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 .
Response to Arguments
Applicant’s arguments, see the after-final response filed 14 January 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 35 U.S.C. 103, as follows, in view of Harlev.
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 15, 22, 25-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (US PGPub No. 2017/0312420), hereinafter Harlev.
Regarding claim 1, Harlev teaches a catheter comprising: a shaft having a proximal end portion and a distal end portion (Fig. 2: catheter shaft 122);
and a tip section mechanically coupled to the distal end portion of the shaft (Figs. 2, 21: ablation electrode 124, 224; par. 0196: “The coupling portion 140 of the ablation electrode 124 can be directly or indirectly mechanically coupled to the catheter shaft 122”),
wherein the tip section includes a plurality of struts defining a plurality of cells (Fig. 21: struts 244b; par. 0307: “an ablation electrode 224 having struts 244b defining a plurality of cells 247”) that together define an expandable portion (par. 0187: “the ablation electrode 124 expands from a compressed state during delivery to an expanded state during treatment at the treatment site”),
and at least some cells of the plurality of cells define an electrode to deliver electrical energy to tissue of a patient (par. 0197: “electrical energy provided at the generator 116 can be delivered to the coupling portion 140 and, thus, to the deformable portion 142 of the ablation electrode 124, where the electrical energy can be delivered to tissue of the patient 102;” par. 0213: “In the uncompressed state, the struts 144b, the joints 141a, and the cells 147 together can form an open framework having a conductive surface along the deformable portion 142 of the ablation electrode 124”).
Harlev teaches wherein the struts are fastened together in a mesh electrode structure (par. 0307: “an ablation electrode 224 having struts 244b defining a plurality of cells 247, with the struts 244b progressively ganged together in a direction from a proximal region to a distal region of a deformable portion 242 of the ablation electrode 224”), but does not explicitly teach wherein the mesh electrode structure includes a plurality of mesh electrode panels. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to construct the mesh electrode structure from a plurality of mesh electrode panels, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 4, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein a first subset of the plurality of struts are coupled together to define a plurality of cells for each mesh electrode panel (Fig. 22 and par. 0307: “an ablation electrode 224 having struts 244b defining a plurality of cells 247, with the struts 244b progressively ganged together”).
Regarding claim 5, Harlev teaches the catheter of claim 4 as described previously. Harlev further teaches wherein the plurality of cells define, at least in part, an open area of the expandable portion through which fluid, blood, or a combination thereof can flow (par. 0194: “the ablation electrode 124 can have greater than about 50 percent open area and less than about 95 percent open area (e.g., about 80 percent open area) […] the open area of the ablation electrode 124 can facilitate the flow of irrigation fluid and blood through ablation electrode 124 during treatment”).
Regarding claim 15, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein the mesh electrode panels each include at least one eyelet (Fig. 12B: eyelets 157), and wherein at least one fastener holds adjacent mesh electrode panels together via corresponding eyelets (Figs. 12C, 21: fastener 141b, 241b; par. 0246: “the fastener 141b can couple the portion of the struts 144b to one another at the eyelets 157”).
Regarding claim 22, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein: each of the mesh electrode panels includes a keyed portion at a proximal end of the mesh electrode panel (Figs. 10, 12B: struts 144a);
the keyed portions are configured to interface with a first coupler at the distal end portion of the shaft, and the keyed portions and the first coupler is configured to mechanically couple the mesh electrode panels to the distal end portion of the shaft (par. 0196: “the coupling portion 140 can include struts 144a directly coupled to the catheter shaft 122 or coupled to a transition part coupled to the catheter shaft 122 […] the coupling portion 140 can include a complete ring directly or indirectly mechanically coupled to the catheter shaft 122”).
Examiner notes that as the limitations of this claim are stated in the alternative, the claim is considered to be met by the prior art when only one of the limitations are met.
