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 Group I and Species A in the reply filed on April 2nd, 2026 is acknowledged. Claims 11-12 & 19-20 withdrawn from consideration and Claims 1-10 & 13-18 remain for examination on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted November 2nd, 2022 and August 20th, 2024 have been considered by the Examiner.
Claim Objections
Claim 14 objected to because of the following informalities:
Claim 14, line 1: “spine protrusion” should read --the spine protrusion--.
Appropriate correction is required.
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 1, 10 & 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (U.S. Pub. No. 20210022803), herein referred to as “Olson” in view of Hagstrom et al. (U.S. Pub. No. 20240197394, earliest effective filing date), herein referred to as “Hagstrom”.
Regarding claim 1, Olson discloses an expandable basket assembly (Abstract: A medical device; [0083]: radially expanding members; see Fig. 7A) comprising:
at least one spine (radially expanding members 306-1 … 306-4) extending along a longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form ([0080]: as the shaft 304 can be extended or retracted in relation to the catheter tip 310, causing the radially expanding members 306-1, 306-2, 306-3, 306-4 to radially expand or radially retract), the at least one spine comprising a spine width (see width of radially expanding members 306 in Fig. 7B) and a spine height (see height of radially expanding members 306 in Fig. 7A);
a spine protrusion comprising a protrusion width and a protrusion height ([0083]: For example, the electrodes 312-1, 312-2, 312-3, 312-4 can extend upwards from a surface of each one of the radially expanding members 306-1, 306-2, 306-3, 306-4. The electrodes 312-1, 312-2, 312-3, 312-4 can be formed as discussed in relation to FIGS. 2 to 5B; see Fig. 3B where the electrode 200 includes three-dimensional base 202 (interpreted as the spine) such that the electrode + spine structure is seen as a unitary structure therefore comprising a spine protrusion comprising a protrusion width (Fig. 3A) and a protrusion height (Fig. 3B)), at least one of the protrusion width or the protrusion height is greater than at least one of the spine width and the spine height (see Fig. 3B where the protrusion height of electrode 200 is greater than the spine height, where the spine is seen as the three-dimensional base 202); and
an electrode assembly (electrode 200) being positioned at the spine ([0083]: For example, the electrodes 312-1, 312-2, 312-3, 312-4 can extend upwards from a surface of each one of the radially expanding members 306-1, 306-2, 306-3, 306-4. The electrodes 312-1, 312-2, 312-3, 312-4 can be formed as discussed in relation to FIGS. 2 to 5B) and comprising:
an electrode layer (electrode 210 & tie layer 212; [0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc.); and
an insulating layer disposed between the electrode layer and the spine protrusion ([0057]: A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202).
While the spine protrusion is being interpreted as part of a collection of features, based on an alternate interpretation of Olson, Olson fails to explicitly disclose a spine protrusion comprising a protrusion width and a protrusion height, at least one of the protrusion width or the protrusion height is greater than at least one of the spine width and the spine height; and an electrode assembly being positioned at the spine protrusion.
However, Hagstrom discloses a spine protrusion comprising a protrusion width and a protrusion height, at least one of the protrusion width or the protrusion height is greater than at least one of the spine width and the spine height ([0069]: in the illustrated embodiment, the intermediate portion 219A-219F of each spline 216A-216F has a lateral width that is greater than the lateral width of each of the respective proximal end portion 218A-218F and the distal end portions 217A-217F; see Figs. 2A-2D where the spines comprise a spine protrusion comprising a protrusion width and protrusion height (where the height is the thickness of the splines) and that the protrusion width is greater than a width of the spine width); and
an electrode assembly (electrodes 244 & 250) being positioned at the spine protrusion (see Figs. 2A-2D).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the spines of Olson to comprise spine protrusions, as taught by Hagstrom, for the purpose of optimizing to provide desired mechanical and therapeutic/diagnostic capabilities, providing desired electrical characteristics for the particular clinical application, and enabling the electrode to be as large as possible (Hagstrom: [0069], [0080], [0082]).
