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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/609,408 filed 12/13/2023.
Status of Claims
This Office Action is responsive to the claims filed on 03/30/2026. Claims 4-13, 16-18, and 20 have been amended. Claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 14, 15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hamm (US 20240108210) in view of Cottone (US 20190160259).
Regarding claim 1, Hamm teaches a intravascular imaging device (Paragraph [0012]; the present disclosure provides a novel imaging guidewire configured to function well as a guidewire platform for therapy delivery, and as an imaging modality for assessing vessel stenoses and morphology), comprising:
a catheter shaft (Paragraph [0057]; the imaging guide wire 100 includes a guidewire body 100, Figs. 1-2) including a hypotube region (Paragraph [0057]; the guidewire body 120 includes, in order from the proximal end to the distal end, a rigid hypotube section 130, a semi-rigid hypotube section, Fig. 2), an imaging window region (Paragraph [0057]; and a semi-flexible window section 140 with a hyper-flexible floppy tip attached to the window section 160, Fig. 2), and a distal end region having a guidewire lumen formed therein (Paragraph [0059]; The guidewire body 120 is shown as an elongated tubular shaft spanning from a proximal end (left-hand side) to a distal end (right-hand side) with a central lumen that spans from a proximal end to distal end along a longitudinal axis (Ox), Fig. 2);
wherein the hypotube region includes a slotted section (Paragraph [0061]; the slotted hypotube section 130, Fig. 2) having a plurality of slots formed therein (Paragraph [0069]-[0070]; slotted hypotube section 130 includes a predetermined pattern of laser-cut coils 132; Here, a varying pitch of a helical slot machined in the slotted hypotube creates different stiffnesses along the length of the slotted segment); and
an imaging core disposed within the catheter shaft (Paragraph [0052]; with an imaging core arranged inside the imaging guidewire 100).
Hamm does not explicitly teach the slotted section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone;
wherein the first zone has a constant flexural rigidity;
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof.
Cottone, however, teaches an intravascular imaging device (Paragraph [0008]; a guide catheter extension), comprising:
a catheter shaft (Paragraph [0080]; guide catheter extension devices, Fig. 1a) including a hypotube region (Paragraph [0080]; a distal tube frame 1005, Fig. 1a), and a distal end region having a guidewire lumen formed therein (Paragraph [0085]; a distal end 1013; Paragraph [0158]; the distal end 1013 of the tube frame 1005 may further include a catheter tip 1023… coupled to the distal end of the tube frame 5 such that the catheter tip 1023 is substantially coaxially with the longitudinal axis LA of the tube frame 1005 and the lumen 1008 therethrough);
wherein the hypotube region includes a slotted section (Paragraph [0085]; The tube frame 1005 has a plurality of cut patterns 1015, 1016) having a plurality of slots formed therein (Paragraph [0095]; the cut patterns of the tube frame 1005 can form a series or plurality of interrupted spiral cut patterns 15-18. FIGS. 2a-h. The various cut patterns can be distributed at any point along the length of the tube frame 1005);
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Figure A: Adapted from Cottone, Fig. 8a
wherein the slotted section includes a plurality of discrete zones (Paragraph [0014] and [0109]; The guide catheter extension may further include seven zones, Fig. 8a; Paragraph [0110]; The tube can be provided with fewer, 1, 2, 3, 4, 5 or 6, or more zones, 7, 8, 9, 10, 11, 12, 13, 14 or 15 (higher numbers are also possible) including a first zone (Paragraph [0108]-[0110]; enabling the segment of the tube shown in this embodiment to have a gradually increasing bending flexibility; portion of Zone 7, 8007; Fig. 8a-c; See above Fig. A, element A), a second zone disposed proximal of the first zone (Paragraph [0109]; Portion of zones 7, 6, and 5, Fig. 8a; See above Fig. A, element B), a third zone disposed proximal of the second zone (Paragraph [0109]; Portions of zone 5, Zone 4, and zone 3, Fig. 8a; See above Fig. A, element C), a fourth zone disposed proximal of the third zone (Paragraph [0109]; Portion of zone 3, 8003, Fig. 8a; See above Fig. A, element D), and a fifth zone disposed proximal of the fourth zone (Paragraph [0109]; Portions of zone 3, Zone 2, and zone 1, Fig. 8a; See above Fig. A, element E);
wherein the first zone has a constant flexural rigidity (Paragraph [0109]; Within each zone, all of the units of cutout segments may have an equal open surface area (i.e., the open surface area is the area enclosed by the contour of the segments in a contiguous manner) as well as an equal cut-pattern perimeter length, the length of a continuous line traced along the shape of the cutout segment; Paragraph [0118]; The change in flexibility across multiple different zones can be… constant);
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof (Paragraph [0116]; the width across any uncut portion, may be varied, i.e., the width may be reduced. This reduction in width will result in an increase in the open surface area 1004; Paragraph [0117]; flexibility of the tube frame 1005 may be controlled at any position along the tube frame 1005 by combining one or more zones at various positions along the length of the tube; Fig. A above shows the cut area changes through each zones B, C, and E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the slotted section of Hamm to include a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone; wherein the first zone has a constant flexural rigidity; wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof as taught by Cottone because the transitional flexibility improves the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen, which could otherwise occur with abrupt significant changes in stiffness across distal sections of the guide catheter extension (Cottone, Paragraph [0108]). Furthermore, by using different zone patterns along the shaft length, flexibility can be increased or decreased along the shaft length, as well as other characteristics of the tube, such as torque, flexibility, pushability, resistance to axial compression and stretch, maintaining lumen diameter and kink resistance (Paragraph [0119]).
