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 Amendment
The amendments under 37 CFR 1.132 filed 02/20/2026 is sufficient to overcome the rejection of independent claim 1 and 21 based upon the current rejection failing to teach all aspects of the claims.
Newly added claim 22 is acknowledged. Claims 1-15 and 18-22 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/20/2026, with respect to the rejection(s) of claim(s) 21 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Selkee (US 20180177547 A1).
Applicant's arguments regarding claim 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1).
Applicant's arguments regarding claim 3 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), further in view of Jais (US 20060106295 A1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 2, 4-6, 8, 12, 15, 18, 19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1).
Regarding claim 1, Zirkle teaches a catheter comprising: an elongated shaft extended along a longitudinal axis (Fig 1; shaft/catheter body 12 having a longitudinal axis); an intermediate section extended along the longitudinal axis distal from the elongated shaft (Fig 1; intermediate section 14 distal of the catheter body) and comprising an intermediate tube comprising a first plurality of lumens therethrough (Fig 6; The deflectable intermediate section 14 comprises a short section of tubing 15 having multiple lumens, each occupied by the various components extending through the intermediate section. In the illustrated embodiment of FIG. 6, there are six lumens); a distal section comprising a generally straight region extended along the longitudinal axis distal from the intermediate section (Fig 1; distal assembly 17), a circular ([0012] The configuration of the electrode-bearing portion of the distal assembly is generally curved or circular) main region distal from the generally straight region and generally orthogonal to the longitudinal axis, and a distal tube (Fig 9; is an end cross-sectional view of a section of the distal end portion) comprising a second plurality of lumens therethrough; a cross-over region (Fig 5b; transitional section 20) ([0067] transitional section 20, as shown in FIGS. 1 and 7, having a tubing of suitable material, e.g., PEEK, with a central lumen that allows the various components extending therethrough to reorient before entering the distal assembly 17) between a distal end of the intermediate tube and a proximal end of the distal tube; and a support member (Fig 5b and 6; support member 50) ([0063] For the distal assembly 17, a shape-memory support member 50 surrounded by a nonconductive tubing 52, e.g., a polyimide tubing, extends proximally from the distal assembly 17 for a relatively short distance into a fifth lumen 37) affixed within in the intermediate section within a first lumen of the first plurality of lumens, extended through the cross-over region so that the support member is angled (Fig 5b; support member 50) in relation to the longitudinal axis, and extended through the distal section within a second lumen (Fig 9; fourth lumen 60 for the support member 50) of the second plurality of lumens that is non-coaxial to the first lumen ([0074] the tubing 56 has four off-axis lumens, namely, a first lumen 57 for the cable 46 and optionally the SAS 48, a second lumen 58 for the ring electrode wire pairs 40, 41, a third lumen 59 for irrigation fluid, and a fourth lumen 60 for the support member 50 and the contraction wire 44), the support member comprising an approximately rectangular cross-sectional shape approximate a distal end of the distal section and comprising an approximately semicircular cross-sectional shape within the intermediate section ([0123] The nitinol wire/shape memory support member 121 extends from at or near the distal end of the multi-lumen tube 125 into the shaft 145 for approximately 25 millimeters into the shaft. This provides stability to the distal assembly 117. Nitinol wire 121 is preferably square in cross-section .009 inch by .009 inch) but could be square, circular or rectangular in cross-section with a width or diameter between .006 inch and .012 inch).
Zirkle fails to fully teach the support member comprising an approximately rectangular cross-sectional shape approximate a distal end of the distal section and comprising an approximately semicircular cross-sectional shape within the intermediate section.