Regarding claim 25, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein at least one of the mesh electrode panels includes: a first strut mechanically coupled to the distal end portion of the shaft; a second strut coupled to the first strut at a proximal-most portion of the second strut; and a third strut coupled to the first strut at a proximal-most portion of the third strut (Fig. 21: struts 244b coupled to one another as well as to the distal end portion of the shaft 222).
Regarding claims 26-27, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein at least one mesh electrode panel includes a proximal portion, a distal portion, and a middle portion or equator between the proximal portion and the distal portion, and wherein the middle portion is wider than the proximal and the distal portion, or the expandable portion includes a greater number of cells of the plurality of cells about the equator than about the distal section and/or about the proximal section (see annotated Fig. 21 with outlined mesh electrode panel wider and having more cells around the middle portion/equator; see also par. 0308: “the struts 244b can be progressively ganged together in the direction toward the distal end of the deformable portion 242 such that the number of cells 247 defined by the struts decreases in the direction toward the distal end of the deformable portion 242. Thus, as compared to a configuration in which struts are uniformly disposed about a shape, the closed end of the deformable portion 242 of the ablation electrode 224 can be formed by joining together relatively few of the struts 244b. This can be advantageous with respect to, for example, achieving acceptable manufacturing tolerances or, further or instead, facilitating substantially uniform distribution of current density along the deformable portion 242”).
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Annotated Figure 21
Regarding claims 28-30, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein a first subset of the plurality of struts defines a plurality of cells of the expandable portion (par. 0202: “each cell 147 can be defined by at least three struts 144b”); and at least one cell of the plurality of cells, namely a distalmost or proximal-most cell, is formed by (i) a first strut of the first subset belonging to a first one of the mesh electrode panels and (ii) a second strut of the first subset belonging to a second one of the mesh electrode panels different from the first one (par. 0202: “each strut 144b can define a portion of at least two of the cells 147”).
Regarding claim 31, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein the electrode panels each comprise a plurality of struts; the plurality of struts includes (i) a first subset of struts having one or more first lengths (Fig. 21: longer struts towards distal end of ablation electrode 224) and (ii) a second subset of struts having one or more second lengths smaller than the one or more first lengths; and the first subset of struts includes a distalmost strut of the plurality of struts or a proximal-most strut of the plurality of struts (Fig. 21: distalmost struts shorter than the long struts of the first subset; examiner notes that as the conditions in the limitations of this claim are stated in the alternative, the claim is considered to be met when the prior art reads on only one of each condition).
Regarding claim 32, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein the plurality of struts defines a plurality of cells of the expandable portion; and at least one cell of the plurality of cells is formed by at least four struts (Fig. 21: each diamond-shaped cell 247 formed by at least four struts).
Regarding claim 33, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein a strut may include a first portion having a first width and a second portion having a second width smaller than the first width (par. 0206: “at least some of the struts 144b can include a width increasing along the length of the respective strut 144b in a direction from a proximal region to a distal region of the ablation electrode 124”), which provides the ability to adjust current density distribution (par. 0206: “at least some of the struts 144b can have a non-uniform width along a length of the respective strut 144b such that the amount of material along a given strut is varied, resulting in an associated distribution in current density”). Harlev does not explicitly teach wherein the strut with non-uniform width is a proximal-most strut, but it would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide non-uniform width at a proximal-most strut of Harlev’s ablation electrode in order to adjust current density distribution at the proximal area of the electrode, since applicant has not disclosed that non-uniform width in the proximal-most strut solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with non-uniform width in any selected strut where an adjustment of current density would be necessary.
Regarding claim 35, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein, in the absence of external force, the expandable portion assumes a deployed state having a diameter greater than a largest diameter of the shaft (Fig. 21: diameter of ablation electrode 224 greater than diameter of shaft 222; par. 0212: “the deformable portion 142 can be expandable (e.g., self-expandable) from the compressed state to the uncompressed state. For example, the struts 144b can be biased to move in one or more directions away from one another to self-expand the deformable portion 142 from the compressed state to the uncompressed state”).