Regarding claim 2, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm does not explicitly teach a pitch of the slots in one or more of the first zone and the fourth zone is constant.
Cottone, however, further teaches a pitch of the slots in one or more of the first zone and the fourth zone is constant (Paragraph [0111]; The spacing, dc, is equal within a single band and may be constant across the length of the tube in different zones; as d1, d2 and d3; d1=d2=d3, where the spacing is measured between the lines, Fig. 8b; Fig. 8a and A above shows the regions A and D are bands within a zone and have equal spacing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Hamm in view of Cottone such that a pitch of the slots in one or more of the first zone and the fourth zone is constant as further taught by Cottone because it would have been a known method of spacing cuts within a flexible tube that would have ensured the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen.
Regarding claim 3, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm does not explicitly teach a pitch of the slots in one or more of the second zone, third zone, and the fifth zone varies along the length thereof.
Cottone, however, further teaches a pitch of the slots in one or more of the second zone, third zone, and the fifth zone varies along the length thereof (Paragraph [0111]; the spacing between bands within a zone may be greater than or less than the spacing between the bands in two different zones, e.g., d1=d2=d3>d12=d23=d34 or d1=d2=d3<d12=d23=d34; Figs. 8a, 8b, and Fig. A above shows sections B, C, and E include bands of the zones and bands between zones which may be greater than or less than the spacing between the bands in two different zones as described in paragraph [0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Hamm in view of Cottone such that a pitch of the slots in one or more of the second zone, third zone, and the fifth zone varies along the length thereof as further taught by Cottone because it would have been a known method of spacing cuts within a flexible tube that would have ensured the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen.
Regarding claim 14, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm further teaches the catheter shaft includes a distal end zone disposed distal of the first zone, the distal end zone being free of slots (Paragraph [0069]; Here, the slotted hypotube section 130 seamlessly transitions into the window section 140; Paragraph [0071]; the pitch P varies in a direction of the proximal end to the distal end until the slotted hypotube section 130 is nearly as soft as the window section 140 to create a smooth stiffness transition between the two sections; Fig. 5a and 5b shows the slots end between the slotted section and the window).
Regarding claim 15, Hamm teaches an intravascular imaging device (Paragraph [0012]; the present disclosure provides a novel imaging guidewire configured to function well as a guidewire platform for therapy delivery, and as an imaging modality for assessing vessel stenoses and morphology), comprising:
a catheter shaft (Paragraph [0057]; the imaging guide wire 100 includes a guidewire body 100, Figs. 1-2) including a hypotube region (Paragraph [0057]; the guidewire body 120 includes, in order from the proximal end to the distal end, a rigid hypotube section 130, a semi-rigid hypotube section, Fig. 2) and an imaging window region (Paragraph [0057]; and a semi-flexible window section 140 with a hyper-flexible floppy tip attached to the window section 160, Fig. 2);
wherein the hypotube region includes a first section (Paragraph [0057]; a rigid hypotube section 130) and a second section (Paragraph [0057]; a semi-rigid hypotube section, Fig. 2);
wherein one or more of the first zone, the second zone, the third zone, the fourth zone, and the fifth zone (Paragraph [0061]; the slotted hypotube section 130, Fig. 2) have a plurality of slots formed therein (Paragraph [0069]-[0070]; slotted hypotube section 130 includes a predetermined pattern of laser-cut coils 132; Here, a varying pitch of a helical slot machined in the slotted hypotube creates different stiffnesses along the length of the slotted segment); and
an imaging core disposed within the catheter shaft (Paragraph [0052]; with an imaging core arranged inside the imaging guidewire 100).
