal element coupled to respective distal ends of the electrode elements (claim 4); wherein the distally-coupled longitudinal element comprises: a longitudinal-element active electrode; a longitudinal-element reference electrode disposed inside the longitudinal- element active electrode; and an electrically-insulating element disposed between the longitudinal-element reference electrode and the longitudinal-element active electrode (claim 5); wherein the distally-coupled longitudinal element extends distally to the electrode elements (claim 6) ([0033], [0037], [0038], [0050], [0065], & [0070]; Figures 2 & 4-6—elements 120, 128, 214, & 314; in the first interpretation, the examiner is considering the distally-coupled longitudinal element to be the distal end 120 of the electrode assembly 114; which comprises longitudinal element reference electrode 214, longitudinal element active electrode 314 separated by insulator 128).
Regarding claims 7-8, in the second interpretation, Dale in light of Steinke disclose all of the limitations of claim 1, as described above.
Dale further discloses wherein the electrode elements are configured to expand so as to define one or more loops (claim 7) ([0034], [0041], [0053]; Figures 1—elements 114, 224, & 324; the examiner is considering the one or more loops to be defined by each of the struts 224, & 324 of the electrode element 114 in the expanded configuration); further comprising a distal electrode element disposed at respective distal ends of the loops and comprising: a distal active electrode; a distal reference electrode disposed inside the distal active electrode; and a distal electrically-insulating element disposed between the distal reference electrode and the distal active electrode (claim 8) ([0033], [0037], [0038], [0050], [0065], & [0070]; Figures 2 & 4-6—elements 120, 128, 214, & 314; the examiner is considering the distal electrode element to be the distal end 120 of the electrode assembly 114; which comprises a distal reference electrode 214 and a distal active electrode 314 separated by a distal insulator 128).
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 9 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Meadowcroft, in light of Steinke, and further in view of Solis et al. (US 20170027638 A1), hereinafter “Solis”.
Regarding claim 9, Meadowcroft in light of Steinke disclose all of the limitations of claim 7, as described above.
Meadowcroft does not disclose wherein the loops include: a proximal set of one or more proximal loops; and a distal set of one or more distal loops coupled to respective distal ends of the proximal loops, the distal set having a maximal width that is less than that of the proximal set.
Solis teaches an expandable multi-layered electrode element comprising one or more loops ([0033]; Figure 1—element 16; with the loop being defined by the basket shaped electrode assembly 16), wherein the loops include: a proximal set of one or more proximal loops; and a distal set of one or more distal loops coupled to respective distal ends of the proximal loops, the distal set having a maximal width that is less than that of the proximal set ([0034] & [0040]; Figure 2—element 32 & 34; the proximal loop being the proximal convex portion 34 and the distal loop being the distal convex portion 32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the loop shape, as disclosed by Meadowcroft, to include wherein the loops include: a proximal set of one or more proximal loops; and a distal set of one or more distal loops coupled to respective distal ends of the proximal loops, the distal set having a maximal width that is less than that of the proximal set, as taught by Solis, as both references and the claimed invention are directed toward electrosurgical devices comprising expandable multi-layered electrode elements. As disclosed by Solis, the expandable electrode element may comprise a proximal loop and a distal loop, the distal loop having a maximum width that is less than the proximal loop so as to correspond to smaller and larger diameter treatment regions ([0007], [0037], & [0040]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the loop shape, as disclosed by Meadowcroft, to include wherein the loops include: a proximal set of one or more proximal loops; and a distal set of one or more distal loops coupled to respective distal ends of the proximal loops, the distal set having a maximal width that is less than that of the proximal set, as taught by Solis, as such a modification would allow for the expandable electrode element shape to correspond to different sized treatment regions.
Regarding claim 12, Meadowcroft in light of Steinke disclose all of the limitations of claim 1, as described above.
Meadowcroft does not disclose wherein the electrode elements are configured to expand to define a shape having a width that decreases moving distally along a distal portion of the shape.
Solis teaches an expandable multi-layered electrode element ([0033]; Figure 1—element 16), wherein the electrode elements are configured to expand to define a shape having a width that decreases moving distally along a distal portion of the shape ([0034] & [0040]; Figure 2—element 32 & 34; the proximal portion 34 comprising a larger width than the distal portion 32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the expandable electrode shape, as disclosed by Meadowcroft, to include wherein the electrode elements are configured to expand to define a shape having a width that decreases moving distally along a distal portion of the shape, as taught by Solis, as both references and the claimed invention are directed toward electrosurgical devices comprising expandable multi-layered electrode elements. As disclosed by Solis, the expandable electrode element may comprise a proximal portion and a distal portion, the distal portions having a width that is less than the proximal portion so as to correspond to smaller and larger diameter treatment regions ([0007], [0037], & [0040]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expandable electrode shape, as disclosed by Meadowcroft, to include wherein the electrode elements are configured to expand to define a shape having a width that decreases moving distally along a distal portion of the shape, as taught by Solis, as such a modification would allow for the expandable electrode element shape to correspond to different sized treatment regions.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Meadowcroft, in light of Steinke, and further in view of Haverkost et al. (US 20140378966 A1), hereinafter “Haverkost”.
Regarding claim 18, Meadowcroft in light of Steinke disclose all of the limitations of claim 14, as described above.
Meadowcroft does not disclose wherein at least one of the insulating layers is narrower than (i) the reference layer, or (ii) an adjacent one of the active layers.