Claims 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Falwell et al. (US Patent No. 8,527,027), hereinafter Falwell.
Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein areas of the electrode can be electrically isolated from one another (par. 0193: “the ablation electrode 124 can include electrically isolated portions such that the ablation electrode 124 includes two electrodes of a bipolar electrode configuration”) but does not explicitly teach wherein the active conductive portion is distal to the insulated portion or wherein the mesh electrode panels of the expandable portion are electrically isolated from one another such that electrical energy can be delivered from any one of the mesh electrode panels independently from the other of the mesh electrode panels. However, in an analogous art, Falwell teaches an ablation catheter with mesh electrode panels wherein an active conductive portion is positioned relative to an insulated portion to face an intended direction of ablation (col 9, lines 11-17: “The insulation may also be removed in a preferential manner so that a particular portion of the circumferential surface of a filament 34 is exposed. In this manner, when braided conductive member 28 is radially expanded, the stripped portions to of filaments may preferentially face an intended direction of mapping or ablation”), wherein the insulated portion allows the areas of the electrode to be activated independently or concurrently (col 9, lines 21-22: “The mapping and ablation filaments may be activated independently or may be activated concurrently”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to position the active conductive portion relative to the insulated portion to face an intended direction of ablation (that is, a distal direction) and isolate the electrode portions from one another, as suggested by Falwell, so that the insulated portion may allow areas of the electrode to be activated independently or concurrently, as taught by Falwell.
Claims 6-7 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Govari et al. (US PGPub No. 2019/0217065), hereinafter Govari ‘065
Regarding claims 6-7, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein the tip section further includes a deployment member mechanically coupled to the expandable portion (par. 0272: “a catheter such as any one or more of the catheters described herein can include a sliding member extending from the handle, though a catheter shaft, and to an ablation electrode. The sliding member can be coupled (e.g., mechanically coupled) to the ablation electrode such that axial movement of the sliding member relative to the catheter shaft can exert compression and/or expansion force on the deformable portion of the ablation electrode”), but does not explicitly teach wherein the deployment member is mechanically coupled at a distalmost portion of the tip section, or wherein the expandable portion envelops at least a portion of the deployment member between the distal end portion of the shaft and the distalmost portion of the tip section, or wherein the deployment member is telescoping. However, in an analogous art, Govari ‘065 teaches a catheter comprising a telescoping deployment member for an expandable component coupled to a distalmost portion of an expandable end effector (Figs. 2A-3B: telescopic assembly 40, puller wire 52; par. 0034: “When physician 30 is ready to inflate balloon 44, the physician command compressing telescopic balloon assembly 40, which is performed by pulling of puller-wire 52. As seen in FIG. 2B, the two-part telescopic assembly 40 is compressed by pulling puller-wire 52 proximally forcefully enough for distal section 46 to force one or more elastic splines 50 to bend”).
Govari ‘065 teaches that this configuration allows the deployment to be controlled by pulling motions only, rather than pulling and pushing, which results in a more flexible catheter (par. 0026: “When using the disclosed configurations, the puller-wire may be very thin and highly flexible. This feature is in contrast to solutions based on pusher-wire, in which the pusher-wire must be rigid and therefore thick and less flexible. As such, the disclosed techniques, enable highly flexible catheter designs capable of performing sharp turns. A highly flexible balloon catheter using the disclosed telescopic assembly assisted by a puller-wire may thus particularly maneuverable via sharp deflections of blood vessels, and by so overcoming an obstacle that may otherwise hinder catheterization”). 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 catheter of Harlev by configuring the deployment member to be telescoping and coupled to the distalmost portion of the expandable portion, as taught by Govari ‘065, in order to allow the catheter to be more flexible, as taught by Govari ‘065.
