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 .
This action is in response to Applicant’s amendments filed 6/14/2026.
Claims 1, 5, 25-30, 31-36, and 39 are amended.
Claims 2 and 30 are cancelled.
Claims 1, 3-29, and 31-39 are being examined in this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29 and 31-38 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites the limitation “a mandrel” in line 3, and “a mandrel” in line 4. It is unclear if “a mandrel” in line 4 is a new separate mandrel, or the previously recited mandrel of line 3. Examiner interprets “a mandrel” of line 4 to be the same previously recited mandrel.
Claim 35 recites the limitation “elongate component“ in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “elongate component” to be the elongate member as recited in claim 29.
All remaining claims are rejected by virtue of their dependance on a rejected claim.
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.
Claim(s) 1, 3-21, 23, 26-29, and 31-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pursley (Pub. No. US 20050131387 A1) in view of Dando et al. (Pub. No. US 20150306805 A1, herein Dando).
Regarding Claim 1, Pursley discloses a catheter (Fig. 10), comprising:
an inner liner (41) defining a lumen (mandrel fitting within core member 41 as shown in Fig. 2) that extends along a longitudinal axis (core member 41 extending from distal end 46 to proximal end 47);
a plurality of wires (40), wherein the wires are coiled over the inner liner (41) about the longitudinal axis spaced apart from another in a first direction to form a first coil layer (Fig. 10, “The filament sources 42-45 are moved in a controlled manner relative to the core member 41 so that windings having either a constant or a variable pitch can be applied over a length of the core member 41 “- Paragraph [0043]).
Pursley does not expressly disclose wherein the wires are coiled about the longitudinal axis spaced apart from one another in a second direction, opposite the first direction, over the first coil layer to form a second coil layer over the first coil layer.
However, in a differing embodiment, Pursley teaches an inner liner (12) defining a lumen that extends along a longitudinal axis (Fig. 2, inner liner 12 allowing mandrel to pass through extending along a longitudinal axis), where a single wire (13) is coiled over the inner liner (Fig. 5) about the longitudinal axis spaced apart from one another in a second direction (Fig. 5, Paragraph [0038]), opposite the first direction (“the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16” – Paragraph [0038]), over the first coil layer to form a second coil layer over the first coil layer (second layer disposed over first layer in Fig. 5); and an outer sheath over the plurality of wires (23, Fig. 7).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing
date of the invention to modify the catheter disclosed by Pursley wherein the wires are coiled about the longitudinal axis spaced apart from one another in a second direction, opposite the first direction, over the first coil layer to form a second coil layer over the first coil layer; and an outer sheath over the plurality of wires as taught by the different embodiment so that a group of wires may span the length of the catheter (Paragraph [0044]).
Modified Pursley does not expressly disclose an elongate member extending at least partially along the longitudinal axis between the first coil layer and the second coil layer; an outer sheath over the plurality of wires and the elongate member; and
an outer sheath over the plurality of wires and the elongate member.
Dando teaches an elongate member (40, Figs. 12-13, through which a pull wire may extend, Paragraph [0035]) extending at least partially along the longitudinal axis (40 extending through outer layer in Fig. 13) between a first coil layer and a second coil layer (Fig. 13, “After the mesh layer 20 is in place, a minor lumen tube 40 may be added on top of the mesh layer 20 and passed through a second extrusion pass, creating the outer layer 22 over the mesh layer 20 and minor lumen 14. In the non-limiting embodiment shown in FIGS. 12 and 13, the minor lumen 14 may be part of the mesh layer 20. For example, the major lumen tube 24 may be covered with a first inner layer 18A during a first pass extrusion, and then the minor lumen tube 40 may be interwoven with (for example, being passed through the openings in the braid, weave, or mesh pattern) or covered in a layer of mesh 20 that is also interwoven with the layer of mesh 20 surrounding the first inner layer 18A” – Paragraph [0044]); and an outer sheath (22) over the elongate member (Fig. 13).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley to include an elongate member extending at least partially along the longitudinal axis between the first coil layer and the second coil layer and an outer sheath over the elongate member as taught by Dando so that an opening is created allowing a pull wire to enter to enable steering (Dando, Paragraph [0034]).