However, Funk teaches the support member comprising an approximately semicircular cross-sectional shape within the intermediate section ([0045] As described above the support member 235 of the support device 230 can have any suitable shape, size, and/or configuration. For example, as shown in FIG. 2A-2D, the support member 235 can be a substantially solid elongate member having a circular or at least semi-circular cross-sectional shape. In other embodiments, however, a support member can have any suitable shape and/or configuration) ([0047] a support device and/or support member can have a cross-sectional shape that is varied along a length thereof. For example, in some embodiments, a support device and/or support member can have a cross-sectional shape that tapers (e.g., is reduced in size) along a length of the support device in a proximal direction or in a distal direction. In other embodiments, a support device and/or support member can have a cross-sectional shape that is different at or near a proximal end thereof from a cross-sectional shape at or near a distal end thereof. In some embodiments, a support device and/or support member (or portion thereof) can form, for example, a spiral, coil, braid, and/or the like). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the support member comprising an approximately semicircular cross-sectional shape within the intermediate section. Doing so allows the varying the cross-sectional shape of the support device and/or support member to vary a stiffness of the support device and/or support member (Funk, [0046]). Furthermore, it would have been an obvious matter of design choice to make the different portions of the support member comprising an approximately semicircular cross-sectional shape within the intermediate section of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Further, Layman teaches the support member comprising an approximately rectangular cross-sectional shape approximate a distal end of the distal section (Fig 4; [0030] flattened region 30 may have two substantially parallel flat surfaces that extend along width W. This may give flattened region 30 a cross-sectional shape that may be rectangular) ([0028] guidewire 10 may be designed to be more flexible in bending by flattening core wire 18 so as to define a flattened region 30). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the support member comprising an approximately rectangular cross-sectional shape approximate a distal end of the distal section. Doing so allows the distal end to increase flexibility and bending.
Regarding claim 2, Zirkle teaches the catheter of claim 1, wherein the first plurality of lumens, and thereby the intermediate tube, comprises four lumens (Fig 6; The deflectable intermediate section 14 comprises a short section of tubing 15 having multiple lumens, each occupied by the various components extending through the intermediate section. In the illustrated embodiment of FIG. 6, there are six lumens), and wherein the second plurality of lumens, and thereby the distal tube, comprises three lumens ([0074] a first lumen 57 for the cable 46 and optionally the SAS 48, a second lumen 58 for the ring electrode wire pairs 40, 41, a third lumen 59 for irrigation fluid, and a fourth lumen 60).
Regarding claim 4, Zirkle teaches the catheter of claim 1, further comprising: a first pull wire extended through the intermediate section within a third lumen of the first plurality of lumens non-coaxial to the first lumen ([0078] The contraction wire 44 extends through the central lumen 18 of the catheter body 12, through the third lumen 35 of the intermediate section 14, the central lumen of the transitional section 20 and the fourth lumen 60 of the distal assembly 17 to its distal end), extended through the cross-over region so that the first pull wire is angled in relation to the longitudinal axis (Fig 5b; wire 44), extended through the second lumen, and affixed within the distal section approximate a distal end of the circular main region (Fig 10; wire 44).
Regarding claim 5, Zirkle teaches the catheter of claim 4, the circular main region being configured to resize in diameter in response to manipulation of the first pull wire ([0113] the contraction wire 44 is drawn proximally by the cam receiver 72 to tighten and decrease the diameter of the helical form when the cam handle is turned in one direction).
Regarding claim 6, Zirkle teaches the catheter of claim 4, further comprising: a second pull wire extended through and anchored within a fourth lumen of the first plurality of lumens of the intermediate section, the fourth lumen being non-coaxial to the first lumen and the third lumen (Fig 6; deflection puller wire 54), the intermediate section being configured to deflect from the longitudinal axis in response to manipulation of the second pull wire ([0091] a deflection puller wire 54 is provided for deflection of the intermediate section 14. The deflection wire 54 extends through the central lumen 18 of the catheter body 12 and the sixth lumen 38 of the intermediate section 14. It is anchored at its proximal end in the control handle 16, and at its distal end to a location at or near the distal end of the intermediate section 14).
Regarding claim 8, Zirkle teaches the catheter of claim 1, further comprising: electrodes distributed around the circular main region and configured to provide electrical energy to ablate intracardiac tissue using irreversible electroporation (Fig 21; ring electrodes 19) (([0108] The console comprises an RF generator for applying RF energy through electrodes on the end section of the catheter in order to ablate the tissue contacted by the distal section).
