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 .
Claim Status
Claims 1-20 are currently pending. Claims 14-20 are herein withdrawn from further consideration as being drawn to nonelected Group II in response to the election of Group I without traverse in the reply filed on March 4th, 2026 in response to the requirement for restriction mailed on January 5th, 2026. As such, Claims 1-13 are currently under consideration.
Claim Objections
Claim 1, 4-5, and 10 are objected to because of the following informalities:
Claim 1 line 1 states “cathether” should read –catheter--.
Claims 4 and 5 states “nitinoil” should read –nitinol--.
Claim 10 line 6 states “adjustbale” should read –adjustable--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spurchise et al. (U.S. Publication 2009/0270800).
Regarding claim 1, Spurchise discloses an aspiration catheter (Title; Figs. 4a-4c) comprising: an elongated, flexible tube 410 defining a lumen (lumen of Fig. 4b wherein the wire lumens 462 are placed) and extending from a proximal end (Fig. 4a end at which element 450 is located) to a distal end (end at which tip 420 is located); an adjustable tip 420 at the distal end; a first pull wire (see below illustrative diagram of Fig. 4b) protruding from the proximal end to create a first pull wire protrusion (¶0045 proximal ends of core wires are operably connected to control handle 450; Fig. 4A can see element 450 extending past catheter shaft 450 and thus protruding from the catheter shaft) and extending along the tube to the adjustable tip (Figs 5 and 6 show extension of core wires to adjustable tip), wherein the first pull wire is connected to a first side of the adjustable tip (see below illustrative diagram of Fig. 4b; pull wires arranged circumferentially and thus on different sides); and a second pull wire (see below illustrative diagram of Fig. 4b) protruding from the proximal end to create a second pull wire protrusion (¶0045 proximal ends of core wires are operably connected to control handle 450; Fig. 4A can see element 450 extending past catheter shaft 450 and thus protruding from the catheter shaft) and extending along the tube to the adjustable tip (Figs 5 and 6 show extension of core wires to adjustable tip), wherein the second pull wire is connected to a second side of the adjustable tip (see below illustrative diagram of Fig. 4b; pull wires arranged circumferentially and thus on different sides); wherein tension on the first pull wire causes the first side of the adjustable tip to recede toward the proximal end, and tension on the second pull wire causes the second side of the adjustable tip to recede toward the proximal end (¶0047 engagement device comprises push/pull rod; ¶0039 core wire to transform the tip by either pushing distally or pulling proximally on the material of tip; both first and second pull wires can be pulled proximally to recede the material of tip).
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Illustrative diagram of Fig. 4b of Spurchise.
Regarding claim 2, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses the tension on the first pull wire is from pulling the first pull wire protrusion, and the tension on the second pull wire is from pulling the second pull wire protrusion (¶0047 engagement device comprises push/pull rod; ¶0039 core wire to transform the tip by either pushing distally or pulling proximally on the material of tip).
Regarding claim 3, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses the adjustable tip can be adjusted through the pull wires to form an angled or beveled tip (Fig. 4A configuration 424b; ¶0046 practitioner may advance and retract core wires singly, in pairs, or multiples to move elastically deformable tip between orthogonal configuration and a variety of oblique configurations).
Regarding claim 7, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses at least one radiopaque marker on the adjustable tip (¶0039 stop 164 comprises a radiopaque marker composed of radiopaque material that may aid in the visualization of the distal end of aspiration catheter).
Regarding claim 8, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses comprising two or more radiopaque markers on the adjustable tip (¶0039 stop 164 comprises a radiopaque marker, each of wires has a stop and therefore each wire comprises a radiopaque marker at the tip).
Regarding claim 9, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses the aspiration catheter further comprising a third pull wire on a third side of the adjustable tip, and a fourth pull wire on a fourth side of the adjustable tip (see above illustrative diagram of Fig. 4a).
Regarding claim 10, Spurchise discloses the aspiration catheter of claim 9. Spurchise further discloses the third pull wire protrudes from the proximal end to create a third pull wire protrusion (¶0045 proximal ends of core wires are operably connected to control handle 450; Fig. 4A can see element 450 extending past catheter shaft 450 and thus protruding from the catheter shaft) and extends along the tube to the adjustable tip (Figs 5 and 6 show extension of core wires to adjustable tip), and the fourth pull wire protrudes from the proximal end to create a fourth pull wire protrusion (¶0045 proximal ends of core wires are operably connected to control handle 450; Fig. 4A can see element 450 extending past catheter shaft 450 and thus protruding from the catheter shaft) and extends along the tube to the adjustable tip (Figs 5 and 6 show extension of core wires to adjustable tip); wherein tension on the third pull wire from pulling the third pull wire protrusion causes the third side of the adjustable tip to recede toward the proximal end, and tension on the fourth pull wire from pulling the fourth pull wire protrusion causes the fourth side of the adjustable tip to recede toward the proximal end (¶0047 engagement device comprises push/pull rod; ¶0039 core wire to transform the tip by either pushing distally or pulling proximally on the material of tip; all pull wires can be pulled proximally to recede the material of tip).