Regarding claim 23, Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches a first strut, a second strut coupled to the first strut at a distalmost portion of the second strut; and a third strut coupled to the first strut at a distalmost portion of the third strut (Fig. 21: struts 244 coupled to one another) but does not explicitly teach wherein the first strut is mechanically coupled to a deployment member at a distalmost portion of the tip section. However, Harlev in view of Govari ‘065 teaches this limitation for the same reasons set forth in the rejection of claims 6-7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Govari ‘065 and further in view of McDaniel et al. (US PGPub No. 2005/0222563), hereinafter McDaniel.
Harlev in view of Govari ‘065 teaches the catheter of claim 6 as described previously. The combination does not explicitly teach wherein the deployment member defines a lumen configured to receive the guidewire. However, in an analogous art, McDaniel teaches a pulmonary vein ablation catheter with a deployment member (Figs. 2-4: expander 26), wherein the deployment member defines a lumen configured to receive a guidewire such that the guidewire can extend through the entire length of the catheter (par. 0056: “The expander has a guidewire lumen 48 (FIGS. 5 and 6) that extends along its entire length. As will be described further below, the guidewire lumen 48 permits a guidewire to extend through the entire length of the catheter 10 for introduction of the catheter into the body”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the deployment member of the combined reference with a lumen for receiving the guidewire, as taught by McDaniel, so that the guidewire can extend through the entire length of the catheter, as taught by McDaniel.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Govari ‘065 and further in view of Tegg et al. (US PGPub No. 2010/0168647), hereinafter Tegg.
Harlev in view of Govari ‘065 teaches the catheter of claim 6 as described previously. The combination does not explicitly teach wherein the deployment member defines a lumen, and wherein the lumen is configured to transport fluid at least between the proximal end portion of the shaft and the distalmost portion of the tip section, or includes a plurality of holes configured to disperse fluid radially from within the expandable portion toward an inner surface of the expandable portion.
However, in an analogous art, Tegg teaches a basket catheter with a deployment member wherein the deployment member defines a lumen configured to transport fluid to the distalmost portion of the tip section (Fig. 3b: deployment member 31, distal portion 42; par. 0042: “the deployment member 31 may be a tubing (or house a tubing) fluidically connected on one end to a fluid source, and on the other end to the distal fluid delivery ports 34a' provided on the deployment member 31”), including a plurality of holes configured to disperse fluid radially from within the expandable portion toward an inner surface of the expandable portion (Fig. 3b: plurality of fluid delivery ports 34a’ configured to disperse fluid radially from within the splines 36). Tegg further teaches that providing irrigation with a basket catheter reduces clotting or thrombus formation (par. 0013: “The basket catheter also includes a fluid delivery tube housed within the basket catheter. The fluid delivery tube has at least one fluid delivery port for irrigating within the basket catheter between the plurality of splines to reduce clotting or thrombus formation”). 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 catheter of the combined reference by configuring the deployment member to transport and disperse fluid radially from within the expandable portion, as taught by Tegg, in order to reduce clotting or thrombus formation, as taught by Tegg.
Claims 16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Govari et al. (US PGPub No. 2017/0172442), hereinafter Govari ‘442.
Regarding claim 16, Harlev teaches the catheter of claim 15 as described previously, but does not explicitly teach wherein the at least one fastener includes at least one sensor, and wherein the at least one sensor includes at least one electrode or a temperature measurement device. However, in an analogous art, Govari ‘442 teaches a catheter with an expandable basket assembly comprising at least one sensor at a fastener, wherein the at least one sensor includes at least one electrode (Fig. 3 and par. 0048: “a distal electrode location sensor 65 mounted at or near the position where the distal ends of the spines are connected”) so that positions of electrodes on the expandable assembly can be determined (par. 0048: “the coordinates of the electrode location sensor 65 relative to those of the electrode location sensor 67 can be determined and taken together with known information pertaining to the curvature of the splines 45 to find the positions of each of the spline electrodes 49”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the catheter of Harlev by including a sensor on the distal fastening structure, as taught by Govari ‘442, in order to determine positions of electrodes on the expandable assembly can be determined, as taught by Govari ‘442.