Regarding Claim 3, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires in the first coil layer have a helical arrangement having a first orientation (Pursley, filament winding 19 demonstrates a helical arrangement along a first pass 20 in Fig. 5), and wherein the wires in the second coil layer have a helical arrangement having a second orientation opposite the first orientation (Pursley, filament winding 19 demonstrates a helical arrangement with a second orientation along second pass 21 in Fig. 5).
Regarding Claim 4, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires each include a continuous end portion (Pursley, filament winding 19 transitioning directions at end 18 in Fig. 5) at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer (Pursley, “When the first pass 20 is completed, the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16. A second pass 21 of the filament winding 19 is then applied over the core member 12 (and over the first pass 20 of the filament winding 19) as the filament source 16 moves back toward the proximal end 14. As a result, the filament winding 19 is continuous from its initial anchor at the proximal end 14, to the end of the first pass 20 at the distal end 18 of the core member 12, and then back to the end of the second pass 21 at the proximal end 14.” – Paragraph [0038]).
Regarding Claim 5, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires each include a self-terminating end portion (Pursley, Filament winding 19 at end 18 in Fig. 5) at which the wire switches from the direction to the second direction and transitions from the first coil layer to the second coil layer (Pursley, “When the first pass 20 is completed, the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16. A second pass 21 of the filament winding 19 is then applied over the core member 12 (and over the first pass 20 of the filament winding 19) as the filament source 16 moves back toward the proximal end 14. As a result, the filament winding 19 is continuous from its initial anchor at the proximal end 14, to the end of the first pass 20 at the distal end 18 of the core member 12, and then back to the end of the second pass 21 at the proximal end 14.” – Paragraph [0038]).
Regarding Claim 6, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are the same (Pursley, “the filament winding 19 can have a constant pitch in which the turns of the winding 19 are evenly spaced over the entire length of the core member 12. When the first pass 20 is completed, the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16” – Paragraph [0038]).
Regarding Claim 7, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are the different (Pursley, “the filament winding 19 can have a constant pitch in which the turns of the winding 19 are evenly spaced over the entire length of the core member 12 … the second pass 21 of the winding 19 can be applied with a variable pitch” – Paragraph [0038]).
Regarding Claim 8, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and/or the second pitch varies along the longitudinal axis (Pursley, “the filament winding 19 can have a variable pitch in which the turns of the winding 19 become closer together near the distal end 18 … the second pass 21 of the winding 19 can be applied with a variable pitch similar to the first pass 20. ” – Paragraph [0038]).
Regarding Claim 9, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires are further (a) coiled about the longitudinal axis in the first direction to form a third coil layer over the second coil layer (Pursley, filament for first additional layer 32 is anchored in the proximal end and wound over first fibrous layer 31 to the distal end 34 in Fig. 8, Paragraph [0040]; fibrous layer 31 is formed using same process to form first layer 22, Paragraph [0040]) and (b) coiled about the longitudinal axis in the second direction over the third coil layer to form a fourth coil layer over the third coil layer (Pursley, second pass of filament in first fibrous layer 32, Fig. 8).
Regarding Claim 10, modified Pursley in view of Dando discloses the catheter of claim 9 wherein the wires each include (a) a first self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer (Pursley, first coil layer transitions to second coil layer forming a first self-terminating end portion at marker band 36 in Figs. 8-9).
Modified Pursley in view of Dando does not expressly disclose (b) a second self-terminating end portion at which the wire switches from the second direction to the first direction and transitions from the second coil layer to the third coil layer.
