DETAILED ACTION
This action is in response to applicant's amendments filed 03/03/26.
The examiner acknowledges the amendments to the claims.
Claims 1-7, 10-22 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species B (Figures 18-19) in the reply filed on 03/03/26 is acknowledged.
Claims 2-3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/26.
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.
Claims 1, 5-6, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Guala et al., hereinafter “Guala” (U.S. Pub. No. 2016/0045219) in view of Murphy (U.S. Pub. No. 2023/0191092).
Regarding claim 1, Guala discloses an apparatus for treating a total occlusion in a blood vessel ([0001]), comprising:
a self-orienting device (Figures 1-1A) comprising an elongate shaft 102, an inflatable orienting element (122A-B; [0060]) disposed on a distal portion of the elongate shaft, and a manifold 151/152 disposed at a proximal end of the elongate shaft;
wherein the elongate shaft comprises a working lumen 112 (within inner shaft component 110) extending from the manifold to a distal facing port 108 (Figure 1D) at a distal end of the elongate shaft;
wherein the elongate shaft comprises an inflation lumen 125 ([0060]) in fluid communication with the inflatable orienting element and the manifold (Id.);
wherein the inflatable orienting element comprises a first inflatable member 122A extending laterally from a central longitudinal axis of the elongate shaft in a first direction and a second inflatable member 122B extending laterally from the central longitudinal axis of the elongate shaft in a second direction different from the first direction.
However, Guala does not disclose in a proximal portion of the elongate shaft proximal of the inflatable orienting element, the inflation lumen has a first noncircular cross-sectional shape and the working lumen has a second noncircular cross-sectional shape.
In Figures 1-5, Murphy teaches a proximal portion 4 of an elongate shaft proximal of an inflatable orienting element 6 having an inflation lumen 9 ([0047]) having a first noncircular cross-sectional shape ([0025]) and a working lumen 8 having a second noncircular cross-sectional shape (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the cross-sectional shapes of the inflation lumen and the working lumen of Guala to be noncircular, as taught by Murphy, for functional advantages as readily known to those familiar with the art (Id.).
Furthermore, Guala does not disclose an outer diameter of the proximal portion of the elongate shaft is 0.045 inches or less, a cross-sectional area of the first noncircular cross-sectional shape is at least 0.00013 square inches, and a cross-sectional area of the second noncircular cross- sectional shape is at least 0.00056 square inches.
Murphy teaches in [0023], [0049] that an outer diameter of the proximal portion of the elongate shaft is 0.045 inches or less (since the shaft diameter can be between 2-3 French, which is 0.03-0.04 inches). It would have been obvious to one of ordinary skill before the effective filing date to modify the elongate shaft of Guala to have an outer diameter of the proximal portion be 0.045 inches or less, as taught by Murphy, as suitable for treatment of a particularly sized blood vessel (Guala; [0058]).
Although Murphy does not teach in [0049] a cross-sectional area of the first noncircular cross-sectional shape is at least 0.00013 square inches, and a cross-sectional area of the second noncircular cross- sectional shape is at least 0.00056 square inches, it would have been obvious to one of ordinary skill before the effective filing date to optimize the respective cross-sectional areas of the inflation lumen and the working lumen such that the elongate shaft has the appropriate pushability and trackability while facilitating movement of material through the lumens of catheter (Murphy; abstract and [0010]) and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, Guala as modified teaches the first noncircular cross-sectional shape 9 is crescent shaped (Murphy; Figures 4-5, [0025]).
Regarding claim 6, Guala as modified teaches the second noncircular cross-sectional shape 8 has a first maximum extent (Murphy, Figure 4; see width of oval shape) extending parallel to a major dimension of the first noncircular (crescent) cross-sectional shape 9 and a second maximum extent (see height of oval shape) oriented perpendicular to the first maximum extent, and the second maximum extent is less than the first maximum extent (Id.).
Regarding claim 10, Guala as modified teaches a re-entry device 134 (Guala, Figures 4 and 20) configured to be slidably advanced within the working lumen 112 ([0092]); wherein the elongate shaft is configured to direct the re-entry device toward a true lumen TL of the blood vessel at a position distal of the total occlusion O (Figure 20).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Guala (U.S. Pub. No. 2016/0045219) in view of Murphy (U.S. Pub. No. 2023/0191092), as applied to claim 1 above, and further in view of Stefanov (U.S. Pub. No. 2021/0145447).