Hamm does not explicitly teach the second section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone;
wherein the first zone has a constant flexural rigidity;
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof.
Cottone, however, teaches an intravascular imaging device (Paragraph [0008]; a guide catheter extension), comprising:
a catheter shaft (Paragraph [0080]; guide catheter extension devices, Fig. 1a) including a hypotube region (Paragraph [0080]; a distal tube frame 1005, Fig. 1a), and a distal end region having a guidewire lumen formed therein (Paragraph [0085]; a distal end 1013; Paragraph [0158]; the distal end 1013 of the tube frame 1005 may further include a catheter tip 1023… coupled to the distal end of the tube frame 5 such that the catheter tip 1023 is substantially coaxially with the longitudinal axis LA of the tube frame 1005 and the lumen 1008 therethrough);
wherein the hypotube region includes a slotted section (Paragraph [0085]; The tube frame 1005 has a plurality of cut patterns 1015, 1016) having a plurality of slots formed therein (Paragraph [0095]; the cut patterns of the tube frame 1005 can form a series or plurality of interrupted spiral cut patterns 15-18. FIGS. 2a-h. The various cut patterns can be distributed at any point along the length of the tube frame 1005);
wherein the slotted section includes a plurality of discrete zones (Paragraph [0014] and [0109]; The guide catheter extension may further include seven zones, Fig. 8a; Paragraph [0110]; The tube can be provided with fewer, 1, 2, 3, 4, 5 or 6, or more zones, 7, 8, 9, 10, 11, 12, 13, 14 or 15 (higher numbers are also possible) including a first zone (Paragraph [0108]-[0110]; enabling the segment of the tube shown in this embodiment to have a gradually increasing bending flexibility; portion of Zone 7, 8007; Fig. 8a-c; See above Fig. A, element A), a second zone disposed proximal of the first zone (Paragraph [0109]; Portion of zones 7, 6, and 5, Fig. 8a; See above Fig. A, element B), a third zone disposed proximal of the second zone (Paragraph [0109]; Portions of zone 5, Zone 4, and zone 3, Fig. 8a; See above Fig. A, element C), a fourth zone disposed proximal of the third zone (Paragraph [0109]; Portion of zone 3, 8003, Fig. 8a; See above Fig. A, element D), and a fifth zone disposed proximal of the fourth zone (Paragraph [0109]; Portions of zone 3, Zone 2, and zone 1, Fig. 8a; See above Fig. A, element E);
wherein the first zone has a constant flexural rigidity (Paragraph [0109]; Within each zone, all of the units of cutout segments may have an equal open surface area (i.e., the open surface area is the area enclosed by the contour of the segments in a contiguous manner) as well as an equal cut-pattern perimeter length, the length of a continuous line traced along the shape of the cutout segment; Paragraph [0118]; The change in flexibility across multiple different zones can be… constant);
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof (Paragraph [0116]; the width across any uncut portion, may be varied, i.e., the width may be reduced. This reduction in width will result in an increase in the open surface area 1004; Paragraph [0117]; flexibility of the tube frame 1005 may be controlled at any position along the tube frame 1005 by combining one or more zones at various positions along the length of the tube; Fig. A above shows the cut area changes through each zones B, C, and E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second section of Hamm to include a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone; wherein the first zone has a constant flexural rigidity; wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof as taught by Cottone because the transitional flexibility improves the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen, which could otherwise occur with abrupt significant changes in stiffness across distal sections of the guide catheter extension (Cottone, Paragraph [0108]). Furthermore, by using different zone patterns along the shaft length, flexibility can be increased or decreased along the shaft length, as well as other characteristics of the tube, such as torque, flexibility, pushability, resistance to axial compression and stretch, maintaining lumen diameter and kink resistance (Paragraph [0119]).
Regarding claim 19, together Hamm and Cottone teach all of the limitations of claim 15 as noted above.
Hamm further teaches the catheter shaft includes a distal end zone disposed distal of the first zone, the distal end zone being free of slots (Paragraph [0069]; Here, the slotted hypotube section 130 seamlessly transitions into the window section 140; Paragraph [0071]; the pitch P varies in a direction of the proximal end to the distal end until the slotted hypotube section 130 is nearly as soft as the window section 140 to create a smooth stiffness transition between the two sections; Fig. 5a and 5b shows the slots end between the slotted section and the window).