However, Pursley teaches where filament winding is continuous (Paragraph [0013], Paragraph [0015]) and where multiple fibrous reinforcement layers can be formed by repeating the filament forming process (Paragraph [0040]). Examiner interprets one may continuously wrap the filament towards the proximal end of the catheter before changing direction back towards the distal end, forming a second self-terminating end portion, and a third coil layer.
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the catheter disclosed by modified Pursley in view of Dando wherein (b) a second self-terminating end portion at which the wire switches from the second direction to the first direction and transitions from the second coil layer to the third coil layer as taught by Pursley so that multiple layers of reinforcement may be provided (Pursley, Paragraph [0040]).
Regarding Claim 11, modified Pursley in view of Dando discloses the catheter of claim 10 wherein the first self-terminating end portions are positioned at a distal end portion of the catheter (Pursley, end at marker band 36 in Fig. 8), and wherein the second self-terminating end portions are positioned at a proximal end portion of the catheter (Examiner interprets since Pursley discloses filament winding may be continuous, Paragraph [0013], second self-terminating end portions would be positioned at the right most portion of catheter 30 in Fig. 8).
Regarding Claim 12, modified Pursley in view of Dando discloses the catheter of claim 10 wherein the first self-terminating end portions are at a different position along the longitudinal axis relative to the second self-terminating end portions (Pursley, first self-terminating end portions at marker band 36 in Fig. 8, second self-terminating end portions would be formed at the fight most end of catheter, Paragraph [0040]).
Regarding Claim 13, modified Pursley in view of Dando discloses the catheter of claim 9 wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis (Pursley, “The distal end 34 of the first additional layer 32 can be an intermediate point along the catheter 30 between the proximal and distal ends” – Paragraph [0041], Fig. 9).
Regarding Claim 14, modified Pursley in view of Dando discloses the catheter of claim 9.
Modified Pursley in view of Dando does not expressly disclose wherein the third coil layer extends entirely over the second coil layer along the longitudinal axis.
However, Pursley teaches where the additional layers can be an intermediate point along the catheter between the proximal and distal ends (Paragraph [0041] and where multiple layers can be formed to impart different properties along a length of the catheter (Paragraph [0040]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the catheter disclosed by modified Pursley in view of Dando wherein the third coil layer extends entirely over the second coil layer along the longitudinal axis so that an entire length of the catheter can be reinforced (Pursley, Paragraph [0040]).
Regarding Claim 15, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the wires are first wires (Pursley, wires within first fibrous layer 31 in Fig. 8), and further comprising a plurality of second wires (Pursley, wires within first additional layer 32 in Fig. 8), wherein the second wires are (a) coiled about the longitudinal axis in the first direction to form a third coil layer over the second coil layer (Pursley, filament for first additional layer 32 is anchored in the proximal end and wound over first fibrous layer 31 to the distal end 34 in Fig. 8, Paragraph [0040]) and (b) coiled about the longitudinal axis in the second direction over the third coil layer to form a fourth coil layer over the third coil layer (Pursley, second pass of 32 in Fig. 8).
Regarding Claim 16, modified Pursley in view of Dando discloses the catheter of claim 15 wherein the first wires each include a first self-terminating end portion (Pursley, end at marker band 36 where wires transition from first pass to second pass in Fig. 8) at which the first wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer (Pursley, filament switches direction from first pass to second pass), and wherein the second wires each include a second self-terminating end portion at which the second wire switches from the first direction to the second direction and transitions from the third coil layer to the fourth coil layer (Pursley, fibrous reinforcement layers 31, 32, 33 can be formed by the same process used to form the first layer 22, Paragraph [0040], second self-terminating end at distal end 34 in Fig. 8).
Regarding Claim 17, modified Pursley in view of Dando discloses the catheter of claim 16 wherein the first self-terminating end portions are positioned at a same position along the longitudinal axis relative to the second self-terminating end portions (Pursley, “distal end 34 of the first additional layer 32 can be an intermediate point along the catheter 30 between the proximal and distal ends”- Paragraph [0041], examiner interprets that the second self-terminating end portions may be wound atop the first self-terminating end portions at marker band 36 in Fig. 8).