Regarding claim 7, Guala as modified teaches the claimed invention, as discussed above, except for the first maximum extent of the second noncircular cross-sectional shape is greater than the major dimension of the first noncircular cross-sectional shape.
In Figures 5A-5F and [0072], Stefanov teaches a first noncircular cross-sectional shape of an inflation lumen 120 and a working lumen 140 with a second cross-sectional shape, wherein a first maximum extent (width) of the second cross-sectional shape is greater than a major (greater) dimension (width) of the first non-circular cross-sectional shape.
It would have been obvious to one of ordinary skill before the effective filing date to modify the first and second noncircular cross-sectional shapes of Guala as modified, such that the first maximum extent is greater than the major dimension as claimed, in order to maintain a smaller outer circumference of the elongate shaft (Stefanov; [0072]),
and therefore maintain a smaller profile of the apparatus to facilitate advancement through vasculature.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., hereinafter “Wang” (U.S. Pub. No. 2014/0277053) in view of Guala (U.S. Pub. No. 2016/0045219) and Efremkin (U.S. Pub. No. 2019/0142453).
Regarding claim 11, Wang discloses an apparatus for treating a total occlusion in a blood vessel ([0002]-[0003]), comprising:
a self-orienting device (Figures 1-2) comprising an elongate shaft 12, an inflatable orienting element 20 ([0027]) disposed on a distal portion of the elongate shaft, and a manifold 14 disposed at a proximal end of the elongate shaft;
wherein the elongate shaft comprises a working lumen 24 ([0028]; Figures 1A-2A) extending from the manifold to a distal facing port 26 at a distal end of the elongate shaft;
wherein the elongate shaft comprises an inflation lumen 22 ([0029]; Figures 1A-2A) in fluid communication with the inflatable orienting element and the manifold;
wherein the inflatable orienting element extends laterally from a central longitudinal axis of the elongate shaft in a first direction (see segment 43 in Figures 1A-2A) and extending laterally from the central longitudinal axis of the elongate shaft in a second direction (see segment 44; Id.) opposite the first direction;
wherein the elongate shaft comprises a distal tail (see distal segment 18 of shaft including port 28; Figures 1-2, 11) extending distally from the inflatable orienting element 20 to the distal end of the elongate shaft;
wherein the elongate shaft comprises an aperture 28 communicating with the working lumen ([0030]) and opening in a third direction different from the first direction and the second direction (28 extends in a direction that aligns with stiffening members 40, which is in a third direction different from the first direction and the second direction of inflatable segments 43, 44; Figures 1-2, 1A-2A, 11), wherein the aperture is disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end.
However, Wang does not disclose the inflatable orienting element comprises a first inflatable member extending laterally from the central longitudinal axis of the elongate shaft in the first direction and a second inflatable member extending laterally from the central longitudinal axis of the elongate shaft in the second direction opposite the first direction.
In the same field of art, namely an apparatus for treating a total occlusion in a blood vessel, Guala teaches in Figures 1-3 and [0060] that an alternative to a single cylindrical balloon (inflatable orienting element, such as 20 in Wang), dual lateral balloons 122A-B can be utilized for stabilization of the occlusion bypassing apparatus, wherein a first inflatable member 122A extends laterally from a central longitudinal axis of an elongate shaft 102 in a first direction and a second inflatable member 122B extends laterally from the central longitudinal axis of the elongate shaft in a second direction opposite the first direction.
It would have been obvious to one of ordinary skill before the effective filing date to modify the inflatable orienting element of Wang to have first and second inflatable members as claimed, as taught by Guala, since doing so would be substitution of one known inflatable orienting element for another, which would yield predictable results, namely stabilizing or anchoring the elongate shaft apparatus within a subintimal space of a vessel (Guala; [0059]). See MPEP 2143.
Furthermore, Wang does not disclose the elongate shaft comprises a plurality of first apertures communicating with the working lumen.
In the same field of endeavor, namely an apparatus for treating an occlusion in a blood vessel, in Figure 1, [0046]-[0047] Efremkin teaches an elongate shaft 50 having a distal tail 56 comprising a plurality of first apertures 54 communicating with a working lumen 52 in order to facilitate catching or collecting debris or allowing delivery of medication (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the single aperture in Wang such that the elongate shaft comprises a plurality of first apertures, as taught by Efremkin, in order to provide further functionality at the distal tail, such as collecting debris or discharging medication (Id.). It is noted that when the combination is made, the plurality of first apertures will open in the third direction different from the first direction and the second direction, wherein the plurality of first apertures is disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end.