Regarding claim 12, Zirkle teaches the catheter of claim 8, the electrodes being separated by an edge-to-edge distance of about 4 millimeters ([0121] In a preferred embodiment for renal ablation five ring electrodes are used each having an electrode length (W) of 3 millimeters and an inter-electrode spacing (S) of 4 millimeters).
Regarding claim 15, Zirkle teaches the catheter of claim 1, further comprising: a distal advanced current localization sensor affixed over the generally straight region of the distal section ([0123] Lumen 153 is in multi-lumen tube 125 is unused in the preferred embodiment but could be used for wiring for additional thermocouples or other sensors that are desired in the tip assembly); and a proximal advanced current localization sensor affixed over the intermediate section ([0099] the cable carries three SASs that are positioned under the distal-most AR electrode, the proximal-most AR electrode, and a mid-AR electrode, for sensing location and/or position of the helical form).
Regarding claim 16, Zirkle teaches the catheter of claim 1, the support member configured, within the circular main region, to be more flexible in a radial direction that is orthogonal to the longitudinal axis compared to flexibility in the direction of the longitudinal axis ([0061] The catheter body 12 is flexible, i.e., bendable, but substantially non-compressible along its length).
Regarding claim 18, Zirkle teaches the catheter of claim 1, but fails to fully teach the rectangular cross-sectional shape comprising a height and width such that the width is at least twice the height, the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis.
However, Layman teaches the rectangular cross-sectional shape comprising a height which decreases from the intermediate section towards the distal end of the distal section ([0031] Generally, because width W is longer than height H, guidewire 10 may be more flexible in bending in those directions that are oriented in the direction corresponding to or defining height H) ([0032] It can be appreciated that the size of width W relative to height H can vary depending upon the degree to which flattened region 30 is flattened), and a width which increases from the intermediate section towards the distal end of the distal section ([0032]), such that at the distal end of the distal section the width is at least twice the height ([0032] In still other embodiments, width W may be about 2 times as large as height H or more. In still other embodiments, width W may be about 3 times as large as height H or more), the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis (Fig 4). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the rectangular cross-sectional shape comprising a height and width such that the width is at least twice the height, the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis. Doing so allows the distal end to have increased flexibility and bending.
Regarding claim 19, Zirkle teaches the catheter of claim 1, further comprising: an atraumatic polymer dome at a distal end of the distal section: and a knotted cord comprising ultra-high weight molecular polymer, disposed within the distal section, and anchoring the polymer dome to the distal section (Fig 22; [0117] The dome 136 is provides an atraumatic tip and also an anchor for the nitinol helix 121. The nitinol helix extends into the tip of the distal assembly distal the distal most electrode 19 which tip provides a leader for positioning the catheter into the PV, renal artery, renal vein or other vessel).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), further in view of Jais (US 20060106295 A1).
Regarding claim 3, Zirkle teaches the catheter of claim 2, but fails to fully teach wherein the first plurality of lumens consists of four lumens, and wherein the second plurality of lumens consists of three lumens.
However, Jais teaches wherein the first plurality of lumens consists of four lumens ([0065] The proximal region 38' comprises a tubing 39' having a length ranging between about 60 mm and about 70 mm and preferably about 65 mm having at least three lumens 130, 132 and 134, which may or may not of equal size but may be about 0.025 inches in diameter. There may also be a fourth lumen 136 which may be occupied by other wires or tubing), and wherein the second plurality of lumens consists of three lumens ([0034] With further reference to FIG. 2, the intermediate section 14 comprises a short section of tubing 22 having three lumens). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include wherein the first plurality of lumens consists of four lumens, and wherein the second plurality of lumens consists of three lumens. Doing so allows for a specific amount of lumens corresponding to the number of wires needed for each.
Claim(s) 7, 10, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), in view of Esguerra (US 20200015703 A1).