Regarding Claim 18, modified Pursley in view of Dando discloses the catheter of claim 16 wherein the first self-terminating end portions and the second self-terminating end portions are positioned at a distal end portion of the catheter (Pursley, “distal end 34 of the first additional layer 32 can be an intermediate point along the catheter 30 between the proximal and distal ends”- Paragraph [0041], examiner interprets that the second self-terminating end portions may be wound atop the first self-terminating end portions at marker band 36 in Fig. 8).
Regarding Claim 19, modified Pursley in view of Dando discloses the catheter of claim 16 wherein the first self-terminating end portions are positioned at a different position along the longitudinal axis relative to the second self-terminating end portions (Pursley, self-terminating end portions, end at marker band 36, and self-terminating end portions at 34, are positioned at different lengths of the catheter in Fig. 8).
Regarding Claim 20, modified Pursley in view of Dando discloses the catheter of claim 15 wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis (Pursley, first pass of 32 only partially covers second pass of 31 in Fig. 9).
Regarding Claim 21, modified Pursley in view of Dando discloses the catheter of claim 15 wherein the third coil layer extends entirely over the second coil layer along the longitudinal axis (Pursley, “distal end 34 of the first additional layer 32 can be an intermediate point along the catheter 30 between the proximal and distal ends” – Paragraph [0041], examiner interprets that the third coil layer may be extended to cover first layer 31 in Fig. 8).
Regarding Claim 23, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the plurality of wires comprises 4 wires (Pursley, “the group of filaments 40 can be supplied from a plurality of filament sources 42-45” – Paragraph [0043], Fig. 10).
Regarding Claim 26, modified Pursley in view of Dando discloses the catheter of claim 1 wherein the elongate member (Dando, 40) comprises a secondary lumen (Dando, minor lumen 14, Fig. 13).
Therefore, it would be obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley wherein the elongate member comprises a secondary lumen as taught by Dando so that the lumen may house a pull wire to allow steering (Dando, Paragraph [0034]).
Regarding Claim 27, modified Pursley in view of Dando discloses the catheter of claim 1, further comprising a secondary lumen (Dando, 14, Fig. 13) extending between the second coil layer and the outer sheath (Dando, 14 placed between mesh layer 20 and outer layer 22, Fig. 13, “a minor lumen tube 40 may be added on top of the mesh layer 20 and passed through a second extrusion pass, creating the outer layer 22 over the mesh layer 20 and minor lumen 14. In the non-limiting embodiment shown in FIGS. 12 and 13, the minor lumen 14 may be part of the mesh layer 20. For example, the major lumen tube 24 may be covered with a first inner layer 18A during a first pass extrusion, and then the minor lumen tube 40 may be interwoven with (for example, being passed through the openings in the braid, weave, or mesh pattern) or covered in a layer of mesh 20 that is also interwoven with the layer of mesh 20 surrounding the first inner layer 18A.” – Paragraph [0044]).
Therefore, it would be obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley, further comprising a secondary lumen extending between the second coil layer and the outer sheath as taught by Dando so that the lumen may house a pull wire to allow steering (Dando, Paragraph [0034]).
Regarding Claim 28, modified Pursley in view of Dando discloses the catheter of claim 1, further comprising a secondary lumen (Dando, 14, Fig. 13) extending between the first coil layer (Dando, 20) and the inner liner (Dando, 18B, Fig. 13, ““a minor lumen tube 40 may be added on top of the mesh layer 20 and passed through a second extrusion pass, creating the outer layer 22 over the mesh layer 20 and minor lumen 14. In the non-limiting embodiment shown in FIGS. 12 and 13, the minor lumen 14 may be part of the mesh layer 20. For example, the major lumen tube 24 may be covered with a first inner layer 18A during a first pass extrusion, and then the minor lumen tube 40 may be interwoven with (for example, being passed through the openings in the braid, weave, or mesh pattern) or covered in a layer of mesh 20 that is also interwoven with the layer of mesh 20 surrounding the first inner layer 18A.” – Paragraph [0044]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley further comprising a secondary lumen extending between the first coil layer and the inner liner as taught by Dando so that the lumen may house a pull wire to allow steering (Dando, Paragraph [0034]).