Regarding claim 20, Hamm teaches a method for imaging a blood vessel (Paragraph [0057]; the guidewire disclosed herein can be used during minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems; Paragraph [0012]; uses radiative energy to assess vessel lumen size and vessel morphology), the method comprising:
disposing an intravascular imaging device within the blood vessel (Paragraph [0050]; A custom guide catheter 125 designed to access coronary arteries is inserted into the vessel 750, and the distal tip of the catheter is seated in the ostium, the opening to the right or left coronary artery. Then, the guidewire 100 is inserted and advanced into the vessel of interest until the imaging plane is distal to the stenosis of interest), the intravascular imaging device comprising:
a catheter shaft (Paragraph [0057]; the imaging guide wire 100 includes a guidewire body 100, Figs. 1-2) including a hypotube region (Paragraph [0057]; the guidewire body 120 includes, in order from the proximal end to the distal end, a rigid hypotube section 130, a semi-rigid hypotube section, Fig. 2), an imaging window region (Paragraph [0057]; and a semi-flexible window section 140 with a hyper-flexible floppy tip attached to the window section 160, Fig. 2), and a distal end region having a guidewire lumen formed therein (Paragraph [0059]; The guidewire body 120 is shown as an elongated tubular shaft spanning from a proximal end (left-hand side) to a distal end (right-hand side) with a central lumen that spans from a proximal end to distal end along a longitudinal axis (Ox), Fig. 2),
wherein the hypotube region includes a slotted section (Paragraph [0061]; the slotted hypotube section 130, Fig. 2) having a plurality of slots formed therein (Paragraph [0069]-[0070]; slotted hypotube section 130 includes a predetermined pattern of laser-cut coils 132; Here, a varying pitch of a helical slot machined in the slotted hypotube creates different stiffnesses along the length of the slotted segment), and
an imaging core disposed within the catheter shaft (Paragraph [0052]; with an imaging core arranged inside the imaging guidewire 100); and
translating the imaging core relative to the catheter shaft (Paragraph [0062]; when the imaging core 200 is pulled back, the core hypotube 201 translates in a linear direction LD with respect to the guidewire body 120… the core hypotube 201 moves linearly with respect to the guidewire body 120 (i.e., the core hypotube 201 moves telescopically with respect to the outer hypotube), Fig. 3).
Hamm does not explicitly teach the slotted section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone;
wherein the first zone has a constant flexural rigidity;
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof.
Cottone, however, teaches an intravascular imaging device (Paragraph [0008]; a guide catheter extension), comprising:
a catheter shaft (Paragraph [0080]; guide catheter extension devices, Fig. 1a) including a hypotube region (Paragraph [0080]; a distal tube frame 1005, Fig. 1a), and a distal end region having a guidewire lumen formed therein (Paragraph [0085]; a distal end 1013; Paragraph [0158]; the distal end 1013 of the tube frame 1005 may further include a catheter tip 1023… coupled to the distal end of the tube frame 5 such that the catheter tip 1023 is substantially coaxially with the longitudinal axis LA of the tube frame 1005 and the lumen 1008 therethrough);
wherein the hypotube region includes a slotted section (Paragraph [0085]; The tube frame 1005 has a plurality of cut patterns 1015, 1016) having a plurality of slots formed therein (Paragraph [0095]; the cut patterns of the tube frame 1005 can form a series or plurality of interrupted spiral cut patterns 15-18. FIGS. 2a-h. The various cut patterns can be distributed at any point along the length of the tube frame 1005);
wherein the slotted section includes a plurality of discrete zones (Paragraph [0014] and [0109]; The guide catheter extension may further include seven zones, Fig. 8a; Paragraph [0110]; The tube can be provided with fewer, 1, 2, 3, 4, 5 or 6, or more zones, 7, 8, 9, 10, 11, 12, 13, 14 or 15 (higher numbers are also possible) including a first zone (Paragraph [0108]-[0110]; enabling the segment of the tube shown in this embodiment to have a gradually increasing bending flexibility; portion of Zone 7, 8007; Fig. 8a-c; See above Fig. A, element A), a second zone disposed proximal of the first zone (Paragraph [0109]; Portion of zones 7, 6, and 5, Fig. 8a; See above Fig. A, element B), a third zone disposed proximal of the second zone (Paragraph [0109]; Portions of zone 5, Zone 4, and zone 3, Fig. 8a; See above Fig. A, element C), a fourth zone disposed proximal of the third zone (Paragraph [0109]; Portion of zone 3, 8003, Fig. 8a; See above Fig. A, element D), and a fifth zone disposed proximal of the fourth zone (Paragraph [0109]; Portions of zone 3, Zone 2, and zone 1, Fig. 8a; See above Fig. A, element E);
wherein the first zone has a constant flexural rigidity (Paragraph [0109]; Within each zone, all of the units of cutout segments may have an equal open surface area (i.e., the open surface area is the area enclosed by the contour of the segments in a contiguous manner) as well as an equal cut-pattern perimeter length, the length of a continuous line traced along the shape of the cutout segment; Paragraph [0118]; The change in flexibility across multiple different zones can be… constant);
wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof (Paragraph [0116]; the width across any uncut portion, may be varied, i.e., the width may be reduced. This reduction in width will result in an increase in the open surface area 1004; Paragraph [0117]; flexibility of the tube frame 1005 may be controlled at any position along the tube frame 1005 by combining one or more zones at various positions along the length of the tube; Fig. A above shows the cut area changes through each zones B, C, and E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the slotted section of Hamm to include a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone; wherein the first zone has a constant flexural rigidity; wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof as taught by Cottone because the transitional flexibility improves the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen, which could otherwise occur with abrupt significant changes in stiffness across distal sections of the guide catheter extension (Cottone, Paragraph [0108]). Furthermore, by using different zone patterns along the shaft length, flexibility can be increased or decreased along the shaft length, as well as other characteristics of the tube, such as torque, flexibility, pushability, resistance to axial compression and stretch, maintaining lumen diameter and kink resistance (Paragraph [0119]).