Regarding claim 7, Zirkle teaches the catheter of claim 1, through a fifth lumen of the second plurality of lumens non-coaxial to the first lumen ([0074] the tubing 56 has four off-axis lumens, namely, a first lumen 57 for the cable 46 and optionally the SAS 48, a second lumen 58 for the ring electrode wire pairs 40, 41, a third lumen 59 for irrigation fluid, and a fourth lumen 60 for the support member 50 and the contraction wire 44) ([0063] A cable 46 for a position sensor assembly 48, including a plurality of single axis sensors (SAS) positioned on the distal assembly 17, passes through a fourth lumen 36), extended through the cross-over region so that the first plurality of wires are angled in relation to the longitudinal axis, and extended through the first lumen ([0099] the position sensor 48 includes a plurality of single axis sensors ("SAS") carried on the cable 46 that extends through the first lumen 57 of the distal assembly 17 (FIG. 9), where each SAS occupies a known or predetermined position on the helical form 22. The cable 46 extends proximally from the distal assembly 17 through the central lumen of the transitional section 20, the fourth lumen 36 of the intermediate section 14 (FIG. 6), the central lumen 18 of the catheter body 12, and into the control handle 16). Zirkle fails to teach a navigation sensor assembly comprising inductive coils positioned within the circular main region and comprising a first plurality of wires extending proximally from the inductive coils. However, Esguerra teaches a navigation sensor assembly comprising inductive coils positioned within the circular main region (Fig 6; the distal sensor coil 303A) and comprising a first plurality of wires extending proximally from the inductive coils ([0068] the distal sensor coil 303A is wound on the tubing 305, followed by soldering of the ends 306A, 307A to the spliced distal end of cable 308A which is then fed into the central lumen 310 via the aperture 312A formed by perforation with a preheated needle or in any similar method). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include a navigation sensor assembly comprising inductive coils positioned within the circular main region and comprising a first plurality of wires extending proximally from the inductive coils. Doing so allows for the coils to be within the catheter and connected with wires extending throughout the tubing.
Regarding claim 10, Zirkle teaches the catheter of claim 8, further comprising: so that each of the inductive coils is respectively encircled by one of the electrodes ([0099] Each SA sensor can be positioned with a known and equal spacing separating adjacent SA sensors. In the disclosed embodiment, the cable carries three SASs that are positioned under the distal-most AR electrode, the proximal-most AR electrode, and a mid AR electrode, for sensing location and/or position of the helical form. Where the distal assembly carries ten AR electrodes, the SASs are under electrodes AR). Zirkle fails to teach a navigation sensor assembly comprising inductive coils positioned within the circular main region. However, Esguerra teaches a navigation sensor assembly comprising inductive coils positioned within the circular main region (Fig 6; [0070] At a predetermined distance proximal of the mid sensor coil 303B, the proximal coil 303C is wound on the tubing 305 followed by soldering of ends 306C, 307C to spliced distal end of cable 308C which is fed into the central lumen 310 via aperture 312C to extend along with the cables 308A, 308B toward the mapping and localization system). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include a navigation sensor assembly comprising inductive coils positioned within the circular main region. Doing so allows for the sensors to be located within the tubing and would enhance the mapping accuracy.