Regarding Claim 29, Pursley discloses a method of manufacturing a catheter (Paragraph [0035]), the method comprising:
positioning an inner liner (12) over a mandrel (11, Fig. 2);
coiling a wire (13) about a mandrel (11) over the inner liner in a first direction to form an inner coil layer over the inner liner (First pass 20, Paragraph [0013], Fig. 3);
coiling the wire about the mandrel in a second direction opposite the first direction to form an outer coil layer (second pass 21, Paragraph [0013]) over the inner coil layer (Fig. 5);
positioning an outer sheath (23) over the inner and outer coil layers (Fig. 7); and
coupling the outer sheath to the inner and outer coil layers (“the plastic coating 23 can be applied by laminating a plastic tube over an outer surface of the core member 12 and the fibrous layer 22” – Paragraph [0039], Fig.7).
Pursley does not expressly disclose coiling a plurality of wires about a mandrel over the inner liner in a first direction to form an inner coil layer over the inner liner; coiling the wires about the mandrel in a second direction opposite the first direction to form an outer coil layer over the inner coil layer.
However, in a different embodiment, Pursley teaches using a plurality of wires (40, Fig. 10) to form a catheter (Paragraph [0043]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of manufacturing a catheter disclosed by Pursley were coiling a plurality of wires about a mandrel over the inner liner in a first direction to form an inner coil layer over the inner liner; coiling the wires about the mandrel in a second direction opposite the first direction to form an outer coil layer over the inner coil layer as taught by the differing embodiment so that multiple filaments from a variety of filament sources may be used to manufacture a catheter (Pursley, Paragraph [0043]).
Modified Pursley does not expressly disclose positioning an elongate member over a portion of the inner coil layer, coiling the wires about the mandrel in a second direction opposite the first direction to form an outer coil layer over the inner coil layer and the elongate member; and positioning an outer sheath over the inner and outer coil layers and the elongate member.
Dando teaches positioning an elongate member (40, Fig. 13) over a portion of the inner coil layer (20, Paragraph [0044]); coiling the wires about the elongate member (“the minor lumen tube 40 may be interwoven with (for example, being passed through the openings in the braid, weave, or mesh pattern) or covered in a layer of mesh 20 that is also interwoven with the layer of mesh 20 surrounding the first inner layer 18A” – Paragraph [0044]); and positioning an outer sheath (22) over the inner and outer coil layers and the elongate member (Fig. 13).
Examiner interprets the elongate member disclosed by Dando would be placed within the inner coil layer and outer coil layers disclosed by Pursley.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of manufacturing a catheter disclosed by Pursley to position an elongate member over a portion of the inner coil layer; coiling the wires about the mandrel in a second direction opposite the first direction to form an outer coil layer over the inner coil layer and the elongate member and positioning an outer sheath over the inner and outer coil layers and the elongate member as taught by Dando so that there may be a lumen to for a pull wire to enter and allow the catheter to be steered (Dando, Paragraph [0034]).
Regarding Claim 31, modified Pursley in view of Dando discloses the method of claim 29 wherein coupling the outer sheath to the inner and outer coil layers and the elongate member (Dando, 40) includes fusing the outer sheath and the inner liner together (Pursley, “the plastic coating 23 can be applied by laminating a plastic tube over an outer surface of the core member 12 and the fibrous layer 22” – Paragraph [0039], Fig. 7, Examiner interprets that the plastic coating disclosed by Pursley may be placed over elongate member disclosed by Dando before lamination to secure the elongate member to the inner liner).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Pursley in view of Dando wherein coupling the outer sheath to the inner and outer coil layers and the elongate member includes fusing the outer sheath and the inner liner together over the elongate member taught by Dando so that the filaments are coated and secured to the inner liner (Pursley, Paragraph [0039]).