Regarding claim 18, the combination teaches the catheter of claim 16 as described previously. Govari ‘442 further teaches wherein an electrical lead extends from the at least one sensor, within an interior of the expandable portion, and into the shaft (Figs. 2-3; par. 0041: “The outer diameter of the shaft 39 is not critical, but is preferably no more than about 8 french, more preferably 7 french. Likewise the thickness of the outer wall is not critical, but is preferably thin enough so that the central lumen can accommodate a puller wire, lead wires, sensor cables and any other wires, cables or tubes;” examiner notes that a sensor cable extending from shaft 39 to distal sensor 65 necessarily extends within an exterior of the expandable portion and into the shaft).
The combination does not explicitly teach wherein an additional sensor is formed by or positioned on the electrical lead within the interior of the expandable portion. However, Harlev further teaches a center electrode within the interior of the expandable portion (Fig. 21: center electrode 235) that can be used together with sensors on the exterior of the expandable portion to provide near-unipolar electrograms (par. 0237: “the sensors 126 and a center electrode can cooperate to provide near-unipolar electrograms”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the catheter of the combined reference by placing an additional sensor on the electrical lead within the interior of the expandable portion, that is, in the center of the expandable portion, as taught by Harlev, so that it can be used together with sensors on the exterior of the expandable portion to provide near-unipolar electrograms, as taught by Harlev.
Regarding claim 19, Harlev teaches the catheter of claim 1 as described previously, but does not teach further comprising a displacement measuring device configured to measure a displacement of a deployment member mechanically coupled to the expandable portion to determine a shape of the expandable portion. However, Govari ‘442 teaches a displacement measuring device configured to measure a displacement of a deployment member mechanically coupled to an expandable portion (Figs. 2-3: basket-shaped electrode assembly 43, contraction wire 47, electrode location sensors 65 and 67; par. 0042: “When the contraction wire 47 is moved longitudinally to expand and contract the electrode assembly 43, in the expanded position the splines 45 are bowed outwardly and in the contracted position the splines 45 are generally straight”) to determine a shape of the expandable portion, positions of electrodes on the expandable assembly can be determined (par. 0048: “the catheter 37 is provided with a distal electrode location sensor 65 mounted at or near the position where the distal ends of the spines are connected, and a proximal electrode location sensor 67 mounted at or near the proximal end of the electrode assembly 43, whereby, in use, the coordinates of the electrode location sensor 65 relative to those of the electrode location sensor 67 can be determined and taken together with known information pertaining to the curvature of the splines 45 to find the positions of each of the spline electrodes 49”).
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 catheter of Harlev by providing distal and proximal electrode location sensors for determining the shape of the expandable portion, as taught by Govari ‘442, in order to determine positions of electrodes on the expandable assembly can be determined, as taught by Govari ‘442.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Govari ‘442 and further in view of Tran et al. (US PGPub No. 2017/0281268), hereinafter Tran.
Harlev in view of Govari ‘442 teaches the catheter of claim 16 as described previously. Harlev further teaches wherein the at least one eyelet of each of the mesh electrode panels is directly connected to at least one strut (par. 0084: “the second end region of each respective strut of the portion of struts can define an eyelet”), but the combination does not explicitly teach wherein the at least one strut includes a bend such that the at least one sensor is recessed relative to an exterior of the expandable portion when the adjacent mesh electrode panels are held together via the at least one fastener.