Claims 4, 6, 8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hamm in view of Cottone as applied to claim 1 above, and further in view of Buck (US 20220331509).
Regarding claim 4, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the first zone has a length of 20-60 mm.
Buck, however, teaches a catheter shaft (Paragraph [0039]; The system 10 includes a thrombectomy catheter 12, Fig. 1) including a plurality of discrete zones (Paragraph [0099]; one example of an outer jacket segment stacking pattern for a progressive flexibility catheter of the type discussed in connection with FIG. 1, Fig. 7A) including a first zone (Paragraph [0099]; distal segment 120), wherein the first zone has a length of 20-60 mm (Paragraph [0099]; A distal segment 120 may have a length within the range of about 1-3 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone such that the first zone has a length of 20-60 mm as taught by Buck because it would have been a well-known and understood method of creating a flexible catheter with progressive flexibility (Paragraph [0099]) that further would have additionally functioned as a strain relief or anti buckling feature (Paragraph [0098]).
Regarding claim 6, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the second zone has a length of 20-60 mm.
Buck, however, teaches a catheter shaft (Paragraph [0039]; The system 10 includes a thrombectomy catheter 12, Fig. 1) including a plurality of discrete zones (Paragraph [0099]; one example of an outer jacket segment stacking pattern for a progressive flexibility catheter of the type discussed in connection with FIG. 1, Fig. 7A) including a second zone (Paragraph [0099]; adjacent proximal segment 122, Fig. 7A), wherein the second zone has a length of 20-60 mm (Paragraph [0099]; adjacent proximal segment 122 may have a length within the range of about 4-6 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone such that the second zone has a length of 20-60 mm as taught by Buck because it would have been a well-known and understood method of creating a flexible catheter with progressive flexibility (Paragraph [0099]) that further would have additionally functioned as a strain relief or anti buckling feature (Paragraph [0098]).
Regarding claim 8, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the third zone has a length of 50-150 mm.
Buck, however, teaches a catheter shaft (Paragraph [0039]; The system 10 includes a thrombectomy catheter 12, Fig. 1) including a plurality of discrete zones (Paragraph [0099]; one example of an outer jacket segment stacking pattern for a progressive flexibility catheter of the type discussed in connection with FIG. 1, Fig. 7A) including a third zone (Paragraph [0099]; adjacent proximal segment 124, Fig. 7A), wherein the third zone has a length of 50-150 mm (Paragraph [0099]; An adjacent proximal segment 124 may have a length within the range of about 4-6 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone such that the third zone has a length of 50-150 mm as taught by Buck because it would have been a well-known and understood method of creating a flexible catheter with progressive flexibility (Paragraph [0099]) that further would have additionally functioned as a strain relief or anti buckling feature (Paragraph [0098]).
Regarding claim 10, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the fourth zone has a length of 40-120 mm.
Buck, however, teaches a catheter shaft (Paragraph [0039]; The system 10 includes a thrombectomy catheter 12, Fig. 1) including a plurality of discrete zones (Paragraph [0099]; one example of an outer jacket segment stacking pattern for a progressive flexibility catheter of the type discussed in connection with FIG. 1, Fig. 7A) including a fourth zone (Paragraph [0099]; adjacent proximal segment 126, 128, and 130 Fig. 7A), wherein the fourth zone has a length of 40-120 mm (Paragraph [0099]; An adjacent proximal segments 126, 128, and 130 may have a length within the range of about 1-3 cm; segments 126, 128, and 130 have a range of 3-9 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone such that the fourth zone has a length of 40-120 mm as taught by Buck because it would have been a well-known and understood method of creating a flexible catheter with progressive flexibility (Paragraph [0099]) that further would have additionally functioned as a strain relief or anti buckling feature (Paragraph [0098]).