Regarding Claim 32, modified Pursley in view of Dando discloses the method of claim 29 wherein the wires in the inner coil layer have a helical arrangement (Pursley, filament winding 19 demonstrating helical arrangement in Fig. 4) having a first orientation (Pursley, first pass 20), and wherein the wires in the outer coil layer have a helical arrangement (Pursley, filament winding 19 in second direction demonstrating helical arrangement in Fig. 4) having a second orientation opposite the first orientation (Pursley, second pass 21 demonstrating second orientation in Fig. 5).
Regarding Claim 33, modified Pursley in view of Dando discloses the method of claim 29 wherein coiling the wires about the mandrel over the inner liner in the first direction to form the inner coil layer includes varying a pitch between the wires in the first direction (Pursley, “the filament winding 19 can have a variable pitch in which the turns of the winding 19 become closer together near the distal end 18 of the core member 12” – Paragraph [0038], Fig. 4).
Regarding Claim 34, modified Pursley in view of Dando discloses the method of claim 29 wherein coiling the wires about the mandrel over the inner liner in the second direction to form the outer coil layer includes varying a pitch between the wires in the second direction (Pursley, “the second pass 21 of the winding 19 can be applied with a variable pitch similar to the first pass 20.” – Paragraph [0038], Fig. 5).
Regarding Claim 35, modified Pursley in view of Dando discloses the method of claim 29 wherein coiling the wires about the mandrel in the second direction to form the outer coil layer (Pursley, second pass 21, Fig. 5) includes coiling the wires over the elongate component (Dando, 40) to secure the elongate component between the inner and outer coil layers (Examiner interprets that one would place the elongate member 40 disclosed by Dando before the second pass 21 of Pursley in order to secure the elongate members between the coil layers).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Pursley to include coiling the wires over the elongate component as taught by Dando in order to secure the elongate member between the inner and outer coil layers preventing movement when a pull wire is inserted in the elongate component (Dando, Paragraph [0034]).
Regarding Claim 36, modified Pursley in view of Dando discloses the method of claim 29 wherein the elongate member (Dando, 40) comprises a lumen (Dando, 14, Fig. 13).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Pursley wherein the elongate member comprises a lumen as taught by Dando so that a pull wire may be inserted to enable steering (Dando, Paragraph [0034]).
Regarding Claim 37, modified Pursley in view of Dando discloses the method of claim 29 wherein coiling the wires about the mandrel in the second direction includes forming a continuous end portion (Pursley, filament wrapping over itself at distal end 18 in Fig. 5) of each of the wires at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer (Pursley, “When the first pass 20 is completed, the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16. A second pass 21 of the filament winding 19 is then applied over the core member 12 (and over the first pass 20 of the filament winding 19) as the filament source 16 moves back toward the proximal end 14.” – Paragraph [0038]).
Regarding Claim 38, modified Pursley in view of Dando discloses the method of claim 29 wherein coiling the wires about the mandrel in the second direction includes forming a self-terminating end portion (Pursley, filament wrapping over itself at distal end 18 in Fig. 5) of each of the wires at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer (Pursley, “When the first pass 20 is completed, the filament source 16 reverses its direction of axial movement while the core member 12 continues to rotate relative to the filament source 16. A second pass 21 of the filament winding 19 is then applied over the core member 12 (and over the first pass 20 of the filament winding 19) as the filament source 16 moves back toward the proximal end 14.” – Paragraph [0038]).