Regarding claim 14, Zirkle teaches the catheter of claim 8, polymeric tube segments each comprising a length of about 7 millimeters, each positioned over the support member, ([0079] a nonconductive protective tubing 62 (e.g., a braided polyimide tubing) is provided in surrounding relationship with the support member 50 along its length), and each positioned centrally under a respective electrode ([0099] Each SA sensor can be positioned with a known and equal spacing separating adjacent SA sensors. In the disclosed embodiment, the cable carries three SASs that are positioned under the distal-most AR electrode, the proximal-most AR electrode, and a mid AR electrode, for sensing location and/or position of the helical form. Where the distal assembly carries ten AR electrodes, the SASs are under electrodes AR), but fails to fully teach polymeric tube segments each comprising a length of about 7 millimeters, each positioned over the support member, and each positioned centrally under a respective electrode to thereby provide preferential bending locations along the circular main region between the electrodes for at least a portion of the electrodes. However, Esguerra teaches polymeric tube segments each comprising a length of about 7 millimeters, each positioned over the support member ([0078] A protective tubing 416, for example, of polyimide, of sufficient length is placed over the tubing, coil, soldering joints and the most distal strain relief 720 degree winding for sensor 403A) ([0078] FIG. 31, the distal sensor 401A includes a conducting member 403A, e.g., a wire, that is wound repeatedly around a predetermined length of a nonconductive tubing 404 surrounding the support member 54 to form a sensing coil), and each positioned centrally under a respective electrode ([0081] The assembly 400 is sufficiently flexible to allow expansion or contraction of the mapping assembly 17 as needed or appropriate and the assembly 400 is ready for mounting of ring electrodes 26, as described below) ([0083] A series of ring electrodes 26 are mounted on the non-conductive cover 52 forming the generally circular main region 39 of the mapping assembly 17, as shown in FIG. 11) to thereby provide preferential bending locations along the circular main region between the electrodes for at least a portion of the electrodes ([0078] The distal section 406A and a proximal section 407A of the wire both extend proximally past the coil 403A and are each joined, e.g., by wrapping and/or soldering, to a respective exposed distal end of a wire encased in a respective dual side-by-side wire cable 408A at a joint region located just proximal of the coil 403A and the tubing 404A. In the joint region are strain relief adaptations, including the provision at each end of the wire a predetermined amount of slack S proximal in the joint region so as to minimize the risk of breakage and detachment at the soldering joint). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include a polymeric tube segments each comprising a length of about 7 millimeters, each positioned over the support member, and each positioned centrally under a respective electrode to thereby provide preferential bending locations along the circular main region between the electrodes for at least a portion of the electrodes. Doing so However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to include a polymeric tube segments each comprising a length of about 7 millimeters, since applicant has not disclosed that a length of about 7 millimeters solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a protective tubing of sufficient length. Further, it would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include each segment positioned over the support member, and each positioned centrally under a respective electrode to thereby provide preferential bending locations along the circular main region between the electrodes for at least a portion of the electrodes. Doing so minimizes the risk of damage to the electrodes when bending.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), in view of Mori (US 20170354463 A1).
Regarding claim 9, Zirkle teaches the catheter of claim 8, further comprising: a second plurality of wires extended proximally from the electrodes through a sixth lumen of the second plurality of lumens, extended through the cross-over region so that the second plurality of wires are angled in relation to the longitudinal axis ([0089] Each AR electrode is connected to a respective pair of wires 40, 41. In the disclosed embodiment, wire 40 of the wire pair is a copper wire, e.g. a number "40" copper wire. The other wire 41 of the wire pair is a constantan wire. The wires of each pair are electrically isolated from each other except at their distal ends where they are twisted together, fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode (FIG. 14). The wire pairs for each electrode extend from the control handle 16, through the central lumen 18 of the catheter body 12, the first lumen 33 of the intermediate section 14, the central lumen of the transitional section 20, and the second lumen 58 of the distal assembly 17). Zirkle fails to teach the wires extended through a seventh lumen of the first plurality of lumens non-coaxial to the sixth lumen. However, Mori teaches and extended through a seventh lumen of the first plurality of lumens non-coaxial to the sixth lumen ([0058] The fourth lumen 14 and the seventh lumen 17 shown in FIGS. 5 and 8 are operation wire insertion lumens, the first operation wire 41 is inserted into the fourth lumen 14, and the second operation wire 42 is inserted into the seventh lumen 17). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the wires extended through a seventh lumen of the first plurality of lumens non-coaxial to the sixth lumen. Doing so isolates the wires from being twisted or disconnected from the control.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), in view of Moisa (US 20200022653 A1).