Regarding claim 12, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the fifth zone has a length of 10-50 mm.
Buck, however, teaches a catheter shaft (Paragraph [0039]; The system 10 includes a thrombectomy catheter 12, Fig. 1) including a plurality of discrete zones (Paragraph [0099]; one example of an outer jacket segment stacking pattern for a progressive flexibility catheter of the type discussed in connection with FIG. 1, Fig. 7A) including a fifth zone (Paragraph [0099]; adjacent proximal segment 132 Fig. 7A), wherein the fifth zone has a length of 10-50 mm (Paragraph [0099]; An adjacent proximal segment 132 may have a length within the range of about 1-3 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone such that the fifth zone has a length of 10-50 mm as taught by Buck because it would have been a well-known and understood method of creating a flexible catheter with progressive flexibility (Paragraph [0099]) that further would have additionally functioned as a strain relief or anti buckling feature (Paragraph [0098]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hamm in view of Cottone as applied to claim 1 above, and further in view of Voeller (US 20140052107).
Regarding claim 5, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone does not explicitly teach the first zone has a flexural rigidity of 20-40 N*mm2.
Voeller, however, teaches a intravascular device (Paragraph [0004]; tubular members for use in medical devices) that has a flexural rigidity of 20-40 N*mm2 (Paragraph [0043]; flexural rigidity of section 56 may also be essentially constant. For example, the flexural rigidity of section 56 may be in the range of about… 9*10-3 lbs*in2; 9*10-3 lbs*in2= 25 N*mm2 which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first zone of Hamm in view of Cottone to have had a flexural rigidity of 20-40 N*mm2 as taught by Voeller because it would have been a known method of fabricating an interventional device with desirable flexural characteristics (Paragraph [0032]).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hamm in view of Cottone as applied to claim 1 and 15 above, respectively, and further in view of Starksen (US 20140155783).
Regarding claim 7, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the second zone has a distal flexural rigidity adjacent to the first zone that is 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is 40-80 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a second zone has a distal flexural rigidity adjacent to the first zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1) that is 20-40 N*mm2 (Paragraph [0034]; a flexible elongate body with a low bending stiffness may have a flexural rigidity that is less than 50 N(mm2), e.g. about 20 N(mm2) to about 30 N(mm2), about 30 N(mm2) to about 40 N(mm2)) and a proximal flexural rigidity adjacent to the third zone (Paragraph [0032]; a stiff proximal portion 102, Fig. 1) that is 40-80 N*mm2 (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2), e.g. about 50 N(mm2) to about 150 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to the first zone that is 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is 40-80 N*mm2 as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Regarding claim 16, together Hamm and Cottone teach all of the limitations of claim 15 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the second zone has a distal flexural rigidity adjacent to the first zone that is 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is 40-80 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a second zone has a distal flexural rigidity adjacent to the first zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1) that is 20-40 N*mm2 (Paragraph [0034]; a flexible elongate body with a low bending stiffness may have a flexural rigidity that is less than 50 N(mm2), e.g. about 20 N(mm2) to about 30 N(mm2), about 30 N(mm2) to about 40 N(mm2)) and a proximal flexural rigidity adjacent to the third zone (Paragraph [0032]; a stiff proximal portion 102, Fig. 1) that is 40-80 N*mm2 (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2), e.g. about 50 N(mm2) to about 150 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to the first zone that is 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is 40-80 N*mm2 as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Claims 9, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hamm in view of Cottone as applied to claims 1 and 15 above, respectively, and further in view of Starksen (US 20140155783) and Seiss (US 20200155739).
Regarding claim 9, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the third zone has a distal flexural rigidity adjacent to second zone that is 40-80 N*mm2 and a proximal flexural rigidity adjacent to the fourth zone that is 1000-1500 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a third zone has a distal flexural rigidity adjacent to second zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1) that is 40-80 N*mm2 (Paragraph [0034]; a flexible elongate body with a low bending stiffness may have a flexural rigidity that is less than 50 N(mm2), e.g. about 40 N(mm2) to about 50 N(mm2)) and a proximal flexural rigidity adjacent to the fourth zone that is greater (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the third zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to second zone that is 40-80 N*mm2 and a proximal flexural rigidity that is greater as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Together Hamm, Cottone, and Starksen fail to explicitly teach proximal flexural rigidity adjacent to the fourth zone that is about 1000-1500 N*mm2.