Haverkost teaches a multi-layered electrode comprising an insulating layer, a reference layer, and an active layer ([0041] & [0053]; Figure 5—elements 202 & 222), wherein at least one of the insulating layers is narrower than (i) the reference layer, or (ii) an adjacent one of the active layers ([0047] & [0053]; the electrodes 222 may be 0.038 mm thick while the insulating layer 202 may be 0.01 to 0.02 mm thick).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the insulating, reference, and active layers, as disclosed by Meadowcroft, to include wherein at least one of the insulating layers is narrower than (i) the reference layer, or (ii) an adjacent one of the active layers, as taught by Haverkost, as both references and the claimed invention are directed toward electrosurgical devices comprising expandable multi-layered electrodes. As disclosed by Haverkost, the insulating layer may be from about 0.01 to 0.02 mm thick, while the bipolar electrodes may be about 0.038 mm thick ([0041], [0047], & [0053]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the insulating, reference, and active layers, as disclosed by Meadowcroft, to include wherein at least one of the insulating layers is narrower than (i) the reference layer, or (ii) an adjacent one of the active layers, as taught by Haverkost, as such a modification would provide for a known and suitable thickness for insulating layers and bipolar electrodes of an expandable multi-layered electrode; the examiner further notes it would have been an obvious matter of design choice to include wherein at least one of the insulating layers is narrower than (i) the reference layer, or (ii) an adjacent one of the active layers, since such a modification would have involved a mere change in the size of a component; a change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lagodzki in light of Steinke, and further in view of Viswanathan (US 20220071699 A1), hereinafter “Viswanathan”.
Regarding claim 20, Lagodzki in light of Steinke disclose all of the limitations of claim 19, as described above.
Lagodzki does not disclose wherein the respective one of the reference electrodes and the respective one of the active electrodes protrude into one another.
Viswanathan teaches an electrosurgical device comprising a reference electrode and an active electrode ([0088]; Figure 17A—element 1711 & 1712), wherein the respective one of the reference electrodes and the respective one of the active electrodes protrude into one another ([0088]; Figure 17A—elements “V” & “P”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the reference electrode and active electrode, as disclosed by Lagodzki, to include wherein the respective one of the reference electrodes and the respective one of the active electrodes protrude into one another, as taught by Viswanathan, as both references and the claimed invention are directed toward electrosurgical devices comprising bipolar electrodes. As disclosed by Viswanathan, the reference electrode and active electrodes may have contoured edges that are synchronized (e.g. a valley of the reference electrode is synchronized with a peak of the active electrode), the contoured configuration of the electrodes reduce current densities at the electrode edges ([0026] & [0088]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the reference electrode and active electrode, as disclosed by Lagodzki, to include wherein the respective one of the reference electrodes and the respective one of the active electrodes protrude into one another, as taught by Viswanathan, as such a modification would provide for an electrode configuration that reduces current density at the electrode edges.
Claim 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (previously presented-US 20140277013 A1), hereinafter “Sepetka”, in view of Meadowcroft.
Regarding claim 23, Sepetka discloses an apparatus, comprising: one or more expandable electrode elements configured to advance to a thrombus in a body of a subject while collapsed inside a sheath within the body, and to expand distally to the sheath following the advance to the thrombus ([0048], [0049], [0086], [0087], & [0089]; Figure 31—element 12 & 18; the examiner is considering the one or more expandable electrode elements to be the retriever 12 which comprises a positive electrode); and an electrically-conductive longitudinal element coupled to respective distal ends of the electrode elements and configured to pass through the sheath ([0086], [0087], & [0089]; Figure 31—elements 38 & 40; the examiner is considering the electrically-conductive longitudinal element to be the guidewire 40 which may be a negative electrode; the guide wire 40 is coupled to a distal end of the one or more electrode elements via marker 38), each of the electrode elements comprising one or more active electrodes configured to attract the thrombus, following the expansion of the electrode elements, upon application of a voltage between the active electrodes and the longitudinal element ([0047], [0086], [0087], & [0089]; Figure 31—element 12 & 40).
Sepetka does not disclose the one or more expandable electrode elements configured to expand distally so as to define one or more loops.
Meadowcroft teaches an electrosurgical device comprising one or more expandable electrode elements ([0102]-[0108]; Figures 12A-13D—elements 410), wherein the one or more expandable electrode elements configured to expand distally so as to define one or more loops ([0020] & [0108]; Figure 13A—element 410).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the shape of the expandable electrode elements, as disclosed by Sepetka, to include the one or more expandable electrode elements configured to expand distally so as to define one or more loops, as taught by Meadowcroft, as both references and the claimed invention are directed toward electrosurgical devices comprising expandable electrode elements. As disclosed by Sepetka the one or more expandable electrode elements may comprise any number of different shapes and configurations, for example the expandable electrode element may be helical ([0048], [0059], [0066], & [0089]). As disclosed by Meadowcroft, the one or more expandable electrode elements may comprise a helical shape or looped shape ([0020], [0107], & [0108]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the shape of the expandable electrode elements, as disclosed by Sepetka, to include the one or more expandable electrode elements configured to expand distally so as to define one or more loops, as taught by Meadowcroft, as such a modification of providing a looped shape expandable electrode element is a known and suitable alternative in the art to providing a helically shaped expandable electrode element.
Allowable Subject Matter
Claims 16-17 & 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The references cited in the above rejections do not provide a teaching for “wherein the active layers comprise a first active layer and a second active layer disposed on opposite sides of the reference layer, and wherein the insulating layers comprise: a first insulating layer disposed between the first active layer and the reference layer; and a second insulating layer disposed between the second active layer and the reference layer, as recited in independent claims 16-17 & 21-22; the examiner notes that no other reference or combination of references have been found to disclose, suggest, or make obvious each and every limitation set forth in dependent claims 16-17 & 21-22.
Conclusion
Accordingly, claims 1-15, 18-20, & 23 are rejected; claim 16-17 & 21-22 are objected to as being dependent upon a rejected base claim; claims 24-33 are withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794