Regarding Claim 39, Pursley discloses a catheter (10), comprising:
an inner liner (12) defining a lumen that extends along a longitudinal axis (mandrel 11 running through 12 between distal end 18 and proximal end 14);
a wire (13), wherein-
the wire is coiled about the longitudinal axis over the inner liner in a first direction (first pass 20, Paragraph [0038]) to form a first coil layer (Fig. 3),
the wire is coiled about the longitudinal axis in a second direction (second pass 21, Paragraph [0038]), opposite the first direction (Fig. 5), over the first coil layer to form a second coil layer over the first coil layer (Fig. 5, Paragraph [0038]), and
the wire includes a self-terminating end portion (where first pass 20 overlaps second pass 21 at distal end in Fig. 5) at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer (Paragraph [0038]),
Pursley does not expressly disclose a plurality of wires, wherein the wires are coiled about the longitudinal axis over the inner liner in a first direction to form a first coil layer, the wires are coiled about the longitudinal axis in a second direction, opposite the first direction, over the first coil layer to form a second coil layer over the first coil layer, and the wires each include a self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer.
However, in a differing embodiment, Pursley teaches using a plurality of wires (40) to wrap around a core member (41) in order to form a catheter (Paragraphs [0043]-[0044]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley to include a plurality of wires, wherein the wires are coiled about the longitudinal axis over the inner liner in a first direction to form a first coil layer, the wires are coiled about the longitudinal axis in a second direction, opposite the first direction, over the first coil layer to form a second coil layer over the first coil layer, and the wires each include a self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer as taught by the differing embodiment so that a plurality of wires may be used simultaneously (Pursley, Paragraph [0043]).
Modified Pursley does not expressly disclose an elongate member extending at least partially along the longitudinal axis between the first coil layer and the second coil layer; and
an outer sheath over the wires and the elongate member.
Dando teaches an elongate member (40) extending at least partially along the longitudinal axis between the first coil layer and the second coil layer (40 extending along length of 20 in Fig. 13, “After the mesh layer 20 is in place, a minor lumen tube 40 may be added on top of the mesh layer 20 and passed through a second extrusion pass, creating the outer layer 22 over the mesh layer 20 and minor lumen 14. In the non-limiting embodiment shown in FIGS. 12 and 13, the minor lumen 14 may be part of the mesh layer 20. For example, the major lumen tube 24 may be covered with a first inner layer 18A during a first pass extrusion, and then the minor lumen tube 40 may be interwoven with (for example, being passed through the openings in the braid, weave, or mesh pattern) or covered in a layer of mesh 20 that is also interwoven with the layer of mesh 20 surrounding the first inner layer 18A” – Paragraph [0044]); and
an outer sheath (22) over the wires and the elongate member (Fig. 13).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Pursley to include an elongate member extending at least partially along the longitudinal axis between the first coil layer and the second coil layer; and an outer sheath over the wires and the elongate member as taught by Dando so that there may be a lumen that allows a pull wire to enter to enable steering of the catheter (Dando, Paragraph [0034]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pursley in view of Dando further in view of Nita et al. (US 5951539 A, herein Nita).
Regarding Claim 22, modified Pursley in view of Dando discloses the catheter of claim 1.
Modified Pursley in view of Dando does not expressly disclose wherein the wires have a rectangular cross-sectional shape.
Nita teaches wherein the wires have a rectangular cross-sectional shape (206, Col. 12 Lines 6-18).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the catheter disclosed by modified Pursley in view of Dando wherein the wires have a rectangular cross-sectional shape as taught by Nita so that the wires may have a better strength-to-weight ratio (Nita, Col. 11 Lines 42-45).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pursley in view of Dando further in view of Boismier (Pub. No. US 20050137519 A1).
Regarding Claim 24, modified Pursley in view of Dando discloses the catheter of claim 1.
Modified Pursley in view of Dando does not expressly disclose wherein the plurality of wires comprises 12 wires.