Additionally, Wang does not disclose the distal tail is at least 15 millimeters long. In [0136] of the present application publication, it merely states that in some embodiments the distal tail may be at least 15 millimeters long, although can be at least 20-40 millimeters long. It would have been obvious to one of ordinary skill before the effective filing date to modify Wang as modified such that the distal tail may be at least 15 millimeters long to accommodate the plurality of first apertures, and since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. Pub. No. 2014/0277053) in view of Guala (U.S. Pub. No. 2016/0045219) and Efremkin (U.S. Pub. No. 2019/0142453), as applied to claim 11 above, and further in view of Kugler et al., hereinafter “Kugler” (U.S. Pub. No. 2014/0277068).
Regarding claims 12-13, Wang as modified teaches the claimed invention, as discussed above, including the elongate shaft comprises a plurality of second apertures communicating with the working lumen (Efremkin, Figure 1; for instance, every other port 54 can include the plurality of first apertures 54 which alternates with a plurality of second apertures 54) wherein the plurality of second apertures are disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end, and wherein the plurality of second apertures is longitudinally spaced apart from the plurality of first apertures (Id.). However, Wang as modified does not teach the plurality of second apertures opening in a fourth direction opposite the third direction.
In the same field of endeavor, namely an apparatus for treating an occlusion in a blood vessel, Kugler teaches in Figure 23 and [0098] apertures 226, 228 that extend in third and fourth directions, respectively, away from a first direction of a first inflatable member and second direction of a second inflatable member ([0081]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the plurality of first and second apertures such that they extend in third and fourth directions, respectively, as taught by Kugler, in order to allow access to the blood vessel lumen or intima of the blood vessel in different orientations ([0086], [0090]; Kugler).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. Pub. No. 2014/0277053) in view of Guala (U.S. Pub. No. 2016/0045219) and Efremkin (U.S. Pub. No. 2019/0142453), as applied to claim 11 above, and further in view of Murphy (U.S. Pub. No. 2023/0191092).
Regarding claim 14, Wang as modified teaches the claimed invention, as discussed above, except for in a proximal portion of the elongate shaft proximal of the inflatable orienting element, the inflation lumen has a first noncircular cross-sectional shape and the working lumen has a second noncircular cross-sectional shape; wherein an outer diameter of the proximal portion of the elongate shaft is 0.045 inches or less, a cross-sectional area of the first noncircular cross-sectional shape is at least 0.00013 square inches, and a cross-sectional area of the second noncircular cross- sectional shape is at least 0.00056 square inches.
In Figures 1-5, Murphy teaches a proximal portion 4 of an elongate shaft proximal of an inflatable orienting element 6 having an inflation lumen 9 ([0047]) having a first noncircular cross-sectional shape ([0025]) and a working lumen 8 having a second noncircular cross-sectional shape (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the cross-sectional shapes of the inflation lumen and the working lumen of Wang as modified to be noncircular, as taught by Murphy, for functional advantages as readily known to those familiar with the art (Id.).
Murphy further teaches in [0023], [0049] that an outer diameter of the proximal portion of the elongate shaft is 0.045 inches or less (since the shaft diameter can be between 2-3 French which is 0.03-0.04 inches). It would have been obvious to one of ordinary skill before the effective filing date to modify the elongate shaft of Wang as modified to have an outer diameter of the proximal portion be 0.045 inches or less, as taught by Murphy, as suitable for treatment of a particularly sized blood vessel.
Although Murphy does not teach in [0049] a cross-sectional area of the first noncircular cross-sectional shape is at least 0.00013 square inches, and a cross-sectional area of the second noncircular cross- sectional shape is at least 0.00056 square inches, It would have been obvious to one of ordinary skill before the effective filing date to optimize the respective cross-sectional areas of the inflation lumen and the working lumen such that the elongate shaft has the appropriate pushability and trackability while facilitating movement of material through the lumens of catheter (Murphy; abstract and [0010]) and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. Pub. No. 2014/0277053) in view of Guala (U.S. Pub. No. 2016/0045219), Efremkin (U.S. Pub. No. 2019/0142453), and Nicholson et al., hereinafter “Nicholson” (U.S. Pub. No. 2020/0315639).