Regarding claim 10, Olson in view of Hagstrom discloses the protrusion width includes a width greater than the spine width (Hagstrom: [0069]: in the illustrated embodiment, the intermediate portion 219A-219F of each spline 216A-216F has a lateral width that is greater than the lateral width of each of the respective proximal end portion 218A-218F and the distal end portions 217A-217F).
Regarding claim 13, Olson in view of Hagstrom discloses the spine protrusion and electrode assembly defining a curvilinear profile (Olson: [0053]: the perimeter interface 208 is oblong in shape. However, the perimeter interface 208 can be any shape, including circular, square, rectangular, polygonal, triangular, elliptical, etc.; [0056]: the electrode 210 can be of another shape, which can be circular, square, rectangular, polygonal, triangular, elliptical, pyramidal, hourglass, etc.; see Fig. 3B where the electrode assembly comprises a curvilinear profile comprising straight and curved sections; Hagstrom: see Fig. 2D where the spine protrusion & the electrode assembly define a curvilinear profile with the width forming the curve and linear portions).
Regarding claim 14, Olson discloses spine protrusion and the electrode assembly form a substantially curvilinear profile having a generally flat surface at a top of each of the electrode assemblies ([0053]: the perimeter interface 208 is oblong in shape. However, the perimeter interface 208 can be any shape, including circular, square, rectangular, polygonal, triangular, elliptical, etc.; [0056]: the electrode 210 can be of another shape, which can be circular, square, rectangular, polygonal, triangular, elliptical, pyramidal, hourglass, etc.; see Fig. 3B where the electrode assembly comprises a curvilinear profile comprising straight and curved sections with the top surface being generally flat).
Regarding claim 15, Olson discloses the electrode layer (electrode 478; Fig. 15; [0139]: Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation) includes a portion (contact pad 482) electrically connected to a medical probe (probe 470) with an electrical connector (electrical leads 480), and the electrical connector includes a wire (see Fig. 15 where the leads are shown as wires and “electrical leads” are known in the art to be wires).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Basu et al. (U.S. Pub. No. 20210137589), herein referred to as “Basu”.
Regarding claim 2, Olson discloses the electrode layer includes a film on the insulating layer ([0056]: an electrode 210 can be formed on top of the three-dimensional base 202. In an example, the electrode 210 can be formed from a metallic material, in some embodiments. For instance, the electrode 210 can be formed from gold, platinum, silver, etc.; [0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc. A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202) but Olson in view of Hagstrom fails to disclose the electrode layer includes a film deposited onto the insulating layer.
However, Basu discloses the electrode layer includes a film deposited onto the insulating layer ([0073]: Third layer (424) includes an etched or vapor deposited material that is electrically conductive. In versions where third layer (424) is formed in several discrete zones that are separated from each other, second layer (418) may electrically isolate these separate zones of third layer (424) from each other (in addition to second layer (418) electrically isolating the zones of third layer (424) from first layer (412))). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode layer of Olson in view of Hagstrom to comprise a deposited film, as taught by Basu, for the purpose of the deposition of the film is controlled by a chemical reaction (Basu: [0080]).
Additionally, Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP § 2173.05(p) & §2113.
Regarding claim 3, Olson discloses the electrode layer includes a conductive film ([0056]: an electrode 210 can be formed on top of the three-dimensional base 202. In an example, the electrode 210 can be formed from a metallic material, in some embodiments. For instance, the electrode 210 can be formed from gold, platinum, silver, etc.; [0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc. A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202) but Olson in view of Hagstrom fails to disclose the electrode layer includes a vapor- deposited conductive film.
However, Basu discloses the electrode layer includes a vapor- deposited conductive film ([0073]: Third layer (424) includes an etched or vapor deposited material that is electrically conductive. In versions where third layer (424) is formed in several discrete zones that are separated from each other, second layer (418) may electrically isolate these separate zones of third layer (424) from each other (in addition to second layer (418) electrically isolating the zones of third layer (424) from first layer (412))). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode layer of Olson in view of Hagstrom to comprise a vapor-deposited film, as taught by Basu, for the purpose of the deposition of the film is controlled by a chemical reaction (Basu: [0080]).
Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP § 2173.05(p) & §2113.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Geistert et al. (U.S. Pub. No. 20140378803), herein referred to as “Geistert”.
Regarding claim 4, Olson discloses the electrode layer comprising a platinum layer ([0056]: the electrode 210 can be formed from gold, platinum, silver, etc.) of at least 5 microns nominally in thickness but Olson in view of Hagstrom fails to disclose the electrode layer comprising a layer of at least 5 microns nominally in thickness.
However, Geistert discloses the electrode layer comprising a layer of at least 5 microns nominally in thickness ([0038]: The lower layer 35 of the electrode 30 has a layer thickness of approximately 5 to 7 µm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode layer of Olson in view of Hagstrom to the electrode layer of Geistert for the purpose of forming a very compact structure and simplifying the manufacturing method (Geistert: [0011]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Basu et al. (U.S. Pub. No. 20210077184), herein referred to as “Basu 2”
Regarding claim 5, Olson discloses the insulating layer includes a film on the spine protrusion ([0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc. A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202) but Olson in view of Hagstrom fails to disclose the insulating layer includes a film deposited onto the spine protrusion.
However, Basu discloses the insulating layer includes a film deposited onto the spine protrusion (dielectric layer 650; [0065]: all the layers (642, 650, 652, 654, 656, 658, 660) shown on the exterior side of strip body (610) may be applied to strip body (610) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the insulating layer of Olson in view of Hagstrom to comprise a deposited film, as taught by Basu 2, for the purpose of deposition process enabling direct application of one feature to another (Basu 2: [0044], [0050], [0053], [0056]).
Additionally, Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP § 2173.05(p) & §2113.
Regarding claim 6, Olson discloses the insulating layer includes an insulative film ([0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc. A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202), but Olson in view of Hagstrom fails to disclose the insulating layer includes a vapor- deposited insulative film.
However, Basu 2 discloses the insulating layer includes a vapor- deposited insulative film (dielectric layer 650; [0065]: all the layers (642, 650, 652, 654, 656, 658, 660) shown on the exterior side of strip body (610) may be applied to strip body (610) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the insulating layer of Olson in view of Hagstrom to comprise a vapor-deposited film, as taught by Basu 2, for the purpose of deposition process enabling direct application of one feature to another (Basu 2: [0044], [0050], [0053], [0056]).
Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP § 2173.05(p) & §2113.
Claims 7 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Beeckler (U.S. Pub. No. 20160338768), herein referred to as “Beeckler”.
Regarding claim 7, Olson discloses the insulating layer includes an insulative film ([0057]: a tie layer 212 can be disposed between the three-dimensional base 202 and the electrode 210, which can help to bond the electrode 210 to the three-dimensional base 202. The tie layer 212 can be formed from a conductive material such as a metal. In an example, the tie layer 212 can be formed from a metal such as nickel, sputtered chrome, etc. A dielectric layer can be disposed beneath the tie layer, insulating the electrode 210 and the dielectric layer from the three-dimensional base 202) but Olson in view of Hagstrom fails to disclose the insulating layer includes a film-cast insulative film.
However, Beeckler discloses the insulating layer includes a film-cast insulative film ([0033]: the formed member comprising the core 14 and the layers 18, and 16 can then be run through a multiple layer coating process, i.e. film cast, to apply an insulating polymer layer to the outside). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the insulating later of Olson in view of Hagstrom to comprise a film-case insulative layer, as taught by Beeckler, for the purpose of applying a polymer layer (Beeckler: [0033]).
Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP § 2173.05(p) & §2113.
Regarding claim 16, Olson in view of Hagstrom fails to disclose at least a portion of the electrical connector comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material.