Regarding claim 11, Zirkle teaches the catheter of claim 8, the electrodes each comprising an outer diameter of about 8 French ([0059] The outer diameter of the intermediate section 14, like that of the catheter body 12, is preferably no greater than about 8 French), a length of about 3 millimeters ([0082] FIGS. 11 and 12, the length is about 1 to 4 mm, in length the outer diameter (OD) is about 2.5 mm and the inner diameter (ID) is about 2.23 mm and the number of which embodiment is optimized for use in the renal anatomy. In another embodiment in FIG. 13, the length is about 3.0mm, the outer diameter is about 2.8mm, and the inner diameter is about 2.33 mm). Zirkle fails to teach an effective surface area of about 21 square millimeters. However, Moisa teaches and an effective surface area of about 21 square millimeters ([0108] if each electrode in this pair instead has approximately 20 mm.sup.2 of surface area, it may be expected that such pair of electrodes will sufficiently ablate intra-cardiac tissue to a depth of approximately 3.1 mm with 4 W of power and to a depth of approximately 4.4 mm with 8 W of power). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include an effective surface area of about 21 square millimeters. Doing so is an optimal surface area for the electrodes to preform ablation internally.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1), in view of McCaffery (US 20200129196 A1).
Regarding claim 13, Zirkle teaches the catheter of claim 8, but fails to teach the electrodes being configured to withstand 900 Volts between adjacent electrodes and configured to withstand 1800 Volts between alternate electrodes. However, McCaffery teaches the electrodes being configured to withstand 900 Volts between adjacent electrodes and configured to withstand 1800 Volts between alternate electrodes ([0136] In the case of electrical pulses, electrical signal generator 66 may be configured to generate and deliver pulses having an amplitude of about 500 volts (V) to about 5000 V (e.g., between about 1500V to about 3000 V)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the electrodes being configured to withstand 900 Volts between adjacent electrodes and configured to withstand 1800 Volts between alternate electrodes. Doing so is a voltage for the electrodes to preform ablation internally.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Funk (US 20190201668 A1) and Layman (US 20090254000 A1), further in view of Ku (US 20120116382 A1).
Regarding claim 20, Zirkle teaches the catheter of claim 1, further comprising: circumscribing a distal portion of the distal section approximate a distal end of the distal section, and inhibiting flexion of the distal portion ([0123] Atraumatic tip dome 136 is a polyurethane dome with a shaft that extends into the end of the irrigation lumen 130 at the end of the multi-lumen tube 125. The nitinol wire/shape memory support member 121 extends from at or near the distal end of the multi-lumen tube 125 into the shaft 145 for approximately 25 millimeters into the shaft. This provides stability to the distal assembly 117). Zirkle fails to teach further comprising: a tubular sleeve having a length measuring approximately 7 millimeters. However, Ku teaches further comprising: a tubular sleeve having a length measuring approximately 7 millimeters ([0120] FIG. 4B, the deployed helically-shaped support structure 22 optionally comprises a distal extension 26a distal to the helical portion that is relatively straight and may terminate with an atraumatic (e.g., rounded) tip 50. The distal extension 26a including the tip 50 may reduce the risk of injuring the blood vessel as the helical structure is expanding and/or as a delivery sheath is retracted, and may facilitate alignment of the helical structure in a vessel as it expands. In some embodiments, the distal extension 26a is generally straight (but flexible) and has a length of less than about 40 mm (e.g., between 2 mm and 10 mm)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include a tubular sleeve having a length measuring approximately 7 millimeters. Doing so is within optimal range for operation of the device.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Selkee (US 20180177547 A1).