Regarding claim 15, Wang discloses a method of treating a total occlusion in a blood vessel (Figures 8-12; [0057]-[0063]), comprising:
advancing a self-orienting device (Figures 1-2, 10) comprising an elongate shaft 12, an inflatable orienting element 20 ([0027]) disposed on a distal portion of the elongate shaft, and a manifold 14 disposed at a proximal end of the elongate shaft into a subintimal space (between 82 and 86) within a wall of the blood vessel adjacent the total occlusion 90;
wherein the elongate shaft comprises a working lumen 24 ([0028]; Figures 1A-2A) extending from the manifold to a distal facing port 26 at a distal end of the elongate shaft, and an inflation lumen 22 ([0029]; Figures 1A-2A) in fluid communication with the inflatable orienting element and the manifold;
wherein the inflatable orienting element extends laterally from a central longitudinal axis of the elongate shaft in a first direction (see segment 43 in Figures 1A-2A) and a second inflatable member extending laterally from the central longitudinal axis of the elongate shaft in a second direction (see segment 44; Id.) different from the first direction;
wherein the elongate shaft comprises a distal tail (see distal segment 18 of shaft including port 28; Figures 1-2, 11) extending distally from the inflatable orienting element 20 to the distal end of the elongate shaft;
wherein the elongate shaft comprises an aperture 28 communicating with the working lumen ([0030]) and opening in a third direction different from the first direction and the second direction (28 extends in a direction that aligns with stiffening members 40, which is in a third direction different from the first direction and the second direction of inflatable segments 43, 44; Figures 1-2, 1A-2A, 11), wherein the aperture is disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end;
positioning the inflatable orienting element 20 radially outward of the total occlusion within the subintimal space (Figure 10) such that the inflatable orienting element longitudinally overlaps the total occlusion and the distal tail extends distal of the total occlusion within the subintimal space (Id.);
inflating the inflatable orienting element 20 (Figures 11-12; [0059]) within the subintimal space such that the inflatable orienting element cooperates with the wall of the blood vessel to orient the aperture 28 toward a true lumen 88 of the blood vessel.
However, Wang does not disclose the inflatable orienting element comprises a first inflatable member extending laterally from the central longitudinal axis of the elongate shaft in the first direction and a second inflatable member extending laterally from the central longitudinal axis of the elongate shaft in the second direction different from the first direction.
In the same field of art, namely an apparatus for treating a total occlusion in a blood vessel, Guala teaches in Figures 1-3 and [0060] that an alternative to a single cylindrical balloon (inflatable orienting element, such as 20 in Wang), dual lateral balloons 122A-B can be utilized for stabilization of the occlusion bypassing apparatus, wherein a first inflatable member 122A extends laterally from a central longitudinal axis of an elongate shaft 102 in a first direction and a second inflatable member 122B extends laterally from the central longitudinal axis of the elongate shaft in a second direction different from the first direction.
It would have been obvious to one of ordinary skill before the effective filing date to modify the inflatable orienting element of Wang to have first and second inflatable members as claimed, as taught by Guala, since doing so would be substitution of one known inflatable orienting element for another, which would yield predictable results, namely stabilizing or anchoring the elongate shaft apparatus within a subintimal space of a vessel (Guala; [0059]). See MPEP 2143.
Furthermore, Wang does not disclose the elongate shaft comprises a plurality of first apertures communicating with the working lumen.
In the same field of endeavor, namely an apparatus for treating an occlusion in a blood vessel, in Figure 1, [0046]-[0047] Efremkin teaches an elongate shaft 50 having a distal tail 56 comprising a plurality of first apertures 54 communicating with a working lumen 52 in order to facilitate catching or collecting debris or allowing delivery of medication (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the single aperture in Wang such that the elongate shaft comprises a plurality of first apertures, as taught by Efremkin, in order to provide further functionality at the distal tail such as collecting debris or discharging medication (Id.). It is noted that when the combination is made, the plurality of first apertures will open in the third direction different from the first direction and the second direction, wherein the plurality of first apertures is disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end.
Additionally, Wang as modified does not disclose the distal tail is at least 15 millimeters long. In [0136] of the present application publication, it merely states that in some embodiments the distal tail may be at least 15 millimeters long, although can be at least 20-40 millimeters long. It would have been obvious to one of ordinary skill before the effective filing date to modify Wang as modified such that the distal tail may be at least 15 millimeters long to accommodate the plurality of first apertures, and since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Wang as modified also does not disclose aspirating blood from within the subintimal space through the working lumen, although Efremkin teaches that the plurality of first apertures 54 can be used for aspiration ([0042], [0046]).