However, Beeckler discloses at least a portion of the electrical connector comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material ([0033]: The present invention includes a method of manufacturing a thermocouple wire pair member 10 … With reference to FIG. 6, a layered (predrawn) member 10′ includes the elongated solid core 14 of a first metallic material which is surrounded circumferentially by a layer of insulating material (e.g., ceramic) forming the insulating layer 18. The core 14 and the layer 18 are surrounded circumferentially by a layer of a second metallic material dissimilar to the first metallic material of the core, forming the outer layer 16 … As shown in FIG. 6, the formed member comprising the core 14 and the layers 18, and 16 can then be run through a multiple layer coating process, i.e. film cast, to apply an insulating polymer layer to the outside; [0030]: The core 14 and the metallic layer 16 may be of any suitable metals, including, for example, constantan and copper, or vice versa; where copper is known to be more electrically conductive than constantan such that an electrically conductive core material comprising copper and an electrically conductive cover material comprising constantan is seen as meeting the claim’s limitations). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrical connector of Olson in view of Hagstrom to the electrical connector of Beeckler for the purpose of enabling temperature sensing (Beeckler: [0010]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Zhang et al. (U.S. 20220378498), herein referred to as “Zhang”.
Regarding claim 8, Olson in view of Hagstrom fails to disclose the insulating layer includes a layer of polyimide.
However, Zhang discloses the insulating layer includes a layer of polyimide ([0081]: portions of each spline 904 may be covered with insulating material 920 (e.g., heat-shrink (e.g., PET) or polymer tubing or spray or dip coat with polyimide or PEBA)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the insulating layer of Olson in view of Hagstrom to include a layer of polyimide, as taught by Zhang, for the purpose of the insulating layer controlling the ablation zone of each spline (Zhang: [0081]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Whisenant et al. (U.S. Pub. No. 20080045937), herein referred to as “Whisenant”.
Regarding claim 9, while Olson discloses the protrusion height comprises a height greater than the spine height (see Fig. 3B; [0052]: a three-dimensional electrode 200; wherein the electrode assembly and spline are seen as a unitary structure) but Olson in view of Hagstrom fails to explicitly disclose the protrusion heigh comprises a height greater than the spine height (under the interpretation of the spline itself is protruded).
However, Whisenant discloses the protrusion height comprises a height greater than the spine height (thin-walled sections 610 in relation to struts/legs 616; see Fig. 9 where struts 616 have a protrusion height comprising a height greater than the thin-walled sections 610). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the protrusion of Olson in view of Hagstrom to comprise a protrusion height, as taught by Whisenant, for the purpose of the thinner, more flexible sections can act as flexible elements (hinges or pivots) while sections that are thicker and/or stiffer can remain, in one configuration, straighter, giving a particular shape to the deployed anchor (Whisenant: [0158]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hagstrom as applied to claim 1 above, and further in view of Harlev et al. (U.S. Pub. No. 20230012307), herein referred to as “Harlev”.
Regarding claim 17, Olson discloses the electrode layer (electrode 478; Fig. 15; [0139]: Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation) includes a portion (contact pad 482) electrically connected a medical probe (probe 470) with an electrical connector (electrical leads 480) but fails to disclose the electrical connector includes a flexible circuit.
However, Harlev discloses the electrical connector includes a flexible circuit ([0091]: Electrical leads 806 extend from each sensor 826, within or along the interior of the expandable portion 250 and into the shaft 122 (FIG. 2). The electrical leads 806 may comprise wires (e.g., insulated wires) or printed circuits (e.g., flexible printed circuits)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed inventio to modify the electrical conductor of Olson in view of Hagstrom to comprise a flexible circuit, as taught by Harlev, for the purpose of the flexible circuit enabling electrical isolation between adjacent electrodes (Harlev: [0067]).
Regarding claim 18, Olson in view of Hagstrom and Harlev discloses the flexible circuit comprises a printed conductive wire (Harlev: [0091]: Electrical leads 806 extend from each sensor 826, within or along the interior of the expandable portion 250 and into the shaft 122 (FIG. 2). The electrical leads 806 may comprise wires (e.g., insulated wires) or printed circuits (e.g., flexible printed circuits)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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