Siess, however, teaches an intravascular device (Paragraph [0006]; the catheter of an intravascular blood pump) with a flexural rigidity of 1000-1500 N*mm2 (Paragraph [0006]; The stiffening structure has a minimum bending stiffness of about 0.00005 Nm2 to about 0.01 Nm2; 0.01 Nm2 is 10000 Nmm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the third zone of Hamm in view of Cottone and Starksen to have had a proximal flexural rigidity adjacent to the third zone that is 1000-1500 N*mm2 as taught by Siess because it would have been a known method of manufacturing an intravascular device with a stiffening structure prevents kinking while providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel (Paragraph [0007]).
Regarding claim 17, together Hamm and Cottone teach all of the limitations of claim 15 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the third zone has a distal flexural rigidity adjacent to second zone that is 40-80 N*mm2 and a proximal flexural rigidity adjacent to the fourth zone that is 1000-1500 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a third zone has a distal flexural rigidity adjacent to second zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1) that is about 40-80 N*mm2 (Paragraph [0034]; a flexible elongate body with a low bending stiffness may have a flexural rigidity that is less than 50 N(mm2), e.g. about 40 N(mm2) to about 50 N(mm2)) and a proximal flexural rigidity adjacent to the fourth zone that is greater (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the third zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to second zone that is 40-80 N*mm2 and a proximal flexural rigidity that is greater as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Together Hamm, Cottone, and Starksen fail to explicitly teach proximal flexural rigidity adjacent to the fourth zone that is 1000-1500 N*mm2.
Siess, however, teaches an intravascular device (Paragraph [0006]; the catheter of an intravascular blood pump) with a flexural rigidity of about 1000-1500 N*mm2 (Paragraph [0006]; The stiffening structure has a minimum bending stiffness of about 0.00005 Nm2 to about 0.01 Nm2; 0.01 Nm2 is 10000 Nmm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the third zone of Hamm in view of Cottone and Starksen to have had a proximal flexural rigidity adjacent to the fourth zone that is 1000-1500 N*mm2 as taught by Siess because it would have been a known method of manufacturing an intravascular device with a stiffening structure prevents kinking while providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel (Paragraph [0007]).
Regarding claim 13, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the fifth zone has a distal flexural rigidity adjacent to the fourth zone that is 1000-1500 N*mm2 and a proximal flexural rigidity that is 2000-3000 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a fifth zone has a distal flexural rigidity adjacent to the fourth zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1; (Paragraph [0034]; a flexible elongate body with a low bending stiffness) and a proximal flexural rigidity that is greater (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fifth zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to the fourth zone and a proximal flexural rigidity that is greater as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Together Hamm, Cottone, and Starksen do not explicitly teach the flexural rigidity of 1000-1500 N*mm2 and the flexural rigidity of 2000-3000 N*mm2.
Siess, however, teaches an intravascular device (Paragraph [0006]; the catheter of an intravascular blood pump) with a flexural rigidity of 1000-1500 N*mm2 and flexural rigidity of 2000-3000 N*mm2 (Paragraph [0006]; The stiffening structure has a minimum bending stiffness of about 0.00005 Nm2 to about 0.01 Nm2; 0.00005 Nm2 is 50 Nmm2 and 0.01 Nm2 is 10000 Nmm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fifth zone of Hamm in view of Cottone and Starksen to have had a distal flexural rigidity that is 1000-1500 N*mm2 and a proximal flexural rigidity of 2000-3000 N*mm2 as taught by Siess because it would have been a known method of manufacturing an intravascular device with a stiffening structure prevents kinking while providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel (Paragraph [0007]).
Regarding claim 18, together Hamm and Cottone teach all of the limitations of claim 15 as noted above.
Hamm further teaches a stiffness transition in the semi-rigid slotted hypotube section (Paragraph [0073]), but fails to explicitly teach the fifth zone has a distal flexural rigidity adjacent to fourth zone that is 1000-1500 N*mm2 and a proximal flexural rigidity that is 2000-3000 N*mm2.
Starksen, however, teaches a intravascular device (Paragraph [0003]; devices and methods for guide elements used to deliver one or more devices or components to a target site… one embodiment of a guide element is configured with variable stiffness, with one or more flexible portions and one or more stiff portions) wherein a fifth zone has a distal flexural rigidity adjacent to fourth zone (Paragraph [0032]; a tether 100 comprising a flexible distal portion 101, Fig. 1; (Paragraph [0034]; a flexible elongate body with a low bending stiffness) and a proximal flexural rigidity that is greater (Paragraph [0034]; a rigid elongate body may have a flexural rigidity of about 50 N(mm2) to about 600 N(mm2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fifth zone of Hamm in view of Cottone to have had a distal flexural rigidity adjacent to fourth zone and a proximal flexural rigidity that is greater as taught by Starksen because it would have been known method of manufacturing a guide element with a variable stiffness while further allowing the distal portion provide a desired amount of tension while the proximal portion remains rigid to resist buckling (Paragraph [0004] and [0029]).