However, in an analogous art, Tran teaches providing a bend in struts of a basket catheter such that a fastening structural element is recessed relative to an exterior of the expandable basket (Fig. 5: bends in spines 18 such that cap 24 is recessed; par. 0046: “distal portions of spines 18 that exhibit a concave configuration”), which keeps the structural element flush with the outer curvature for a relatively blunt and atraumatic surface (par. 0046: “This invaginated design keeps the top of basket-shaped electrode assembly 16 approximately flush with the outer curvature for safety reasons, by presenting a relatively blunt and atraumatic surface”). 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 catheter of the combined reference by providing a bend in the struts of the mesh electrode panels such that the fastener and sensor are recessed relative to an exterior of the expandable portion, as suggested by Tran, in order to achieve a relatively blunt and atraumatic surface, as taught by Tran.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of de la Rama et al. (US PGPub No. 2010/0076426), hereinafter de la Rama.
Harlev teaches the catheter of claim 1 as described previously but does not explicitly teach further comprising a shaft electrode mounted to the distal end portion of the shaft. However, in an analogous art, de la Rama teaches an ablation catheter with a shaft electrode mounted to the distal end portion of the shaft (Fig. 2A: shaft electrodes 19 at distal end of shaft 16), which can be used for visualization or mapping purposes (par. 0036: “shaft electrodes 19 are disposed near the distal end of the shaft 16 for visualization and/or mapping purposes”). 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 catheter of Harlev by providing a shaft electrode mounted to the distal end portion of the shaft, as taught by de la Rama.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of McLawhorn et al. (US PGPub No. 2015/0066010), hereinafter McLawhorn.
Harlev teaches the catheter of claim 1 as described previously. Harlev further teaches wherein the expandable portion is moveable between a compressed state and a deployed state, and the expandable portion includes an active body portion configured to deliver electrical energy to tissue of a patient and conform to tissue (par. 0028: “the ablation electrode can include a deformable portion, the deformable portion resiliently flexible from a compressed state to an uncompressed state;” par. 0204: “the deformable portion 142 can deform upon contact with tissue and the deformable portion 142 can engage the tissue through one or more of the cells 147 to resist lateral movement of the deformable portion 142 relative to the tissue. That is, as compared to a closed surface in contact with tissue, the deformable portion 142 will resist unintended movement (e.g., sliding with respect to the tissue) with which it is in contact”), but does not explicitly teach ostial ablation and thus does not explicitly teach that while the expandable portion is in the deployed state a distal portion of the active body portion forms a distal surface that can be positioned relatively flat against tissue about an ostium of a pulmonary vein of the patient, and the maximum radial dimension of the active body portion is larger than a maximum radial dimension of the ostium such that all or a portion of the active body portion is prevented from entering the pulmonary vein.
However, in a related art, McLawhorn teaches an ostial ablation catheter with an expandable ablation portion that can be positioned relatively flat against tissue about an ostium of a pulmonary vein of the patient, and the maximum radial dimension of the ablation portion is larger than a maximum radial dimension of the ostium such that all or a portion of the ablation portion is prevented from entering the pulmonary vein (Fig. 10: ablation catheter 400 with expandable mesh 402 positioned relatively flat against tissue about ostium of pulmonary vein 116; par. 0045: “the ablation device of FIG. 4 ablating a wall 1000 proximate the pulmonary vein 116. The distal end of the expandable mesh 402 is fitted within the pulmonary vein 116 centering the ablation device 400, in some embodiments the distal end of the inner shaft may extend beyond the flexible mesh 402 to form an elongated tip. The elongated tip may be used to center the location device in the vessel. The outer shaft 408 has been advanced relative to the inner shaft 406 expanding the expandable mesh 402. The expandable mesh 402 conforms to the shape of the ostium of the pulmonary vein 116”). 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 catheter of Harlev such that the maximum radial dimension of the ablation portion is larger than a maximum radial dimension of the ostium such that all or a portion of the ablation portion is prevented from entering the pulmonary vein, as taught by McLawhorn, in order that the catheter may be used to perform ablation at the ostium of a pulmonary vein while centered in the vessel, as taught by McLawhorn.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794