Boismier teaches wherein the plurality of wires comprises 12 wires (“the filament aggregate 76 can include substantially more than the three illustrated filaments 70, 72 and 74. In some embodiments, as many as 16 filaments can be woven in a first direction … and as many as 16 filaments can be woven in a second direction” – Paragraph [0046]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the catheter disclosed by modified Pursley in view of Dando wherein the plurality of wires comprises 12 wires as taught by Boismier so that the wires may comprise different materials (Boismier, Paragraph [0041]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pursley in view of Dando further in view of Dolendo et al. (Pub. No. US 20220151647 A1, herein Dolendo).
Regarding Claim 25, modified Pursley in view of Dando discloses the catheter of claim 1.
Modified Pursley in view of Dando does not expressly disclose wherein the lumen has a diameter of 20 French or greater.
Dolendo teaches a lumen (121, Paragraph [0035]), wherein the lumen has a diameter of 20 French or greater (“the inner liner 232 can have a diameter D (FIG. 2) of greater than about 6 French, greater than about 10 French, greater than about 16 French, greater than about 20 French, greater than about 24 French, or greater. In some embodiments, the diameter D is about 8 French, about 16 French, about 20 French, or about 24 French.” – Paragraph [0035]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the catheter disclosed by modified Pursley in view of Dando wherein the lumen has a diameter of 20 French or greater as taught by Dolendo so that the catheter can be steered in difficult-to-reach regions of the anatomy (Dolendo, Paragraph [0041]).
Response to Arguments
Applicant’s arguments filed 6/14/2026 have been fully considered.
In regards to Applicant’s argument that:
“Claim 5 was objected to for an informality. Claim 5 has been amended to address the alleged informality. Accordingly, the objection to claim 5 should be withdrawn.”
This argument is persuasive and the objection for claim 5 has been withdrawn.
In regards to Applicant’s argument that:
“Claims 26, 27, and 32 were rejected under 35 U.S.C. § 112(b) as allegedly being indefinite. Without commenting on or conceding the merits of this rejection, claims 26, 27, and 32 have been amended to address the alleged indefiniteness. Accordingly, the Section 112(b) rejection of claims 26, 27, and 32 should be withdrawn.”
This argument is persuasive and the 35 U.S.C. § 112(b) rejection for claims 26, 27, and 32 are withdrawn. However, a new 35 U.S.C. § 112(b) rejection has been made for claims 29 and 31-39.
In regards to Applicant’s argument that:
“Claims 1-21, 23, and 29-39 were rejected under 35 U.S.C. § 103 over Pursley. Without commenting on or conceding the merits of the rejection of these claims, claims 2 and 30 have been canceled and independent claims 1, 29, and 39 have been amended to further clarify the claimed subject matter. Accordingly, the rejection of claims 2 and 30 is now moot.”
This argument is persuasive and the 35 U.S.C. § 103 for claims 1-21, 23, and 29-39 are withdrawn. However, upon further consideration, a new ground of rejection is made in view of Pursley and Dando.
In regards to Applicant’s argument that:
“Claims 26-28 were rejected under 35 U.S.C. § 103 over a combination of Pursley and Tanner. Claims 26-28 depend from independent claim 1. Without conceding that Tanner provides the teachings for which it was cited, Tanner nevertheless fails to cure the above-noted deficiencies of Pursley to support a Section 103 rejection of independent claim 1”
This argument is persuasive and the 35 U.S.C. § 103 rejection for claims for 26-28 are withdrawn. However, upon further consideration, a new ground of rejection is made in view of Pursley and Dando.
In regards to Applicant’s argument that:
“Claims 22, 24, and 25 were rejected under 35 U.S.C. § 103 over the combination of Pursley and Nita, Boismier, or Dolendo, respectively. Claims 22, 24, and 25 depend from independent claim 1. Pursley cannot support a Section 103 rejection of independent 1 for at least the reasons discussed above.”
This argument is persuasive and the 35 U.S.C. § 103 rejection for claims 22, 24, and 25 are withdrawn. However, upon further consideration, a new ground of rejection is made in view of Pursley and Dando.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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