Regarding claim 21, Zirkle teaches a catheter comprising: an elongated shaft extended along a longitudinal axis (Fig 1; shaft/catheter body 12 having a longitudinal axis); an intermediate section extended along the longitudinal axis distal from the elongated shaft (Fig 1; intermediate section 14 distal of the catheter body) and comprising an intermediate tube comprising a first plurality of lumens therethrough (Fig 6; The deflectable intermediate section 14 comprises a short section of tubing 15 having multiple lumens, each occupied by the various components extending through the intermediate section. In the illustrated embodiment of FIG. 6, there are six lumens); a distal section comprising a generally straight region extended along the longitudinal axis distal from the intermediate section (Fig 1; distal assembly 17), a circular ([0012] The configuration of the electrode-bearing portion of the distal assembly is generally curved or circular) main region distal from the generally straight region and generally orthogonal to the longitudinal axis, and a distal tube (Fig 9; is an end cross-sectional view of a section of the distal end portion), comprising a second plurality of lumens therethrough; a cross-over region between (Fig 5b; transitional section 20) a distal end of the intermediate tube and a proximal end of the distal tube ([0067] transitional section 20, as shown in FIGS. 1 and 7, having a tubing of suitable material, e.g., PEEK, with a central lumen that allows the various components extending therethrough to reorient before entering the distal assembly 17); and a support member (Fig 5b and 6; support member 50) ([0063] For the distal assembly 17, a shape-memory support member 50 surrounded by a nonconductive tubing 52, e.g., a polyimide tubing, extends proximally from the distal assembly 17 for a relatively short distance into a fifth lumen 37) affixed within in the intermediate section within a first lumen of the first plurality of lumens, extended through the cross-over region so that the support member is angled (Fig 5b; support member 50) in relation to the longitudinal axis, extended through the distal section within a second lumen (Fig 9; fourth lumen 60 for the support member 50) ([0074] the tubing 56 has four off-axis lumens, namely, a first lumen 57 for the cable 46 and optionally the SAS 48, a second lumen 58 for the ring electrode wire pairs 40, 41, a third lumen 59 for irrigation fluid, and a fourth lumen 60 for the support member 50 and the contraction wire 44) of the second plurality of lumens that is non-coaxial to the first lumen, and configured, within the circular main region, to be more flexible in a radial direction that is orthogonal to the longitudinal axis compared to flexibility in the direction of the longitudinal axis ([0061] The catheter body 12 is flexible, i.e., bendable, but substantially non-compressible along its length).
Zirkle fails to fully teach a support member configured, within the circular main region, to be more flexible in a radial direction that is orthogonal to the longitudinal axis compared to flexibility in the direction of the longitudinal axis.
However, Selkee teaches within the circular main region (distal end 25, distal assembly 17), to be more flexible in a radial direction that is orthogonal to the longitudinal axis compared to flexibility in the direction of the longitudinal axis ([0065] This tapered configuration biases the support member 50 to have increasing less resistance to coiling toward the distal end 25 such as when contracted by the contraction wire 24, while providing increasingly more resistance to oblique forces toward the distal end 25 such as when the distal assembly 17 contacts tissue surface head on. Thus, this varied cross-sectional shape allows the distal assembly 17 to exhibit improved contraction characteristics, including the distal portion 15 being able to contract and coil readily with minimal deformation of the elbow junction 21 and the elbow junction 21 being better able to withstand the load from an axial force that is applied when the distal assembly 17 comes into contact with target tissue. With this varied cross-sectional shape applied to the support member 50, the distal assembly 17 can be adjusted, upon actuation of the contraction wire 24, to assume a smaller loop size (see FIG. 2B), for example, where the distal portion 15 assumes a curvature that is generally equal to or even be lesser than the curvature of the distal section 21D). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include a support member configured, within the circular main region, to be more flexible in a radial direction that is orthogonal to the longitudinal axis compared to flexibility in the direction of the longitudinal axis. Doing so allows for a desired increase in flexibility of the distal end that would result in bending in a radial direction.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zirkle (EP 2664295 A1) in view of Selkee (US 20180177547 A1), further in view of Layman (US 20090254000 A1).
Regarding claim 22, Zirkle teaches the catheter of claim 21, but fails to fully teach the support member having a cross-sectional shape comprising a height and width such that the width is greater than the height in the distal section, the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis.
However, Layman teaches the support member having a cross-sectional shape comprising a height and width such that the width is greater than the height in the distal section ([0032] It can be appreciated that the size of width W relative to height H can vary depending upon the degree to which flattened region 30 is flattened. In some embodiments, width W may be about 1.1 times as large as height H or more. In still other embodiments, width W may be about 1.4 as large as height H or more. In still other embodiments, width W may be about 2 times as large as height H or more. In still other embodiments, width W may be about 3 times as large as height H or more), the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis (Fig 4). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zirkle to include the support member having a cross-sectional shape comprising a height and width such that the width is greater than the height in the distal section, the width being measured approximately parallel the longitudinal axis and the height being measured approximately orthogonal to the longitudinal axis. Doing so allows for increased flexibility of the distal end for preferred bending.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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