In the same field of art, namely an apparatus for treating a total occlusion in a blood vessel, Nicholson teaches in [0101]-[0102], [0110] an elongate shaft having a plurality of first apertures (aspiration ports) for aspirating blood from a subintimal space through a working lumen in order to reduce the blood volume and/or stabilize the apparatus within the subintimal space to facilitate re-entry into the blood vessel lumen, and also to prevent hematoma.
It would have been obvious to one of ordinary skill before the effective filing date to modify Wang as modified with aspirating blood from within the subintimal space through the working lumen, as taught by Nicholson, to help stabilize the apparatus within the subintimal space and prevent hematoma (Id.).
Regarding claim 16, Wang as modified teaches advancing a re-entry device 2’ (Wang; Figure 11, [0060]) within the working lumen 24 and out one aperture 28 of the plurality of first apertures into the true lumen 88 of the blood vessel.
Regarding claim 17, Wang as modified teaches the re-entry device 2’ is disposed within the working lumen 24 (Id.), but not necessarily prior to advancing the self-orienting device into a subintimal space within a wall of the blood vessel adjacent the total occlusion. However, Wang teaches in [0060] in another embodiment that the re-entry device 2’ may be the guidewire, and therefore be disposed in the working lumen prior to advancement of the device in order to guide the self-orienting device within the wall of the blood vessel.
Regarding claim 18, Wang as modified teaches aspirating blood from within the subintimal space occurs while the re-entry device is disposed within the working lumen (Nicholson, [0101]; aspiration is accomplished while a reentry device punctures and reenters the lumen).
Regarding claim 19, Wang as modified teaches aspirating blood from within the subintimal space includes aspirating blood through the distal facing port (Nicholson teaches in Figure 12 and [0100]-[0101] that aspiration can be accomplished in a distal facing port 156) and the plurality of first apertures (dedicated aspiration ports, as taught in Nicholson and Efremkin, discussed above).
Regarding claim 20, Wang as modified teaches aspirating blood from within the subintimal space occurs while positioning the inflatable orienting element radially outward of the total occlusion within the subintimal space (Nicholson, [0101]; aspiration is accomplished while a reentry device punctures and reenters the lumen, as in Figures 11-12 of Wang).
Claim 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Guala (U.S. Pub. No. 2016/0045219) in view of Murphy (U.S. Pub. No. 2023/0191092), as applied to claim 1 above, and further in view of Efremkin (U.S. Pub. No. 2019/0142453).
Regarding claims 21-22, Guala as modified teaches the claimed invention, as discussed above, including the elongate shaft comprises a distal tail (distal portion of 102 and 126 in Guala) extending distally from the inflatable orienting element 122A-B to the distal end of the elongate shaft, except for a plurality of side apertures disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end, the plurality of side apertures each in communication with the working lumen, wherein the plurality of side apertures are longitudinally spaced apart from one another
In the same field of endeavor, namely an apparatus for treating an occlusion in a blood vessel, in Figure 1, [0046]-[0047] Efremkin teaches an elongate shaft 50 having a distal tail 56 comprising a plurality of side apertures 54 proximal of a distal end and communicating with a working lumen 52 and being longitudinally spaced apart. The side apertures facilitate catching or collecting debris or allowing delivery of medication (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Guala as modified such that the elongate shaft comprises a plurality of first apertures, as taught by Efremkin, in order to provide functionality at the distal end such as collecting debris or discharging medication (Id.). It is noted that when the combination is made, the plurality of first apertures will open in the third direction different from the first direction and the second direction, wherein the plurality of first apertures is disposed in the distal tail distal of the inflatable orienting element and proximal of the distal end.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious an apparatus for treating a total occlusion in a blood vessel including, inter alia, an elongate shaft, an inflatable orienting element disposed on a distal portion of the elongate shaft, wherein in a proximal portion of the elongate shaft comprises:
a proximal section wherein an inflation lumen has a first noncircular cross-sectional shape and a working lumen has a second noncircular cross-sectional shape, and
a distal section wherein the inflation lumen and the working lumen each have circular cross-sectional shapes, wherein a length of the proximal section is at least 50% of an overall length of the proximal portion of the elongate shaft. Although Murphy (U.S. Pub. No. 2023/0191092) teaches a proximal portion 4 of the elongate shaft having a proximal section with a first noncircular cross-sectional shape 9 and a second noncircular cross-sectional shape 8 (Figures 3-5), and a distal section wherein the lumens 8, 9 each have circular cross-sectional shapes (Figures 6-7), Murphy does not teach or render obvious a length of the proximal section is at least 50% of an overall length of the proximal portion of the elongate shaft.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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