Together Hamm, Cottone, and Starksen do not explicitly teach the flexural rigidity of 1000-1500 N*mm2 and the flexural rigidity of 2000-3000 N*mm2.
Siess, however, teaches an intravascular device (Paragraph [0006]; the catheter of an intravascular blood pump) with a flexural rigidity of 1000-1500 N*mm2 and flexural rigidity of 2000-3000 N*mm2 (Paragraph [0006]; The stiffening structure has a minimum bending stiffness of about 0.00005 Nm2 to about 0.01 Nm2; 0.00005 Nm2 is 50 Nmm2 and 0.01 Nm2 is 10000 Nmm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fifth zone of Hamm in view of Cottone and Starksen to have had a distal flexural rigidity that is 1000-1500 N*mm2 and a proximal flexural rigidity of 2000-3000 N*mm2 as taught by Siess because it would have been a known method of manufacturing an intravascular device with a stiffening structure prevents kinking while providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel (Paragraph [0007]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hamm in view of Cottone as applied to claim 1 above, and further in view of Siess (US 20200155739).
Regarding claim 11, together Hamm and Cottone teach all of the limitations of claim 1 as noted above.
Together Hamm and Cottone do not explicitly teach the fourth zone has a flexural rigidity of 1000-1500 N*mm2.
Siess, however, teaches an intravascular device (Paragraph [0006]; the catheter of an intravascular blood pump) with a flexural rigidity of 1000-1500 N*mm2 (Paragraph [0006]; The stiffening structure has a minimum bending stiffness of about 0.00005 Nm2 to about 0.01 Nm2; 0.01 Nm2 is 10000 Nmm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fourth zone of Hamm in view of Cottone to have had a proximal flexural rigidity that is 1000-1500 N*mm2 as taught by Siess because it would have been a known method of manufacturing an intravascular device with a stiffening structure prevents kinking while providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel (Paragraph [0007]).
Response to Arguments
Specification
Examiner acknowledges the amendments to the specification and withdraws all objections to the specification.
Claim Objections
Examiner acknowledges the amendments to the claims and withdraws all objections to the claims.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claims 4-13, 16-18, and 20 and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 103
Applicant's arguments filed regarding rejections of claims 1, 15, and 20 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues the reference of Cottone does not teach one or more zones having a flexural rigidity that varies along a length thereof. Examiner respectfully disagrees. While Cottone does not explicitly mention the flexural rigidity of the hypotube, the flexural rigidity is an inherent quality of the slotted tube which depends on the number and shape of slots, for example as evidenced in at least Voeller, paragraphs [0040] and [0048] (“structure of tubular member 20 may vary in a number of different ways so as to provide the desired flexural rigidity… tubular member 20 showing slots 30 formed therein and arranged in a pattern that may provide the desired flexural rigidity”; “For example, one sample part may be made with essentially "shallow" cuts (e.g., the beam height may be relatively high). This sample may represent a "stiff" sample tube or a tube with a relatively high flexural rigidity.”). For these reasons, the tube frame with the cut pattern described in at least Cottone Paragraph [0109] and Fig. 8a is considered to result in tube zones having differing flexural rigidity. Furthermore, groups of the zones as described in Cottone where the spacing between each zones changes is considered to read on the claimed second zone, third zone, and fifth zone respectively. The flexural rigidity of groups of zones would have vary across the length due to the change in spacing of the cuts. For these reasons, the groups of zones which different cut patterns described in Cottone is considered to read on the claimed limitations of a zone having a flexural rigidity that varies along a length thereof. Furthermore, while not explicitly relied on in the art, in paragraphs [0110] and [0111] Cottone describes the cut area of tube as being gradually decreasing, which further is understood to mean a changing cut pattern and thus a variable flexural rigidity. For these reasons, Cottone is considered to read on the claimed limitations. One of ordinary skill in the art would have been motivated to modify the hypotube of Hamm to include the variable cut sections of Cottone because the transitional flexibility improves the ability of the guide catheter extension to navigate tortuous anatomy without compromising or kinking the internal lumen as described in Cottone. For these reasons, the rejections of claims 1, 15, and 20, and all corresponding dependent claims, under 35 USC 103 are maintained.
All claim rejections under 35 USC 103 are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/17/26
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