Regarding claim 11, Spurchise discloses the aspiration catheter of claim 9. Spurchise further discloses first, second, third, and fourth radiopaque markers near the first, second, third, and fourth pull wires respectively (¶0039 stop 164 comprises a radiopaque marker, each of wires has a stop and therefore each wire comprises a corresponding radiopaque marker at the tip).
Regarding claim 12, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses the elongated, flexible tube being fabricated from a memory alloy (¶0035 superelastic alloys such as nitinol).
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.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spurchise et al. (U.S. Publication 2009/0270800) in view of Kawashima et al. (U.S. Publication 2020/0353217).
Regarding claims 4 and 5, Spurchise discloses the aspiration catheter of claim 1. Spurchise further discloses a first region (¶0035 proximal portion of shaft) of nitinol coil with a braid (115; ¶0035 braided or wound filaments may comprise metal wires off…nitinol) and a second region of the catheter having no braiding (¶0035 omitted in distal portion to increase flexibility of the distal portion of shaft) that is closer to the distal end of the catheter (¶0035 omitted in distal portion) for the purpose of allowing increased flexibility in the distal portion ¶0035.
Spurchise does not expressly disclose or suggest the second region being of nitinol coil with a braid, wherein the braid in the second region is less dense than the braid in the first region (Claim 4), or the second region being of nitinol coil with no braid (Claim 5).
However, Kawashima, in the same field of endeavor of catheters with braided reinforcement elements (Fig. 9), teaches a catheter (Fig. 9, Fig. 10) having a first braided region (see illustrative diagram of Fig. 10 below, Region 1) and second braided regions (see illustrative diagram of Fig 10 below, Regions 2a and 2b) closer to the distal end of the catheter (Fig. 9 shows regions in relation to distal tip 2) than the first region, wherein one of the second braided regions has a less dense braid than the first region (illustrative diagram region 2a) and the other second braided region has metal wires with no braids (illustrative diagram region 2b) in order to reduce the rigidity on the distal end side of the catheter (¶0108 rigidity on the more distal end side than the distal end joint part is reduced as compared with the rigidity of the more proximal end side) in a gradual manner (¶0110 gradually reduced) for the purpose of reducing the sudden rigidity difference and reduce kinking (¶0006 a rigidity difference between the most distal end portion and the linear body of the catheter is large…the distal end portion of the catheter may be kinked due to such a rigidity difference).
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Illustrative diagram of Fig. 10 of Kawashima.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nitinol coil braid of Spurchise to have had the regions positioned closer to the distal end of the catheter than the first region that include a less dense braid than the first region and no braid, as taught by Kawashima, for the purpose of reducing the rigidity on the distal end side of the catheter (¶0108 rigidity on the more distal end side than the distal end joint part is reduced as compared with the rigidity of the more proximal end side) in a gradual manner (¶0110 gradually reduced) for the purpose of reducing the sudden rigidity difference and reduce kinking (¶0006 a rigidity difference between the most distal end portion and the linear body of the catheter is large…the distal end portion of the catheter may be kinked due to such a rigidity difference).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spurchise et al. (U.S. Publication 2009/0270800).
Regarding claim 6, Spurchise discloses the aspiration catheter of claim 1. Spurchise does not expressly disclose the elongated flexible tube being at least 135 cm in length from the proximal end to the distal end.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the elongate flexible tube at least 135 cm in length in order to fit the particular application since this claimed dimension of 135 cm does not change the ability of elongate flexible tube to aspirate materials through its lumen. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Paragraph [0010] of applicant specification, the tube is at least 135 cm in length), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spurchise et al. (U.S. Publication 2009/0270800 in view of Miki et al. (U.S. Publication 2005/0240165).
Regarding claim 13, Spurchise disclose the aspiration catheter of claim 1. Spurchise does not expressly disclose the elongated, flexible tube including a hydrophilic coating on an outer surface thereof.
However, Miki, in the same field of endeavor of aspiration catheters, teaches providing an aspiration catheter with a hydrophilic coating on an outer surface (¶0035 outer diameter of tube constituting the main shaft increases, and thereby sliding friction of the aspiration catheter with the inner wall of the blood vessel increases with the aspiration catheter is inserted into the blood vessel…preferably applied with a hydrophilic coating to reduce sliding friction) for the purpose of reducing friction when the catheter is inserted into the patient (¶0035 inserted into tortuous blood vessels…reduce sliding friction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongated, flexible tube of Spurchise to have included a hydrophilic coating on an outer surface, as taught by Miki, for the purpose of reducing friction when the catheter is inserted into the patient (¶0035 inserted into tortuous blood vessels…reduce sliding friction).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rothe et al. (U.S. Patent No. 12,193,638) discloses a catheter device including pull wires for angling the distal tip.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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