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
The amendment submitted on July 2nd, 2026 has been entered. Claims 1-14, 16-18, and 20-22 are currently pending. Claims 14, 16-18, and 20 remain withdrawn from further consideration as being drawn to nonelected Group II in response to the election of Group I without traverse in the reply filed on March 4th, 2026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. Claims 15 and 19 have been newly cancelled. Claims 21 and 22 have been newly added. Claims 1, 2, 4-5, 10, and 16-17 have been amended. As such, claims 1-13 and 21-22 are currently pending and under consideration. All previously set forth claim objections have been overcome.
Response to Arguments
Applicant's arguments filed July 2nd, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Spurchise fails to disclose a first pull wire protrusion and a second pull wire protrusion that are external to the aspiration catheter and that Spurchise only discloses pull wires that are still entirely within the aspiration catheter, even if they do protrude from the catheter shaft, examiner does not find this argument persuasive in that Spurchise depicts control handle 450 in the same configuration as that of Fig. 1A 150 and states in ¶0045 that aspects of the aspiration catheter are the same configuration as that of Fig. 1A 150, Fig. 1A 150 details the pull wire 160 protruding past proximal end 112 of catheter shaft through connector fitting 130 within 162 and then external to 162 past element 152, this extension past the proximal end of the catheter 110 presents the portion of the wire protruding past the catheter, i.e. the pull wire protrusion being external to the catheter 110 as it extends past the exterior boundary of the catheter at the proximal end 112, each pull wire would comprise same protrusion manipulation by control handle 150 as depicted by Fig. 4A 450 similarity to Fig. 1A 150 and evidenced in the statement that aspiration catheter 400 has same aspects as 100. Furthermore ¶0041 describes the connection of push/pull know 154 to proximal end of core wire and its advancement and retracting of core wire in relation to lumen 162 and locking know 152 showing the extension of the proximal end 160 external to the end of 162 which is shown in Fig. 1A to extend external to 110 past element 130 and thus 160 is external to both the 162 lumen and 110 at its connection to 154 and when 154 retracts the core wire.
As such this argument is not found to be persuasive.
All further arguments are drawn to the above argument of Spurchise failing to disclose external protrusion of the pull wires and as such are addressed by the above comments.
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, and 22 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 410 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); and
wherein the first pull wire protrusion and the second pull wire protrusion are external to the aspiration catheter (Fig. 4A depicts control handle 450 in the same configuration as that of Fig. 1A 150, ¶0045 many aspects of the aspiration catheter 400 are the same as or similar to aspiration catheters 100…and will not be discussed further…Aspiration catheter 400 differs in the number and placement of core wires and core wire lumens. Fig. 1A 150 details the pull wire 160 protruding past proximal end 112 of catheter shaft through connector fitting 130 within 162 and then external to 162 past element 152, this extension past the proximal end of the catheter presents the portion of the wire protruding past the catheter, i.e. the pull wire protrusion being external to the catheter 110 as it extends past the exterior boundary of the catheter at the proximal end 112, each pull wire would comprise same protrusion manipulation by control handle 150 as depicted by Fig. 4A 450 similarity to Fig. 1A 150 and evidenced in the statement that aspiration catheter 400 has same aspects as 100).
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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).
Regarding claim 22, 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 410 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);
wherein tension applied on the first pull wire causes the adjustable tip to form a first beveled tip; wherein tension applied on the second pull wire causes the adjustable tip to form a second beveled tip (pulling tension applied to any of the individual pull wires would inherently result in the receding of that pull wire with regard to the other pull wires resulting in a bevel that is specific to the individual pull wires position in relation to the catheter, thus tension placed on a first pull wire would result in beveling in the first pull wire direction and tension on a second pull wire would result in a beveling in the second pull wire direction); and
wherein release of the tension on the first pull wire and the second pull wire causes the adjustable tip to form a non-beveled tip (¶0046 moved from an orthogonal configuration to oblique configuration when wires are manipulated, ¶0044 orthogonal position is its relaxed state thus pull wires are not in state of retract or expanded tension).
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 discloses 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).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spurchise et al. (U.S. Publication 2009/0270800) in view of Giles (U.S. Publication 2018/0008251).
Regarding claim 21, 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 410 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).
Spurchise further discloses the does not expressly disclose or suggest the elongated flexible tube having an outer diameter of from 0.066 inches to 0.092 inches, the flexible tube having a length of at least 115 cm.
However, Giles, in the same field of endeavor of aspiration catheters (¶0184 catheters, microcatheters, ¶0185 aspirations), discloses a device having an outer diameter between 1 French to 34 French (0.013 inches – 0.4462 inches), and a length between 10 and 500 cm depending on the desired or required application or use of the device (¶0184 diameter can vary…as desired or required…length can vary depending on the application or use).
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 device of Spurchise to have had outer diameter and length dimensions within the ranges suggested by Giles for the purpose of selecting an appropriate diameter and length based on the patient application site in which the device would be used.
Moreover, it would have been obvious to one of ordinary skill in the art to have modified Spurchise as suggested by Giles, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
While Spurchise in view of Giles do not expressly suggest the claimed ranges of “0.066 inches to 0.092 inches” and “at least 115 cm”, these ranges lie inside of the ranges disclosed by the prior art and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)), a prima facie case of obviousness exists for one of ordinary skill in the art to have modified the device to have been within the claimed ranges as they lie inside the ranges disclosed by the prior art. In the instant case, Spurchise in view of Giles would not operate differently within the claimed range. Furthermore, applicant places no criticality on the ranges claimed indicating simply that “the outer diameter of the tube may be, for example in the range of from about 0.066 inches to about 0.092 inches” (¶0028 of applicants specification) and “the tube has a length of about 115 cm” (¶0027 of applicant’s specification).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
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